Adverse reactions : תופעות לוואי

4.8 Undesirable effects

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 infrequently, and may in some cases progress to severe anaphylaxis (including shock).
On rare occasions, fever has been observed.
The adverse drug reactions reported are summarised and categorised according to the MedDRA system organ class in the table below. Within each frequency grouping, undesirable effects are presented in order of decreasing of seriousness. Frequency has been determined using the following criteria:
- very common: ≥1/10 infusions
- common: ≥1/100 to <1/10 infusions
- uncommon: ≥1/1,000 to <1/100 infusions
- rare: ≥1/10,000 to <1/1,000 infusions
- very rare: <1/10,000, not known (cannot be estimated from the available data.) 
System Organ Class                  Body System Preferred Term          ADR frequency evaluation Blood and lymphatic system          FVIII inhibitors                    Uncommon (PTPs)* disorders                                                               Very common (PUPs)* General disorders and               Pyrexia                             Rare administration site conditions
* Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients 
Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with Fanhdi® (see section 5.1). 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 information on transmissible agents' safety, see section 4.4.

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 (www.health.gov.il) according to the National Regulation by using an online form https://sideeffects.health.gov.il