PALONOSETRON TEVA

Ülke: İsrail

Dil: İngilizce

Kaynak: Ministry of Health

Aktif bileşen:

PALONOSETRON AS HYDROCHLORIDE

Mevcut itibaren:

TEVA ISRAEL LTD

ATC kodu:

A04AA05

Farmasötik formu:

SOLUTION FOR INJECTION

Kompozisyon:

PALONOSETRON AS HYDROCHLORIDE 0.05 MG/ML

Uygulama yolu:

I.V

Reçete türü:

Required

Tarafından üretildi:

TEVA ISRAEL LTD, ISRAEL

Terapötik alanı:

PALONOSETRON

Terapötik endikasyonlar:

Palonosetron Teva is indicated in adults and in paediatric patients 1 month of age and older for the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy, and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Yetkilendirme tarihi:

2023-02-12

Ürün özellikleri

Palonosetron Teva FW Notification 02-2023
Summary of Product Characteristics
1.
NAME OF THE MEDICINAL PRODUCT
PALONOSETRON TEVA
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 50 micrograms palonosetron (as
hydrochloride) (0.05 mg/ml).
Each vial of 5 ml of solution contains 250 micrograms palonosetron (as
hydrochloride) (0.25 mg/5 ml).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Palonosetron Teva is indicated in adults and in paediatric patients 1
month of age and older for the
prevention of acute nausea and vomiting associated with highly
emetogenic cancer chemotherapy, and
prevention of nausea and vomiting associated with moderately
emetogenic cancer chemotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Palonosetron Teva should be used only before chemotherapy
administration. This medicinal product should
be administered by a healthcare professional under appropriate medical
supervision.
Posology
_Adults_
250 micrograms palonosetron administered as a single intravenous bolus
approximately 30 minutes before
the start of chemotherapy. Palonosetron Teva should be injected over
30 seconds.
The efficacy of Palonosetron Teva in the prevention of nausea and
vomiting induced by highly emetogenic
chemotherapy may be enhanced by the addition of a corticosteroid
administered prior to chemotherapy.
_Elderly people_
No dose adjustment is necessary for the elderly.
_Paediatric population_
_Children and Adolescents (aged 1 month to 17 years):_
20 micrograms/kg (the maximum total dose should not exceed 1500
micrograms) palonosetron administered
as a single 15 minute intravenous infusion beginning approximately 30
minutes before the start of
chemotherapy.
The safety and efficacy of palonosetron in children aged less than 1
month have not been established. No
data are available. There are limited data on the use of palonosetron
in the prevention of nausea and
vomiting in