Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ondansetron hydrochloride dihydrate
Ennogen Healthcare Ltd
A04AA01
Ondansetron hydrochloride dihydrate
8mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000; GTIN: 05060254923000
Page 1 of 1 PRODUCT SUPERSEDED ITEM CODE NO.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 BS-13/02/19-V01 Page 1 of 1 PRODUCT SUPERSEDED ITEM CODE NO.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 Les hele dokumentet
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 Les hele dokumentet