Rekovelle 36micrograms1.08ml solution for injection cartridges

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Follitropin delta

Tilgængelig fra:

Ferring Pharmaceuticals Ltd

ATC-kode:

G03GA10

INN (International Name):

Follitropin delta

Dosering:

33.33microgram/1ml

Lægemiddelform:

Solution for injection

Indgivelsesvej:

Subcutaneous

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF:

Indlægsseddel

Package leaflet: Information for the user
Rekovelle
®
36 micrograms/1.08 mL
solution for injection
follitropin delta
▼
This medicine is subject to additional monitoring. This
will allow quick identification of new safety information. You
can help by reporting any side effects you may get. See the
end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start using
this medicine because it contains important information
for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
-
This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1. What REKOVELLE is and what it is used for
2. What you need to know before you use
REKOVELLE
3. How to use REKOVELLE
4. Possible side effects
5. How to store REKOVELLE
6. Contents of the pack and other information
1. What REKOVELLE is and what it is used for
REKOVELLE contains follitropin delta, a follicle stimulating
hormone which belongs to the family of hormones called
gonadotropins. Gonadotropins are involved in reproduction
and fertility.
REKOVELLE is used in the treatment of female infertility
and in women undergoing assisted reproduction
programmes such as_ in vitro _fertilisation (IVF) and
intracytoplasmic sperm injection (ICSI). REKOVELLE
stimulates the ovaries to grow and develop many egg sacs
(‘follicles’), from which eggs are collected and fertilised in
the laboratory.
2. What you need to know 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.
Do not use REKOVELLE if:
·
you are allergic to follicle stimulating hormone or any of
the other ingredients of this medicine (listed in section 6

Produktets egenskaber

OBJECT 1
REKOVELLE SOLUTION FOR INJECTION 12MCG
Summary of Product Characteristics Updated 18-May-2017 | Ferring
Pharmaceuticals Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
REKOVELLE 12 micrograms/0.36 mL solution for injection
REKOVELLE 36 micrograms/1.08 mL solution for injection
REKOVELLE 72 micrograms/2.16 mL solution for injection
2. Qualitative and quantitative composition
REKOVELLE 12 micrograms/0.36 mL solution for injection
One multidose cartridge contains 12 micrograms follitropin delta* in
0.36 mL solution.
REKOVELLE 36 micrograms/1.08 mL solution for injection
One multidose cartridge contains 36 micrograms follitropin delta* in
1.08 mL solution.
REKOVELLE 72 micrograms/2.16 mL solution for injection
One multidose cartridge contains 72 micrograms follitropin delta* in
2.16 mL solution.
One mL of solution contains 33.3 micrograms of follitropin delta*
*recombinant human follicle-stimulating hormone (FSH) produced in a
human cell line (PER.C6) by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection (injection).
Clear and colourless solution with a pH of 6.0-7.0.
4. Clinical particulars
4.1 Therapeutic indications
Controlled ovarian stimulation for the development of multiple
follicles in women undergoing assisted
reproductive technologies (ART) such as an _in vitro f_ertilisation
(IVF) or intracytoplasmic sperm
injection (ICSI) cycle.
There is no clinical trial experience with REKOVELLE in the long GnRH
agonist protocol (see section
5.1).
4.2 Posology and method of administration
Treatment should be initiated under the supervision of a physician
experienced in the treatment of fertility
problems.
Posology
The posology of REKOVELLE is individualised for each patient and aims
to obtain an ovar