METOCLOPRAMIDE-BAXTER metoclopramide (as hydrochloride) solution for injection 10 mg/2 mL ampoule

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

metoclopramide hydrochloride, Quantity: 5 mg/mL

Commercializzato da:

Baxter Healthcare Pty Ltd

INN (Nome Internazionale):

metoclopramide hydrochloride monohydrate

Forma farmaceutica:

Injection, solution

Composizione:

Excipient Ingredients: citric acid monohydrate; sodium citrate dihydrate; sodium hydroxide; hydrochloric acid; water for injections; nitrogen; sodium chloride

Via di somministrazione:

Intravenous

Confezione:

25 x 2 mL, 10 x 2 mL, 5 x 2 mL

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

Adults (20 years or older): - Relief of nausea and vomiting associated with migraine, cancer therapy (chemotherapy or radiation), malignant disease, labour, infectious disease and uraemia. - Control of post-operative vomiting - Assist in small bowel intubation.,Metoclopramide is of little benefit for the prevention or treatment of motion sickness.,Young adults and children (over 1 year of age): Metoclopramide should be restricted to the following conditions and only used as second line therapy, when used to treat children and young adults under 20 years of age because of the risk of adverse effects - Severe intractable vomiting of known cause - Vomiting associated with radiation therapy or intolerance to cytotoxic drugs. - Assist in small bowel intubation

Dettagli prodotto:

Visual Identification: A clear, colourless solution, essentially free from visible particles.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Stato dell'autorizzazione:

Licence status A

Data dell'autorizzazione:

2016-09-29

Foglio illustrativo

1
METOCLOPRAMIDE-CLARIS v4
METOCLOPRAMIDE-CLARIS
_Metoclopramide hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about
METOCLOPRAMIDE-CLARIS.
It does not contain all the available information. It does not take
the place of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking
METOCLOPRAMIDE-CLARIS against the benefits they expect it will have
for you.
This medicine is likely to be used while you are at the clinic or in
hospital. If possible, please
read this leaflet carefully before this medicine is given to you. In
some cases this leaflet may
be given to you after the medicine has been used.
If you have any concerns about taking this medicine, ask your doctor
or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT METOCLOPRAMIDE-CLARIS IS USED FOR
In adults over 20 years this medicine is used to:
•
relieve nausea and vomiting in migraine, cancer treatment, childbirth
and infectious
diseases
•
control vomiting after surgery
•
help with placing tubes into the intestine
When used to treat children and young adults under 20 years of age,
Metoclopramide should
be restricted to the following conditions and only used as second line
therapy:
•
treat severe vomiting of known cause or following chemotherapy or
radiation
treatment.
•
help with placing tubes into the intestine.
2
METOCLOPRAMIDE-CLARIS v4
METOCLOPRAMIDE-CLARIS should not be used in children below 1 year of
age.
METOCLOPRAMIDE-CLARIS belongs to a group of medicines known as
antiemetics.
Antiemetics stop or prevent nausea and vomiting.
METOCLOPRAMIDE-CLARIS may be used for the management of other
conditions that
are not mentioned above.
Your doctor will be able to tell you about the specific condition for
which you have been
prescribed METOCLOPRAMIDE-CLARIS.
_HOW METOCLOPRAMIDE-CLARIS WORKS_
_ _
This medicine works by blocking the action of a chemical in the brain
which causes nausea
a

Scheda tecnica

Metoclopramide-Baxter (Metoclopramide hydrochloride)
Version 1.0
1 of 13
AUSTRALIAN PRODUCT INFORMATION
METOCLOPRAMIDE-BAXTER (METOCLOPRAMIDE
HYDROCHLORIDE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Metoclopramide hydrochloride (as monohydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Metoclopramide hydrochloride 10 mg/ 2 mL, solution for injection
Metoclopramide-Baxter Injection is a clear, colourless, sterile,
preservative-free solution
containing metoclopramide hydrochloride 5 mg / 1 mL.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS (20 YEARS OR OLDER)
•
Relief
of
nausea
and
vomiting
associated
with
migraine,
cancer
therapy
(chemotherapy or radiation), malignant disease, labour, infectious
disease and uraemia
•
Control of post-operative vomiting
•
Assist in small bowel intubation
Metoclopramide is of little benefit for the prevention or treatment of
motion sickness.
YOUNG ADULTS AND CHILDREN (OVER 1 YEAR OF AGE)
Metoclopramide should be restricted to the following conditions and
only used as second
line therapy, when used to treat children and young adults under 20
years of age because of
the risk of adverse effects.
•
Severe intractable vomiting of known cause
•
Vomiting associated with radiation therapy or intolerance to cytotoxic
drugs
•
Assist in small bowel intubation
4.2
DOSE AND METHOD OF ADMINISTRATION
EACH METOCLOPRAMIDE-BAXTER AMPOULE IS FOR USE IN ONE PATIENT ON
ONE OCCASION ONLY. CONTAINS NO ANTIMICROBIAL PRESERVATIVE.
Metoclopramide-Baxter (Metoclopramide hydrochloride)
Version 1.0
2 of 13
Metoclopramide-Baxter Injection is available as 10 mg/2 mL strength
ampoules.
The dosage recommendations should be strictly adhered to in order to
minimise the
possibility of dystonic side effects. Metoclopramide should only be
used after careful
examination has excluded any underlying disorder (such as cerebral
irritation) that may have
induced the nausea and vomiting.