HAEMONINE Powder and solvent for solution for injection Ref.[2678] Active ingredients: Coagulation factor IX

Treatment should be under the supervision of a physician experienced in the treatment of haemophilia.

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 infusions. Individual patients may vary in their response to factor IX, demonstrating different half-lives and recoveries. Dose based on bodyweight may require adjustment in underweight or overweight patients. In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor IX activity) is indispensable.

Posology

Dose and duration of the substitution therapy depend on the severity of the factor IX deficiency, on the location and extent of the bleeding and on the patient´s clinical condition.

The number of units of factor IX administered is expressed in International Units (IU), which are related to the current WHO standard for factor IX products. Factor IX activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an International Standard for factor IX in plasma).

One International Unit (IU) of factor IX activity is equivalent to that quantity of factor IX in one ml of normal human plasma.

On demand treatment

The calculation of the required dosage of factor IX is based on the empirical finding that 1 International Unit (IU) factor IX per kg body weight raises the plasma factor IX activity by 1-2% of normal activity. The required dose is determined using the following formula:

Required units = body weight (kg) x desired factor IX rise (%) (IU/dl) x 0.8

The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.

In the case of the following haemorrhagic events, the factor IX activity should not fall below the given plasma activity level (in % of normal or in IU/dl) in the corresponding period. The following table can be used to guide dosing in bleeding episodes and surgery:

Prophylaxis

For long term prophylaxis against bleeding in patients with severe haemophilia B, the usual doses are 20 to 40 IU of factor IX per kilogram of body weight at intervals of 3 to 4 days. In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.

Paediatric population

There are insufficient data to recommend the use of Haemonine in children less then 6 years of age.

Method of administration

Intravenous use.

For instructions on dilution of the medicinal product before administration, see section 6.6. It is recommended to not exceed a maximal infusion rate of 5 ml/min.

No case of overdose has been reported.

Shelf life: 2 years.

Use immediately after reconstitution.

Do not store above 25°C.

Do not freeze.

Keep the vials in the outer carton in order to protect from light.

1 package Haemonine 500 contains:

• 1 vial with powder, glass type I (Ph.Eur.), closed with chlorobutyl rubber stopper, type I (Ph.Eur.)
• 1 vial with solvent (5 ml), glass type I (Ph.Eur.), closed with bromobutyl rubber stopper, type I (Ph.Eur.)

The pack also contains: 1 disposable syringe (5 ml), 1 double-filter transfer system, 1 butterfly cannula.

1 package Haemonine 1000 contains:

• 1 vial with powder, glass type I (Ph.Eur.), closed with chlorobutyl rubber stopper, type I (Ph.Eur.)
• 1 vial with solvent (10 ml), glass type I (Ph.Eur.), closed with bromobutyl rubber stopper, type I (Ph.Eur.)

The pack also contains: 1 disposable syringe (10 ml), 1 double-filter transfer system, 1 butterfly cannula.

Absolute sterility is to be ensured in all steps of the procedure !

Dissolution of the concentrate

*Bring the unopened vials of the solvent (water for injections) and product to room temperature. If a water bath is used for warming, it must be scrupulously ensured that the water does not come into contact with the caps or stoppers of the vials. Otherwise contamination of the medicine may occur.

• Remove the caps from both vials in order to expose the central portions of the rubber stoppers (1). Ensure that the rubber stoppers of the product and solvent vials are treated with a disinfectant.
• Remove the top of the transfer system packaging (2). Place the blue part of the transfer system onto the upright standing vial containing the solvent (3).
• Remove the remaining part of the packaging of the transfer system. Now the transparent part of the transfer system is visible.
• Place the product vial on an even surface.
• Turn the combination of transfer system and solvent vial upside down. Push the spike of the transparent part of the adapter straight down through the product vial stopper (4). The vacuum present in the product vial causes the solvent to flow into the product vial. (5) Immediately unscrew the blue part of the transfer system together with the solvent vial. Discard the solvent vial with the blue part of the transfer system attached (6). Gently swirling the product vial helps in dissolving the powder. Do not shake vigorously, all foaming is to be avoided! The solution is clear or slightly opalescent.

The solution ready for use must be used immediately after dissolving. Do not use solutions that are cloudy or have deposits.

Injection

• Once you have dissolved the dry substance as described above, screw the enclosed syringe with its Luer-Lock connector onto the substrate vial with the transparent part of the transfer system. This will allow you to draw the dissolved preparation easily into the syringe. A separate filter is unnecessary because the transfer system has its own integral filter.
• Carefully unscrew the bottle with the transparent part of the transfer system and inject the injection preparation slowly intravenously using the enclosed butterfly needle. The injection rate must not exceed 2-3 ml/minute.
• After the butterfly needle has been used, it can be made safe with the protective cap.

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