CETROTIDE 0.25

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

CETRORELIX AS ACETATE

Disponível em:

MERCK SERONO LTD

Código ATC:

H01CC02

Forma farmacêutica:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composição:

CETRORELIX AS ACETATE 0.25 MG/VIAL

Via de administração:

S.C

Tipo de prescrição:

Required

Fabricado por:

MERCK HEALTHCARE KGAA, GERMANY

Grupo terapêutico:

CETRORELIX

Área terapêutica:

CETRORELIX

Indicações terapêuticas:

Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques.

Data de autorização:

2014-12-31

Folheto informativo - Bula

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Características técnicas

1
PRESCRIBING INFORMATION
CETROTIDE
® 0.25
1.
NAME OF THE MEDICINAL PRODUCT
Cetrotide
®
0.25 mg powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 0.25 mg cetrorelix (as acetate).
After reconstitution with the solvent provided, each mL of the
solution contains 0.25 mg cetrorelix.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Appearance of the powder: white lyophilisate
Appearance of the solvent: clear and colourless solution
The pH of the reconstituted solution is 4.0 – 6.0
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of premature ovulation in patients undergoing a controlled
ovarian stimulation, followed by oocyte
pick-up and assisted reproductive techniques.
In clinical trials Cetrotide was used with human menopausal
gonadotropin (HMG), however, limited
experience with recombinant follicule-stimulating hormone (FSH)
suggested similar efficacy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Cetrotide
®
should only be prescribed by a specialist experienced in this field.
Posology
The first administration of Cetrotide should be performed under the
supervision of a physician and under
conditions where treatment of possible allergic/pseudo-allergic
reactions (including life-threatening
anaphylaxis) is immediately available. The following injections may be
self-administered as long as the
patient is made aware of the signs and symptoms that may indicate
hypersensitivity, the consequences of such
a reaction and the need for immediate medical intervention.
2
The contents of 1 vial (0.25 mg cetrorelix) are to be administered
once daily, at 24 h intervals, either in the
morning or in the evening. Following the first administration, it is
advised that the patient be kept under
medical supervision for 30 minutes to ensure there is no
allergic/pseudo-allergic reaction to the injection.
_Elderly_
There is no relevant use of Cetrotide in the geriatric population.
_Paediatric pop