PERGOVERIS follitropin alfa (rch) / lutropin alfa (rch) powder for injection vial with diluent vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Follitropin alfa, Quantity: 150 IU; Lutropin alfa, Quantity: 75 IU

Available from:

Merck Healthcare Pty Ltd

INN (International Name):

Follitropin alfa,Lutropin alfa,water for injections

Pharmaceutical form:

Injection, powder for

Composition:

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

Administration route:

Subcutaneous

Units in package:

1 Vial powder plus 1 Vial diluent, 10 vials powder plus 10 vials diluent, 3 vials powder plus 3 vials diluent

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

PERGOVERIS is indicated for the stimulation of follicular development in women with severe LH and FSH deficiency.

Product summary:

Visual Identification: White to off-white powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2009-11-19

Patient Information leaflet

PERGOVERIS
®
_150 IU / 75 IU_
_Follitropin alfa (rch)/Lutropin alfa (rch) Powder for Injection_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PERGOVERIS.
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 PERGOVERIS
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 PERGOVERIS IS
USED FOR
PERGOVERIS is a medicine
containing follitropin alfa, a
recombinant follicle stimulating
hormone (FSH) and lutropin alfa, a
recombinant luteinising hormone
(LH) which are essentially similar to
the hormones found naturally in
humans, but they are made by means
of biotechnology. They belong to the
family of hormones called
gonadotrophins, which are involved
in the normal control of reproduction.
PERGOVERIS 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. PERGOVERIS is
used to bring about the development
of a single mature follicle. Follicles
are structures in the ovaries that
mature the eggs (ova). Once adequate
follicular development is achieved, a
single injectable dose of human
chorionic gonadotrophins (hCG) is
given, which leads to the release of
an egg from the follicle (ovulation).
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
PERGOVERIS HAS BEEN
PRESCRIBED FOR YOU.
You doctor may have prescribed it
for another reason.
PERGOVERIS is available only on a
doctor's prescription.
PERGOVERIS is not habit-forming.
BEFORE YOU ARE GIVEN
PERGOVERIS
_WHEN YOU MUST NOT USE IT_
DO NOT USE PERGOVERIS 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 inc

Summary of Product characteristics

Version: A006-0119 Page 1 of 14 Supersedes: A005-1014
AUSTRALIAN PRODUCT INFORMATION – PERGOVERIS
® (FOLLITROPIN
ALFA (RCH)/LUTROPIN ALFA (RCH)) POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Follitropin alfa (rch)/lutropin alfa (rch)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PERGOVERIS contains follitropin alfa (recombinant human follicle
stimulating hormone (r-
hFSH)) and lutropin alfa (recombinant human luteinising hormone
(r-hLH)) produced by
genetically engineered Chinese Hamster Ovary (CHO) cells. Each vial of
PERGOVERIS contains
150 IU (equivalent to 10.92 microgram) of follitropin alfa and 75 IU
of lutropin alfa (equivalent
to 3.0 microgram) 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).
PERGOVERIS is presented as a sterile, white to off-white lyophilised
powder. It is intended for
reconstitution with sterile water for injections. The pH of the
reconstituted solution is 6.5-7.5.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
PERGOVERIS is indicated 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 PERGOVERIS should be initiated under the supervision of
a physician
experienced in the treatment of fertility problems. The injection site
should be alternated daily
to prevent lipoatrophy. Self-administration of PERGOVERIS 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 PERGOVERIS therapy is
to develop a single
mature Graafian follicle from which the oocyte will be liberated
following administration of
human chorionic gonadotrophin (hCG). PERGOVERIS should be given as a
course of daily
injections. Since these patients are amenorrhoeic and have low
endogenous oestrogen
secretion, treatment can commence at any