LUVERIS FOR INJECTION 75 iuvial (Revised formula)

País: Cingapura

Língua: inglês

Origem: HSA (Health Sciences Authority)

Ingredientes ativos:

LUTROPIN ALFA

Disponível em:

MERCK PTE. LTD.

Código ATC:

G03GA07

Dosagem:

3.7μg (82.5IU) (10% overage)

Forma farmacêutica:

INJECTION, POWDER, FOR SOLUTION

Composição:

LUTROPIN ALFA 75 IU/vial

Via de administração:

SUBCUTANEOUS

Tipo de prescrição:

Prescription Only

Fabricado por:

Merck Serono SA

Status de autorização:

ACTIVE

Data de autorização:

2004-01-30

Folheto informativo - Bula

NAME OF THE MEDICINAL PRODUCT 
Luveris® 75 IU, powder and solvent for solution for injection. 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
One vial contains 75 IU of lutropin alfa
(recombinant human luteinising hormone {LH}). Lutropin alfa 
is produced in genetically engineered Chinese hamster ovary (CHO) cells. 

PHARMACEUTICAL FORM 
Powder and solvent for solution for injection. 
Appearance of the product: white lyophilized pellet 
Appearance of the solvent: clear colourless solution 

CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
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. 

POSOLOGY AND METHOD OF ADMINISTRATION 
Treatment with Luveris® should be initiated under
the supervision of a physician experienced in the 
treatment of fertility problems. 

Self-administration of
Luveris® should only be performed by patients who are
well-motivated, 
adequately trained and with access to expert advice. 

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 human chorionic gonadotrophin (hCG). Luveris® should be given as a
course of 
daily injections simultaneously with FSH. Since these patients are amenorrhoeic and have low 
endogenous oestrogen secretion, treatment can commence
at any time. 

All clinical
experience to date with Luveris® in this indication has been gained with concomitant 
administration of follitropin alfa. 
Luveris® is intended for subcutaneous administration. The powder 

Características técnicas

LUVERIS 75 IU
NAME OF THE MEDICINAL PRODUCT
Luveris® 75 IU, powder and solvent for solution for injection.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 75 IU of lutropin alfa (recombinant human
luteinising hormone {LH}). Lutropin alfa is produced in genetically
engineered Chinese hamster ovary (CHO) cells.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection. Appearance of the
product: white lyophilized pellet Appearance of the solvent:
clear colourless solution
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Luveris® in association with a follicle stimulating hormone (FSH)
preparation is Indicated for the stimulation of follicular
development in women with severe LH and FSH deficiency. (_See clinical
efficacy section)_
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Luveris® should be initiated under the supervision of
a physician experienced in the treatment of fertility
disorders.
Self-administration of Luveris® should only be performed by patients
who are well-motivated, adequately trained and with access
to expert advice.
In LH and FSH deficient women, the objective of Luveris® therapy in
association with FSH is to promote follicular development
followed by final maturation after the administration of human
chorionic gonadotrophin (hCG). Luveris® should be given as a
course of daily injections simultaneously with FSH. If the patients is
amenorrhoeic and haslow endogenous oestrogen secretion,
treatment can commence at any time.
All clinical experience to date with Luveris® in this indication has
been gained with concomitant administration of follitropin alfa.
Luveris® is intended for subcutaneous administration. The injection
site should be alternated daily. The powder should be
reconstituted, immediately prior to use, with the solvent provided.
A recommended regimen commences at 75 IU of lutropin alfa (ie. one
vial of Luveris®) daily with 75-150 IU FSH. Treatment should
be tailored to the individual patient’s response as assessed by
measuring (i) follicle size by ultra