FIDAXOMICIN

1). 1). If a dose has been forgotten, the missed dose should be taken as soon as possible or, if it's nearly time for the next dose, the tablet should be skipped altogether. Special populations Renal impairment No dose adjustment is considered necessary.

2). Hepatic impairment No dose adjustment is considered necessary. 2). Paediatric population For appropriate dosing in the paediatric population, granules for oral suspension or film-coated tablets may be used. 5 kg is 200 mg (5 ml oral suspension) administered twice daily (once every 12 hours) for 10 days.

The recommended dose of the oral suspension in paediatric patients, by body weight, to be administered twice daily (once every 12 hours) for 10 days, is presented in the table below. 5 kg 200 mg 5 ml Method of administration FIDAXOMICIN is intended for oral use (by ingestion or via an enteral feeding tube using a syringe, if necessary).

The granules for oral suspension can be taken with or without food. 6.

Instructions for use for the oral suspension:

The bottle should be taken from the refrigerator 15 minutes prior to administration and approximately 10 times gently shaken. Once reconstituted, the oral suspension should only be administered using the oral syringe and adaptor provided by the healthcare professional.

The bottle should be stored in a refrigerator after each use.

2%). Tabulated list of adverse reactions Table 2 displays adverse reactions associated with twice daily administration of fidaxomicin in the treatment of C. difficile infection, reported in at least two patients, presented by system organ class.

The frequency of adverse reactions is defined as follows: 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).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 4). Paediatric population The safety and efficacy of fidaxomicin has been evaluated in 136 patients from birth to less than 18 years of age.

Frequency, type and severity of adverse reactions in children are expected to be the same as in adults. In addition to the ADRs shown in table 2, two cases of urticaria were reported. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

8). If a severe allergic reaction occurs during treatment with fidaxomicin, the medicinal product should be discontinued and appropriate measures taken. Some patients with hypersensitivity reactions reported a history of allergy to macrolides.

Fidaxomicin should be used with caution in patients with a known macrolides allergy. 2). Pseudomembranous colitis, fulminant or life threatening CDI Due to limited clinical data, fidaxomicin should be used with caution in patients with pseudomembranous colitis, fulminant or life threatening CDI.

2). In case fidaxomicin is administered concomitantly with potent P-glycoprotein inhibitors, caution is advised. FIDAXOMICIN contains sodium FIDAXOMICIN contains less than 1 mmol sodium (23 mg) per 5 ml suspension, that is to say essentially ‘sodium-free’.

Paediatric population Only one paediatric patient below 6 months of age and no patients with a body weight below 4 kg have been exposed to fidaxomicin in clinical trials. Therefore, fidaxomicin should be used with caution in these patients.

Testing for C. difficile colonization or toxin is not recommended in children younger than 1 year due to high rate of asymptomatic colonisation unless severe diarrhoea is present in infants with risk factors for stasis such as Hirschsprung disease, operated anal atresia or other severe motility disorders.

Alternative aetiologies should always be sought and C. difficile enterocolitis be proven. 5 mg sodium benzoate (E 211) in each ml oral suspension. Sodium benzoate (E 211) may increase jaundice in newborn babies (up to 4 weeks old).

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