ARANESP 30 MCG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DARBEPOETIN ALFA

Available from:

AMGEN EUROPE B.V.

ATC code:

B03XA02

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

DARBEPOETIN ALFA 30 MCG / 0.3 ML

Administration route:

S.C, I.V

Prescription type:

Required

Manufactured by:

AMGEN EUROPE B.V., NETHERLANDS

Therapeutic area:

DARBEPOETIN ALFA

Therapeutic indications:

Aranesp ® is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients ≥ 1 year of age

Authorization date:

2021-12-31

Patient Information leaflet

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATION
(PREPARATIONS) – 1986
This medicine is dispensed with a doctor’s prescription only.
ARANESP
® SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 10 MCG, 20 MCG, 30
MCG, 40 MCG, 50 MCG, 60 MCG,
80 MCG, 100 MCG, 150 MCG, 300 MCG, 500 MCG
ACTIVE INGREDIENT
Each pre-filled syringe of Aranesp 10 mcg, contains 10 mcg of
darbepoetin alfa in 0.4 mL (25 mcg/1 mL)
Each pre-filled syringe of Aranesp 20 mcg, contains 20 mcg of
darbepoetin alfa in 0.5 mL (40 mcg/1 mL)
Each pre-filled syringe of Aranesp 30 mcg, contains 30 mcg of
darbepoetin alfa in 0.3 mL (100 mcg/1 mL)
Each pre-filled syringe of Aranesp 40 mcg, contains 40 mcg of
darbepoetin alfa in 0.4 mL (100 mcg/1 mL)
Each pre-filled syringe of Aranesp 50 mcg, contains 50 mcg of
darbepoetin alfa in 0.5 mL (100 mcg/1 mL)
Each pre-filled syringe of Aranesp 60 mcg, contains 60 mcg of
darbepoetin alfa in 0.3 mL (200 mcg/1 mL)
Each pre-filled syringe of Aranesp 80 mcg, contains 80 mcg of
darbepoetin alfa in 0.4 mL (200 mcg/1 mL)
Each pre-filled syringe of Aranesp 100 mcg, contains 100 mcg of
darbepoetin alfa in 0.5 mL (200 mcg/1 mL)
Each pre-filled syringe of Aranesp 150 mcg, contains 150 mcg of
darbepoetin alfa in 0.3 mL (500 mcg/1 mL)
Each pre-filled syringe of Aranesp 300 mcg, contains 300 mcg of
darbepoetin alfa in 0.6 mL (500 mcg/1 mL)
Each pre-filled syringe of Aranesp 500 mcg, contains 500 mcg of
darbepoetin alfa in 1 mL (500 mcg/1 mL)
FOR INACTIVE INGREDIENTS AND ALLERGENS IN THE MEDICINE – SEE SECTION
6 “ADDITIONAL INFORMATION’’ READ THIS
LEAFLET CAREFULLY AND UNTIL THE END BEFORE USING THIS MEDICINE.
This leaflet contains essential information about the
medicine. If you have any additional questions, contact your doctor or
pharmacist.
This medicine is prescribed for treating your specific illness. Do not
pass it on to others. It may cause them harm
even if it appears to you that their illness is the same.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Aranesp is registered for the treatment of anemia

Summary of Product characteristics

1
REVISED IN MARCH 2021 ACCORDING TO MOHS GUIDELINES.
Prescribing Information
ARANESP
®
SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
SOLUTION FOR INJECTION IN A PRE-FILLED PEN (SURE-CLICK
®
)
1.
NAME OF THE MEDICINAL PRODUCT
ARANESP
®
10, 20, 30, 40, 50, 60, 80, 100, 150, 300, 500 micrograms, solution
for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe
or pre-filled pen contains: 10, 20, 30, 40, 50, 60, 80, 100, 150, 300,
500 micrograms of darbepoetin alfa.
Darbepoetin alfa is produced by gene-technology in Chinese Hamster
Ovary Cells (CHO-K1).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe or pre-filled pen
(Sure-Click
®
).
Clear, colorless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
ARANESP
®
is indicated for the treatment of symptomatic anemia associated with
chronic renal
failure (CRF) in adults and pediatric patients ≥ 1 year of age (see
section 4.2).
•
ARANESP
®
150 mcg, 300 mcg and 500 mcg are indicated for the treatment of
symptomatic
anemia in adult cancer patients with non-myeloid malignancies
receiving chemotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ARANESP
®
treatment
should
be
initiated
by
physicians
experienced
in
the
above
mentioned
indications.
ARANESP
®
may be administered subcutaneously by the patient or a carer after
being trained by a
doctor, nurse or pharmacist.
ARANESP
®
is supplied ready for use in a pre-filled syringe or pre-filled pen
(Sure-Click
®
).
The pre-filled syringe is administered either subcutaneously or
intravenously.
The pre-filled pen is only for subcutaneous administration.
The instructions for use, handling and disposal are given in section
special precautions for disposal.
_ _
_TREATMENT OF SYMPTOMATIC ANEMIA IN CHRONIC RENAL FAILURE PATIENTS _
Anemia symptoms and sequelae may vary with age, gender, and overall
burden of disease; a
physician’s
evaluation
of
the
individual
patient’s
clinical
course
and
condition
is
necessary.