Hysomide may be available in the countries listed below.
Ingredient matches for Hysomide
Scopolamine
Scopolamine is reported as an ingredient of Hysomide in the following countries:
- Bangladesh
International Drug Name Search
Thursday, October 27, 2016
Rodinac
Rodinac may be available in the countries listed below.
Ingredient matches for Rodinac
Diclofenac
Diclofenac potassium salt (a derivative of Diclofenac) is reported as an ingredient of Rodinac in the following countries:
- Argentina
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Thioridazin-neuraxpharm
Thioridazin-neuraxpharm may be available in the countries listed below.
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Thioridazine
Thioridazine hydrochloride (a derivative of Thioridazine) is reported as an ingredient of Thioridazin-neuraxpharm in the following countries:
- Germany
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Wednesday, October 26, 2016
Gentamicina IDI
Gentamicina IDI may be available in the countries listed below.
Ingredient matches for Gentamicina IDI
Gentamicin
Gentamicin sulfate (a derivative of Gentamicin) is reported as an ingredient of Gentamicina IDI in the following countries:
- Italy
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Tuesday, October 25, 2016
Anplag
Anplag may be available in the countries listed below.
Ingredient matches for Anplag
Sarpogrelate
Sarpogrelate hydrochloride (a derivative of Sarpogrelate) is reported as an ingredient of Anplag in the following countries:
- China
- Japan
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Monday, October 24, 2016
Koortslip SDG
Koortslip SDG may be available in the countries listed below.
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Acyclovir
Aciclovir is reported as an ingredient of Koortslip SDG in the following countries:
- Netherlands
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Monoethanolamine Oleate
In some countries, this medicine may only be approved for veterinary use.
Scheme
Rec.INN
ATC (Anatomical Therapeutic Chemical Classification)
C05BB01
CAS registry number (Chemical Abstracts Service)
0002272-11-9
Chemical Formula
C20-H41-N-O3
Molecular Weight
343
Therapeutic Categories
Sclerosing agent
Agent for local antivaricose therapy
Chemical Name
9-Octadecenoic acid (Z)-, compd. with 2-aminoethanol (1:1)
Foreign Names
- Monoethanolamini Oleas (Latin)
- Monoethanol aminoleat (German)
- Oléate de Monoéthanolamine (French)
- Oleato de monoetanolamina (Spanish)
Generic Name
- Ethanolamine Oleate (OS: USAN)
Brand Names
- Cophos B (Monoethanolamine Oleate and Cyanocobalamin (veterinary use))
Nature Vet, Australia - Ethamolin
Great Wealth, Taiwan; QOL, United States - Ethanolamine Oleate
Evans, Israel; IFET, Greece; UCB Pharma, United Kingdom - Oldamin
Fuji Yakuhin, Japan
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Glossary
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Click for further information on drug naming conventions and International Nonproprietary Names.
Clindamycin Proel
Clindamycin Proel may be available in the countries listed below.
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Clindamycin
Clindamycin dihydrogen phosphate (a derivative of Clindamycin) is reported as an ingredient of Clindamycin Proel in the following countries:
- Greece
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Roxiratio
Roxiratio may be available in the countries listed below.
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Roxithromycin
Roxithromycin is reported as an ingredient of Roxiratio in the following countries:
- Poland
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Sunday, October 23, 2016
Clonea
Clonea may be available in the countries listed below.
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Clotrimazole
Clotrimazole is reported as an ingredient of Clonea in the following countries:
- Australia
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Clomipramin-neuraxpharm
Clomipramin-neuraxpharm may be available in the countries listed below.
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Clomipramine
Clomipramine hydrochloride (a derivative of Clomipramine) is reported as an ingredient of Clomipramin-neuraxpharm in the following countries:
- Germany
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Ibuprofeno Genfar
Ibuprofeno Genfar may be available in the countries listed below.
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Ibuprofen
Ibuprofen is reported as an ingredient of Ibuprofeno Genfar in the following countries:
- Chile
- Colombia
- Ecuador
- Peru
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Saturday, October 22, 2016
Regurin 20mg tablets (Speciality European Pharma)
1. Name Of The Medicinal Product
Regurin 20mg tablets
2. Qualitative And Quantitative Composition
The active ingredient is trospium chloride. Each coated tablet contains 20 mg trospium chloride.
Excipients:
For excipients, see 6.1.
3. Pharmaceutical Form
Coated tablet
Brownish-yellow, glossy coated, biconvex tablets
4. Clinical Particulars
4.1 Therapeutic Indications
Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder (e.g. idiopathic or neurologic detrusor overactivity).
4.2 Posology And Method Of Administration
One coated tablet twice daily (equivalent to 40 mg of trospium chloride per day).
In patients with severe renal impairment (creatinine clearance between 10 and 30 ml/min.1.73 m2) the recommended dosage is one coated tablet per day or every second day (equivalent to 20mg of trospium chloride per day or every second day).
The coated table should be swallowe whole with a glass of water before meals on an empty stomach.
The need for continued treatment should be reassessed at regular intervals of 3-6 months.
Since no data are available, use in children under 12 years of age is contra-indicated.
4.3 Contraindications
Trospium chloride is contraindicated in patients with urinary retention, severe gastro-intestinal condition (including toxic megacolon), myasthenia gravis, narrow-angle glaucoma, and tachyarrhythmia.
Trospium chloride is also contraindicated in patients who have demonstrated hypersensitivity to the active substance or to any of the excipients.
