........Patients should be informed of early signs of hypersensitivity reactions including difficult breathing, shortness of breath, swelling, hives, itching, tightness of the chest, bronchospasm, laryngospasm, wheezing, hypotension, blurred vision, and anaphylaxis.

Immune system disorders

Uncommon:      Neutralising antibodies (factor IX inhibition)*

Rare:                Hypersensitivity/allergic reactions; such reactions may include anaphylaxis*, bronchospasm/respiratory distress, (dyspnoea), hypotension, angioedema, tachycardia, chest tightness, urticaria, hives, rash, burning sensation in jaw and skull, chills (rigors), tingling, flushing, lethargy, restlessness, dry cough/sneezing, blurred vision

Section 4.2            Posology and method of administration

New paragraph on administration by continuous infusion

Section 4.4            Special warnings and precautions for use

Additional early signs of hypersensitivity reactions

New paragraph on safety and efficacy of continuous infusion

Section 4.8            Undesirable effects

Amendment to Rare Immune system disorders

New paragraphs on Thrombotic events and Inadequate therapeutic response and inadequate factor IX recovery

Section 5.2            Pharmacokinetic properties

Change to title of Table 1 and change to explanation

Section 6.6            Special precautions for disposal and other handling

Change to useage instructions

4.5            Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

5.1             Pharmacodynamic properties

Pharmacotherapeutic group: antihaemorrhagic Blood Coagulation Factor IX; ATC code: B02BD09

6.6       Special precautions for disposal and other handling

BeneFIX is administered by intravenous (IV) injection after reconstitution of the lyophilised powder for injection with the supplied solvent (0.234% w/v sodium chloride solution) in the pre-filled syringe.

BeneFIX, when reconstituted, contains polysorbate-80, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC). This should be considered during the preparation and administration of BeneFIX. It is important that the recommendations in section 4.2 be followed closely.

Any unused product or waste material should be disposed of in accordance with local requirements.

The reconstituted solution should be used immediately or within 3 hours.

Because the use of BeneFIX by continuous infusion has not been evaluated, BeneFIX should not be mixed with infusion solutions or be given in a drip.

10.       DATE OF REVISION OF THE TEXT

14 February 2008