TOPOGYNE Tablet (2014)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Topogyne 400 microgram tablets
Qualitative and quantitative composition
One tablet contains 400 microgram misoprostol. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White, round, flat tablets, with a diameter of 11 mm and thickness of 4.4 mm, with M400 engraved on one side.
Therapeutic indications
Medical termination of developing intra-uterine pregnancy, in sequential use with mifepristone, up to 49 days of amenorrhea (see section 4.2). Misoprostol is indicated in adults.
Posology and method of administration
Posology Misoprostol is taken as a single 400 microgram oral dose 36 to 48 hours after taking a single 600 mg oral dose of mifepristone. Information on the posology of mifepristone can be found in the ...
Contraindications
Hypersensitivity to misoprostol or other prostaglandins, or to any of the excipients listed in section 6.1 Pregnancy not confirmed by ultrasound scan or biological tests Suspected ectopic pregnancy Contraindication ...
Special warnings and precautions for use
In the absence of specific studies, the combination of the sequential use of mifepristone and misoprostol is not recommended for use in patients with: Malnutrition Hepatic failure Renal failure Warnings ...
Interaction with other medicinal products and other forms of interaction
Misoprostol is predominantly metabolised via fatty acid oxidising systems and has shown no adverse effect on the hepatic microsomal mixed function oxidase (P450) enzyme system. A decrease of the efficacy ...
Fertility, pregnancy and lactation
Pregnancy Use in pregnancy has been associated with birth defects/malformations for ongoing pregnancies exposed to mifepristone and misoprostol or misoprostol alone. Prenatal exposure to misoprostol has ...
Effects on ability to drive and use machines
No data showing an effect on the ability to drive are known. Dizziness could occur as a side effect. When driving or using machines one should take this possible side effect into account.
Undesirable effects
The side effects of misoprostol are usually an extension of the pharmacological action and of the drug bioavailability. The most common adverse reactions are gastrointestinal disorders e.g. nausea, vomiting, ...
Overdose
In the event of overdosage, symptomatic treatment and appropriate medical care should be done. Gastrointestinal haemorrhage, renal failure, acute rhabdomyolysis, uterine haemorrhage and death have been ...
Pharmacodynamic properties
Pharmacotherapeutic class: Other gynaecological drugs, oxytocics prostaglandins ATC code: G02AD06 Misoprostol (a synthetic analogue of prostaglandin E1) is used in combination with mifepristone for the ...
Pharmacokinetic properties
Absorption Misoprostol is rapidly absorbed following oral administration, with peak plasma levels of the active metabolite (misoprostol acid) occurring after about 30 minutes. The plasma elimination half-life ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential. At high repeated doses in rats ...
List of excipients
Microcrystalline cellulose Hypromellose Sodium starch glycolate (type A) Hydrogenated castor oil
Incompatibilities
Not applicable.
Shelf life
PVC-PCTFE/Alu blister: 1 year. OPA-Alu-PVC/Alu blister: 24 months.
Special precautions for storage
Store below 25°C. Any tablet stored outside the blister or not used immediately has to be discarded.
Nature and contents of container
1, 4, 16 or 40 tablet per carton box. Tablets are packed in perforated unit-dose PVC-PCTFE/Alu or OPA-Alu-PVC/Alu blister. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements. Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
EXELGYN, 216, Boulevard Saint-Germain, 75007 Paris, France
Marketing authorization number(s)
PL 16152/0003
Date of first authorization / renewal of the authorization
18/01/2013
Date of revision of the text
19/03/2014
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