Država: Južnoafrička Republika
Jezik: engleski
Izvor: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
ASPEN ABACAVIR 20 mg/mL (oral solution) SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): ASPEN ABACAVIR 20 mg/mL (oral solution) WARNING Hypersensitivity: In clinical studies, approximately 4% of subjects receiving ASPEN ABACAVIR developed a hypersensitivity reaction which in rare cases proved fatal. Description: This is characterised by the appearance of symptoms indicating multiorgan/body-system involvement. The majority of patients have fever and/or rash as part of the syndrome. The symptoms of this hypersensitivity reaction can occur at any time during treatment with ASPEN ABACAVIR, but usually appear within the first 6 weeks of initiation of treatment with ASPEN ABACAVIR (median time to onset 11 days), and most often include fever, gastrointestinal symptoms (nausea, vomiting, diarrhoea and abdominal pain), rash and fatigue or malaise. Other symptoms may include myalgia, arthralgia, oedema, paraesthesia and respiratory symptoms such as dyspnoea, sore throat or cough. The symptoms worsen with continued therapy and can be life-threatening. These symptoms usually resolve upon discontinuation of ASPEN ABACAVIR. Management: To avoid a delay in diagnosis and minimize the risk of a life threatening hypersensitivity reaction, ASPEN ABACAVIR should be permanently discontinued if hypersensitivity cannot be ruled out, even when other diagnoses are possible (respiratory diseases, flu-like illness, gastroenteritis or reactions to other medications). ASPEN ABACAVIR should not be re-started even if a recurrence of symptoms occurs following re-challenge with alternative medication(s). An Alert Card with information for the patient about the hypersensitivity reaction is included in the ASPEN ABACAVIR pack. Special considerations following an interruption of ASPEN ABACAVIR therapy: If therapy wi Pročitajte cijeli dokument