OVIDREL choriogonadotropin alfa (rch) 250 microgram/ 0.5mL solution for injection pre-filled pen

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

Choriogonadotropin alfa, Quantity: 250 microgram

Beszerezhető a:

Merck Healthcare Pty Ltd

INN (nemzetközi neve):

Choriogonadotropin alfa

Gyógyszerészeti forma:

Injection, solution

Összetétel:

Excipient Ingredients: mannitol; water for injections; methionine; dibasic sodium phosphate dihydrate; poloxamer; phosphoric acid; sodium hydroxide; monobasic sodium phosphate monohydrate

Az alkalmazás módja:

Subcutaneous

db csomag:

1 pre-filled pen and 2 needles

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

Ovidrel is indicated in the treatment of (i) Women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF): Ovidrel is administered to trigger final follicular maturation and luteinisation after stimulation of follicular growth. (ii) Anovulatory or oligo-ovulatory women: Ovidrel is administered to trigger ovulation and luteinisation in anovulatory or oligo-ovulatory patients after stimulation of follicular growth.

Termék összefoglaló:

Visual Identification: Colourless, transparent glass cartridge with bromobutyl plunger and aluminium crimp cap. Liquid: clear and practically free from visible particles.; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Engedélyezési státusz:

Licence status A

Engedély dátuma:

2010-07-30

Betegtájékoztató

OVIDREL
®
_(choriogonadotropin alfa (rch)) solution for injection pre-filled
pen_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about OVIDREL.
It does not contain all of 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 OVIDREL against
the benefits it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS INFORMATION WITH YOUR
MEDICINE.
You may want to read it again later.
WHAT OVIDREL IS
USED FOR
OVIDREL belongs to a family of
hormones known as gonadotrophins,
which are involved in the normal
control of reproduction.
The active substance of OVIDREL is
choriogonadotropin alfa that is
produced in mammalian cells
modified by recombinant DNA
technology.
OVIDREL is used in women
undergoing assisted reproductive
techniques such as in vitro
fertilisation (IVF). Other medicines
are given first to bring about the
growth and development of several
follicles to produce eggs. Follicles
are the structures in your ovaries that
contain the egg. OVIDREL is then
used to ripen (mature) these follicles.
OVIDREL is also used in women
who do not produce eggs
(anovulation), or who produce too
few eggs (oligo-ovulation). It is used
to trigger the release of eggs
(ovulation), after other medicines
have been used to develop the
follicles.
Your doctor may prescribe
OVIDREL for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY OVIDREL
HAS BEEN PRESCRIBED FOR YOU.
OVIDREL is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU USE
OVIDREL
_WHEN YOU MUST NOT USE IT_
DO NOT USE OVIDREL IF YOU HAVE
OR HAVE HAD AN ALLERGY TO:
•
choriogonadotropin alfa or any of
the ingredients listed at the end of
this leaflet.
Symptoms of an allergic reaction
to OVIDREL may include
shortness of breath, wheezing or
difficulty breathing, swelling of
the face, lips, tongu

Termékjellemzők

Version: A005-0521 Page 1 of 20 Supersedes: A004-0320
AUSTRALIAN PRODUCT INFORMATION – OVIDREL
®
(CHORIOGONADOTROPIN ALFA (RCH)) SOLUTION FOR INJECTION PRE-FILLED PEN
1
NAME OF THE MEDICINE
Choriogonadotropin alfa (rch)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
OVIDREL is a preparation of chorionic gonadotrophin hormone produced
by genetically
engineered Chinese hamster ovary (CHO) cells. Each pre-filled pen
contains choriogonadotropin
alfa (rch) (recombinant human chorionic gonadotrophin hormone) 250
microgram in 0.5 mL.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Solution for injection in pre-filled pen.
OVIDREL is presented as a sterile liquid, single dose pre-filled pen.
Contains no antimicrobial
preservative.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
OVIDREL is indicated in the treatment of
(i)
_Women undergoing superovulation prior to assisted reproductive
techniques such as in vitro _
_fertilisation (IVF)_: OVIDREL is administered to trigger final
follicular maturation and
luteinisation after stimulation of follicular growth.
(ii)
_Anovulatory or oligo-ovulatory women_: OVIDREL is administered to
trigger ovulation and
luteinisation in anovulatory or oligo-ovulatory patients after
stimulation of follicular
growth.
4.2
D
OSE AND METHOD OF ADMINISTRATION
OVIDREL is intended for subcutaneous administration.
Treatment with OVIDREL should be performed under the supervision of a
physician
experienced in the treatment of fertility problems.
In comparative clinical trials, administration of a dose of 250
microgram of OVIDREL was as
effective as 5000 IU or 10,000 IU of urinary-derived hCG for the
Assisted Reproductive
Technologies (ART) endpoint of number of oocytes retrieved per patient
treated. In an
Ovulation Induction (OI) study, 250 microgram of OVIDREL was as
effective as 5000 IU of
urinary hCG in inducing final follicular maturation and ovulation.
Consequently, the following
dosing regimen should be applied:
Version: A005-0521 Page 2 of 20 Supersede