4.4 Special Warnings And Precautions For Use
Trospium chloride should be used with caution by patients:
- with obstructive conditions of the gastrointestinal tract such as pyloric stenosis
- with obstruction of the urinary flow with the risk of formation of urinary retention
- with autonomic neuropathy
- with hiatus hernia associated with reflux oesophagitis
- in whom fast heart rates are undesirable e.g. those with hyperthyroidism, coronary artery disease and congestive heart failure.
As there are no data in patients with severe hepatic impairment, treatment of these patients with trospium chloride is not recommended. In patients with mild to moderate liver impairment caution should be exercised.
Trospium chloride is mainly eliminated by renal excretion. Marked elevations in the plasma levels have been observed in patients with severe renal impairment.
Therefore, in this population but also in patients with mild to moderate renal impairment caution should be exercised (see 4.2).
Before commencing therapy organic causes of urinary frequency, urgency, and urge incontinence, such as heart diseases, diseases of the kidneys, polydipsia, or infections, or tumours of urinary organs should be excluded.
Regurin contains lactose monohydrate, sucrose and wheat starch. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Patients with rare hereditary problems of fructose intolerance or sucrose-isomaltase insufficiency should not take this medicine.
Patients with wheat allergy (different from coeliac disease) should not take this medicine. Apart from that, trospium chloride is suitable for people with coeliac disease.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Pharmacodynamic interactions:
The following potential pharmacodynamic interactions may occur: Potentiation of the effect of drugs with anticholinergic action (such as amantadine, tricyclic antidepressants), enhancement of the tachycardic action of ß-sympathomimetics; decrease in efficacy of pro-kinetic agents (e.g. metoclopramide).
Since trospium chloride may influence gastro-intestinal motility and secretion, the possibility cannot be excluded that the absorption of other concurrently administered medicinal products may be altered.
Pharmacokinetic interactions:
An inhibition of the absorption of trospium chloride with drugs like guar, cholestyramine and colestipol cannot be excluded. Therefore the simultaneous administration of these drugs with trospium chloride is not recommended.
Metabolic interactions of trospium chloride have been investigated in vitro on cytochrome P450 enzymes involved in active substance metabolism (P450 1A2, 2A6, 2C9, 2C19, 2D6, 2E1, 3A4). No influence on their metabolic activities were observed. Since trospium chloride is metabolised only to a low extent and since ester hydrolysis is the only relevant metabolic pathway, no metabolic interactions are expected.
4.6 Pregnancy And Lactation
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). In rats, placental transfer and passage into the maternal milk of trospium chloride occurs.
For Regurin 20mg no clinical data on exposed pregnancies are available.
Caution should be exercised when prescribing to pregnant or breastfeeding women.
4.7 Effects On Ability To Drive And Use Machines
Principally, disorders of accommodation can lower the ability to actively participate in road traffic and to use machines.
However, examinations of parameters characterising the ability to participate in road traffic (visual orientation, general ability to react, reaction under stress, concentration and motor coordination) have not revealed any effects of trospium chloride.
4.8 Undesirable Effects
Anticholinergic effects such as dry mouth, dyspepsia and constipation may occur during treatment with trospium chloride.
Very common (>10%)
gastrointestinal system: dry mouth
Common (>1%)
gastrointestinal system: dyspepsia, constipation, abdominal pain, nausea
Uncommon (<1%)
gastrointestinal system: flatulence
Rare (<0.1%)
urinary system: micturition disorders (e.g. formation of residual urine)
cardiovascular system: tachycardia
vision disorders: disorders of accommodation (this applies in particular to patients who are hypometropic and whose vision has not been adequately corrected)
gastro-intestinal system: diarrhoea
respiratory system: dyspnoea
skin: rash
body as a whole: asthenia, chest pain
Very Rare (<0.01%)
urinary system: urinary retention
cardiovascular system: tachyarrhythmia
musculoskeletal system: myalgia, arthralgia
skin: angio-oedema
liver and biliary system: mild to moderate increase in serum transaminase levels
body as a whole: anaphylaxis
central nervous system: headache, dizziness
4.9 Overdose
After administration of a maximum single dose of 360 mg trospium chloride to healthy volunteers, dryness of the mouth, tachycardia and disorders of micturition were observed to an increased extent. No manifestations of severe overdose or intoxication in humans have been reported to date. Increased anticholinergic symptoms are to be expected as signs of intoxication.
In the case of intoxication the following measures should be taken:
- gastric lavage and reduction of absorption (e.g. activated charcoal)
- local administration of pilocarpine to glaucoma patients
- catheterisation in patients with urinary retention
- treatment with a parasympathomimetic agent (e.g. neostigmine) in the case of severe symptoms
- administration of beta blockers in the case of insufficient response, pronounced tachycardia and/or circulatory instability (e.g. initially 1 mg propranolol intravenously along with monitoring of ECG and blood pressure).
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Urinary Antispasmodic, ATC code: G04BD15
Trospium chloride is a quaternary derivative of nortropane and therefore belongs to the class of parasympatholytic or anticholinergic active drugs, as it competes concentration-dependently with acetylcholine, the body's endogenous transmitter at postsynaptic, parasympathic binding sites.
Trospium chloride binds with high affinity to muscarinic receptors of the so called M1-, M2- and M3- subtypes and demonstrates negligible affinity to nicotinic receptors.
