Adverse reactions : תופעות לוואי

Adverse reactions
Patients naive to Omri-Hep-B™ 5% IV might experience a higher frequency of minor events than those well maintained on regular therapy. These might include inflammatory reactions, manifested by a rise in temperature, chills, nausea and vomiting and appear to be related to the rate of infusion.
During or shortly after the application of intravenous immunoglobulins minor side effects such as headache, chills, dizziness, fever, vomiting, allergic reactions, nausea, athralgia, low blood pressure and moderate back pain may occur occasionally. Dyspnea and tachycardia may occur more frequently and require medical attention. Cases of reversible   meningitis,    nephrotoxicity   isolated   cases   of   reversible   haemolytic anemia/haemolysis and rare cases of regressive cutaneous reactions, often eczema- like, have been observed with human immunoglobulin. Increase in creatininemia and/or acute renal failure have been observed.
Thrombotic events have been reported in the elderly, in patients with signs of cerebral or cardiac ischemia, and in overweight and overly volume depleted patients.


Rarely immunoglobulins may cause a fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no sensitivity to previous administrations. Slowing or stopping the infusion should allow the symptoms to disappear promptly. Thereafter the infusion may be started again using a lower infusion rate. Allergic and anaphylactic reactions necessitate immediate cessation of the infusion.
Less severe reactions may be controlled with glucocorticoids and/or antihistamines.


Patients previously sensitized to certain antigens, most commonly IgA, may be at risk of immediate anaphylactoid and hypersensitivity reactions. Epinephrine should be available for the treatment       of any acute anaphylactoid reaction          (see Warnings and Contraindications). When severe reactions occur, treatment for shock must be initiated according to current guidelines. For this purpose see the recommendations given in the following table.
Immediate measures to be taken in case of intolerable reaction:


Clinical symptoms                 Measures
Subjective         complaints Stop infusion
(backache, nausea, etc.)

Skin       symptoms      (flush, Antihistamines urticaria, etc.)

Tachycardia, moderate drop in Glucocorticoids i.v. (100-500 mg prednisolone) blood pressure (below 90 mm
Hg systolic)

Dyspnea Shock                     Dopamine continuous infusion (2-4 g/kg/min) high doses of glucocorticoids i.v. (up to 1 g prednisolone
[water soluble]), oxygen, volume expander, possibly increased diuresis using furosemide in case of normovolaemia, control of acid base balance and electrolytes (if necessary, correct).

Persistent      normovolaemic Dopamine dosage up to a maximum of 10 g/kg/min in shock                         combination with noradrenalin.

Cardiac or respiratory arrest     Resuscitation



Dosage
10,000 IU Omri-Hep-B™ 5% IV should be administered in the unhepatic stage of Liver Transplantation followed by maximum dose of 10,000 IU administered daily for the first 5-7 days after transplantation.


It is recommended that patients be tested periodically for Hepatitis B antibody levels in order to determine individual bioavailability.


It is accepted by convention that in order to prevent reinfection of graft, anti-HBsAg levels should be maintained above 100-150 mIU/ml. After an initial period of acclimation to Omri-Hep-B™ 5% IV, the interval between injections is usually 6-8 weeks but might vary from patient to patient. Prophylactic treatment and dosage should be adapted to the anti-HBsAg levels of the patient.
Administration
•   Omri-Hep-B ™ 5% IV should be infused intravenously at an initial rate of 0.01- 0.02 mL/kg/min for 15 minutes.
•   Infusion rate may increase gradually to a maximum of 0.08 mL/kg/min.
•   It is recommended not to exceed a rate of 2 mL/min.