Posology : מינונים

4.2    Posology and method of administration

Posology
The recommended dose is 150 mg administered as an infusion over 20-30 minutes on Day 1, initiated approximately 30 minutes prior to chemotherapy (see section 6.6). EMEND IV should be administered in conjunction with a corticosteroid and a 5-HT3 antagonist as specified in the tables below.
The following regimens are recommended for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy.

Highly Emetogenic Chemotherapy Regimen
Day 1           Day 2                         Day 3           Day 4
EMEND IV             150 mg            none                         none            none intravenously
Dexamethasone       12 mg orally     8 mg orally            8 mg orally twice   8 mg orally twice daily               daily
5-HT3          Standard dose of         none                  none                none antagonists     5-HT3 antagonists.
See the product information for the selected 5-HT3 antagonist for appropriate dosing information
Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 to 4. Dexamethasone should also be administered in the evenings on Days 3 and 4. The dose of dexamethasone accounts for active substance interactions.

Moderately Emetogenic Chemotherapy Regimen
Day 1
EMEND IV            150 mg intravenously
Dexamethasone             12 mg orally
5-HT3 antagonists    Standard dose of 5-HT3 antagonists. See the product information for the selected 5-HT3 antagonist for appropriate dosing information
Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1.
The dose of dexamethasone accounts for active substance interactions.

Efficacy data in combination with other corticosteroids and 5-HT3 antagonists are limited. For additional information on the co-administration with corticosteroids, see section 4.5.

Refer to the Summary of Product Characteristics of co-administered 5-HT3 antagonist medicinal products.

Special populations
Elderly (≥65 years)
No dose adjustment is necessary for the elderly (see section 5.2).

Gender
No dose adjustment is necessary based on gender (see section 5.2).
Renal impairment
No dose adjustment is necessary for patients with renal impairment or for patients with end stage renal disease undergoing haemodialysis (see section 5.2).
Hepatic impairment
No dose adjustment is necessary for patients with mild hepatic impairment. There are limited data in patients with moderate hepatic impairment and no data in patients with severe hepatic impairment. EMEND IV should be used with caution in these patients (see sections 4.4 and 5.2).

Paediatric population
The safety and efficacy of EMEND IV in children and adolescents below 18 years of age has not yet been established. No data are available.

Method of administration
EMEND IV 150 mg should be administered intravenously and should not be given by the intramuscular or subcutaneous route. Intravenous administration occurs preferably through a running intravenous infusion over 20-30 minutes (see section 6.6). Do not administer EMEND IV as a bolus injection or undiluted solution.

For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.