REFIXIA 1000 IU

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

NONACOG BETA PEGOL

Commercializzato da:

NOVO NORDISK LTD., ISRAEL

Codice ATC:

B02BD04

Forma farmaceutica:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composizione:

NONACOG BETA PEGOL 1000 IU/VIAL

Via di somministrazione:

I.V

Tipo di ricetta:

Required

Prodotto da:

NOVO NORDISK A/S, DENMARK

Area terapeutica:

COAGULATION FACTOR IX

Indicazioni terapeutiche:

Treatment and prophylaxis of bleeding in pretreated patients with haemophilia B (congenital factor IX deficiency).

Data dell'autorizzazione:

2023-03-15

Foglio illustrativo

1
1986
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REGULATIONS (PREPARATIONS)
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS'
This medicine is dispensed with a doctor’s prescription only
REFIXIA 1000 IU
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ACTIVE INGREDIENT:
nonacog beta pegol
Pegylated human coagulation factor IX (rDNA). Each vial of Refixia
contains nominally 1000 IU
nonacog beta pegol, corresponding to approximately 250 IU/ml after
reconstitution with histidine
solvent.
Inactive ingredients and allergens: See section 2 ‘Important
information about some of this
medicine’s ingredients’, and 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.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Refixia is indicated for treatment and prophylaxis of bleeding in
pretreated patients with
haemophilia B (congenital factor IX deficiency).
THERAPEUTIC GROUP: antihaemorrhagics, coagulation factor IX.
Refixia contains the active substance nonacog beta pegol. It is a
long-acting version of factor
IX.
Factor IX is a protein naturally found in the blood, which helps to
stop bleeding.
In patients with haemophilia B, factor IX is missing or does not work
properly. Refixia replaces
the faulty or missing factor IX and helps to form blood clots at the
site of bleeding.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active substance or to any of the
other ingredients in
this medicine (see section 6).
•
You are allergic to hamster proteins.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
TALK TO YOUR DOCTOR BEFORE USING REFIXIA.
ALLERGIC REACTIONS AND DEVELOPMENT OF INHIBITORS
There is a rare risk that you may experience a sudden and severe
allergic reaction (e.g.
anaphy

Scheda tecnica

1
1.
NAME OF THE MEDICINAL PRODUCT
Refixia 1000 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Refixia 1000 IU powder and solvent for solution for injection
Each vial contains nominally 1000 IU nonacog beta pegol*.
After reconstitution, 1 ml of Refixia contains approximately 250 IU
nonacog beta pegol.
*recombinant human factor IX, produced in Chinese Hamster Ovary (CHO)
cells by recombinant
DNA technology, covalently conjugated to a 40 kDa polyethylene-glycol
(PEG).
The potency (IU) is determined using the European Pharmacopoeia
one-stage clotting test. The
specific activity of Refixia is approximately 144 IU/mg protein.
Refixia is a purified recombinant human factor IX (rFIX) with a 40 kDa
polyethylene-glycol (PEG)
selectively attached to specific N-linked glycans in the rFIX
activation peptide. Upon activation of
Refixia, the activation peptide including the 40 kDa
polyethylene-glycol moiety is cleaved off, leaving
the native activated factor IX molecule. The primary amino acid
sequence of the rFIX in Refixia is
identical to the Ala148 allelic form of human plasma-derived factor
IX. No additives of human or
animal origin are used in the cell culture, purification, conjugation,
or formulation of Refixia.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder is white to off-white.
The solvent is clear and colourless.
pH: 6.4.
Osmolality: 272 mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding in pretreated patients with
haemophilia B (congenital factor IX
deficiency).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be under the supervision of a physician experienced
in the treatment of haemophilia.
Previously untreated patients
The safety and efficacy of Refixia in previously untreated patients
have not yet been established.
2
Treatment monitoring
Routine monitoring of factor IX activity levels for the purpose of
dose adjustment is n