Ondansetron 8mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Ondansetron hydrochloride dihydrate

Διαθέσιμο από:

Ennogen Healthcare Ltd

Φαρμακολογική κατηγορία (ATC):

A04AA01

INN (Διεθνής Όνομα):

Ondansetron hydrochloride dihydrate

Δοσολογία:

8mg

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 04060000; GTIN: 05060254923000

Φύλλο οδηγιών χρήσης

Page 1 of 1
PRODUCT
SUPERSEDED ITEM CODE NO. :
VERSION :
REASON FOR ISSUE :
ITEM CODE
SUBSTRATE:
MARKET
COLOR :
MFG. LOCATION
DIMENSION
PHARMA CODE :
COMPONENT
CHANGE PART LAYOUT:
NO. OF. COLORS :
Ondansetron 4 mg & 8 mg tablets
OETB30564
Dholka
Export (Ennogen UK)
leaflet-Front Side
240 x 400 mm
NA
28 gsm Bible Paper Pack Insert ( Folding size : 120 x 25 )
OETB20564
Pantone P Black
01
3195
03
Text matter changed
C A D IL A P H A R MA C E U T IC A L S LT D .
BS-13/02/19-V01
Page 1 of 1
PRODUCT
SUPERSEDED ITEM CODE NO. :
VERSION :
REASON FOR ISSUE :
ITEM CODE
SUBSTRATE:
MARKET
COLOR :
MFG. LOCATION
DIMENSION
PHARMA CODE :
COMPONENT
CHANGE PART LAYOUT:
NO. OF. COLORS :
OETB30564
Bhavin
Kalola
Digitally signed
by Bhavin Kalola
Date: 2020.12.21
10:35:33 Z

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ondansetron 8mg Orodispersible Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains ondansetron 8mg.
Excipient with known effect
Each orodispersible tablet contains 6mg aspartame.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Orodispersible tablets.
Round, white to off-white, flat, bevelled edged, tablets plain on both
the surfaces,
having strawberry odour.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Adults: _
Ondansetron orodispersible tablets are indicated for the management of
nausea and
vomiting induced by cytotoxic chemotherapy and radiotherapy.
Ondansetron orodispersible tablets are indicated for the prevention of
post-operative
nausea and vomiting (PONV).
For treatment of established PONV, administration by injection is
recommended.
_Paediatric Population:_
_ _
Ondansetron is indicated for the management of chemotherapy-induced
nausea and
vomiting (CINV) in children aged
≥
6 months.
No studies have been conducted on the use of orally administered
ondansetron in the
prevention and treatment of PONV in children aged
≥
1 month, administration by IV
injection is recommended for this purpose.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Chemotherapy and radiotherapy induced nausea and vomiting:
_Adults: _
The emetogenic potential of cancer treatment varies according to the
doses and
combinations of chemotherapy and radiotherapy regimens used. The
selection of dose
regimen should be determined by the severity of the emetogenic
challenge.
_ _
_Emetogenic chemotherapy and radiotherapy:_ Ondansetron can be given
either by
rectal, oral (as orodispersible tablet, tablets or syrup) intravenous
or intramuscular
administration.
For oral administration: 8 mg taken 1 to 2 hours before chemotherapy
or radiation
treatment, followed by 8 mg every 12 hours for a maximum of 5 days to
protect
against delayed or prolonged emesis.
_For highly emetogenic chemotherapy_: a single dose of up