Consequently, the anticholinercic effect of trospium chloride exerts a relaxing action on smooth muscle tissue and organ functions mediated by muscarinic receptors. Both in preclinical as well as in clinical experiments, trospium chloride diminishes the contractile tone of smooth muscle in the gastrointestinal and genito-urinary tract.
Furthermore, it can inhibit the secretion of bronchial mucus, saliva, sweat and the occular accommodation. No effects on the central nervous system have so far been observed.
In two specific safety studies in healthy volunteers trospium chloride has been proven not to affect cardiac repolarisation, but has been shown to have consistent and dose dependent heart rate accelerating effect.
A long term clinical trial with trospium chloride 20mg bid found an increase of QT> 60 ms in 1.5% (3/197) of included patients. The clinical relevance of these findings has not been established. Routine safety monitoring in two other placebo-controlled clinical trials of three months duration do not support such an influence of trospium chloride: In the first study an increase of QTcF>= 60 msec was seen in 4/258 (1.6%) in trospium-treated patients vs. 9/256 (3.5%)in placebo-treated patients. Corresponding figures in the second trial were 8/325 (2.5%) in trospium-treated patients vs. 8/325 (2.5%) in placebo-treated patients.
An increase in ECG heart rate of about 6 bpm was observed during two pivotal phase-III studies (IP631-018, IP631-022) in patients given the prolonged release formulation of trospium chloride (total number of patients exposed to drug substance N= 948, duration of trials = 9 months). No other significant ECG abnormality was found.
5.2 Pharmacokinetic Properties
After oral administration of trospium chloride maximum plasma levels are reached at 4-6 hours. Following a single dose of 20mg the maximum plasma level is about 4ng/ml. Within the tested interval, 20 to 60mg as a single dose, the plasma levels are proportional to the administered dose. The absolute bioavailability of a single oral dose of 20 mg of trospium chloride (1 coated tablet Regurin 20mg) is 9.6 ± 4.5% (mean value ± standard deviation). At steady state the intraindividual variability is 16%, the interindividual variability is 36%.
Simultaneous intake of food, especially high fat diets, reduces the bioavailability of trospium chloride. After a high fat meal mean Cmax and AUC are reduced to 15-20% of the values in the fasted state.
Trospium chloride exhibits diurnal variability in exposure with a decrease of both Cmax and AUC for evening relative to morning doses.
Most of the systemically available trospium chloride is excreted unchanged by the kidneys, though a small portion (10% of the renal excretion) appears in the urine as the spiroalcohol, a metabolite formed by ester hydrolysis. The terminal elimination half life is in the range of 10-20 hours. No accumulation occurs. The plasma protein binding is 50-80%.
Pharmacokinetic data in elderly patients suggests no major differences. There are also no gender differences.
In a study in patients with severe renal impairment (creatinine clearance 8-32 ml/min) mean AUC was 4-fold higher, Cmax was 2-fold higher and the mean half-life was prolonged 2-fold compared with healthy subjects.
Pharmacokinetic results of a study with mildly and moderately hepatically impaired patients do not suggest a need for dose adjustment in patients with hepatic impairment, and are consistent with the limited role of hepatic metabolism in the elimination of trospium chloride.
5.3 Preclinical Safety Data
Preclinical data reveal no special hazard to humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenicity, and toxicity to reproduction.
Placental transfer and passage of trospium chloride into the maternal milk occurs in rats.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Tablet core: Wheat starch
Microcrystalline cellulose
Lactose monohydrate
Povidone
Croscarmellose sodium
Stearic acid
Silica colloidal anhydrous
Talc
Tablet Coat: Sucrose
Carmellose sodium
Talc
Silica colloidal anhydrous
Calcium carbonate E170
Macrogol 8000
Titanium dioxide (E171)
Iron oxide hydrate yellow (E172)
Beeswax white
Carnauba wax
Note for diabetics: 1 coated tablet corresponds to 0.06g of carbohydrate (equivalent to 0.005 bread units).
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
5 years
6.4 Special Precautions For Storage
This medicinal product does not require any special storage conditions.
6.5 Nature And Contents Of Container
PVC foiled aluminium blister.
Pack sizes approved: 2, 20, 28, 30, 40, 50, 56, 60, 90, 100, 120, 150, 200, 500, 600, 1000, 1200, 2000.
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other Handling
No special requirements.
7. Marketing Authorisation Holder
MADAUS GmbH
51101 Cologne
Germany
Tel.: 0221/8998-0
Fax: 0221 / 8998-711
e-mail: info@madaus.de
8. Marketing Authorisation Number(S)
PL 25843/0002
9. Date Of First Authorisation/Renewal Of The Authorisation
24 July 2007
10. Date Of Revision Of The Text
10 June 2009
Ivermectina
Ivermectina may be available in the countries listed below.
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Ivermectin
Ivermectin is reported as an ingredient of Ivermectina in the following countries:
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Belcopan
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Scopolamine
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Gliben-CT
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Glibenclamide
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Epirubicine Panpharma
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Epirubicin
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Friday, October 21, 2016
Enat
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Tocopherol, α-
Tocopherol, α- acetate (a derivative of Tocopherol, α-) is reported as an ingredient of Enat in the following countries:
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Aristocal
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Calcium Carbonate
Calcium Carbonate is reported as an ingredient of Aristocal in the following countries:
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Tarivid
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Ofloxacin
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Ofloxacin hydrochloride (a derivative of Ofloxacin) is reported as an ingredient of Tarivid in the following countries:
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| SPC | Summary of Product Characteristics (UK) |
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Bisoprolol Apotex
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Bisoprolol
Bisoprolol fumarate (a derivative of Bisoprolol) is reported as an ingredient of Bisoprolol Apotex in the following countries:
- Belgium
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Adriblastina PFS
Adriblastina PFS may be available in the countries listed below.
