Zantac Solution for Injection or infusion 25mg/ml

Pays: Malte

Langue: anglais

Source: Malta Medicines Authority

Ingrédients actifs:

RANITIDINE

Disponible depuis:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Code ATC:

A02BA02

DCI (Dénomination commune internationale):

RANITIDINE 25 mg/ml

forme pharmaceutique:

SOLUTION FOR INFUSION OR INJECTION

Composition:

RANITIDINE 25 mg/ml

Type d'ordonnance:

POM

Domaine thérapeutique:

DRUGS FOR ACID RELATED DISORDERS

Statut de autorisation:

Withdrawn

Date de l'autorisation:

2006-11-23

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZANTAC
® SOLUTION FOR INJECTION OR INFUSION 25 MG/ML
RANITIDINE (AS HYDROCHLORIDE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1
What Zantac is and what it is used for
2
What you need to know before you have Zantac
3
How to have Zantac Solution for Injection or Infusion
4
Possible side effects
5
How to store Zantac
6
Contents of the pack and other information
1
WHAT ZANTAC IS AND WHAT IT IS USED FOR
Zantac contains a medicine called ranitidine. This belongs to a group
of medicines
called H
2
-receptor antagonists. It lowers the amount of acid in your stomach.
FOR ADULTS (INCLUDING THE ELDERLY) Zantac is used to:

treat ulcers in the stomach, or the part of the gut it empties into
(the duodenum)

manage problems caused by acid in the food pipe (oesophagus) or too
much
acid in the stomach. Both of these can cause pain or discomfort
sometimes
known as ‘indigestion’, ‘dyspepsia’ or ‘heartburn’

prevent acid coming up from the stomach while under anaesthetic during
an
operation

prevent bleeding from the stomach and part of the gut it empties into
(the
duodenum)

treat Zollinger-Ellison syndrome – a condition in which there is
increased
production of the hormone gastrin
FOR CHILDREN (6 MONTHS TO 18 YEARS) Zantac is used to:

treat ulcers in the stomach, or the part of the gut it empties into
(the duodenum)

treat and stop problems caused by acid in the food pipe (oesophagus)
or too
much acid in the stomach. Both of these can cause pain or discomfort
sometimes
known as “indigestion”, “dyspepsia” or “heartburn”
2
WHAT YOU NEED TO KNOW BEFORE YOU

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Zantac Solution for Injection or infusion 25mg/ml
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains ranitidine hydrochloride equivalent to 50 mg
ranitidine in 2 ml
i.e.
25mg/ml.
Each ampoule also contains
of Zantac injection 50 mg/2 ml
2.9mg (0.09mmol) of sodium and 0.6mg
(0.015mmol) of potassium.
For a full list of excipients see Section 6.1.
3. PHARMACEUTICAL FORM
Solution for Injection or infusion
A sterile, clear colourless to pale yellow aqueous solution
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zantac is used in the treatment of benign ulceration of the
oesophagus, stomach, upper intestinal
tract (including post-operative stomal area), and of the
Zollinger-Ellison syndrome.
In the management of conditions benefiting from reduced gastric acid
secretion, such as reflux
oesophagitis.
As prophylaxis against:
(i)
acid aspiration (Mendelson’s) syndrome
(ii)
stress lesions of the upper gastrointestinal tract.
(iii)
recurrent haemorrhage from the upper gastrointestinal tract.
Children (6 months to 18 years):

Short term treatment of peptic ulcer

Treatment of gastro-oesophageal reflux, including reflux oesophagitis
and symptomatic relief
of gastro-oesophageal reflux disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults (including the elderly) / Adolescents (12 years and over)
2
Zantac Injection may be given either as a slow (over two minutes)
intravenous injection of 50 mg,
diluted to a volume of 20 ml, every six to eight hours as required
until oral therapy can be
introduced; or as an intermittent intravenous infusion at 25 mg per
hour for two hours, repeated at
six to eight hour intervals; or as an intramuscular injection of 50 mg
every six to eight hours.
In the prophylaxis of upper gastrointestinal haemorrhage from stress
ulceration in seriously ill
patients a priming dose of 50 mg as a slow intravenous injection
followed by the continuous
intravenous infusion of 0.125-0.250 mg/kg/hr may be preferr