Ondansetron Accord Solution for Injection 2mg/ml (4ml vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ONDANSETRON

Available from:

Accord Healthcare Limited

ATC code:

A04AA01

INN (International Name):

ONDANSETRON

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

ONDANSETRON 2 mg/ml

Prescription type:

POM

Therapeutic area:

ANTIEMETICS AND ANTINAUSEANTS

Authorization status:

Authorised

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ONDANSETRON 2 MG/ML SOLUTION FOR
INJECTION OR INFUSION
Ondansetron
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as
yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This
includes any possible side effects not listed in this leaflet.
The name of the medicinal product is Ondansetron 2mg/ml Solution for
Injection or Infusion but will be referred to as Ondansetron Injection
throughout the package leaflet
WHAT IS IN THIS LEAFLET:
1. What Ondansetron Injection is and what it is used for
2. What you need to know before you use Ondansetron Injection
3. How to use Ondansetron Injection
4. Possible side effects
5. How to store Ondansetron Injection
6. Contents of the pack and other information 1. WHAT ONDANSETRON INJECTION IS AND WHAT IT IS
USED FOR
Ondansetron Injection contains the active ingredient ondansetron,
which
belongs to a group of medicines called anti-emetics.
Ondansetron Injection is used for
•
Preventing nausea (feel sick) and vomiting (be sick) caused by
-
chemotherapy for cancer in adults and in children aged ≥6 months.
-
radiotherapy for cancer in adults
•
Preventing and treatment of nausea and vomiting after surgery in
adults
and in children aged ≥ 1 month.
Ask your doctor, nurse or pharmacist if you would like any further
explanation about this uses. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE
ONDANSETRON INJECTION
DO NOT USE ONDANSETRON INJECTION:
-
If you are allergic to Ondansetron or any of the other ingredients of
this
medicine (listed in section 6)or to any similar medicines e.g.
granisetron
or dolasetron.
-
If you are taking Apomorphine (medicine used to treat Parkinson’s

Summary of Product characteristics

1.3.1 SPC, LABELLING AND PACKAGE LEAFLET
1.3.1.1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ondansetron 2 mg/ml Solution for Injection or Infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for injection or infusion contains 2mg ondansetron
(as ondansetron
hydrochloride dihydrate)
Each ampoule with 2ml contains 4mg ondansetron (as ondansetron
hydrochloride dihydrate).
Each ampoule with 4ml contains 8mg ondansetron (as ondansetron
hydrochloride dihydrate).
Excipient with known effect: 1 ml solution for injection or infusion
contains 3.62 mg of
sodium as sodium citrate, sodium chloride and sodium hydroxide.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Solution for Injection or Infusion
Clear colourless solution
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults:
Management of nausea and vomiting induced by cytotoxic chemotherapy
and radiotherapy,
Prevention and treatment of post-operative nausea and vomiting (PONV).
Paediatric Population:
Management of chemotherapy-induced nausea and vomiting in children
aged ≥6 months.
Prevention and treatment of post-operative nausea and vomiting in
children aged ≥ 1 month.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For intravenous injection or intramuscular injection or intravenous
infusion after dilution.
For instructions on dilution of the product before administration, see
section 6.6
Prescribers intending to use ondansetron in the prevention of delayed
nausea and vomiting
associated with chemotherapy or radiotherapy in adults, adolescents or
children should take
into consideration current practice and appropriate guidelines.
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 route
of administration
and dose of ondansetron should be flexible in the range of 8-32 mg a
day and selected as
shown below.
_Emetogenic chemotherapy and radio