LUBION Solution for injection (2018)
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Περιεχόμενα
1. Name of the medicinal product
Lubion 25 mg solution for injection.
2. Qualitative and quantitative composition
Each vial (1.112ml) contains 25 mg of progesterone (theoretical concentration 22.48mg/ml). For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection. Clear colourless solution.
4.1. Therapeutic indications
Lubionis indicated in adults for luteal support as part of an Assisted Reproductive Technology (ART) treatment program in infertile women who are unable to use or tolerate vaginal preparations.
4.2. Posology and method of administration
Posology Adults Once daily injection of 25 mg from day of oocyte retrieval, usually until 12 weeks of confirmed pregnancy. As the indications for Lubionare restricted to women of child-bearing age, dosage ...
4.3. Contraindications
Lubion should not be used in individuals with any of the following conditions: Hypersensitivity to progesterone or to any of the excipients. Undiagnosed vaginal bleeding. Known missed abortion or ectopic ...
4.4. Special warnings and precautions for use
Lubion should be discontinued if any of the following conditions are suspected: myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism, thrombophlebitis, or retinal thrombosis. ...
4.5. Interaction with other medicinal products and other forms of interaction
Drugs known to induce the hepatic cytochrome-P450-3A4 system (e.g. rifampicin, carbamazepine, griseofulvin, phenobarbital, phenytoin or St. Johns Wort (Hypericum perforatum-containing herbal products) ...
4.6. Fertility, pregnancy and lactation
Fertility Lubion is used in the treatment of some forms of infertility (see section 4.1 for full details). Pregnancy Lubion is indicated for luteal support as part of an Assisted Reproductive Technology ...
4.7. Effects on ability to drive and use machines
Lubionhas minor or moderate influence on the ability to drive and use machines. Progesterone may cause drowsiness and/or dizziness; therefore caution is advised in drivers and those operating machinery. ...
4.8. Undesirable effects
The most frequently reported adverse drug reactions during treatment with Lubionduring clinical trial are administration site reactions, breast and vulvo-vaginal disorders. The table below displays the ...
4.9. Overdose
High doses of progesterone may cause drowsiness. Treatment of overdose consists of discontinuation of Lubiontogether with initiation of appropriate symptomatic and supportive care.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Sex hormones and modulators of the genital system; Progestogens; Pregnen-(4) derivatives <b>ATC code:</b> G03DA04 Progesterone is a naturally occurring steroid that is ...
5.2. Pharmacokinetic properties
Absorption Progesterone serum concentrations increased following the subcutaneous (s.c.) administration of 25 mg of Lubionto 12 healthy post-menopausal females. By one hour post-administration of a single ...
5.3. Preclinical safety data
Rabbits were treated with 6.7 mg/kg/dayof Lubionfor up to 7 consecutive days by s.c. and i.m. injection. No relevant effect attributed to the treatment with Lubionby the s.c. route was seen at local, macroscopic ...
6.1. List of excipients
Hydroxypropylbetadex Water for injections
6.2. Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3. Shelf life
2 years. The medicinal product must be used immediately after first opening: any remaining solution must be discarded.
6.4. Special precautions for storage
Store below 25°C. Do not refrigerate or freeze. Store in the original package in order to protect from light.
6.5. Nature and contents of container
Colourless Type I glass vial fitted with a bromobutyl rubber stopper, and an aluminium seal and flip off cap. Each pack contains 1, 7 or 14 vials. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
The solution is for single use only. A medical specialist must perform all i.m. injections. The solutionshould not be administered if it contains particles or is discoloured. Any unused product or waste ...
7. Marketing authorization holder
IBSA Farmaceutici Italia Srl, Via Martiri di Cefalonia 2, 26900 Lodi (Italy)
8. Marketing authorization number(s)
PL21039/0026
9. Date of first authorization / renewal of the authorization
22/02/2013
10. Date of revision of the text
03/2018
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