Posology : מינונים

4.2     Posology and method of administration

Posology
Rybrila is recommended for short-term intermittent use (see section 4.4 and 5.1) The dosage must be measured and administered with the graduated syringe included in the pack.
The dosing schedule for Rybrila is based on the weight of the child with the initial dosing of 0.02 mg/kg to be given orally three times daily and titrate in
increments of 0.02 mg/kg every 5-7 days based on therapeutic response and adverse reactions.
The maximum recommended dosage is 0.1 mg/kg three times daily not to exceed 1.5-3 mg per dose based upon weight. For greater detail, see Table 1.
During the four-week titration period, dosing can be increased with the recommended dose titration schedule while ensuring that the anticholinergic adverse events are tolerable. Prior to each increase in dose, review the tolerability of the current dose level with the patient’s caregiver.
Younger children may be more susceptible to adverse events and this should be kept in mind when dose adjustments are carried out.
Table 1: Dosing tables for children and adolescents aged 3 years and older Weight     Dose Level 1        Dose Level 2       Dose Level 3          Dose Level 4       Dose Level 5 kg         (~0.02 mg/kg)       (~0.04 mg/kg)      (~0.06 mg/kg)         (~0.08 mg/kg)      (~0.1 mg/kg) 13-17      0.3 mg    1.5 ml    0.6 mg    3 ml     0.9 mg    4.5 ml      1.2 mg    6 ml     1.5 mg    7.5 ml 18-22      0.4 mg    2 ml      0.8 mg    4 ml     1.2 mg    6 ml        1.6 mg    8 ml     2.0 mg    10 ml 23-27      0.5 mg    2.5 ml    1.0 mg    5 ml     1.5 mg    7.5 ml      2.0 mg    10 ml    2.5 mg    12.5 ml
28-32      0.6 mg    3 ml      1.2 mg    6 ml     1.8 mg    9 ml        2.4 mg    12 ml    3.0 mg    15 ml
33-37      0.7 mg    3.5 ml    1.4 mg    7 ml     2.1 mg    10.5 ml     2.8 mg    14 ml    3.0 mg    15 ml 38-42      0.8 mg    4 ml      1.6 mg    8 ml     2.4 mg    12 ml       3.0 mg    15 ml    3.0 mg    15 ml 43-47      0.9 mg    4.5 ml    1.8 mg    9 ml     2.7 mg    13.5 ml     3.0 mg    15 ml    3.0 mg    15 ml
≥48        1.0 mg    5 ml      2.0 mg    10 ml    3.0 mg    15 ml       3.0 mg    15 ml    3.0 mg    15 ml 
Rybrila oral solution is not recommended for use in children younger than 3 years.

The medicinal product will be prescribed by physicians specialized in the treatment of pediatric patients with neurological disorders.

Hepatic Impairment
Clinical studies have not been evaluated in patients with hepatic impairment. Glycopyrrolate is eliminated largely from the renal excretion and hepatic impairment is not thought to result in an increase in a systemic exposure of Glycopyrronium.

Renal impairment
Elimination of glycopyrrolate is severely impaired in patients with renal failure therefore reduction in doses should be considered.

High fat food should be avoided. The presence of high fat food reduces the oral bioavailability of Rybrila if given shortly after a meal. Therefore, it should be given at least one hour before or two hours after meals. If the patient’s specific needs determine that co- administration with food is required, dosing of the medicinal product should be consistently performed during food intake (see section 5.2).

Method of administration

For oral use and use with nasogastric and or PEG tubes.
The correct quantity of Rybrila oral solution should be measured and administered using the syringe included in the pack.

Nasogastric feeding tubes, if used, should be flushed with 20 ml of water immediately after dosing. See Section 6.6 for instructions for use.