NANOFIX 500 International Unit Pdr+Solv for Soln for Inj
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
23-03-2016
Summary of Product characteristics
(SPC)
28-12-2016
Active ingredient:
FACTOR IX, HUMAN
Available from:
Octapharma Limited
ATC code:
B02BD04
INN (International Name):
FACTOR IX, HUMAN
Dosage:
500 International Unit
Pharmaceutical form:
Pdr+Solv for Soln for Inj
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Blood coagulation factors
Authorization status:
Authorised
Authorization date:
2010-10-15
Patient Information leaflet
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PACKAGE LEAFLET: INFORMATION FOR THE USER
NANOFIX 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 NanoFIX is and what it is used for
2. What you need to know before you use NanoFIX
3. How to use NanoFIX
4. Possible side effects
5. How to store NanoFIX
6. Contents of the pack and other information
1.
WHAT NANOFIX IS AND WHAT IT IS USED FOR
NanoFIX 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.
NanoFIX 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.
NanoFIX 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 YOU NEED TO KNOW BEFORE YOU USE NANOFIX
DO NOT USE NANOFIX:
• if you are allergic to huma
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
NanoFix 500 IU, 500 IU powder and solvent for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
NanoFix 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.).
NanoFix 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 NanoFix is approximately
100 IU/mg protein.
This medicinal product contains up to 3 mmol (or 69 mg) sodium for 1 vial NanoFix 500 IU and up to 6 mmol (or
138 mg) sodium for 1 vial NanoFix 1000 IU per dose. To be taken into consideration by patients on a controlled
sodium diet.
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.
_Previously untreated patients_
The safety and efficacy of NanoFix in previously untreated patients have not yet been established.
Treatment monitoring
During the course of treatment, appropriate determination of factor IX levels is advised to guide the dose to be
administered and the frequency of repeated infus
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