BEMFOLA

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

FOLLITROPIN ALFA

متاح من:

ILEX MEDICAL LTD, ISRAEL

ATC رمز:

G03GA05

الشكل الصيدلاني:

SOLUTION FOR INJECTION

تركيب:

FOLLITROPIN ALFA 600 IU/ML

طريقة التعاطي:

S.C

نوع الوصفة الطبية :

Required

المصنعة من قبل:

GEDEON RICHTER PLC, HUNGARY

المجال العلاجي:

FOLLITROPIN ALFA

الخصائص العلاجية:

In adult women• Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate.• Stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT).• Follitropin alfa in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. Inclinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/l.In adult men• Follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotrophin (hCG) therapy

تاريخ الترخيص:

2016-03-03

نشرة المعلومات

The content of this leaflet was updated according to the guidelines of
the Ministry of Health on
October 2017
PATIENT INFORMATION LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS
(PREPARATIONS), 1986
The medicine is dispensed with a doctor’s prescription only
BEMFOLA
SOLUTION FOR INJECTION IN PRE-FILLED PEN.
FOR SUBCUTANEOUS INJECTION.
ACTIVE INGREDIENT: FOLLITROPIN ALFA 600 IU/ML
Inactive ingredients: See paragraph 6.
Provided in the following dosages:
Bemfola 75 IU/0.125 mL
Bemfola 150 IU/0.25 mL
Bemfola 225 IU/0.375 mL
Bemfola 300 IU/0.50 mL
Bemfola 450 IU/0.75 mL
Read this entire leaflet carefully in its entirety before using this
medicine. This leaflet contains
concise information about the medicine. If you have any additional
questions contact 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.
Bemfola is not indicated for use in children and adolescents under 18
years of age.
FOR YOUR ATTENTION: it is important you make sure you always receive
the same medicine that
was prescribed to you by the attending expert physician, each time you
receive the medicine
at the pharmacy. If the medicine you received looks different than the
one you usually receive
or if the directions for use have changed, please refer immediately to
the pharmacist to make
sure you received the correct medicine. Any replacement or change of
dosage of a medicine
containing FOLLITROPIN ALFA must be done by the attending expert
physician. Please
check the commercial name of the product prescribed by the expert
physician in the
prescription against the medicine you received from the pharmacist and
make sure they are
identical.
1.
WHAT IS BEMFOLA USED FOR?
Bemfola is a medicine containing Follitropin Alfa, a type of follicle
stimulating hormone (FSH)
that stimulates the follicles in the ovaries that contain the egg
cells. FSH belongs to the group
of hormones known as gonadotropins, which are involved in

خصائص المنتج

1
_The content of this leaflet was updated according to the guidelines
of the Ministry of Health_
on October 2017
1.
NAME OF THE MEDICINAL PRODUCT
Bemfola
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of the solution contains 600 IU (equivalent to 44 micrograms)
of follitropin alfa*.
-
Bemfola 75 IU/0.125 mL solution for injection in pre-filled pen- each
pre-filled pen delivers
75 IU (equivalent to 5.5 micrograms) in 0.125 mL.
-
Bemfola 150 IU/0.25 mL solution for injection in pre-filled pen- each
pre-filled pen delivers
150 IU (equivalent to 11 micrograms) in 0.25 mL.
-
Bemfola 225 IU/0.375 mL solution for injection in pre-filled pen- each
pre-filled pen delivers
225 IU (equivalent to 16.5 micrograms) in 0.375 mL.
-
Bemfola 300 IU/0.50 mL solution for injection in pre-filled pen- each
pre-filled pen delivers
300 IU (equivalent to 22 micrograms) in 0.5 mL.
-
Bemfola 450 IU/0.75 mL solution for injection in pre-filled pen- Each
pre-filled pen delivers
450 IU (equivalent to 33 micrograms) in 0.75 mL.
* recombinant human follicle stimulating hormone (r-hFSH) produced in
Chinese Hamster Ovary
(CHO) cells by recombinant DNA technology.
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled pen (injection).
Clear colourless solution.
The pH of the solution is 6.7 - 7.3.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
IN ADULT WOMEN
• Anovulation (including polycystic ovarian disease, PCOD) in women
who have been
unresponsive to treatment with clomiphene citrate.
• Stimulation of multifollicular development in patients undergoing
superovulation for assisted
reproductive technologies (ART) such as _in vitro _fertilisation
(IVF), gamete intra-fallopian
transfer (GIFT) and zygote intra-fallopian transfer (ZIFT).
• Follitropin alfa in association with a luteinising hormone (LH)
preparation is recommended
for the stimulation of follicular development in women with severe LH
and FSH deficiency. In
clinical trials these patients were defined by an endog