BRAVELLE Powder and solvent for solution for injection (2016)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
BRAVELLE 75 IU powder and solvent for solution for injection.
Qualitative and quantitative composition
Each vial of powder contains 82.5 IU of highly purified urinary follicle stimulating hormone (FSH), urofollitropin. When reconstituted with the solvent provided, each vial delivers 75 IU of FSH. For the ...
Pharmaceutical form
Powder and solvent for solution for injection. Appearance of powder: Lyophilised, white to off-white caked mass. Appearance of solvent: Clear colourless solution.
Therapeutic indications
BRAVELLE is indicated for the treatment of female infertility in the following clinical situations: Anovulation (including polycystic ovarian disease (PCOD)) in women who have been unresponsive to treatment ...
Posology and method of administration
Treatment with BRAVELLE should be initiated under the supervision of a physician experienced in the treatment of fertility problems. Posology There are great inter- and intra-individual variations in the ...
Contraindications
BRAVELLE is contraindicated in women who have: Tumours of the pituitary or hypothalamic glands Ovarian, uterine or mammary carcinoma Pregnancy and lactation Gynaecological haemorrhage of unknown aetiology ...
Special warnings and precautions for use
BRAVELLE is a potent gonadotropic substance capable of causing mild to severe adverse reactions, and should only be used under the supervision of physicians who are thoroughly familiar with infertility ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Although there is no clinical experience, it is expected that the concomitant use of BRAVELLE and clomiphene citrate may enhance the follicular response. When ...
Pregnancy and lactation
BRAVELLE is contraindicated in women who are pregnant or lactating (see section 4.3). To date no teratogenic risk has been reported when gonadotropins are used clinically for controlled ovarian hyperstimulation. ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, BRAVELLE is unlikely to have influence on the patients performance to drive and use machines.
Undesirable effects
The most commonly reported adverse events during treatment with BRAVELLE in clinical trials are headache and abdominal pain, both occurring in 10% of patients followed by nausea, vaginal haemorrhage, OHSS ...
Overdose
The effects of an overdose is unknown, nevertheless ovarian hyperstimulation syndrome could be expected to occur (see section 4.4).
Pharmacodynamic properties
Pharmacotherapeutic group: Gonadotropins ATC code: G03GA04 BRAVELLE contains a highly purified preparation of urinary FSH extracted from the urine of postmenopausal women. FSH stimulates ovarian follicular ...
Pharmacokinetic properties
Following single doses of SC administration of BRAVELLE maximum FSH concentrations were reached within 21 hours. Steady-state was observed after 4 to 5 days. After 7 days of repeated administration, the ...
Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of cardiovascular safety pharmacology, single and repeat dose toxicity, and local tolerance. Impaired fertility was observed ...
List of excipients
Powder: Lactose monohydrate Polysorbate 20 Sodium phosphate dibasic heptahydrate (for pH adjustment) Phosphoric acid (for pH adjustment) Water for injections Solvent: Sodium chloride Hydrochloric acid ...
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
2 years. After reconstitution: use immediately.
Special precautions for storage
Do not store above 25°C. Do not freeze. Store in the original container in order to protect from light.
Nature and contents of container
Powder: The powder for solution for injection is supplied in a 2 mL single dose colourless type I glass vial with a bromobutyl rubber stopper closed with an aluminium/polypropen cap. Solvent: The solvent ...
Special precautions for disposal and other handling
BRAVELLE should only be reconstituted with the solvent provided prior to use. Attach the reconstitution needle to the syringe. Withdraw the entire content from the ampoule with solvent and inject the total ...
Marketing authorization holder
Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom
Marketing authorization number(s)
PL 03194/0087
Date of first authorization / renewal of the authorization
24<sup>th</sup> March 2009
Date of revision of the text
July 2016
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