INTRAGAM Solution for infusion Ref.[50451] Active ingredients: Immunoglobulins, normal human, IV

Dose

Replacement therapy

Replacement therapy should be commenced and monitored under the supervision of a healthcare professional experienced in the treatment of immunodeficiency.

The optimal dose and frequency of administration of Intragam P must be determined for each patient. Freedom from recurrent bacterial infections is usually achieved with a serum IgG level above 5 g/litre. Most patients receive a dose of 0.2–0.6 g IgG/kg body weight (bw)/month, either as a single dose or as two equal doses, at fortnightly intervals. Following initial diagnosis, higher doses (0.4 to 0.6 g IgG/kg bw/month) may be required for several months to provide rapid protection against recurrent infections. Adjustment of both dose and infusion interval is empirical and should be based on the patient’s clinical state and the pre-infusion IgG level.

Immunomodulatory therapy

Idiopathic Thrombocytopenic Purpura (ITP)

The optimal dose and frequency of administration of Intragam P must be determined for each patient. Patients may receive a dose of up to a maximum total cumulative dose of 2 g IgG/kg bw, over 2 to 5 days Adjustment of both dose and infusion interval is empirical and should be based on the patient’s clinical state.

Guillain-Barré Syndrome (GBS)

Intragam P should be administered at a dose of 0.4 g IgG/kg bw/day, over 5 days.

Kawasaki Disease

The optimal dose and frequency of administration of Intragam P must be determined for each patient. Patients should receive 1.6–2.0 g IgG/kg bw, administered in divided doses over 2 to 5 days or 2 g IgG/kg bw as a single dose. Patients should receive concomitant treatment with acetylsalicylic acid.

Paediatric population

The dose in children is not different from that of adults as the dose for each indication is given by body weight and adjusted based on the pre-infusion IgG level and/or the clinical outcome.

Method of administration

For intravenous use.

The infusion should be commenced at the rate of 1 mL/minute (60 mL/hour). After 15 minutes the rate may be gradually increased to a maximum of 3–4 mL/minute (180–240 mL/hour) over a further 15 minutes. Consideration should be given to reducing the rate of infusion in patients naive to Intragam P, patients switching from an alternative IVIg, patients who have not received IVIg for a long time, paediatric and elderly patients and in patients with pre-existing renal disease (see section 4.4).

A rate of infusion which is too rapid may cause flushing and changes in heart rate and blood pressure.

Intragam P may be infused undiluted. It may also be infused diluted with up to 2 parts of 0.9% saline or 5% glucose.

For further instructions, see sections 4.4 and 6.6.

Overdosage may lead to fluid overload and hyperviscosity, particularly in the elderly and in patients with cardiac or renal impairment.

For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).

2 years at 2°C to 8°C.

Shelf life after first opening: Intragam P contains no antimicrobial preservative. It must, therefore, be used immediately after opening the bottle.

Temporary storage: Shelf life of 3 months when not refrigerated (below 25°C).

Store at 2°C to 8°C (Refrigerate. Do not freeze).

Once removed from refrigeration, store below 25°C and use within 3 months.

Do not use if the solution has been frozen.

Protect from light.

For storage conditions after first opening of the medicine, see section 6.3.

Solution in a single vial (type I glass), with a rubber closure, an aluminium seal, a flip-top cap (plastic).

Pack sizes:

One bottle of 10 mL solution containing 0.6 g human normal immunoglobulin.

One bottle of 50 mL solution containing 3 g human normal immunoglobulin.

One bottle of 200 mL solution containing 12 g human normal immunoglobulin.

One bottle of 500 mL solution containing 30 g human normal immunoglobulin.

Not all pack sizes may be marketed.

Use in one patient on one occasion only.

If Intragam P appears to be turbid or to contain any sediment, it must not be used. The unopened bottle should be returned to the New Zealand Blood Service.

Intragam P should be administered separately from other intravenous fluids or medications the patient might be receiving.

Intragam P may be administered through any standard IV infusion giving set. The following procedure is recommended:

1. Allow the preparation to reach room temperature before use.

2. Remove the plastic cover from the seal.

3. Apply a suitable antiseptic to the exposed part of the rubber stopper and allow to dry.

4. Stand the bottle upright and insert the air vent needle vertically in one of the indentations of the stopper. It is preferable to use a long airway needle fitted with a filter. If not available, a short needle attached to a non-wettable filter may be used.

5. Clamp the tubing of the giving set and insert the needle at the upper end of the giving set vertically through another indentation of the stopper. Should the stopper become dislodged, do not use this bottle and discard the solution appropriately.

6. Invert the bottle and attach the hanger to a support approximately one metre above the patient.

7. Allow the tubing to fill by adjusting the clamp. Attach the giving set to the venous access device (cannula) and adjust the rate of flow.

8. When the bottle is empty, clamp the tubing and transfer the needle at the upper end of the giving set to a further bottle of Intragam P.

9. Should leakage become evident during administration, cease the infusion and discard the solution appropriately. Recommence the infusion with a new bottle and giving set.

Any unused portion should be discarded appropriately.