FASENRA

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

BENRALIZUMAB

Διαθέσιμο από:

ASTRAZENECA (ISRAEL) LTD

Φαρμακολογική κατηγορία (ATC):

R03DX10

Φαρμακοτεχνική μορφή:

SOLUTION FOR INJECTION

Σύνθεση:

BENRALIZUMAB 30 MG / 1 ML

Οδός χορήγησης:

S.C

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

CATALENT INDIANA LLC, USA

Θεραπευτική περιοχή:

BENRALIZUMAB

Θεραπευτικές ενδείξεις:

Fasenra is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists.

Ημερομηνία της άδειας:

2018-10-09

Φύλλο οδηγιών χρήσης

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
FASENRA®
SOLUTION FOR INJECTION IN PRE-FILLED PEN
FOR SUBCUTANEOUS INJECTION
COMPOSITION:
Each pre-filled pen (1 ml) contains:
Benralizumab 30 mg
For inactive ingredients, refer to section 6 – further information.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE YOU START TAKING
THIS MEDICATION.
This leaflet contains concise information about the medicine. If you
have further questions, refer to the
doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it on to others. It
may harm them even if it seems to you that their ailment/medical
condition is similar.
1.
WHAT FASENRA IS AND WHAT THE MEDICINE IS INTENDED FOR?
Fasenra is indicated as an add-on maintenance treatment in adult
patients with severe eosinophilic
asthma inadequately controlled despite high-dose inhaled
corticosteroids and long-acting β-agonists.
THERAPEUTIC GROUP:
Anti-interleukin-5 receptor α monoclonal antibody.
What Fasenra is
Fasenra is a medicine containing the active substance benralizumab,
which is a monoclonal antibody,
a type of protein that recognises and attaches to a specific target
site in the body. The target site of
benralizumab is a protein called interleukin-5 receptor, which is
found particularly on a type of white
blood cell called an eosinophil.
How Fasenra works
Eosinophils are white blood cells involved in asthma inflammation in
eosinophilic asthma. By attaching
to the eosinophils, Fasenra helps to reduce their numbers.
Eosinophilic asthma is a type of asthma
characterized by high levels of eosinophils-type white blood cells in
the blood or lungs.
What are the benefits of using Fasenra:
Fasenra may reduce the number of asthma attacks you are experiencing,
help you breathe better and
decrease your asthma symptoms. If you are taking medicines called
‘oral corticosteroids’, using
Fasenra may also allow you to reduce

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Fasenra 30 mg solution for injection in pre-filled pen
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled pen contains 30 mg benralizumab* in 1 mL
*Benralizumab is a humanised monoclonal antibody 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.
Clear to opalescent, colourless to yellow solution and may contain
translucent or white to
off-white particles.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Fasenra is indicated as an add-on maintenance treatment in adult
patients with severe
eosinophilic asthma inadequately controlled despite high-dose inhaled
corticosteroids
plus long-acting β-agonists.
4.2 Posology and method of administration
Fasenra treatment should be
initiated by a physician experienced in the diagnosis and
treatment of severe asthma.
After proper training in the subcutaneous injection technique and
education about signs
and symptoms of hypersensitivity reactions, patients with no known
history of
anaphylaxis or their caregivers may administer Fasenra if their
physician determines that
it is appropriate, with medical follow-up as necessary.
Self-administration should only be
considered in patients already experienced with Fasenra treatment.
Posology
The recommended dose of benralizumab is 30 mg by subcutaneous
injection every 4
weeks for the first 3 doses, and then every 8 weeks thereafter. If an
injection is missed on
the planned date, dosing should resume as soon as possible on the
indicated regimen; a
double dose must not be administered.
Fasenra is intended for long-term treatment. A decision to continue
the therapy should be
made at least annually based on disease severity, level of
exacerbation control and blood
eosinophil counts.
Elderly
No dose adjustment is required for elderly patients (see section 5.2).
Renal and hepatic impairment
No dose adjustment is required fo