OCTAPLASLG Solution for infusion Ref.[27958] Active ingredients: Human plasma protein fraction

Posology

The dosage depends upon the clinical situation and underlying disorder, but 12-15 ml octaplasLG/kg body weight is a generally accepted starting dose. This should increase the patient’s plasma coagulation factor levels by approximately 25%.

It is important to monitor the response, both clinically and with measurement of e.g. activated partial thromboplastin time (aPTT), prothrombin time (PT), and/or specific coagulation factor assays.

Dosage for coagulation factor deficiencies

An adequate haemostatic effect in minor and moderate haemorrhages or surgery in coagulation factor deficient patients is normally achieved after the infusion of 5-20 mL octaplasLG/kg body weight. This should increase the patient’s plasma coagulation factor levels by approximately 10-33 %. In the event of major haemorrhage or surgery, the expert advice of a haematologist should be sought.

Dosage for TTP and haemorrhages in intensive plasma exchange

For therapeutic plasma exchange procedures, the expert advice of a haematologist should be sought.

In TTP patients the whole plasma volume exchanged should be replaced with octaplasLG.

Method of administration

Administration of octaplasLG must be based on ABO-blood group specificity. In emergency cases, octaplasLG blood group AB can be regarded as universal plasma since it can be given to all patients regardless of blood group.

OctaplasLG must be administered by intravenous infusion after thawing, as described in section 6.6, using an infusion set with a filter. An aseptic technique must be used throughout the infusion.

After thawing the solution is clear to slightly opalescent and free of solid or gelatinous particles.

Citrate toxicity can occur when more than 0.020-0.025 mmol citrate per kg per minute is administered. Therefore, the infusion rate should not exceed 1 mL of octaplasLG per kg per minute. Toxic effects of citrate can be minimised by giving calcium gluconate intravenously into another vein.

Paediatric population

There is limited data in children and adolescents (0-16 years) (see section 4.4, 4.8 and 5.1).

• High dosages or infusion rates may induce hypervolaemia, pulmonary oedema and/or cardiac failure.
• High infusion rates may cause cardiovascular effects as a result of citrate toxicity (fall in ionised calcium), especially in patients with liver function disorders.

4 years.

After thawing, chemical and physical in-use stability has been demonstrated for 5 days at 2-8°C or 8 hours at room temperature (20-25°C).

From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Store and transport frozen (at ≤ -18°C).

Store in the original package in order to protect from light.

200 ml of ABO-blood group specific human plasma proteins in bag (polyvinyl chloride) over-wrapped with a film.

Pack size of 1 and 10.

Do not use after the expiry date given on the label.

There are several options for thawing frozen octaplasLG:

Water bath:

Thaw in the outer wrapper for not less than 30 minutes in a circulating water bath at +30°C to +37°C. An overwrap bag may be used to provide further protection of contents if appropriate.

Prevent water from contaminating the entry port. The minimum thawing time is 30 minutes at 37°C. Temperature in the water bath must never exceed +37°C and should not be lower than +30°C.

The thawing time depends on the number of bags in the water bath. If more plasma bags are thawed in parallel, the thawing time can be prolonged, but should not be longer than 60 minutes.

Using a dry tempering system such as the SAHARA-III:

Place the octaplasLG bags on the agitation plate according to the manufacturer instructions and thaw plasma using the fast tempering function. When a +37°C blood component temperature is indicated on the temperature display, terminate the tempering process and remove the bags.

During thawing of octaplasLG using a dry tempering system, it is recommended to use the protocol printer to record the course of the blood component temperature and error messages in event of failure.

Others:

Other thawing systems for frozen octaplasLG can be used on the condition that the methods are validated for that purpose.

Allow the content of the bag to warm to approximately +37°C before infusion. The temperature of octaplasLG must not exceed +37°C. Remove the outer wrapper and examine the bag for cracks or leaks.

Avoid shaking.

After thawing the solution is clear to slightly opalescent and free of solid or gelatinous particles.

Do not use solutions which are cloudy or have deposits and/or discoloration.

Thawed octaplasLG must not be refrozen. Unused product must be discarded.

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