UTOVLAN Tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Utovlan 5 mg tablets.
Qualitative and quantitative composition
Each tablet contains 5mg norethisterone. Excipient(s) with known effect: Each tablet contains 62.25 mg lactose (as monohydrate). For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White, flat, circular, bevel-edged tablet inscribed SEARLE on one side and U on the other.
Therapeutic indications
At low dose: Dysfunctional uterine bleeding, endometriosis, polymenorrhoea, menorrhagia, metropathia, haemorrhagia, postponement of menstruation and premenstrual syndrome. At high dose: Disseminated carcinoma ...
Posology and method of administration
Posology Low dose Dysfunctional uterine bleeding, polymenorrhoea, menorrhagia, dysmenorrhoea and metropathia haemorrhagia: 1 tablet three times daily for 10 days; bleeding usually stops within 48 hours. ...
Contraindications
Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Pregnancy. Previous idiopathic or current venous thromboembolism (deep vein thrombosis, pulmonary embolism). Active ...
Special warnings and precautions for use
If menstrual bleeding should fail to follow a course of Utovlan, the possibility of pregnancy must be excluded before a further course is given. Therapy should be discontinued if the following occur: ...
Interaction with other medicinal products and other forms of interaction
Interaction with other medicines The metabolism of progestogens may be increased by concomitant administration of compounds known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes. ...
Pregnancy and lactation
Contraindicated in pregnancy.
Effects on ability to drive and use machines
Utovlan has no influence on the ability to drive and use machines.
Undesirable effects
Progestogens given alone at low doses have been associated with the following undesirable effects: Genitourinary: breakthrough bleeding, spotting, amenorrhoea, abnormal uterine bleeding, (irregular, increase, ...
Overdose
Overdosage may be manifested by nausea, vomiting, breast enlargement and later vaginal bleeding. There is no specific antidote and treatment should be symptomatic. Gastric lavage may be employed if the ...
Pharmacodynamic properties
Pharmotherapeutic group (ATC code) L02AB. Norethisterone given at intermediate doses (5-10mg) suppresses ovulation via its effect on the pituitary. The endogenous production of oestrogens and progesterones ...
Pharmacokinetic properties
Norethisterone is rapidly and completely absorbed after oral administration, peak plasma concentration occurring in the majority of subjects between 1 and 3 hours. Due to first-pass metabolism, blood levels ...
Preclinical safety data
The toxicity of norethisterone is very low. Reports of teratogenic effects in animals are uncommon. No carcinogenic effects have been found even in long-term studies.
List of excipients
Maize starch Polyvidone Magnesium stearate Lactose monohydrate
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store below 25°C. Store in the original package to protect from light and moisture.
Nature and contents of container
Pvc/foil blister packs of 30 and 90 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK
Marketing authorization number(s)
PL 00057/1054
Date of first authorization / renewal of the authorization
Date of first authorisation: 15th July 2002 Date of latest renewal: 15th February 2003
Date of revision of the text
01/2019
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