产品特点
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Setofilm 4 mg Orodispersible Films
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film contains 4 mg of ondansetron (as base)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible Film.
White, rectangular (size 3 cm
2
), fast dissolving film.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Setofilm is indicated for :
-
Prophylaxis of acute nausea and vomiting induced by moderately emetogenic chemotherapy in adults,
-
Prophylaxis and treatment of delayed nausea and vomiting induced by moderately to highly emetogenic
chemotherapy in adults,
-
Management of chemotherapy-induced nausea and vomiting in children aged
≥6 months,
-
Prophylaxis and treatment of acute and delayed nausea and vomiting induced by highly emetogenic
radiotherapy in adults,
-
Prophylaxis and treatment of Post operative nausea and vomiting (PONV) in adults and children aged
≥4 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral use. Setofilm is recommended in case of risk of aspiration. It can be useful for patients having difficulties to
swallow, like children or elderly.
METHOD OF ADMINISTRATION
Setofilm orodispersible film should be removed from each individual sachet in the following way:
1. Do not cut the sachet
2. Open very carefully
3. Open only at the tear tag
4. Tear off slowly
5. Check the film for damage
6. Use only undamaged films.
The mouth should be empty before placing Setofilm orodispersible film on the tongue. Setofilm orodispersible film
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 11/08/2011_
_CRN 2095428_
_page number: 1_
should be placed on the tongue with a dry finger. The film disintegrates without
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