Octaplex Adverse Reactions

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Full Prescribing Info

Adverse Reactions

Immune System Disorders: Replacement therapy may rarely (>0.01% and <0.1%) lead to the formation of circulating antibodies inhibiting one or more of the human prothrombin complex factors. If such inhibitors occur, the condition will manifest itself as a poor clinical response.
Allergic or anaphylactic-type reactions and an increase in body temperature have not been observed in clinical studies with Octaplex but may rarely occur (>0.01% and <0.1%).
General Disorders and Administration Site Conditions: Increase in body temperature has not been observed but may rarely occur (>0.01% and <0.1%).
Vascular Disorders: There is a risk of thromboembolic episodes following the administration of human prothrombin complex (see Precautions).
Nervous System Disorders: Headache may rarely occur (>0.01% and <0.1%).
Investigations: A transient increase in liver transaminases has been rarely observed (>0.01% and <0.1%).
For safety with respect to transmissible agents, see Precautions.

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Octaplex Adverse Reactions

Manufacturer:

Octapharma

Distributor:

Pharmaniaga Marketing