MENOPUR MULTIDOSE 1200 IU

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

MENOTROPHIN

Tilgjengelig fra:

FERRING PHARMACEUTICALS LTD

ATC-kode:

G03GA02

Legemiddelform:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Sammensetning:

MENOTROPHIN 1200 IU

Administreringsrute:

S.C, I.M

Resept typen:

Required

Produsert av:

FERRING GmbH ,GERMANY

Terapeutisk gruppe:

HUMAN MENOPAUSAL GONADOTROPHIN

Terapeutisk område:

HUMAN MENOPAUSAL GONADOTROPHIN

Indikasjoner:

Sterility in females with hypo or normogonadotropic ovarian insufficiency: stimulation of follicle growth. Sterility in males with hypo or normogonadotropic hypogonadism: In combination with HCG to spermatogenesis

Autorisasjon dato:

2017-02-28

Informasjon til brukeren

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Preparatomtale

1.
NAME OF THE MEDICINAL PRODUCT
MENOPUR multidose 600 IU
MENOPUR multidose 1200 IU
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MENOPUR 600 IU: Each vial of powder contains highly purified
menotrophin (human
menopausal gonadotrophin, HMG) corresponding to 600 IU human follicle
stimulating
hormone (FSH) and 600 IU human luteinizing hormone (LH) activity.
MENOPUR 1200 IU: Each vial of powder contains highly purified
menotrophin (human
menopausal gonadotrophin, HMG) corresponding to 1200 IU follicle
stimulating hormone
(FSH) and 1200 IU human luteinizing hormone (LH) activity.
Human Chorionic Gonadotrophin (hCG), a naturally occurring hormone
in postmenopausal urine, is present in MENOPUR and contributes to the
overall luteinizing
hormone activity. Menotrophin is produced from human urine.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Appearance of powder: white to off-white lyophilised cake.
Appearance of solvent: clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of Sterility in females with hypo or
normogonadotropic ovarian
insufficiency: stimulation of follicle growth.
Sterility in males with hypo or normogonadotropic hypogonadism: In
combination with HCG
to spermatogenesis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with MENOPUR should be initiated under the supervision of a
physician
experienced in the treatment of fertility problems.
METHOD OF ADMINISTRATION
MENOPUR is intended for subcutaneous (S.C.) or intramuscular (I.M.)
injection after
reconstitution with the solvent provided. The powder should be
reconstituted prior to use. The
reconstituted solution is for multiple injections and can be used for
up to 28 days. Vigorous
shaking should be avoided. The solution should not be used if it
contains particles or if it is
not clear.
DOSAGE
Dosage regimens described below are identical for S.C. and I.M.
administration.
There are great inter-individual variations in the response of the
ov