MENOPUR MULTIDOSE 1200 IU

Riik: Iisrael

keel: inglise

Allikas: Ministry of Health

Osta kohe

Infovoldik Infovoldik (PIL)
20-08-2020
Toote omadused Toote omadused (SPC)
16-06-2020
Avaliku hindamisaruande Avaliku hindamisaruande (PAR)
17-08-2016

Toimeaine:

MENOTROPHIN

Saadav alates:

FERRING PHARMACEUTICALS LTD

ATC kood:

G03GA02

Ravimvorm:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Koostis:

MENOTROPHIN 1200 IU

Manustamisviis:

S.C, I.M

Retsepti tüüp:

Required

Valmistatud:

FERRING GmbH ,GERMANY

Terapeutiline rühm:

HUMAN MENOPAUSAL GONADOTROPHIN

Terapeutiline ala:

HUMAN MENOPAUSAL GONADOTROPHIN

Näidustused:

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

Loa andmise kuupäev:

2017-02-28

Infovoldik

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Toote omadused

                                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
                                
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Dokumendid teistes keeltes

Infovoldik Infovoldik araabia 20-08-2020
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