ODNATRON

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

ONDANSETRON AS HYDROCHLORIDE DIHYDRATE

Disponible des:

K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL

Codi ATC:

A04AA01

formulario farmacéutico:

SOLUTION FOR INJECTION

Composición:

ONDANSETRON AS HYDROCHLORIDE DIHYDRATE 2 MG/ML

Vía de administración:

I.V, I.M

tipo de receta:

Required

Fabricat per:

KLEVA S.A., GREECE

Grupo terapéutico:

ONDANSETRON

Área terapéutica:

ONDANSETRON

indicaciones terapéuticas:

Adults:Odnatron is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Odnatron is indicated for the prevention and treatment of post-operative nausea and vomiting (PONV). Paediatric Population:Odnatron is indicated for the management of chemotherapy-induced nausea and vomiting (CINV) in children aged ≥6 months, and for the prevention and treatment of PONV in children aged ≥ 1 month.

Data d'autorització:

2018-07-31

Informació per a l'usuari

Page 1 of 4
K.S. Kim International Ltd-part of S.K.-Pharma Group
Moshe Aviv Tower, Jabotinsky 7, 35
th
floor, Ramat Gan, Israel 5252007
Tel.: [phone], Fax: [phone]
www.sk-pharma.com
יאמ
2018
KS051
ה/אפור
ה/דבכנ
,
ה/דבכנ ת/חקור
, רישכתה :ןודנה
–
ODNATRON
2MG/ML
SOLUTION FOR INJECTION
תרבח
םיק.סא.ייק
מ"עב לנוישנרטניא
רשיא תואירבה דרשמ יכ םכעידוהל תדבכתמ
ןוכדע
ןודנבש רישכתל היוותה
.
ןוסחאה יאנת
ונכדוע
םה ףא
אפורל ןולעב
.
ה
ןכדועמה ןולע
חווד
תואירבה דרשמל
לולסמב
היצקיפיטונ
.
רישכתל תורשואמה תויוותהה
:
ADULTS:
Odnatron is indicated for the management of nausea and vomiting
induced by cytotoxic chemotherapy and radiotherapy.
Odnatron is indicated for the prevention and treatment of
post-operative nausea and vomiting (PONV).
PAEDIATRIC POPULATION:
Odnatron is indicated for the management of chemotherapy-induced
nausea and vomiting (CINV) in children aged
_ ≥_
6
months, and for the prevention and treatment of PONV in children aged
≥ 1 month.
:הרמחה הווהמה יוניש השענ םהב םיפיעסל
קר תסחייתמ וז העדוה
שגדומ טסקט
בוהצב
עמשמ
ו
חה
ו הרמ
תנמוסמ טסקט תקיחמ
הצוח וקב
.
.םיפסונ םיירונימ םינוכדע םימייק
וכדעה
םינ
יתוהמה
םי
שענש
ו
ןולעב
ה אפורל
םני
:
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
ADULTS:
Odnatron is indicated for the management of nausea and vomiting
induced by cytotoxic chemotherapy and radiotherapy.
Odnatron is indicated for the prevention and treatment of
post-operative nausea and vomiting (PONV).
PAEDIATRIC POPULATION:
Odnatron is indicated for the management of chemotherapy-induced
nausea and vomiting (CINV) in children aged
_ ≥_
6
months, and for the prevention and treatment of PONV in children aged
≥ 2 years 1 month.
4.4.

Fitxa tècnica

ODNATRON
2 MG/ML SOLUTION FOR
INJECTION
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Odnatron
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2mL glass ampoules each containing 4mg ondansetron (as hydrochloride
dihydrate) in aqueous
solution for intramuscular or intravenous administration.
4mL glass ampoules each containing 8mg ondansetron (as hydrochloride
dihydrate) in aqueous
solution for intravenous or intramuscular administration.
Excipients with a known effect: This product contains 7 mg of sodium
per 4 mg dose (see
section 4.4). For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection (aqueous solution).
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
ADULTS:
Odnatron is indicated for the management of nausea and vomiting
induced by cytotoxic chemotherapy
and radiotherapy. Odnatron is indicated for the prevention and
treatment of post-operative nausea and
vomiting (PONV).
PAEDIATRIC POPULATION:
Odnatron is indicated for the management of chemotherapy-induced
nausea and vomiting (CINV) in
children aged
_≥_
6 months, and for the prevention and treatment of PONV in children
aged ≥ 1 month.
4.2.
POSOLOGY AND
METHOD OF ADMINISTRATION
POSOLOGY
CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING (CINV AND
RINV)
_ADULTS _
The emetogenic potential of cancer treatment varies according to the
doses and combinations of
chemotherapy and radiotherapy regimens used. The route of
administration and dose of Odnatron
should be flexible in the range of 8-32mg a day and selected as shown
below.
_Emetogenic chemotherapy and radiotherapy:_
Odnatron can be given either by intravenous _or
intramuscular administration.
For most patients receiving emetogenic chemotherapy or radiotherapy,
the recommended
intravenous (IV) dose of ondansetron is 8mg and should be administered
as a slow intravenous
injection (in not less than 30 seconds) or intramuscular injection
immediately before treatment,
followed by 8mg orally twelve hourly.
To protect against delayed or prolonged emesis after the first