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Doxorubicin
Doxorubicin hydrochloride (a derivative of Doxorubicin) is reported as an ingredient of Adriblastina PFS in the following countries:
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A. F.S. Tylan
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In some countries, this medicine may only be approved for veterinary use.
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Tylosin
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Thursday, October 20, 2016
Aciclovir-1A Pharma
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Acyclovir
Aciclovir is reported as an ingredient of Aciclovir-1A Pharma in the following countries:
- Austria
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Benzirin
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Benzydamine
Benzydamine hydrochloride (a derivative of Benzydamine) is reported as an ingredient of Benzirin in the following countries:
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Wednesday, October 19, 2016
EAC
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Aspirin
Acetylsalicylic Acid is reported as an ingredient of EAC in the following countries:
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Ascorbic Acid
Ascorbic Acid is reported as an ingredient of EAC in the following countries:
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Amlodipino Gelkern
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Amlodipine
Amlodipine besilate (a derivative of Amlodipine) is reported as an ingredient of Amlodipino Gelkern in the following countries:
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Eglonyl
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Sulpiride
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R & C
In the US, R & C (piperonyl butoxide/pyrethrins topical) is a member of the drug class topical anti-infectives and is used to treat Head Lice.
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- R & C Lice Treatment Kit
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Piperonyl Butoxide
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Pyrethrin I
Pyrethrin I is reported as an ingredient of R & C in the following countries:
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Tegaserod MK
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Tegaserod
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Abaglin
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Gabapentin
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Tramadol Asta Medica
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Tramadol
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- Spain
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Flugofenac
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Diclofenac
Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Flugofenac in the following countries:
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Monkasta
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Montelukast
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Fusid
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Furosemide
Furosemide is reported as an ingredient of Fusid in the following countries:
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Furosemide sodium (a derivative of Furosemide) is reported as an ingredient of Fusid in the following countries:
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Trilostane
In some countries, this medicine may only be approved for veterinary use.
Scheme
Prop.INN
ATC (Anatomical Therapeutic Chemical Classification)
H02CA01
CAS registry number (Chemical Abstracts Service)
0013647-35-3
Chemical Formula
C20-H27-N-O3
Molecular Weight
329
Therapeutic Categories
Inhibitor of 3β-hydroxysteroid dehydrogenase
Inhibitor of the adrenocortical corticosteroid synthesis
Chemical Name
Androst-2-ene-2-carbonitrile, 4,5-epoxy-3,17-dihydroxy-, (4α,5α,17ß)-
Foreign Names
- Trilostanum (Latin)
- Trilostan (German)
- Trilostane (French)
- Trilostano (Spanish)
Generic Names
- Trilostane (OS: DCF, USAN, BAN)
- Win 24540 (IS: Winthrop)
Brand Names
- Desopan
Mochida, Japan - Modrenal
Bioenvision, United Kingdom - Vetoryl (veterinary use)
Arnolds, Austria; Arnolds, United Kingdom; Arnolds, Netherlands; Arnolds Veterinary Products, Norway; Intervet, Italy; Janssen Animal Health, Belgium; Janssen Animal Health, Germany; Janssen Santé Animale, France; Orion, Finland; Orion, Sweden; Veterinaria, Switzerland
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Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Prop.INN | Proposed International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Click for further information on drug naming conventions and International Nonproprietary Names.
Fluzole
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Fluconazole
Fluconazole is reported as an ingredient of Fluzole in the following countries:
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Fensipros
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Clomifene
Clomifene citrate (a derivative of Clomifene) is reported as an ingredient of Fensipros in the following countries:
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Carboplatinum
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Carboplatin
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Terizin
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Cetirizine
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Calcio Carbonato EG
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Calcium Carbonate
Calcium Carbonate is reported as an ingredient of Calcio Carbonato EG in the following countries:
- Italy
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Saturday, October 15, 2016
Hy-Spa
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Scopolamine
Scopolamine butylbromide (a derivative of Scopolamine) is reported as an ingredient of Hy-Spa in the following countries:
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Conbriza
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Bazedoxifene
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Analfin
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Morphine
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Micotar
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Miconazole
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Lamotrigin Orion
Lamotrigin Orion may be available in the countries listed below.
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Lamotrigine
Lamotrigine is reported as an ingredient of Lamotrigin Orion in the following countries:
- Hungary
- Slovakia
International Drug Name Search
Friday, October 14, 2016
Exazen
Exazen may be available in the countries listed below.
Ingredient matches for Exazen
Azelaic Acid
Azelaic Acid is reported as an ingredient of Exazen in the following countries:
- Greece
International Drug Name Search
Coldin
Coldin may be available in the countries listed below.
Ingredient matches for Coldin
Carbocisteine
Carbocisteine is reported as an ingredient of Coldin in the following countries:
- Chile
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Cefociclin
Cefociclin may be available in the countries listed below.
Ingredient matches for Cefociclin
Cefoxitin
Cefoxitin sodium salt (a derivative of Cefoxitin) is reported as an ingredient of Cefociclin in the following countries:
- Italy
International Drug Name Search
Ramilife
Ramilife may be available in the countries listed below.
