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As most undesirable effects are based on post-marketing spontaneous reporting, frequency estimation is not possible. Immune system disorders Frequency not known: Hypersensitivity reactions, such as sweating, tachycardia, and skin reactions with itching and urticaria. Gastrointestinal disorders Less frequent: Gastrointestinal complaints, such as nausea, vomiting, diarrhoea and abdominal pain. Skin and subcutaneous tissue disorders Less frequent: Cases of acne or eczema have been reported after high doses of Vitamin B12. General disorders and administration site conditions Frequency not known: Injection site reactions. Renal and urinary disorders Less frequent: Chromaturia (“reddish urine”, appeared during the first 8 hours after an administration and typically resolves within 48 hours). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications

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Moldex® foam earplugs are all disposable foam earplugs and must be discarded once they are soiled/dirty

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