LUVERIS Powder and solvent for solution for injection (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Luveris 75 IU powder and solvent for solution for injection.
Qualitative and quantitative composition
One vial contains 75 IU of lutropin alfa (recombinant human Luteinising Hormone {r-hLH}). Lutropin alfa is produced in genetically engineered Chinese Hamster Ovary (CHO) cells. For the full list of excipients, ...
Pharmaceutical form
Powder and solvent for solution for injection. Appearance of the powder: white lyophilised pellet. Appearance of the solvent: clear colourless solution. The pH of the reconstituted solution is 7.5-8.5. ...
Therapeutic indications
Luveris in association with a Follicle Stimulating Hormone (FSH) preparation is recommended for the stimulation of follicular development in adult women with severe Luteinising Hormone (LH) and FSH deficiency. ...
Posology and method of administration
Treatment with Luveris should be initiated under the supervision of a physician experienced in the treatment of fertility problems. Posology In LH and FSH deficient women, the objective of Luveris therapy ...
Contraindications
Luveris is contraindicated in patients with: hypersensitivity to active substances or to any of the excipients listed in section 6.1. tumours of the hypothalamus and pituitary gland ovarian enlargement ...
Special warnings and precautions for use
Before starting treatment, the couples infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated. In addition, patients should be evaluated for hypothyroidism, ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Luveris should not be administered as a mixture with other medicinal products, in the same injection, except follitropin alfa for which studies have shown that ...
Fertility, pregnancy and lactation
Pregnancy There is no indication for the use of Luveris during pregnancy. Data on a limited number of exposed pregnancies indicate no adverse reactions of gonadotropins on pregnancy, embryonal or foetal ...
Effects on ability to drive and use machines
Luveris has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile Luveris is used for the stimulation of follicular development in association with follitropin alfa. In this context, it is difficult to attribute adverse reactions to any ...
Overdose
The effects of an overdose of Luveris are unknown. Nevertheless there is a possibility that OHSS may occur, which is further described in section 4.4. Single doses of up to 40,000 IU of lutropin alfa have ...
Pharmacodynamic properties
Pharmacotherapeutic group: Sex hormones and modulators of the genital system, gonadotropins ATC code: G03GA07 Lutropin alfa is a recombinant human Luteinising Hormone (r-hLH), a glycoprotein composed of ...
Pharmacokinetic properties
The pharmacokinetics of lutropin alfa have been studied in pituitary desensitised female volunteers from 75 IU up to 40,000 IU. The pharmacokinetic profile of lutropin alfa is similar to that of urinaryderived ...
Preclinical safety data
Non clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential. As expected from the heterologous ...
List of excipients
Powder: Sucrose Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Polysorbate 20 Phosphoric acid, concentrated (for pH adjustment) Sodium hydroxide (for pH adjustment) L-methionine ...
Incompatibilities
This medicinal product must not be administered as a mixture in the same injection with other medicinal products except follitropin alfa.
Shelf life
3 years.
Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from light.
Nature and contents of container
The powder is packaged in 3 ml neutral colourless glass (type I) vials. The vials are sealed with bromobutyl stoppers protected by aluminium seal rings and flip-off caps. The solvent is packaged either ...
Special precautions for disposal and other handling
For immediate and single use following first opening and reconstitution. The powder must be reconstituted with the solvent before use by gentle swirling. The reconstituted solution should not be administered ...
Marketing authorization holder
Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands
Marketing authorization number(s)
EU/1/00/155/001 (1 vial/1 ampoule) EU/1/00/155/002 (3 vials/3 ampoules) EU/1/00/155/003 (10 vials/10 ampoules) EU/1/00/155/004 (1 vial/1 vial) EU/1/00/155/005 (3 vial/3 vials) EU/1/00/155/006 (10 vials/10 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 29th November 2000 Date of latest renewal: 30th November 2005
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