Ingredient matches for Ramilife
Ramipril
Ramipril is reported as an ingredient of Ramilife in the following countries:
- Czech Republic
International Drug Name Search
Thiamine Chloride
Thiamine Chloride may be available in the countries listed below.
Ingredient matches for Thiamine Chloride
Thiamine
Thiamine hydrochloride (a derivative of Thiamine) is reported as an ingredient of Thiamine Chloride in the following countries:
- Georgia
International Drug Name Search
Predinga
Predinga may be available in the countries listed below.
Ingredient matches for Predinga
Prednisolone
Prednisolone is reported as an ingredient of Predinga in the following countries:
- Sri Lanka
International Drug Name Search
Thursday, October 13, 2016
Acétylcystéine Biogaran
Acétylcystéine Biogaran may be available in the countries listed below.
Ingredient matches for Acétylcystéine Biogaran
Acetylcysteine
Acetylcysteine is reported as an ingredient of Acétylcystéine Biogaran in the following countries:
- France
International Drug Name Search
Amikacine Aguettant
Amikacine Aguettant may be available in the countries listed below.
Ingredient matches for Amikacine Aguettant
Amikacin
Amikacin sulfate (a derivative of Amikacin) is reported as an ingredient of Amikacine Aguettant in the following countries:
- France
International Drug Name Search
Paramidol
Paramidol may be available in the countries listed below.
Ingredient matches for Paramidol
Paracetamol
Paracetamol is reported as an ingredient of Paramidol in the following countries:
- Peru
- Romania
International Drug Name Search
Aténolol Qualimed
Aténolol Qualimed may be available in the countries listed below.
Ingredient matches for Aténolol Qualimed
Atenolol
Atenolol is reported as an ingredient of Aténolol Qualimed in the following countries:
- France
International Drug Name Search
Wednesday, October 12, 2016
Barriere
Barriere may be available in the countries listed below.
Ingredient matches for Barriere
Dimeticone
Dimeticone is reported as an ingredient of Barriere in the following countries:
- Canada
International Drug Name Search
Colospan
Colospan may be available in the countries listed below.
Ingredient matches for Colospan
Scopolamine
Scopolamine butylbromide (a derivative of Scopolamine) is reported as an ingredient of Colospan in the following countries:
- Ethiopia
International Drug Name Search
Tuesday, October 11, 2016
Chloortetra
Chloortetra may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Chloortetra
Chlortetracycline
Chlortetracycline hydrochloride (a derivative of Chlortetracycline) is reported as an ingredient of Chloortetra in the following countries:
- Netherlands
International Drug Name Search
Ascorbinezuur Ratiopharm
Ascorbinezuur Ratiopharm may be available in the countries listed below.
Ingredient matches for Ascorbinezuur Ratiopharm
Ascorbic Acid
Ascorbic Acid is reported as an ingredient of Ascorbinezuur Ratiopharm in the following countries:
- Netherlands
International Drug Name Search
Taxol
In the US, Taxol (paclitaxel systemic) is a member of the drug class mitotic inhibitors and is used to treat Breast Cancer, Breast Cancer - Adjuvant, Breast Cancer - Metastatic, Kaposi's Sarcoma, Non-Small Cell Lung Cancer, Ovarian Cancer and Wilms' Tumor.
US matches:
- Taxol
Ingredient matches for Taxol
Paclitaxel
Paclitaxel is reported as an ingredient of Taxol in the following countries:
- Algeria
- Argentina
- Australia
- Austria
- Belgium
- Bosnia & Herzegowina
- Brazil
- Bulgaria
- Canada
- Chad
- China
- Cote D'ivoire
- Czech Republic
- Estonia
- Finland
- France
- Gabon
- Georgia
- Germany
- Greece
- Guinea
- Hong Kong
- Hungary
- Iceland
- Indonesia
- Italy
- Japan
- Latvia
- Lithuania
- Luxembourg
- Mali
- Mauritius
- New Zealand
- Niger
- Oman
- Peru
- Philippines
- Poland
- Romania
- Russian Federation
- Senegal
- Serbia
- Singapore
- Slovakia
- Slovenia
- South Africa
- Spain
- Switzerland
- Taiwan
- Thailand
- Togo
- Tunisia
- Turkey
- United States
International Drug Name Search
Epirizole
Scheme
Prop.INN
CAS registry number (Chemical Abstracts Service)
0018694-40-1
Chemical Formula
C11-H14-N4-O2
Molecular Weight
234
Therapeutic Categories
Analgesic, antipyretic and anti-inflammatory agent
Non-steroidal anti-inflammatory drug, NSAID
Chemical Name
Pyrimidine, 4-methoxy-2-(5-methoxy-3-methyl-1H-pyrazol-1-yl)-6-methyl-
Foreign Names
- Epirizolum (Latin)
- Polihexanid (German)
- Epirizole (French)
- Epirizol (Spanish)
Generic Names
- Epirizole (OS: USAN, JAN)
- DA 398 (IS)
- Knoll 533 (IS: Knoll)
- Methopyrimazole (IS)
- Epirizole (PH: JP XV)
Brand Names
- Analock
Pfizer, Japan - Karmarte
Toho Droge, Japan - Mebron
Daiichi, Taiwan; Daiichi Sankyo, Japan - Mecoton
Shinlon, Taiwan - Meprokisal
Choseido Pharmaceutical, Japan - Neuriton D
Isei, Japan
International Drug Name Search
Glossary
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Prop.INN | Proposed International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Click for further information on drug naming conventions and International Nonproprietary Names.
