FASIGYN Film-coated tablet (2019)
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Περιεχόμενα
Name of the medicinal product
FASIGYN 500mg film-coated tablets.
Qualitative and quantitative composition
Tinidazole 500mg.
Pharmaceutical form
Film-coated tablets. White, round, biconvex film-coated tablet embossed on one side with FAS 500.
Therapeutic indications
Treatment of the following infections: 1. Eradication of Helicobacter pylori associated with duodenal ulcers, in the presence of antibiotic and acid suppressant therapy (see section 4.2). 2. Anaerobic ...
Posology and method of administration
Route: Oral administration during or after a meal. Posology Eradication of H. pylori associated with duodenal ulcers: <u>Adults:</u> the usual dose of Fasigyn is 500mg twice daily coadministered with omeprazole ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. As with other drugs of similar structure, tinidazole is contraindicated in patients having, or with a history ...
Special warnings and precautions for use
As with related compounds, alcoholic beverages should be avoided during Fasigyn therapy because of the possibility of a disulfiram-like reaction (flushing, abdominal cramps, vomiting, tachycardia). Alcohol ...
Interaction with other medicinal products and other forms of interaction
Alcohol Concurrent use of tinidazole and alcohol may produce a disulfiram-like reaction and should be avoided, (see section 4.4, Special warnings and precautions for use). Anticoagulants Drugs of similar ...
Pregnancy and lactation
Pregnancy Fertility studies in rats receiving 100mg and 300mg tinidazole/kg had no effect on fertility, adult and pup weights, gestation, viability or lactation. There was a slight, not significant, increase ...
Effects on ability to drive and use machines
No special precautions should be necessary. However, drugs of similar chemical structure, including Fasigyn, have been associated with various neurological disturbances such as dizziness, vertigo, ataxia, ...
Undesirable effects
Reported side effects have generally been infrequent, mild and self-limiting. The reported undesirable effects are listed below according to MedDRA system organ class classification and frequency. Within ...
Overdose
In acute animal studies with mice and rats, the LD<sub>50</sub> for mice was >3600mg/kg and >2300mg/kg for oral and intraperitoneal administration respectively. For rats, the LD<sub>50</sub> was >2000mg/kg ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antiinfectives for systemic use ATC code: J 01XD02 Fasigyn is active against both protozoa and obligate anaerobic bacteria. The activity against protozoa involves Trichomonas ...
Pharmacokinetic properties
Fasigyn is rapidly and completely absorbed following oral administration. In studies with healthy volunteers receiving 2g tinidazole orally, peak serum levels of 40-51 micrograms/ml were achieved within ...
Preclinical safety data
Tinidazole has been shown to be mutagenic in some bacterial strains tested in vitro (with and without metabolic activation). Tinidazole was negative for mutagenicity in a mammalian cell culture system ...
List of excipients
<u>Tablet Core:</u> Microcrystalline cellulose (Avicel PH 101) Alginic acid Maize starch Magnesium stearate Sodium lauryl sulfate <u>Film Coating:</u> Hydroxypropyl methyl cellulose Propylene glycol Titanium ...
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
Store below 25°C in the original pack to protect from light and moisture.
Nature and contents of container
Aluminium foil backed blister packs of 16 500mg tablets consisting of: a) 250 micron PVC blister coated with 40gsm of PVdC b) 20 micron aluminium foil backing coated with 20gsm PVdC
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ
Marketing authorization number(s)
PL 00057/0150
Date of first authorization / renewal of the authorization
08/02/2006
Date of revision of the text
06/2016
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