CSL Behring Signs Agreements With Canadian Blood Services and Hema-Quebec to Supply Life-Saving... (preparations is that it is stabilized wi...)

CSL Behring Signs Agreements With Canadian Blood Services and Hema-Quebec to Supply Life-Saving Therapies

Date:4/3/2008

preparations is that it is stabilized with the amino acid proline, giving it excellent stability at room temperature (25 C) for a period of 24 months.

Privigen(R) is indicated for the treatment of primary and secondary immune deficiencies as well as immune thrombocytopenic purpura (ITP), a disorder characterized by low platelet counts due to the presence of auto-antibodies directed against the patient's own platelets.

Privigen(R) is contraindicated in individuals with selective IgA deficiency as well as in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. The most common adverse events observed with the use of Privigen(R) include: Headache, nausea, fatigue, chills and pain.

Vivaglobin(R) is the first subcutaneously-administered Ig replacement therapy approved in Canada. It has the added benefit of providing stable steady-state serum Ig levels without the peaks and troughs associated with intravenous Ig therapy.

Vivaglobin(R) has been shown in clinical studies to be safe in both adults and children. As with any medication, side effects may accompany treatment. The frequency of side effects was based on a review of more than 3,600 injections given during clinical trials in the United States and Canada. The most frequently reported side effect was injection/infusion site reaction, which generally consisted of a mild or moderate swelling, redness, and itching at the site of injection/infusion. In clinical trials, these reactions tended to decrease substantially after repeated use.

The most frequent adverse events reported by subjects irrespective of causality included headache, gastrointestinal disorder, fever, nausea, sore throat, rash, allergic reaction, pain, diarrhea and increased cough.

Because Privigen(R) and Vivaglobin(R) are made from human plasma, there is a risk, however slight, that they contain pathogens susceptible to cause diseases. This, in theory, al
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CSL Behring Signs Agreements With Canadian Blood Services and Hema-Quebec to Supply Life-Saving...(preparations is that it is stabilized wi...)