Aleviate Dosage/Direction for Use

Dosage: It is recommended that prescribed doses of Aleviate should be expressed as International Units written in full.
The dosage recommendations provided are general guidelines for therapy. The exact loading and maintenance doses and dosing intervals should be based on the patient's clinical condition and response to therapy. Laboratory tests should be performed to ensure that the desired plasma FVIII and VWF concentrations are achieved.
The active ingredients VWF and FVIII are present in a ratio of 2:1.
Von Willebrand disease population: Provided in Table 4 are VWD dosage guidelines for patients with severe VWD (<10% normal VWF). In patients with less severe VWF deficiency, doses may need to be adjusted down to achieve the desired serum plasma concentrations. It is recommended that plasma VWF and FVIII concentrations are determined at suitable time intervals. (See Table 4.)

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In young patients or patients with gastrointestinal bleeds or menorrhagia, shorter dose intervals or higher doses may be necessary. The clinical status of the individual patient, as well as their VWF:RCo and FVIII:C plasma levels, should be taken into consideration in determining the dose and duration of treatment.
Paediatric VWD population: Based on results from a clinical trial in paediatric patients under 12 years of age to achieve haemostasis, a prophylactic dose range of 40-80 IU VWF:Ac/kg body weight (equivalent to VWF:RCo) 1 to 3 times a week should be considered.
Haemophilia A population: Provided in Table 5 are dosage guidelines for patients with Haemophilia A. (See Table 5.)

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Paediatric haemophilia A population: Dosing in haemophilia A in children (<12 years of age) and adolescents (12 to <18 years of age) is based on body weight and is therefore generally based on the same guidelines as for adults. In some cases shorter dose intervals or higher doses may be necessary. The frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Continuous infusion: Studies using continuous infusion have not been carried out in patients. However, it is suggested that this method is suitable for covering surgical procedures. The product required should be reconstituted to the same volume and in the same diluent as for bolus infusion, and administered using an infusion pump suitable for this volume. Reconstitution should be done under aseptic conditions, and sterile integrity of the delivery device should be maintained.
Monitoring advice: It is recommended that plasma FVIII:C and/or VWF:RCo concentrations be determined in patient's plasma at suitable intervals and during the treatment of severe bleeding episodes.
Administration: 1. With the Aleviate vial upright, attach a plastic disposable syringe to the Mix2Vial (transparent plastic part). Invert the system and draw the reconstituted Aleviate into the syringe by pulling the plunger back slowly. One large syringe may be used to pool several vials of reconstituted Aleviate.
2. Once Aleviate has been transferred into the syringe, firmly hold the barrel of the syringe (keeping the syringe plunger facing down) and detach the Mix2Vial from the syringe. Discard the Mix2Vial (transparent plastic part) and empty Aleviate vial in an appropriate waste container. Fit the syringe to a suitable injection needle to administer the reconstituted Aleviate. Do not use the Mix2Vial for injection.
3. Give the dose slowly by the intravenous route (usually within 5 to 6 minutes, or as tolerated by the patient). The injection/infusion rate should not exceed 6 mL per minute and the patient should be observed carefully during administration. If there is any reaction that might be related to the administration of Aleviate, the rate of injection should be decreased or if needed, the application should be stopped (see Precautions).
4. When the contents of more than one vial are to be given, it will be convenient to pool the total amount prior to administration (e.g. in a large syringe or sterile bag). This must be done aseptically.
5. To reduce microbiological hazard, use as soon as practicable after reconstitution/preparation. For use in surgery, the conditions previously described under Continuous infusion can apply. This product is for single use only and any unused portion remaining in the vial must be discarded appropriately.
6. The solution must not be added or mixed with any other fluids to be given, including whole blood.
Medical personnel, family carers and patients should be adequately trained in the techniques for the preparation and the administration of Aleviate.