ELLAONE Tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
ellaOne 30 mg tablet.
Qualitative and quantitative composition
Each tablet contains 30 mg ulipristal acetate. Excipients with known effect: Each tablet contains 237 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White to marble creamy, round curved tablet of 9 mm diameter engraved with еllа on both sides.
Therapeutic indications
Emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.
Posology and method of administration
Posology The treatment consists of one tablet to be taken orally as soon as possible, but no later than 120 hours (5 days) after unprotected intercourse or contraceptive failure. The tablet can be taken ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
ellaOne is for occasional use only. It should in no instance replace a regular contraceptive method. In any case, women should be advised to adopt a regular method of contraception. Ulipristal acetate ...
Interaction with other medicinal products and other forms of interaction
Potential for other medicinal products to affect ulipristal acetate Ulipristal acetate is metabolised by CYP3A4 in vitro. CYP3A4 inducers: In vivo results show that the administration of ulipristal acetate ...
Fertility, pregnancy and lactation
Pregnancy ellaOne is not intended for use during pregnancy and should not be taken by any woman suspected or known to be pregnant (see section 4.2). Ulipristal acetate does not interrupt an existing pregnancy. ...
Effects on ability to drive and use machines
Ulipristal acetate has minor or moderate influence on the ability to drive or use machines: mild to moderate dizziness is common after ellaOne intake, somnolence and blurred vision are uncommon; disturbance ...
Undesirable effects
Summary of the safety profile The most commonly reported adverse reactions were headache, nausea, abdominal pain and dysmenorrhea. Safety of ulipristal acetate has been evaluated in 4,718 women during ...
Overdose
Experience with ulipristal acetate overdose is limited. Single doses up to 200 mg have been used in women without safety concern. Such high doses were well-tolerated; however, these women had a shortened ...
Pharmacodynamic properties
Pharmacotherapeutic group: Sex hormones and modulators of the genital system, emergency contraceptives ATC code: G03AD02 Ulipristal acetate is an orally-active synthetic selective progesterone receptor ...
Pharmacokinetic properties
Absorption Following oral administration of a single 30 mg dose, ulipristal acetate is rapidly absorbed, with a peak plasma concentration of 176 ± 89 ng/ml occurring approximately 1 hour (0.5-2.0 h) after ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, and genotoxicity. Most findings in general toxicity studies were related ...
List of excipients
Lactose monohydrate Povidone Croscarmellose sodium Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store below 25°C. Store in the original package in order to protect from moisture. Keep the blister in the outer carton in order to protect from light.
Nature and contents of container
PVC-PE-PVDC-Aluminium blister of 1 tablet. PVC-PVDC-Aluminium blister of 1 tablet. Each carton contains one blister. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
LABORATOIRE HRA PHARMA, 200 avenue de Paris, 92320, CHATILLON, France
Marketing authorization number(s)
EU/1/09/522/001 EU/1/09/522/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 15 May 2009 Date of latest renewal: 21 March 2014
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