REKOVELLE 36 mcg1.08 mL solution for injection in pre-filled pen

Country: Մալայզիա

language: անգլերեն

source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

active_ingredient:

Follitropin Delta

MAH:

Ferring Sdn. Bhd.

INN:

Follitropin Delta

units_in_package:

1 Units

manufactured_by:

FERRING GMBH

PIL

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
REKOVELLE
®
Solution for injection in pre-filled pen
12 micrograms/0.36 mL
36 micrograms/1.08 mL
72 micrograms/2.16 mL
1
WHAT IS IN THIS LEAFLET
1. What REKOVELLE is used for
2. How REKOVELLE works
3. Before you use REKOVELLE
4. How to use REKOVELLE
5. While you are using it
6. Side effects
7. Storage and disposal of
REKOVELLE
8. Product description
9. Manufacturer and Product
Registration Holder
10. Date of Revision
WHAT REKOVELLE IS USED FOR
REKOVELLE is used in the treatment
of female infertility and in women
undergoing assisted reproduction
programmes such as in vitro
fertilization (IVF) and
intracytoplasmic sperm injection
(ICSI). REKOVELLE stimulates the
ovaries to grow and develop many egg
sacs (‘follicles’), from which eggs are
collected and fertilized in the
laboratory.
HOW REKOVELLE WORKS
REKOVELLE contains follitropin
delta, a follicle stimulating hormone
which belongs to the family of
hormones called gonadotropins.
Gonadotropins are involved in
reproduction and fertility.
BEFORE YOU USE REKOVELLE
Before starting treatment with this
medicine, a doctor should check you
and your partner for possible causes of
your fertility problems.
_-when you must not use it_
DO NOT take REKOVELLE if:
•
you are allergic to follicle
stimulating hormone or any of the
other ingredients of this medicine
(listed in product description
section)
•
you have a tumour of the uterus,
ovaries, breasts, pituitary gland or
hypothalamus
•
you have enlarged ovaries or cysts
on your ovaries (unless caused by
polycystic ovarian disease)
•
you suffer from bleeding from the
vagina without any known cause
•
you have had an early menopause
•
you have malformations of the
sexual organs which make a
normal pregnancy impossible
•
you have fibroids of the uterus
which make a normal pregnancy
impossible.
_-Before you start to use it _
Check with your doctor before taking
REKOVELLE.
REKOVELLE should be used with
caution in situation:
Ovarian hyperstimulation syndrome
Gonadotrop

SPC

YOUR HEALTHCARE PROVIDER SHOULD SHOW YOU
HOW TO PREPARE AND INJECT REKOVELLE
THE RIGHT WAY BEFORE YOU INJECT IT FOR THE
FIRST TIME.
Do not try to inject yourself until you have
been shown the right way to give your injec-
tions by your healthcare provider.
Read this booklet completely before using
your REKOVELLE pre-filled pen and each
time you get a new pen. There may be new
information. Follow the instructions carefully
even if you have used a similar injection pen
before. Using the pen incorrectly could result
in receiving an incorrect dose of medicine.
Call your healthcare provider (doctor, nurse
or pharmacist) if you have any questions
about how to give your REKOVELLE injec-
tion.
The REKOVELLE pre-filled pen is a dispos-
able, dial-a-dose pen that can be used to
give more than 1 dose of REKOVELLE.
The pen is available in 3 different strengths:
• 12 MICROGRAMS/0.36 ML
• 36 MICROGRAMS/1.08 ML
• 72 MICROGRAMS/2.16 ML
Instructions for Use
REKOVELLE
®
(follitropin delta)
Pre-filled pen
XXXXXXX
25
REKOVELLE pre-filled pen and its parts
Outer needle cap
Needle
Protective foil
Dose knob
Injection button
Inner needle cap
Pen cap
Cartridge holder
Dose scale
Cartridge with medicine
Dose display window
Dose indicator
Warnings
• Do not use a pen if it has been
dropped or hit against hard surfaces.
• If the injection button is not easy to
push in, do not use force. Change
the needle. If the injection button still
is not easy to push in after changing
the needle, use a new pen.
• Do not try to repair a damaged pen.
If a pen is damaged, contact your
healthcare provider or local repre-
sentative of the marketing authorisa-
tion holder (please refer to patient
information leaflet for contact details).
Additional information
Needles
Needles are supplied with your pen.
If you need additional needles contact
your healthcare provider. Use only nee-
dles that come with your
REKOVELLE pre-filled pen or that your
healthcare provider prescribes.
Contact
If you have any questions or problems
related to the pen, contact y