Contraindications : התוויות נגד

4.3   Contraindications

Roferon-A is contraindicated in patients with:
1)    A history of hypersensitivity to recombinant interferon alfa-2a or to any of the excipients listed in section 6.1,

2)    Patients with severe pre-existing cardiac disease or with any history of cardiac illness. No direct cardiotoxic effect has been demonstrated, but it is likely that acute, self-limiting toxicities (i.e., fever, chills) frequently associated with administration of Roferon-A may exacerbate pre-existing cardiac conditions,

3)    Severe renal, hepatic or myeloid dysfunction,

4)    Uncontrolled seizure disorders and/or compromised central nervous system function (see section
4.4.),
5)    Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver, 
6)    Chronic hepatitis who are being or have recently been treated with immunosuppressive agents, 
7)    Benzyl alcohol, which is an excipient in Roferon-A solution for injection has on rare occasions been associated with potentially fatal toxicities and anaphylactoid reactions in children up to 3 years old. Therefore, Roferon-A solution for injection should not be used in premature babies, neonates, infants or children up to 3 years old. Roferon-A solution contains 10 mg/ml benzyl alcohol.

Combination therapy with ribavirin: Also see ribavirin labelling if interferon alfa-2a is to be administered in combination with ribavirin in patients with chronic hepatitis C.