AQNEURSA Granules for oral suspension Ref.[116287] Active ingredients: Levacetylleucine

Posology

Adults and paediatric population aged 6 years and older and weighing at least 20 kg

The recommended dose is based on the patient's body weight in kg according to Table 1. Food and drink should be avoided 0.5 hours before and 2 hours after administration (see section 5.2).

Table 1. Recommended dose:

If a dose is missed, it should be skipped, and the next dose should be taken as scheduled.

Paediatric population aged less than 6 years or weighing under 20 kg

The safety and efficacy of Aqneursa in children aged less than 6 years or weighing under 20 kg have not yet been established. No data are available.

Method of administration

Oral use with liquid

The content of one sachet should be poured into 40 mL (3 tablespoons) of water and stirred until fully dispersed. Using hot liquid is not recommended. The entire suspension should be drunk immediately after preparation (within 30 minutes). If the suspension is not drunk immediately, it should be stirred again before intake. A visible amount of residual suspension may remain after the suspension has been consumed; no additional rinsing should be performed in this case.

All steps must be repeated if a second sachet is required.

Administration via gastrostomy tube

Aqneursa may be administered via gastrostomy tube (French size 18 or larger). The content of one sachet should be emptied into a container with 40 mL of water and mixed until all the granules are dispersed. Afterwards, the suspension should be drawn up into a catheter tip syringe. The content of the syringe is dispensed into the gastrostomy tube by applying steady pressure. Afterwards, the dosing syringe is refilled with water and the tube flushed with at least 20 mL of water. The suspension should be used immediately (within 30 minutes).

See section 6.6 "Further information on administration through gastrostomy tube".

In case of overdose, symptomatic treatment is recommended.

2 years.

This medicinal product does not require any special storage conditions.

Aqneursa is supplied in single-dose paper-backed aluminium/polyethylene sachets.

Pack sizes:

• 28 single-dose sachets
• multipack containing 112 (4 packs of 28) single-dose sachets

Not all pack sizes may be marketed.

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

Appearance of Aqneursa after reconstitution is an aqueous suspension, fluid, homogeneous, white, cloudy of fine particles without agglomeration.

Further information on administration through gastrostomy tube (French size 18 or larger):

• The enteral feeding should be stopped if the patient is on continuous feeding.
• At least 20 mL of water should be drawn into a catheter tip syringe and the tube should be flushed to prevent interactions between enteral feed and Aqneursa.
• The entire suspension with the required dose prepared according to section 4.2 should be drawn into the catheter tip syringe.
• The suspension should be given into the gastrostomy tube immediately (within 30 minutes) by applying steady pressure.
• The catheter tip syringe should be refilled with at least 20 mL of water and the tube flushed.
• The feeding can be restarted when appropriate.