Monday, October 10, 2016
Captin
Captin may be available in the countries listed below.
Ingredient matches for Captin
Paracetamol
Paracetamol is reported as an ingredient of Captin in the following countries:
- Germany
International Drug Name Search
Atenolan
Atenolan may be available in the countries listed below.
Ingredient matches for Atenolan
Atenolol
Atenolol is reported as an ingredient of Atenolan in the following countries:
- Austria
International Drug Name Search
Acido Acetilsalicilico Afom
Acido Acetilsalicilico Afom may be available in the countries listed below.
Ingredient matches for Acido Acetilsalicilico Afom
Aspirin
Acetylsalicylic Acid is reported as an ingredient of Acido Acetilsalicilico Afom in the following countries:
- Italy
International Drug Name Search
Ketoconazol Marfan
Ketoconazol Marfan may be available in the countries listed below.
Ingredient matches for Ketoconazol Marfan
Ketoconazole
Ketoconazole is reported as an ingredient of Ketoconazol Marfan in the following countries:
- Peru
International Drug Name Search
Minegyl
Minegyl may be available in the countries listed below.
Ingredient matches for Minegyl
Metronidazole
Metronidazole benzoate (a derivative of Metronidazole) is reported as an ingredient of Minegyl in the following countries:
- Brazil
International Drug Name Search
Fasoremin
Fasoremin may be available in the countries listed below.
Ingredient matches for Fasoremin
Sofalcone
Sofalcone is reported as an ingredient of Fasoremin in the following countries:
- Japan
International Drug Name Search
Sunday, October 9, 2016
Metamizol-1A Pharma
Metamizol-1A Pharma may be available in the countries listed below.
Ingredient matches for Metamizol-1A Pharma
Metamizole
Metamizole sodium monohydrate (a derivative of Metamizole) is reported as an ingredient of Metamizol-1A Pharma in the following countries:
- Germany
International Drug Name Search
Gabapentin Sandoz
Gabapentin Sandoz may be available in the countries listed below.
Ingredient matches for Gabapentin Sandoz
Gabapentin
Gabapentin is reported as an ingredient of Gabapentin Sandoz in the following countries:
- Czech Republic
- Denmark
- Germany
- Italy
- Sweden
- Switzerland
International Drug Name Search
Roumis
Roumis may be available in the countries listed below.
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Mecobalamin
Mecobalamin is reported as an ingredient of Roumis in the following countries:
- Japan
International Drug Name Search
Alzim
Alzim may be available in the countries listed below.
Ingredient matches for Alzim
Donepezil
Donepezil hydrochloride (a derivative of Donepezil) is reported as an ingredient of Alzim in the following countries:
- Indonesia
International Drug Name Search
Saturday, October 8, 2016
Mikozal
Mikozal may be available in the countries listed below.
Ingredient matches for Mikozal
Miconazole
Miconazole nitrate (a derivative of Miconazole) is reported as an ingredient of Mikozal in the following countries:
- Oman
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Friday, October 7, 2016
Lotemax
In the US, Lotemax (loteprednol ophthalmic) is a member of the drug class ophthalmic steroids and is used to treat Conjunctivitis, Cyclitis, Iritis, Keratitis, Postoperative Ocular Inflammation, Rosacea and Seasonal Allergic Conjunctivitis.
US matches:
- Lotemax Drops
- Lotemax
UK matches:
- Lotemax 0.5% Eye Drops, Suspension (SPC)
Ingredient matches for Lotemax
Loteprednol
Loteprednol etabonate (a derivative of Loteprednol) is reported as an ingredient of Lotemax in the following countries:
- Argentina
- Austria
- Estonia
- Greece
- Hong Kong
- Italy
- Latvia
- Lithuania
- Singapore
- Slovenia
- United Kingdom
- United States
International Drug Name Search
Glossary
| SPC | Summary of Product Characteristics (UK) |
Click for further information on drug naming conventions and International Nonproprietary Names.
Ursofalk Suspension (Dr. Falk Pharma UK Ltd)
1. Name Of The Medicinal Product
Ursofalk 250mg/5ml Suspension
2. Qualitative And Quantitative Composition
5ml (= 1 measuring spoon) of Ursofalk Suspension contains 250mg of ursodeoxycholic acid as the active ingredient.
3. Pharmaceutical Form
Suspension for oral administration.
4. Clinical Particulars
4.1 Therapeutic Indications
Ursofalk 250mg/5ml Suspension is indicated in the treatment of primary biliary cirrhosis (PBC) and for the dissolution of radiolucent gallstones in patients with a functioning gall bladder
4.2 Posology And Method Of Administration
There are no age restrictions on the use of Ursofalk 250mg/5ml suspension. The following daily dose is recommended for the various indications:
For the treatment of primary biliary cirrhosis (PBC)
The daily dose depends on body weight, and is approximately 14 ± 2 mg ursodeoxycholic acid per kg of body weight.
For the first 3 months of treatment, Ursofalk 250mg/5ml suspension should be taken divided over the day. When the liver function parameters improve, the daily dose can be administered once a day in the evening.
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*1 measuring spoonful (5ml oral suspension) contains 250mg of ursodeoxycholic acid.
