CLOPAMON INJECTION 10 mg/2 ML

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Adcock Ingram Critical Care (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

INJECTION

Composition:

EACH 2 ML CONTAINS METOCLOPRAMIDE HYDROCHLORIDE (MONOHYDRATE) EQUIVALENT TO 10 MG METOCLOPRAMIDE BASE

Authorization status:

Registered

Authorization date:

1981-10-11

Patient Information leaflet

PATIENT INFORMATION LEAFLET
Date of approval: 24 April 2023
SCHEDULING STATUS
S4
CLOPAMON INJECTION 10 MG/2 ML
METOCLOPRAMIDE
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE CLOPAMON INJECTION 10 MG/ 2
ML IS
ADMINISTERED TO YOU
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other
healthcare provider.
•
CLOPAMON INJECTION 10 mg/2 ml has been prescribed for you personally
and
you should not share your medicine with other people. It may harm
them, even if
their symptoms are the same as yours.
WHAT IS IN THIS LEAFLET
1.
What CLOPAMON INJECTION 10 mg/2 ml is and what it is used for
2.
What you need to know before CLOPAMON INJECTION 10 mg/2 ml is
administered
to you
3.
How CLOPAMON INJECTION 10 mg/2 ml will be administered to you
4.
Possible side effects
5.
How to store CLOPAMON INJECTION 10 mg/2 ml
6.
Contents of the pack and other information
1. WHAT CLOPAMON INJECTION 10 MG/2 ML IS AND WHAT IT IS USED FOR
CLOPAMON INJECTION 10 mg/2 ml belongs to a group of medicines called
propulsives.
CLOPAMON INJECTION 10 mg/2 ml acts on the muscles in the digestive
system, helping to
stop problems such as feeling sick (nausea) and being sick (vomiting).
5MG/
SOLUTION
CLOPAMON INJECTION 10 mg/2 ml is used for:5ML ORAL
•
Digestive disorders.
•
Feeling sick (nausea) and being sick (vomiting).
•
Delayed nausea and vomiting after radiology treatment (Diagnostic
radiology).
•
Emptying of duodenal content for treatment procedures (Duodenal
intubation).
•
In young adults and children CLOPAMON INJECTION 20mg/2ml is restricted
to
vomiting that is difficult to control and to aid gastrointestinal
intubation (passing a
tube through the nose or mouth into the stomach or small intestine)
and diagnostic
radiology (special medical procedure).
PATIENT INFORMATION LEAFLET
Date of approval: 24 April 2023
2. WHAT YOU NEED TO KNOW BEFORE CLOPAMON INJECTION 10 MG/2 ML IS
ADMINISTERED
TO YOU.
CLOPAMON INJECTION 10MG/2 ML SHOULD NOT BE ADMINISTERED TO

Summary of Product characteristics

PROFESSIONAL INFORMATION
Date of approval: 24 April 2023
SCHEDULING STATUS S4
1. NAME OF THE MEDICINE
CLOPAMON INJECTION 10 MG/2 ML
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml ampoule of CLOPAMON INJECTION 10 mg/2 ml contains 10 mg
metoclopramide.
Sugar free
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Injection
CLOPAMON INJECTION 10 mg/2 ml is a clear, colourless liquid.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
CLOPAMON INJECTION 10 mg/2 ml is indicated for:
•
Digestive disorders:CLOPAMON INJECTION 10 mg/2 ml is of value in any
condition
associated with gastric status or hypomotility. It is, therefore,
useful in the
management of post-vagotomy syndrome.
•
Nausea and vomiting: CLOPAMON INJECTION 10 mg/2 ml is an effective
anti-
emetic medicine in the control of nausea and vomiting associated with
the following
conditions: intolerance to essential medicines possessing emetic
properties, uraemic
conditions, malignant disease, gastrointestinal disorders and
post-anaesthetic
vomiting.
•
Diagnostic radiology: CLOPAMON INJECTION 10 mg/2 ml is effective in
patients
where delayed gastric emptying interferes with radiological
examination of the
stomach and/or small intestine.
•
Duodenal intubation: The action of CLOPAMON INJECTION 10 mg/2 ml in
promoting stomach emptying, combined with its anti-emetic effect, has
proved a very
useful aid to gastrointestinal intubation procedures.
•
Young adults and children: The use of CLOPAMON INJECTION 10 mg/2 ml in
patients under 20 years should be restricted to the following:
Severe intractable vomiting of known cause.
As an aid to gastrointestinal intubation and diagnostic radiology.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
CLOPAMON INJECTION 10 mg/2 ml ampoules should not be diluted for
injection since this
will upset the isotonicity and stability of the medicine.
_Adults: _
PROFESSIONAL INFORMATION
Date of approval: 24 April 2023
10 mg (1 ampoule) 1 to 3 times daily IV or IM depending on the
severity of the conditio