Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).


Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with Haemoctin SDH. If such inhibitors occur, the condition will manifest itself as an insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre be contacted.

For safety information with respect to transmissible agents, see section 4.4.

Tabulated list of adverse reactions
The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
(<1/10,000), not known (cannot be estimated from the available data).
From clinical trials, non interventional studies, spontaneous reporting and regular literature screening the following adverse reactions were reported on Haemoctin® SDH: 
MedDRA Standard Adverse reactions             Frequency
System Organ
Class
Blood and       Factor VIII                   uncommon
lymphatic system      inhibition              (PTPs)* disorders                                     very common
(PUPs)*
Immune system       Anaphylactic shock,     not known disorders        hypersensitivity
Skin and              Erythema,               not known subcutaneous tissue   pruritus,urticaria,
disorder

*Frequency is based on studies with all factor VIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients.

Paediatric population
With exception of factor VIII inhibition, adverse reactions in children are expected to be the same as in adults (see table above).


Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.ilAdditionally, you should also report to Kamada Ltd. to email address: pharmacovigilance@kamada.com