LUVERIS 75 IU

Pajjiż: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

LUTEINIZING HORMONE

Disponibbli minn:

MERCK SERONO LTD

Kodiċi ATC:

G03GA

Għamla farmaċewtika:

POWDER FOR SOLUTION FOR INJECTION

Kompożizzjoni:

LUTEINIZING HORMONE 75 IU/ML

Rotta amministrattiva:

S.C

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

MERCK SERONO S.A., SWITZERLAND

Grupp terapewtiku:

GONADOTROPINS

Indikazzjonijiet terapewtiċi:

Luveris in association with a follicle stimulating hormone (FSH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/L.

Data ta 'l-awtorizzazzjoni:

2021-12-31

Karatteristiċi tal-prodott

1
PRESCRIBING INFORMATION
LUVERIS
® 75 IU
1.
NAME OF THE MEDICINAL PRODUCT
Luveris
®
75 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 75 IU of lutropin alfa*.
* recombinant human luteinising hormone (r-hLH) produced in
genetically engineered Chinese
hamster ovary (CHO) cells by recombinant DNA technology
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 lyophilised pellet
Appearance of the solvent: clear colourless solution
The pH of the reconstituted solution is 7.5 to 8.5.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Luveris in association with a follicle stimulating hormone (FSH)
preparation is recommended for the
stimulation of follicular development in adult women with severe
luteinising hormone (LH) and FSH
deficiency. In clinical trials these patients were defined by an
endogenous serum LH level <1.2 IU/L.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Luveris should be initiated under the supervision of a
physician experienced in the
treatment of fertility disorders.
Posology
In LH and FSH deficient women, the objective of Luveris therapy in
association with FSH is to develop
a single mature Graafian follicle from which the oocyte will be
liberated after the administration of
2
human chorionic gonadotropin (hCG). Luveris should be given as a
course of daily injections
simultaneously with FSH. Since these patients are amenorrhoeic and
have low endogenous estrogen
secretion, treatment can commence at any time.
Luveris should be administered concomitantly with follitropin alfa.
A recommended regimen commences at 75 IU of lutropin alfa (i.e. one
vial of Luveris) daily with 75 to
150 IU FSH. Treatment should be tailored to the individual patient’s
response as assessed by
measuring follicle size by ultrasound and estrogen response.
In clinical trials, Luveris has been shown to increase the ovarian
sensitivity to follitropin al