MERIONAL 150IU POWDER & SOLVENT FOR SOLUTION FOR INJECTION

Country: Cyprus

Bahasa: Greek

Sumber: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Risalah maklumat Risalah maklumat (PIL)
16-03-2018

Bahan aktif:

MENOTROPIN

Boleh didapati daripada:

ANDREAS CONSTANTINIDES (0000003019) GOLGON 21, LEMESOS, 3025

Kod ATC:

G03GA02

INN (Nama Antarabangsa):

HUMAN MENOPAUSAL GONADOTROPHIN

Dos:

150IU

Borang farmaseutikal:

POWDER & SOLVENT FOR SOLUTION FOR INJECTION

Komposisi:

MENOTROPIN (8000016195) 150IU

Laluan pentadbiran:

INTRAMUSCULAR USE; ΥΠΟΔΟΡΙΑ ΧΡΗΣΗ

Jenis preskripsi:

Εθνική Διαδικασία

Kawasan terapeutik:

HUMAN MENOPAUSAL GONADOTROPHIN

Ringkasan produk:

Νομικό καθεστώς: Με Ιατρική Συνταγή; 10 AMPS X 150IU WITH 2ML SOLVENT (940054301) 10 AMPOULE - Εγκεκριμένο - Με Ιατρική Συνταγή; 1 VIAL X 150IU WITH 2ML SOLVENT (940054302) 1 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή

Risalah maklumat

                                MERIONAL®
150 I.U/75 IU
Highly purified Human Menopausal Gonadotrophin (hMG) for i.m. and s.c.
injections, standardized with the addition of
hCG
COMPOSITION
_1 vial of active ingredient contains:_
ACTIVE INGREDIENT: Human Follicle Stimulating Hormone (FSH) 75 or 150
I.U.; Human Luteinizing Hormone (LH) 75 or
150 I.U.
In order to obtain the indicated LH activity, a spiking with hCG is
carried out:
3.5-10.5 I.U. of hCG for a LH activity of 75 IU.
7.0-21.0 IU of hCG for a LH activity of 150 IU.
EXCIPIENTS:
Lactose Monohydrate
_Solvent _1 ml physiological solution (NaCl 0.9%).
PROPERTIES/EFFECTS
Merional contains human Menopausal Gonadotrophin (hMG), which is
extracted from the urine of postmenopausal
women.
In order to obtain an equivalent activity of FSH and LH, Merional is
standardized by the addition of human chorionic
gonadotropin (hCG), which is extracted from the urine of pregnant
women. Postmenopausal urine contains FSH and
LH, as well as a very small quantity of a substance similar to hCG.
According to the present scientific knowledge, there
is nothing to suggest that this substance is different from the hCG
obtained from pregnancy urine. FSH and LH activity
are both needed for the normal maturation of gametes (follicular
maturation in women and spermatogenesis in men, as
well as for the synthesis of steroids in the gonads). Merional can be
used to stimulate these two processes in case of
impaired gonad function. Merional can also be used to stimulate a
multi-follicular growth in Assisted Reproduction
Techniques (ART), such as in-vitro fecondation (IVF), embryo transfer
(ET) and gamete intrafallopian transplant
(GIFT).
Generally, Merional is used in association with a gonadotropin with LH
activity (human chorionic gonadotropin, hCG).
HMG and hCG are administered in succession (in women to induce
ovulation or controlled superovulation) or at the
same time (in men to stimulate Leydig cells).
PHARMACOKINETICS
FSH and LH are eliminated in two phases. In both phases the biological
half-life of FSH is longer than
                                
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