LUVERIS lutropin alfa (rch) 75IU powder for injection vial with diluent vial

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

Lutropin alfa, Quantity: 75 IU

Dostępny od:

Merck Healthcare Pty Ltd

Forma farmaceutyczna:

Injection, powder for

Skład:

Excipient Ingredients: methionine; sodium hydroxide; phosphoric acid; sucrose; polysorbate 20; dibasic sodium phosphate dihydrate; monobasic sodium phosphate monohydrate

Droga podania:

Subcutaneous

Sztuk w opakowaniu:

1 vial of active powder - 75IU with 1 vial of diluent, 10 vials of active powder - 75IU with 10 vials of diluent, 3 vials of active powder - 75IU with 3 vials of diluent

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

LUVERIS in association with a recombinant 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 of less than 1.2 IU/L.

Podsumowanie produktu:

Visual Identification: WHITE LYOPHILISED PELLET; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status autoryzacji:

Registered

Data autoryzacji:

2003-03-24

Ulotka dla pacjenta

LUVERIS
® 75 IU
_Lutropin alfa (rch)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Luveris.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you using Luveris against the
benefits it is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS INFORMATION WITH YOUR
MEDICINE.
You may need to read it again later.
WHAT LUVERIS IS USED
FOR
Luveris is a medicine containing
lutropin alfa, a recombinant
luteinising hormone (LH), which is
essentially similar to the hormone
found naturally in humans, but it is
made by means of biotechnology. It
belongs to the family of hormones
called gonadotrophins, which are
involved in the normal control of
reproduction.
Luveris is for the treatment of
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) also known by the brand name
GONAL-f, to bring about the
development of follicles which are in
the ovaries, the structures maturing
the eggs (ova). It is followed by
treatment with a single dose of
human chorionic gonadotrophins
(hCG), which leads to the release of
an egg from the follicle (ovulation).
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY LUVERIS HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Luveris is available only on a
doctor's prescription.
Luveris is not habit-forming.
BEFORE YOU ARE GIVEN
LUVERIS
_WHEN YOU MUST NOT USE IT_
DO NOT USE LUVERIS IF:
•
you have a history of allergy to
gonadotrophins or to any of the
ingredients listed at the end of
this leaflet.
Symptoms of an allergic reaction
may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue

Charakterystyka produktu

Version: A012-0220
Page 1 of 13
Supersedes: A011-0119
AUSTRALIAN PRODUCT INFORMATION – LUVERIS
® (LUTROPIN ALFA
(RCH))
1
NAME OF THE MEDICINE
Lutropin alfa (rch)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lutropin alfa is a recombinant human luteinising hormone (r-hLH)
derived from a Chinese
Hamster Ovary cell line that has been modified by the addition of
human genes encoding the LH
α- and β-chains.
Each vial of LUVERIS contains 75 IU of lutropin alfa as lyophilised
powder.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Powder for injection in vial(s).
LUVERIS is available as a sterile, lyophilised powder.
It is intended for co-administration with follitropin alfa as
subcutaneous injection after
reconstitution with sterile water for injections.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
LUVERIS in association with a recombinant 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 of less
than 1.2 IU/L.
4.2
D
OSE 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 following
administration of human chorionic gonadotrophin (hCG). LUVERIS should
be given as a course
of daily injections concomitantly with FSH. Since these patients are
amenorrhoeic and have low
endogenous oestrogen secretion, treatment can commence at any time.
Nevertheless, the
possibility of pregnancy should be first excluded by clinical or other
means.
All clinical experience to date with LUVERIS in