Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Biotest Pharma GmbH, Landsteinerstrasse 5, 63303 Dreieich, Germany Tel.: +49 6103 801-0, Fax: +49 6103 801-150, Email: mail@biotest.com
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
This preparation does not contain von Willebrand factor in pharmacologically effective quantities and is therefore not indicated in von Willebrand´s disease.
Treatment should be under the supervision of a physician experienced in the treatment of haemophilia.
During the course of treatment, appropriate determination of factor VIII 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 VIII, 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 VIII activity) is indispensable.
When using an in vitro thromboplastin time (aPTT)-based one stage clotting assay for determining factor VIII activity in patients' blood samples, plasma factor VIII activity results can be significantly affected by both the type of aPTT reagent and the reference standard used in the assay. Also there can be significant discrepancies between assay results obtained by aPTT-based one stage clotting assay and the chromogenic assay according to Ph. Eur. This is of importance particularly when changing the laboratory and/or reagents used in the assay.
The dose and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient´s clinical condition.
The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO concentrate standard for factor VIII products. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or preferably in International Units (relative to an International Standard for factor VIII in plasma).
One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one ml of normal human plasma.
The calculation of the required dose of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by 1% to 2% of normal activity.
The required dose is determined using the following formula:
Required units = body weight (kg) x desired factor VIII rise (%) x 0.5
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 VIII activity should not fall below the given plasma activity level (in % of normal) in the corresponding period. The following table can be used to guide dosing in bleeding episodes and surgery:
| Degree of haemorrhage/Type of surgical procedure | Factor VIII level required (%) | Frequency of doses (hours)/Duration of therapy (days) |
|---|---|---|
| Haemorrhage | ||
| Early haemarthrosis, muscle bleeding or oral bleeding | 20-40 | Repeat every 12 to 24 hours. At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved. |
| More extensive haemarthrosis, muscle bleeding or haematoma | 30-60 | Repeat every 12 to 24 hours for 3-4 days or more until pain and acute disability are resolved. |
| Life threatening haemorrhages | 60-100 | Repeat every 8 to 24 hours until threat is resolved. |
| Surgery | ||
| Minor surgery including tooth extraction | 30-60 | Every 24 hours, at least 1 day, until healing is achieved. |
| Major surgery | 80-100 (pre- and post-operative) | Repeat every 8 to 24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor VIII activity of 30-60%. |
For long term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of factor VIII per kg body weight at intervals of 2 to 3 days. In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.
Intravenous use.
It is recommended not to administer more than 2-3 ml Haemoctin/min. For instructions on reconstitution of the medicinal product before administration, see section 6.6.
No case of overdose has been reported.
Shelf life: 2 years.
After first opening, the product should be used immediately.
Do not store above 25°C. Do not freeze.
Keep the vials in the outer carton in order to protect from light.
1 package Haemoctin contains:
1 vial (20 ml) with powder out of glass type I acc. to Ph. Eur.
Freeze-drying stoppers out of halobutyl-caoutchouc, type I acc. to Ph. Eur.
1 vial with 5 ml solvent, glass type I acc. to Ph. Eur. Injection stoppers out of halobutyl-caoutchouc, type I acc. to Ph. Eur.
The pack also contains:
1 disposable syringe (5 ml), 1 transfer system with integral filter, 1 butterfly cannula
Reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration. The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or have deposits.
Any unused product or waste material should be disposed of in accordance with local requirements.
Absolute sterility is to be ensured in all steps of the procedure!
Dissolution of the concentrate:
Injection:
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