Vitamins B&C Kyowa Kirin IVHP Safety Profile1
Post-marketing adverse reactions are reported voluntarily from a population with an unknown rate of exposure. Therefore it is not possible to estimate the true incidence of adverse reactions and the frequency is “unknown”.
Although potentially serious allergic adverse reactions such as anaphylactic shock may occur rarely during, or shortly after, parenteral administration of Vitamins B&C Kyowa Kirin IVHP, such rare occurrence of serious allergic reactions should not preclude the use of Vitamins B&C Kyowa Kirin IVHP in patients who need treatment by this route of administration particularly those at risk of Wernicke's encephalopathy - for whom treatment with parenteral thiamine is essential.
Initial warning signs of a reaction to Vitamins B&C Kyowa Kirin IVHP are sneezing or mild asthma and those treating patients need to note that the administration of further injections to such patients may give rise to anaphylactic shock. Facilities for treating anaphylactic reactions should be available whenever Vitamins B&C Kyowa Kirin IVHP is administered. To minimise the risk of such events with Vitamins B&C Kyowa Kirin IVHP, this medicinal product should be administered by infusion over a period of 30 minutes.