OVALEAP 300IU/0.5mL follitropin alfa (rch) solution for injection, cartridge

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

Follitropin alfa, Quantity: 300 IU

Διαθέσιμο από:

Theramex Australia Pty Ltd

Φαρμακοτεχνική μορφή:

Injection, solution

Σύνθεση:

Excipient Ingredients: polysorbate 20; water for injections; sodium hydroxide; benzalkonium chloride; benzyl alcohol; mannitol; methionine; monobasic sodium phosphate dihydrate

Οδός χορήγησης:

Subcutaneous

Μονάδες σε πακέτο:

1

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

1. The treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated.,2. For controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies.,3. OVALEAP is indicated with concomitant human chorionic gonadotrophin (hCG) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hCG alone is ineffective.

Περίληψη προϊόντος:

Visual Identification: Clear and colourless liquid in a cartridge consisting of a glass carpule with a grey rubber stopper and a cartridge seal; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2021-03-10

Φύλλο οδηγιών χρήσης

OVALEAP
®
O
V
A
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®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING OVALEAP?
OVALEAP contains the active ingredient follitropin alfa. OVALEAP is
used to stimulate development of follicles in women who
do not ovulate and women undergoing assisted reproductive technologies
(ART) such as in vitro fertilisation (IVF) and in men in
combination with hCG to stimulate the production of sperm. For more
information, see Section 1. Why am I using OVALEAP? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE OVALEAP?
Do not use if you have ever had an allergic reaction to OVALEAP or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2.
What should I know before I use OVALEAP? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with OVALEAP and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I USE OVALEAP?
•
Your doctor will decide the correct dose of OVALEAP for you. Your dose
of OVALEAP may be adjusted depending on your
individual response to treatment. Please consult your doctor if you
are in any doubt.
•
OVALEAP is given as a course of daily injections. You should have your
injection at the same time each day.
More instructions can be found in Section 4. How do I use OVALEAP? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING OVALEAP?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, or pharmacist you visit that you are using
OVALEAP.
•
See your doctor regularly. Your doctor will monitor you closely
throughout your treatment.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
•
Do not use OVALEAP if you are pregnant or breastfeeding
•
Do not us

Αρχείο Π.Χ.Π.

OVALEAP PRODUCT INFORMATION
PI V5-0321
1
AUSTRALIAN PRODUCT INFORMATION
–
OVALEAP
®
(FOLLITROPIN ALFA
(RCH)) SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Follitropin alfa (rch)
OVALEAP is a biosimilar medicine to GONAL-f
®
solution for injection. The evidence for
comparability supports the use of OVALEAP for the listed indications.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
OVALEAP is produced by a Chinese Hamster Ovary cell line transfected
with the human FSH
subunit genes (i.e. by recombinant DNA technology). Each cartridge
contains the active
ingredient follitropin alfa (rch) (recombinant human follicle
stimulating hormone) 300 IU/0.5
mL, 450 IU/0.75 mL or 900 IU/1.5 mL.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Solution for injection available in packs containing 1 glass cartridge
and 10 or 20 injection
needles. The Ovaleap cartridge is designed for use in conjunction with
the Ovaleap Pen only,
which is separately available.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.
The treatment of anovulatory infertility in women who have been
unresponsive to clomiphene citrate or where clomiphene citrate is
contraindicated.
2.
For controlled ovarian hyperstimulation in women undergoing assisted
reproductive technologies.
3.
OVALEAP
is
indicated
with
concomitant
human
chorionic
gonadotrophin
(hCG)
therapy for the stimulation of spermatogenesis in
gonadotrophin-deficient men in
whom hCG alone is ineffective.
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment with OVALEAP should be initiated under the supervision of a
physician
experienced in the treatment of fertility disorders.
OVALEAP should be administered subcutaneously. The injection site
should be alternated daily
to prevent lipoatrophy. Self-administration of OVALEAP should only be
performed by patients
who are well motivated, adequately trained and who have access to
expert advice. Ovaleap
cartridge should only be administered using the OVALEAP Pen. The
instructions for use of the
pen will be provided