Noxafil Adverse Reactions

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Full Prescribing Info

Adverse Reactions

Summary of the safety profile: The safety of posaconazole oral suspension has been assessed in >2,400 patients and healthy volunteers enrolled in clinical studies and from post-marketing experience. The most frequently reported serious related adverse reactions included nausea, vomiting, diarrhoea, pyrexia, and increased bilirubin.
Tabulated list of adverse reactions: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). (See Table 6.)

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Description of selected adverse reactions: Hepatobiliary disorders: During post-marketing surveillance of posaconazole oral suspension, severe hepatic injury with fatal outcome has been reported (see Precautions).

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posaconazole

Manufacturer:

MSD

Distributor:

Zuellig

Agencia Lei Va Hong