Nonafact 100 IE/ml

KOMPOSISI :

Human Factor IX concentrate 500 IU

FARMAKOLOGI :

N/A

INDIKASI :

Prophylactic and on demand therapy of Hemophilia B

Kontra Indikasi :

Known Factor IX inhibitor

Efek Samping :

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 in patients treated with factor IX containing products. In some case, these reactions have progressed to severe anaphylaxis, and they have occurred in close temporal association with development of factor IX inhibitors. Nephrotic syndrome has been reported following attempted immune tolerance induction on haemophilia B patients with factor IX inhibitors and a history of allergic reaction.
On rare occasions, fever has been observed. Haemophilia B patients may develop antibodies (inhibitors) to factor IX. 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 contracted. During clinical trials with Nonafact conducted in previously treated patients development of inhibitors was not reported.
There is no experience of the treatment of previously untreated patients with Nonafact.
There is a potential risk of thromboembolic episodes following the administration of factor IX products, with a higher risk for low purity preparations. The use of low purity factor IX products has been associated with instances of myocardial infarction, disseminated intravascular coagulation, venous thrombosis and pulmonary embolism. The use of high purity factor IX is rarely associated with such side effects.

Peringatan :

- As with any intravenous protein product, allergic type hypersensitivity reactions are possible. The product contains traces of mouse proteins. Patients should be informed of the early signs of hypersensitivity reactions including urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. If these symptoms occur, patients should be advised to discontinue use of the product immediately and contact their physician. In case of shock, the current medical standards for shock-treatment should be observed.
- Since the use of factor IX complex concentrates has historically been associated with the development of thromboembolic complications, the risk being higher in low purity preparations, the use of factor IX-containing products may be potentially hazardous in patients with signs of fibrinolysis and in patients with disseminated intravascular coagulation (DIC). Because of the potential risk ofthrombotic complications, clinical surveillance for early signs of thrombotic and consumptive coagulopathy should be initiated with appropriate biological testing when administering this product to patients with liver disease, to patients post-operatively, to new-born infants, or to patients at risk of thrombotic phenomena or DIC. In each of these situations, the benefit of treatment with Nonafact should be weighed against the risk of these complications.
- Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/ removal of virus. Despite this, when medicines prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses or other pathogens. The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the non-enveloped viruses HAV and parvovirus B19.
- Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of plasma-derived factor IX concentrates.
- It is strongly recommended that every time that Nonafact is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
- After repeated treatment with Nonafact, patients should be monitored for the development of neutralising antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing.
- There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions. Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor. It should be noted that patients with factor IX inhibitors may be at an increased risk of anaphylaxis with subsequent challenge with factor IX. Because of the risk of allergic reactions with factor IX concentrates the initial administrations of factor IX should, according to the treating physicianís judgement, be performed under medical observation where proper medical care for allergic reactions could be provided.
- This medicinal product contains 75mmol/l sodium chloride per dose. To be taken into consideration by patients on a controlled sodium diet.

Aturan Pakai :

Cara Penyimpanan :

Stored at 2°C to 8°C, protected from light

Kemasan :

A glass flacon containing powder

A glass flacon containing 10 ml water for injection

Monoject needle, alcohol swab

No Reg :