Ovidrel

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Choriogonadotropin alfa 250ug; Choriogonadotropin alfa 250ug

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Choriogonadotropin alfa 250 µg

Dosage:

250 mcg/0.5mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Choriogonadotropin alfa 250ug Excipient: Mannitol Methionine Phosphoric acid Poloxamer Sodium hydroxide Water for injection Active: Choriogonadotropin alfa 250ug Excipient: Dibasic sodium phosphate dihydrate Mannitol Methionine Phosphoric acid Poloxamer Sodium hydroxide Sodium phosphate Water for injection

Units in package:

Cartridge, glass, in pre-assembled pen injector with 2 needles, 0.5 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Merck Serono SA

Therapeutic indications:

Anovulatory or oligo-ovulatory women: OVIDREL is administered to trigger ovulation and luteinisation in anovulatory or oligo-ovulatory patients after stimulation of follicular growth.

Product summary:

Package - Contents - Shelf Life: Cartridge, glass, in pre-assembled pen injector with 2 needles - 0.5 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 28 days not refrigerated stored at or below 25°C protect from light. Applied prior to use and within shelf-life. Discard if not used after 28 days. - Syringe, glass, 0.5mL syringe pack - 1 dose units - 24 months unopened stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Single use. Discard any residue. 30 days unopened stored at or below 25°C protect from light. Single use. Discard any residue. - Syringe, glass, 0.5mL syringe pack - 2 dose units - 24 months unopened stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Single use. Discard any residue. 30 days unopened stored at or below 25°C protect from light. Single use. Discard any residue. - Syringe, glass, 0.5mL syringe pack - 10 dose units - 24 months unopened stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Single use. Discard any residue. 30 days unopened stored at or below 25°C protect from light. Single use. Discard any residue.

Authorization date:

2003-10-01

Patient Information leaflet

Ovidrel®
1
OVIDREL
®
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 OVIDREL?
OVIDREL contains the active ingredient choriogonadotropin alfa (rch).
OVIDREL is used in women undergoing assisted
reproductive techniques such as in vitro fertilisation (IVF) and in
women who do not produce eggs (anovulation) or who produce
too few eggs (oligo-ovulation) to trigger the release of eggs
(ovulation) after other medicines have been used to develop follicles.
For more information, see Section 1. Why am I using OVIDREL?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE OVIDREL?
Do not use if you have ever had an allergic reaction to OVIDREL 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, ARE PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
OVIDREL?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with OVIDREL 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 OVIDREL?
•
The dose of OVIDREL is one pre-filled pen (250 microgram in 0.5 mL)
given as a single injection under the skin
(subcutaneously) after stimulation of follicular growth with other
medicines. Your doctor will explain how much and when to
give the injection. Each pre-filled pen is for single use in one
patient only.
•
Follow all directions given to you by your doctor or pharmacist
carefully, including the Instructions for Use provided in the
pack.
More instructions can be found in Section 4. How do I use OVIDREL?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING OVIDREL?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
OVIDREL.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly or ch

Summary of Product characteristics

Version: A006-0323 Page 1 of 19 Supersedes: A005-0721
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
OVIDREL
®
250 microgram/0.5 mL solution for injection pre-filled pen
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:
(i)
_Women undergoing superovulation prior to assisted reproductive
techniques such as in vitro _
_fer