Bemfola

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Follitropin alfa 75 [iU] (5.5 mcg)

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Follitropin alfa 75 IU (5.5 mcg)

Dosage:

600 IU/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Follitropin alfa 75 [iU] (5.5 mcg) Excipient: Dibasic sodium phosphate dihydrate Methionine Monobasic sodium phosphate dihydrate Phosphoric acid Poloxamer Sucrose Water for injection

Prescription type:

Prescription

Manufactured by:

Polymun Scientific Immunobiologische Forschung GmbH

Therapeutic indications:

In adult men: Bemfola is indicated with concomitant human chorionic gonadotrophin (hCG) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hCG alone is ineffective.

Product summary:

Package - Contents - Shelf Life: Cartridge, glass, in prefilled pen - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze). Do not freeze 3 months not refrigerated stored at or below 25°C - Cartridge, glass, in prefilled pen - 5 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 3 months not refrigerated stored at or below 25°C - Cartridge, glass, in prefilled pen - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 3 months not refrigerated stored at or below 25°C

Authorization date:

2016-02-11

Patient Information leaflet

Consumer Medicine Information
Bemfola
Gedeon Richter
May 2022
1
BEMFOLA®
_Recombinant human follicle stimulating hormone (follitropin alfa
[rch]) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Bemfola.
It does not contain all the
available information.
It does not take the place of
talking to your doctor, nurse or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you using
Bemfola against the benefits it
is expected to have for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE, ASK
YOUR DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS INFORMATION WITH
YOUR MEDICINE.
You may need to read it again
later.
WHAT IS BEMFOLA USED
FOR
Bemfola contains follitropin
alfa, which is similar to follicle
stimulating hormone (FSH)
found naturally in humans.
Bemfola belongs to a class of
hormones called
gonadotrophins. FSH is
necessary for the growth and
development of egg cells
(follicles) in women, and sperm
production in men.
Bemfola is an approved
biosimilar to the reference
product Gonal-f®.
Comparability in safety,
efficacy and quality between
Bemfola and Gonal-f® have
been established.
IN WOMEN
Bemfola can be used to bring
about the development of
follicles in women who are not
ovulating and who have not
responded to treatment with
clomiphene citrate.
Bemfola is also used to
stimulate the development of
several follicles in women
undergoing assisted
reproductive technologies
(ART) such as _in vitro_
fertilisation (IVF).
Bemfola can be used together
with another hormone called
Luteinising Hormone (LH) to
stimulate development of
follicles in women who have
been shown to produce very
low levels of some of the
hormones involved in the
natural reproductive cycle.
IN MEN
Bemfola is used in combination
with human chorionic
gonadotrophin (hCG) to
stimulate the production of
sperm.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
BEMFOLA HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have
prescribed it for another
reason.
Bemfola is ava

Summary of Product characteristics

New Zealand Data Sheet
Bemfola, Recombinant human follicle stimulating hormone (follitropin
alfa (rch))
GEDEON RICHTER
BEMFOLA DS–May 2022
Page 1 of 16
DATA SHEET
BEMFOLA
(FOLLITROPIN ALFA (RCH)) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
BEMFOLA Solution for Injection follitropin alfa (rch) 600IU/mL (75
IU/0.125 mL) cartridge in a pre-
filled pen;
BEMFOLA Solution for Injection follitropin alfa (rch) 600IU/mL (150
IU/0.25 mL) cartridge in a pre-
filled pen;
BEMFOLA Solution for Injection follitropin alfa (rch) 600IU/mL (225
IU/0.375 mL) cartridge in a pre-
flled pen;
BEMFOLA Solution for Injection follitropin alfa (rch) 600IU/mL (300
IU/0.5 mL) cartridge in a pre-
filled pen;
BEMFOLA Solution for Injection follitropin alfa (rch) 600IU/mL (450
IU/0.75 mL) cartridge in a pre-
filled pen.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
BEMFOLA is a biosimilar medicinal product, i.e. a medicine that has
been demonstrated to be similar
in quality, safety and efficacy to the reference medicinal product
GONAL-f®. The prescribing
physician should be involved in any decision regarding
interchangeability with other products.
Additional information is available on the following website
(http://www.medsafe.govt.nz/profs/RIss/Biosimilars.asp).
Data comparing BEMFOLA to GONAL-f can be found in “Clinical
Trials” section of this datasheet.
BEMFOLA contains the active ingredient follitropin alfa (rch). This is
produced by a Chinese Hamster
Ovary cell line transfected with the human FSH subunit genes (i.e. by
recombinant DNA technology).
Clear glass cartridges containing BEMFOLA solution for injection are
designed for subcutaneous
injection pre-assembled in a disposable pen. BEMFOLA is available as
solution for injection, containing
follitropin
alfa
(rch)
600IU/mL
in
the
following
presentations:
75
IU/0.125
mL
(5.5
micrograms/0.125mL),
150
IU/0.25
mL
(11
micrograms/0.25mL),
225
IU/0.375
mL
(16.5
micrograms/0.375mL),
300
IU/0.5
mL
(22
micrograms/0.5mL)
or
450 IU/0.75
mL
(33
micrograms/0.75mL) in pre-filled pens.
EXCIPIENT