Luveris

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

lutropin alfa

MAH:

Merck Europe B.V. 

ATC_code:

G03GA07

INN:

lutropin alfa

therapeutic_group:

Sex hormones and modulators of the genital system,

therapeutic_area:

Ovulation Induction; Infertility, Female

therapeutic_indication:

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

leaflet_short:

Revision: 21

authorization_status:

Authorised

authorization_date:

2000-11-29

PIL

21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE USER
Solvent in ampoules
LUVERIS 75 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
lutropin alfa
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Luveris is and what it is used for
2.
What you need to know before you use Luveris
3.
How to use Luveris
4.
Possible side effects
5.
How to store Luveris
6.
Contents of the pack and other information
1.
WHAT LUVERIS IS AND WHAT IT IS USED FOR
WHAT LUVERIS IS
Luveris is a medicine containing lutropin alfa, a recombinant
Luteinising Hormone (LH) which is
essentially similar to the hormone found naturally in humans, but is
made by means of biotechnology.
It belongs to the family of hormones called gonadotropins, which are
involved in the normal control of
reproduction.
WHAT LUVERIS IS USED FOR
Luveris is recommended for the treatment of adult women who have been
shown to produce very low
levels of some of the hormones involved in the natural reproductive
cycle. The medicine is used
together with another hormone called Follicle Stimulating Hormone,
(FSH), to bring about the
development of follicles, which are in the ovary, the structures
maturing the eggs (ova). It is followed
by treatment with a single dose of human Chorionic Gonadotropin (hCG),
which leads to the release
of an egg from the follicle (ovulation).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LUVERIS
DO NOT USE LUVERIS
•
if you are allergic to gonadotropins (such as luteinising hormone,
follicle stimulating hormone
or h

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 (powder 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.
Presentations other than ampoules should be considered for
self-administration by patients.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Luveris in association with a follicle stimulating hormone (FSH)
preparation is indicated for the
stimulation of follicular development in adult women with severe
luteinising hormone (LH) and FSH
deficiency.
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
promote follicular development followed by final maturation after the
administration of human
chorionic gonadotropin (hCG). Luveris should be given as a course of
daily injections simultaneously
with FSH. If the patient is amenorrhoeic and has 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.
3
In clinical trials, Luveris has been shown to increase the ovarian
sensitivity to follitropin alfa. If