Ursofalk 250mg/5ml suspension should be taken in accordance with the dosage regimen given above. The oral suspension must be taken regularly.
The use of Ursofalk 250mg/5ml suspension in primary biliary cirrhosis may be continued indefinitely.
In patients with primary biliary cirrhosis, in rare cases the clinical symptoms may worsen at the beginning of treatment, e.g. the itching may increase. Should this occur, therapy should first be continued with a reduced daily dose of Ursofalk suspension, and the dose then gradually increased (increase of the daily dose weekly) until the dose indicated in the respective dosage regimen is reached again.
Dissolution of Gallstones:
Adults: 8-12mg ursodeoxycholic acid (UDCA) per kg per day in two divided doses. The following dosage regime is recommended:
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If doses are unequal the larger dose should be taken in late evening to counteract the rise in biliary cholesterol saturation which occurs in the early morning. The late evening dose may usefully be taken with food to help maintain bile flow overnight.
The time required for dissolution of gallstones is likely to range from 6 to 24 months depending on stone size and composition.
Follow-up cholecystograms or ultrasound investigation may be useful at 6 month intervals until the gallstones have disappeared.
Treatment should be continued until 2 successive cholecystograms and/or ultrasound investigations 4-12 weeks apart have failed to demonstrate gallstones. This is because these techniques do not permit reliable visualisation of stones less than 2mm in diameter. The likelihood of recurrence of gallstones after dissolution by bile acid treatment has been estimated as up to 50% at 5 years. The efficiency of Ursofalk in treating radio-opaque or partially radio-opaque gallstones has not been tested but these are generally thought to be less soluble than radiolucent stones. Non-cholesterol stones account for 10-15% of radiolucent stones and may not be dissolved by bile acids.
Elderly: There is no evidence to suggest that any alteration in the adult dose is needed but the relevant precautions should be taken into account.
Children: Cholesterol rich gallstones are rare in children but when they occur, dosage should be related to bodyweight.
4.3 Contraindications
Ursofalk 250mg/5ml Suspension should not be used in patients with:
- acute inflammation of the gall bladder or biliary tract
- occlusion of the biliary tract (occlusion of the common bile duct or cystic duct)
- frequent episodes of biliary colic
- radio-opaque calcified gallstones
- impaired contractility of the gall bladder
- hypersensitivity to bile acids or any excipient of the formulation
4.4 Special Warnings And Precautions For Use
Ursofalk 250mg/5ml suspension should be taken under medical supervision.
During the first 3 months of treatment, liver function parameters AST (SGOT), ALT (SGPT) and γ-GT should be monitored by the physician every 4 weeks, thereafter every 3 months. Apart from allowing for identification of responders and non-responders in patients being treated for primary biliary cirrhosis, this monitoring would also enable early detection of potential hepatic deterioration, particularly in patients with advance stage primary biliary cirrhosis.
When used for dissolution of cholesterol gallstones:
In order to assess therapeutic progress and for timely detection of any calcification of the gallstones, depending on stone size, the gall bladder should be visualised (oral cholecystography) with overview and occlusion views in standing and supine positions (ultrasound control) 6 – 10 months after the beginning of treatment.
If the gall bladder cannot be visualised on X-ray images, or in cases of calcified gallstones, impaired contractility of the gall bladder or frequent episodes of biliary colic, Ursofalk suspension should not be used.
When used for treatment of advanced stage of primary biliary cirrhosis:
In very rare cases decompensation of hepatic cirrhosis has been observed, which partially regressed after the treatment was discontinued.
If diarrhoea occurs, the dose must be reduced and in cases of persistent diarrhoea, the therapy should be discontinued.
One measuring spoonful (5 ml) Ursofalk suspension contains 0.50 mmol (11.39mg) sodium. To be taken into consideration by patients on a controlled sodium diet.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Ursofalk 250mg/5ml suspension should not be administered concomitantly with colestyramine, colestipol or antacids containing aluminium hydroxide and/or smectite (aluminium oxide), because these preparations bind ursodeoxycholic acid in the intestine and thereby inhibit its absorption and efficacy. Should the use of a preparation containing one of these substances be necessary, it must be taken at least 2 hours before or after Ursofalk 250mg/5ml suspension.
Ursofalk suspension can increase the absorption of ciclosporin from the intestine. In patients receiving ciclosporin treatment, blood concentrations of this substance should therefore be checked by the physician and the ciclosporin dose adjusted if necessary.
In isolated cases, Ursofalk suspension can reduce the absorption of ciprofloxacin.
Ursodeoxycholic acid has been shown to reduce the plasma peak concentrations (Cmax) and area under the curve (AUC) of the calcium antagonist nitrendipine. An interaction with a reduction of the therapeutic effect of dapsone was also reported.
These observations together with in vitro findings could indicate a potential for ursodeoxycholic acid to induce cytochrome P450 3A enzymes. Controlled clinical trials have shown, however, that ursodeoxycholic acid does not have a relevant inductive effect on cytochrome P450 3A enzymes.
Oestrogenic hormones and blood cholesterol lowering agents such as clofibrate may increase biliary lithiasis, which is a counter-effect to ursodeoxycholic acid used for dissolution of gallstones.
