REKOVELLE Solution for injection (2017)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
REKOVELLE 12 micrograms/0.36 mL solution for injection in a pre-filled pen. REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled pen. REKOVELLE 72 micrograms/2.16 mL solution for injection ...
Qualitative and quantitative composition
REKOVELLE 12 micrograms/0.36 mL solution for injection: One pre-filled multidose pen delivers 12 micrograms follitropin delta* in 0.36 mL solution. REKOVELLE 36 micrograms/1.08 mL solution for injection: ...
Pharmaceutical form
Solution for injection in a pre-filled pen (injection). Clear and colourless solution with a pH of 6.0-7.0.
Therapeutic indications
Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection ...
Posology and method of administration
Treatment should be initiated under the supervision of a physician experienced in the treatment of fertility problems. Posology The posology of REKOVELLE is individualised for each patient and aims to ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 tumours of the hypothalamus or pituitary gland ovarian enlargement or ovarian cyst not due to polycystic ovarian ...
Special warnings and precautions for use
REKOVELLE contains a potent gonadotropic substance capable of causing mild to severe adverse reactions, and should only be used by physicians who are thoroughly familiar with infertility problems and their ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed with REKOVELLE. Clinically significant interactions with other medicinal products have neither been reported during REKOVELLE therapy, nor are expected.
Fertility, pregnancy and lactation
Pregnancy REKOVELLE is not indicated during pregnancy. No teratogenic risk has been reported, following controlled ovarian stimulation, in clinical use with gonadotropins. There are no data from the inadvertent ...
Effects on ability to drive and use machines
REKOVELLE has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of safety profile The most frequently reported adverse reactions during treatment with REKOVELLE are headache, pelvic discomfort, OHSS, pelvic pain, nausea, adnexa uteri pain and fatigue. The frequency ...
Overdose
The effect of an overdose is unknown, nevertheless, there is a risk that OHSS may occur (see section 4.4).
Pharmacodynamic properties
Pharmacotherapeutic group: Sex hormones and modulators of the genital systems, gonadotropins ATC code: G03GA10 Mechanism of action The most important effect resulting from parenteral administration of ...
Pharmacokinetic properties
The pharmacokinetic profile of follitropin delta has been investigated in healthy female subjects and in IVF/ICSI patients undergoing COS. Following repeated daily subcutaneous administrations, REKOVELLE ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and local tolerance. The overdose of follitropin delta resulted in pharmacological ...
List of excipients
Phenol Polysorbate 20 L-methionine Sodium sulphate decahydrate Disodium phosphate dodecahydrate Phosphoric acid, concentrated (for pH-adjustment) Sodium hydroxide (for pH-adjustment) Water for injections ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years. In use: 28 days when stored at or below 25°C.
Special precautions for storage
Store in a refrigerator (2°C–8°C). Do not freeze. Before first use, store in the original package in order to protect from light. REKOVELLE may be removed from the refrigerator, without being refrigerated ...
Nature and contents of container
REKOVELLE 12 micrograms/0.36 mL solution for injection: 3 mL multidose cartridge (Type I glass) with a plunger (halobutyl rubber) and a crimp cap (aluminium) with an inlay (rubber). Each cartridge contains ...
Special precautions for disposal and other handling
The solution should not be administered if it contains particles or is not clear. The instructions for use of the pen must be followed. Discard used needles immediately after injection. Any unused medicinal ...
Marketing authorization holder
Ferring Pharmaceuticals A/S, Kay Fiskers Plads 11, 2300 Copenhagen S, Denmark
Marketing authorization number(s)
EU/1/16/1150/004 EU/1/16/1150/005 EU/1/16/1150/006
Date of first authorization / renewal of the authorization
Date of first authorisation: 12 December 2016
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