ANGUSTA Tablet (2020)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
1. Name of the medicinal product
Angusta 25 microgram tablets.
2. Qualitative and quantitative composition
Each tablet contains 25 micrograms misoprostol. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. White, uncoated oval shaped tablets with the dimensions 7.5 4.5 mm with a score line on one side and plain on the other.The score line is not intended for breaking the tablet.
4.1. Therapeutic indications
Angusta is indicated for induction of labour.
4.2. Posology and method of administration
Posology The recommended dosing regimen for Angusta is 25 micrograms orally every two hours or 50 micrograms orally every four hours according to hospital practice. The maximum dose is 200 micrograms over ...
4.3. Contraindications
Angusta is contraindicated: When there is hypersensitivity to the active substance or to any of the excipients listed in section 6.1. When labour has started. When there is suspicion or evidence of foetal ...
4.4. Special warnings and precautions for use
Angusta should only be administered by trained obstetric personnel in a hospital setting where facilities for continuous fetal and uterine monitoring is available and the cervix should be assessed carefully ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed with Angusta. Concurrent use of oxytocic drugs or other labour induction agents is contraindicated due to the potential of increased uterotonic effects (see sections ...
4.6. Fertility, pregnancy and lactation
Fertility Studies of fertility and embryo development in rats have shown that misoprostol may have an impact on implantation and resorption. This is, however, considered of no relevance for the indicated ...
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
The undesirable effects listed in the table below have been reported in 41 trials where a total of 3,152 women were exposed to oral misoprostol at doses of 20-25 µg every 2 hours or 50 µg every 4 hours. ...
4.9. Overdose
There is no information on overdose with Angusta. In case of overdose symptoms (e.g. excessive uterine stimulation causing prolonged or excessive contractions), dosing with Angusta should be arrested and ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other gynaecologicals, oxytocics, prostaglandins <b>ATC-code:</b> G02AD06 Mechanism of action Misoprostol is a synthetic analogue of Prostaglandin E1 (PGE1), a naturally ...
5.2. Pharmacokinetic properties
Misoprostol, an ester, is rapidly metabolised to its active metabolite misoprostol acid. Only misoprostol acid is detectable in plasma. The acid is further metabolised by beta fatty acid oxidation to inactive ...
5.3. Preclinical safety data
Published literature on misoprostol studies of safety pharmacology, acute and repeated dose toxicity, mutagenicity, carcinogenicity and reproductive toxicity reveals no special hazard for humans. In humans, ...
6.1. List of excipients
Hypromellose Cellulose, microcrystalline Maize starch Crospovidone Croscarmellose sodium Silica, colloidal anhydrous
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
30 months.
6.4. Special precautions for storage
Store in the original package in order to protect from moisture.
6.5. Nature and contents of container
Angusta is available in a pack of double layer aluminium foil blister containing 8 tablets.
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Norgine Pharmaceuticals Limited, Norgine House, Widewater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK
8. Marketing authorization number(s)
PL 20011/0072
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 02 September 2020
10. Date of revision of the text
02/09/2020
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