4.6 Pregnancy And Lactation
There are no adequate data from the use of ursodeoxycholic acid, particularly in the first trimester of pregnancy. Animal studies have provided evidence of a teratogenic effect during the early phase of gestation (see section 5.3, Toxicity to reproduction). Ursofalk suspension must not be used during pregnancy unless clearly necessary. Women of childbearing potential should be treated only if they use reliable contraception: non-hormonal or low-oestrogen oral contraceptive measures are recommended. However, in patients taking Ursofalk for dissolution of gallstones, effective non-hormonal contraception should be used, since hormonal oral contraceptives may increase biliary lithiasis.
The possibility of a pregnancy must be excluded before beginning treatment.
It is not known whether ursodeoxycholic acid passes into breast milk. Therefore, Ursofalk suspension should not be taken during lactation. If treatment with Ursofalk suspension is necessary, the infant should be weaned.
4.7 Effects On Ability To Drive And Use Machines
No effects on the ability to drive and use machines have been observed.
4.8 Undesirable Effects
Very common (
Common (
Uncommon (
Rare (
Very rare/Not known (< 1/10,000/cannot be estimated from available data)
Gastrointestinal disorders:
In clinical trials, reports of pasty stools or diarrhoea during ursodeoxycholic acid therapy were common.
Very rarely, severe right upper abdominal pain has occurred during the treatment of primary biliary cirrhosis.
Hepatobiliary disorders:
During treatment with ursodeoxycholic acid, calcification of gallstones can occur in very rare cases.
During therapy of the advanced stages of primary biliary cirrhosis, in very rare cases decompensation of hepatic cirrhosis has been observed, which partially regressed after the treatment was discontinued.
Skin and subcutaneous disorders:
Very rarely, urticaria can occur.
4.9 Overdose
Diarrhoea may occur in cases of overdose. In general, other symptoms of overdose are unlikely, because the absorption of ursodeoxycholic acid decreases with increasing dose and therefore more is excreted with the faeces.
No specific counter-measures are necessary and the consequences of diarrhoea should be treated symptomatically with restoration of fluid and electrolyte balance.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
UDCA is a bile acid which effects a reduction in cholesterol in biliary fluid primarily by dispersing the cholesterol and forming a liquid-crystal phase. UDCA affects the enterohepatic circulation of bile salts by reducing the ileal reabsorption of endogenous more hydrophobic and potentially toxic salts such as cholic and chenodeoxycholic acids.
In-vitro studies show that UDCA has a direct hepatoprotective effect and reduces the hepatotoxicity of hydrophobic bile salts. Immunological effects have also been demonstrated with a reduction in abnormal expression of HLS Class I antigens on hepatocytes as well as suppression of cytokine and interleukin production.
5.2 Pharmacokinetic Properties
Ursodeoxycholic acid occurs naturally in the body. When given orally it is rapidly and completely absorbed. It is 96-98% bound to plasma proteins and efficiently extracted by the liver and excreted in the bile as glycine and taurine conjugates. In the intestine some of the conjugates are deconjugated and reabsorbed. The conjugates may also be dehydroxylated to lithocholic acid, part of which is absorbed, sulphated by the liver and excreted via the biliary tract.
5.3 Preclinical Safety Data
a) Acute toxicity
Acute toxicity studies in animals have not revealed any toxic damage.
b) Chronic toxicity
Subchronic toxicity studies in monkeys showed hepatotoxic effects in the groups given high doses, including functional changes (e.g. liver enzyme changes) and morphological changes such as bile duct proliferation, portal inflammatory foci and hepatocellular necrosis. These toxic effects are most likely attributable to lithocholic acid, a metabolite of ursodeoxycholic acid, which in monkeys – unlike humans – is not detoxified. Clinical experience confirms that the described hepatotoxic effects are of no apparent relevance in humans.
c) Carcinogenic and mutagenic potential
Long-term studies in mice and rats revealed no evidence of ursodeoxycholic acid having carcinogenic potential.
In vitro and in vivo genetic toxicology tests with ursodeoxycholic acid were negative.
The tests with ursodeoxycholic acid revealed no relevant evidence of a mutagenic effect.
d) Toxicity to reproduction
In studies in rats, tail malformations occurred after a dose of 2000mg of ursodeoxycholic acid per kg of body weight. In rabbits, no teratogenic effects were found, although there were embryotoxic effects (from a dose of 100 mgper kg of body weight). Ursodeoxycholic acid had no effect on fertility in rats and did not affect peri-/post-natal development of the offspring.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Ursofalk 250mg/5ml Suspension contains the following excipients:
Benzoic acid (E210), microcrystalline cellulose and carboxymethyl-cellulose sodium, sodium chloride, sodium citrate, citric acid anhydrous, glycerol, propylene glycol, xylitol, sodium cyclamate, lemon flavouring (Givaudan 87017) and purified water.
6.2 Incompatibilities
None known other than the interactions identified in Section 4.5.
6.3 Shelf Life
48 months.
6.4 Special Precautions For Storage
Do not refrigerate or freeze.
6.5 Nature And Contents Of Container
Amber glass bottle closed with a plastic screw cap, containing 250ml of suspension.
6.6 Special Precautions For Disposal And Other Handling
Shake well before use. After opening the bottle, do not use after 4 months.
7. Marketing Authorisation Holder
Dr Falk Pharma UK Ltd
Unit K, Bourne End Business Park
Cores End Road, Bourne End
Buckinghamshire, SL8 5AS
8. Marketing Authorisation Number(S)
PL 10341/0007
9. Date Of First Authorisation/Renewal Of The Authorisation
31 December 2004
10. Date Of Revision Of The Text
September 2011
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