Octanine Pdr+Solv for Soln for Inj 1000IU

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Toimeaine:

HUMAN COAGULATION, FACTOR IX

Saadav alates:

Octapharma (IP) SPRL Alle de la Recherche 65, 1070 (Anderlecht), Belgium

ATC kood:

B02BD04

INN (Rahvusvaheline Nimetus):

HUMAN COAGULATION FACTOR IX 1000 IU

Ravimvorm:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Koostis:

HUMAN COAGULATION FACTOR IX 1000 IU

Retsepti tüüp:

POM

Terapeutiline ala:

ANTIHEMORRHAGICS

Volitamisolek:

Authorised

Loa andmise kuupäev:

2010-04-05

Infovoldik

Page 1 of 12
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
OCTANINE 500 IU / 1000 IU, POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION
HUMAN COAGULATION FACTOR IX
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET
1. What OCTANINE is and what it is used for
2. What do you need to know before you use OCTANINE
3. How to use OCTANINE
4. Possible side effects
5. How to store OCTANINE
6. Contents of the pack and other information
1.
WHAT OCTANINE IS AND WHAT IT IS USED FOR
OCTANINE
belongs to a group of medicines called clotting factors and contains
the human
blood coagulation factor IX. This is a special protein, which
increases the ability of the blood
to clot.
OCTANINE is used for the treatment and prevention of bleeding in
patients with bleeding
disorder (haemophilia B). This is a medical condition in which
bleeding can go on for longer
than expected. It is due to an in-born deficiency in the amount of
coagulation factor IX in the
blood.
OCTANINE is supplied as a powder and solvent to prepare a solution for
injection. After
reconstitution, it is administered intravenously (injected into a
vein).
2.
WHAT DO YOU NEED TO KNOW BEFORE YOU USE OCTANINE
DO NOT USE OCTANINE:
•
if you are allergic to human blood coagulation factor IX or any of the
other ingredients of
this medicine (listed in section 6).
Page 2 of 12
_ _
•
if you suffer from heparin-induced thrombocytopenia type II, which is
a fall in the number
of platelets in the blood after administration of heparin. Platelets
are cells in th

Toote omadused

_20200228_SPC_220_MT_06.05 _
_ 1/12 _
1
NAME OF THE MEDICINAL PRODUCT
OCTANINE 500 IU
, 500 IU powder and solvent for solution for injection
OCTANINE 1000 IU
, 1000 IU powder and solvent for solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
•
OCTANINE 500 IU is presented as a powder and solvent for solution for
injection
containing nominally 500 IU human coagulation factor IX per vial.
The product contains approximately 100 IU/ml human coagulation factor
IX when
reconstituted with 5 ml water for injections (Ph.Eur.).
•
OCTANINE 1000 IU is presented as a powder and solvent for solution for
injection
containing nominally 1000 IU human coagulation factor IX per vial.
The product contains approximately 100 IU/ml human coagulation factor
IX when
reconstituted with 10 ml water for injections (Ph.Eur.).
OCTANINE is produced from plasma of human donors.
The potency (IU) is determined using the European Pharmacopoeia one
stage clotting test, in
comparison with an international standard from the World Health
Organisation (WHO). The
specific activity of OCTANINE
is approximately 100 IU/mg protein.
Excipients with known effect
This medicinal product contains up to 69 mg sodium for 1 vial OCTANINE
500 IU and up to
138 mg sodium for 1 vial OCTANINE 1000 IU.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder is white or pale yellow also appearing as a friable solid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding in patients with haemophilia B
(congenital factor IX
deficiency).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physician
experienced in the
treatment of haemophilia.
_20200228_SPC_220_MT_06.05 _
_ 2/12 _
_Previously untreated patients _
The safety and efficacy of OCTANINE in previously untreated patients
have not yet been
established.
Treatment monitoring
During the course of treatment, appropriate determination of factor IX
lev