Rekovelle

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

follitropin delta

Διαθέσιμο από:

Ferring Pharmaceuticals A/S

Φαρμακολογική κατηγορία (ATC):

G03GA10

INN (Διεθνής Όνομα):

follitropin delta

Θεραπευτική ομάδα:

Sex hormones and modulators of the genital system,

Θεραπευτική περιοχή:

Anovulation

Θεραπευτικές ενδείξεις:

Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.

Περίληψη προϊόντος:

Revision: 6

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2016-12-12

Φύλλο οδηγιών χρήσης

25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE USER
REKOVELLE 12 MICROGRAMS/0.36 ML SOLUTION FOR INJECTION IN A PRE-FILLED
PEN
follitropin delta
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)
•
if you have a tumour of the uterus, ovaries, breasts, pituitary gland
or hypothalamus
•
if you have enlarged ovaries or cysts on your ovaries (unless caused
by polycystic ovarian

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
REKOVELLE 12 micrograms/0.36 mL solution for injection in a pre-filled
pen
REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled
pen
REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled
pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
REKOVELLE 12 micrograms/0.36 mL solution for injection
One pre-filled multidose pen delivers 12 micrograms follitropin delta*
in 0.36 mL solution.
REKOVELLE 36 micrograms/1.08 mL solution for injection
One pre-filled multidose pen delivers 36 micrograms follitropin delta*
in 1.08 mL solution.
REKOVELLE 72 micrograms/2.16 mL solution for injection
One pre-filled multidose pen delivers 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 in a pre-filled pen (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.
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 ovarian
response which is associated with a favourable safety/efficacy
profile, i.e. aims to achieve an adequate
number of oocytes retrieved and reduce the interventions to prevent
ovarian hyperstimulation
syndrome (OHSS). REKOVELLE is dosed in micrograms (see section 5.1).
The dosing regimen is
specific for REKOVELLE and the microgram dose cannot be ap