DIFICLIR Granules for oral suspension Ref.[50705] Active ingredients: Fidaxomicin

Posology

Adults

The recommended dose is 200 mg (5 ml) administered twice daily (once every 12 hours) for 10 days.

Special populations

Renal impairment

No dose adjustment is considered necessary. Due to the limited clinical data in this population, fidaxomicin should be used with caution in patients with severe renal impairment (see sections 4.4 and 5.2).

Hepatic impairment

No dose adjustment is considered necessary. Due to the limited clinical data in this population, fidaxomicin should be used with caution in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).

Paediatric population

For appropriate dosing in the paediatric population, granules for oral suspension or film-coated tablets may be used.

The recommended dose in paediatric patients weighing at least 12.5 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.

Table 1. Dosing instruction for the oral suspension:

Method of administration

DIFICLIR 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.

For instructions on reconstitution of the medicinal product before administration and administration via an enteral feeding tube, see section 6.6.

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.

No adverse reactions for acute overdose have been reported during clinical studies or from post-marketing data. However, the potential for adverse reactions cannot be ruled out and general supportive measures are recommended.

3 years.

The reconstituted suspension is stable for 12 days in a refrigerator (2°C–8°C).

This medicinal product does not require any special temperature storage conditions.

For storage conditions after reconstitution, see section 6.3.

Store in the original package in order to protect from light.

Amber glass bottle with a polypropylene child-resistant cap in an aluminium pouch containing 7.7 g of granules for oral suspension.

DIFICLIR granules for oral suspension should be reconstituted by a pharmacist or other healthcare professional prior to dispensing to the patient. Patients or caregivers should not prepare the oral suspension at home.

Instructions for reconstitution:

1. Shake the glass bottle to ensure the granules move around freely and no caking of the granules has occurred.

2. Measure 105 ml of purified water and add to the glass bottle. Note that the stability of fidaxomicin granules suspended in mineral water, tap water, or other liquids has not been established.

3. Close the glass bottle and shake vigorously for at least 1 minute.

4. Verify that the resulting liquid has no remaining caked granules left at the bottom of the bottle or any lumps. If caked granules or any lumps are observed, shake the glass bottle vigorously again for at least 1 minute.

5. Let the bottle stand for 1 minute.

6. Verify if a homogenous suspension is obtained.

7. Write the date of expiration of the reconstituted suspension on the bottle label (the shelf-life of the reconstituted suspension is 12 days).

8. Store the bottle at refrigerated temperature (2-8°C) before and during use.

9. Select an appropriate oral syringe and bottle adaptor suitable for dispensing liquid medicinal product to measure the correct dose.

After reconstitution, the suspension (110 ml) will appear as white to yellowish white.

An appropriate commercially available oral syringe and adaptor suitable for dispensing of liquid medicines should be selected by the healthcare professional in order to allow the patient or caregiver to measure the correct dose. The adaptor should be suitable for use in combination with the selected oral syringe and fits the bottle neck size, for example a press-in bottles adaptor (27 mm) or universal bottle adapter.

In case the treatment with fidaxomicin started in a hospital setting and the patient is discharged before the end of the treatment at the hospital, the patient should be provided with the oral suspension and a suitable oral syringe and adaptor. Patients or caregivers should not prepare the oral suspension at home.

Recommended oral syringe capacity for measuring the dose of the oral suspension is presented in the table below.

Table 3. Suggested oral syringe capacity for accurate dispensing:

If possible, the graduation corresponding to the appropriate dose should be marked or highlighted (according to the dosing table in section 4.2) on the oral syringe.

Administration via an enteral feeding tube:

In case of administration using an enteral feeding tube, an appropriate commercially available tube should be selected by the healthcare professional. Enteral feeding tubes made of polyvinylchloride (PVC) and polyurethane (PUR) have been shown compatible with the oral suspension. The recommended enteral feeding tube size and flush volume of water are provided in the table below.

Table 4. Recommended enteral feeding tube size and flush volume:

^* Based on tubes of 120 cm

Any unused product or waste material should be disposed of in accordance with local requirements.