REKOVELLE 72

Maa: Israel

Kieli: englanti

Lähde: Ministry of Health

Aktiivinen ainesosa:

FOLLITROPIN DELTA

Saatavilla:

FERRING PHARMACEUTICALS LTD

ATC-koodi:

G03GA10

Lääkemuoto:

SOLUTION FOR INJECTION

Koostumus:

FOLLITROPIN DELTA 72 MCG / 2.16 ML

Antoreitti:

S.C

Prescription tyyppi:

Required

Valmistaja:

FERRING GmbH ,GERMANY

Terapeuttinen alue:

FOLLITROPIN DELTA

Käyttöaiheet:

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. There is no clinical trial experience with Rekovelle in the long GnRH agonist protocol

Valtuutus päivämäärä:

2022-10-31

Pakkausseloste

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
REKOVELLE 12/36/72
SOLUTION FOR INJECTION UNDER THE SKIN
COMPOSITION: Each Rekovelle 12 multi-dose pen contains 12 mcg
follitropin delta
Each Rekovelle 36 multi-dose pen contains 36 mcg
follitropin delta
Each Rekovelle 72 multi-dose pen contains 72 mcg
follitropin delta
INACTIVE INGREDIENTS - See section 6 ‘Additional information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains concise information about this
medicine.
If you have any further questions, consult your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it seems to you that their medical
condition is similar to yours.
This medicine is intended for adult women over 18 years old.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Rekovelle is a medicine that contains follitropin delta. This is 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 women undergoing assisted
reproduction programmes such as _ in vitro_ fertilisation (IVF) and
intracytoplasmic sperm injection (ICSI) micromanipulation.
Rekovelle stimulates the ovaries to produce several follicles from
which eggs are collected and fertilised in the laboratory.
THERAPEUTIC GROUP: gonadotropins
2. BEFORE USING THIS MEDICINE
Before starting treatment, you and your partner in the fertility
treatment process must be checked by a fertility specialist.
_DO NOT USE THIS MEDICINE IF:_
you are sensitive (allergic) to follitropin delta or any of the
inactive
ingredients
in
this
medicine
(see
section 6)
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 syndrome)
you have vaginal bleeding for an unkno

Valmisteyhteenveto

1
1.
NAME OF THE MEDICINAL PRODUCT
REKOVELLE 12
REKOVELLE 36
REKOVELLE 72
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
REKOVELLE 12
One pre-filled multidose pen/cartridge delivers 12 micrograms
follitropin delta* in 0.36 mL solution.
REKOVELLE 36
One pre-filled multidose pen/cartridge delivers 36 micrograms
follitropin delta* in 1.08 mL solution.
REKOVELLE 72
One pre-filled multidose pen/cartridge 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) /cartridge.
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 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 applied to
other gonadotropins.
For the first treatment cycle, the individual daily dose will be
determined on the basis of the woman’s
serum anti-Müllerian hormone (AMH) concentration and her body weight.