Zantac

Nazione: Nuova Zelanda

Lingua: inglese

Fonte: Medsafe (Medicines Safety Authority)

Principio attivo:

Ranitidine hydrochloride 28 mg/mL equivalent to ranitidine 25 mg/mL;  

Commercializzato da:

GlaxoSmithKline NZ Limited

INN (Nome Internazionale):

Ranitidine hydrochloride 28 mg/mL (equivalent to ranitidine 25 mg/mL)

Dosaggio:

50mg/2mL

Forma farmaceutica:

Solution for injection

Composizione:

Active: Ranitidine hydrochloride 28 mg/mL equivalent to ranitidine 25 mg/mL   Excipient: Dibasic sodium phosphate Monobasic potassium phosphate Sodium chloride Water for injection

Confezione:

Ampoule, 2 mL ampoules, 5 dose units

Classe:

Prescription

Tipo di ricetta:

Prescription

Prodotto da:

Glaxo Wellcome Manufacturing Pte Ltd

Indicazioni terapeutiche:

ZANTAC Injection is indicated for the short-term treatment of duodenal ulcer, benign gastric ulcer, post-operative ulcer, reflux oesophagitis, Zollinger-Ellison syndrome, and the following conditions where a reduction of gastric secretion and acid output is desirable: the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patients, the prophylaxis of recurrent haemorrhage in patients with bleeding peptic ulcers and before general anaesthesia in patients considered to be at risk of acid aspiration (Mendelson's) syndrome, particularly obstetric patients during labour.

Dettagli prodotto:

Package - Contents - Shelf Life: Ampoule, 2 mL ampoules - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light

Data dell'autorizzazione:

1983-05-12

Foglio illustrativo

ZANTAC
 ®
 INJECTION 
1 
ZANTAC
® 
INJECTION 
_50 mg injection _
_Ranitidine hydrochloride _
NEW ZEALAND CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET? 
Please read this leaflet carefully 
before you start using Zantac 
injection. 

This leaflet does not have all 
information available about your 
medicine. If you have any questions 
about your medicine, you should ask 
your doctor or pharmacist. 

All medicines have some risks. Your 
doctor has weighed the risks of you 
using Zantac injection against the 
benefits he/she expects it will have 
for you. 

If there is anything you do not 
understand, ask your doctor or 
pharmacist. If you want more 
information, ask your doctor or 
pharmacist. 
WHAT ZANTAC IS USED 
FOR 
The medicine in your Zantac 
injection is called ranitidine (as 
hydrochloride). This belongs to a 
group of medicines called H2-
antagonists. 

Zantac injection is used for short-
term. It is used for:  

•  reflux oesophagitis (also known 
as reflux)  
•  stomach and duodenal ulcer 
disease (also known as peptic 
ulcer) 
•  post-operative ulcer  
•  Zollinger-Ellison disease – where 
the stomach produces very large 
amounts of acid, much more than 
in ulcers and reflux disease. 
These problems are caused, in part, 
by too much acid in the stomach. 
This can lead to pain such as 
heartburn. 
Zantac works by reducing the 
amount of acid in the stomach. This 
reduces the pain and also allows the 
ulcer and reflux to heal.  
Zantac is also used to reduce stomach 
acid in the following situations: 
•  prevention of bleeding from 
stress ulcers in seriously ill 
patients 
•  prevention of later bleeding in 
patients with bleeding peptic 
ulcers 
•  before general anaesthesia in 
patients at risk of inhaling their 
a

Scheda tecnica

_ _
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
ZANTAC Injection 50 mg/2 mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ZANTAC contains 50 mg ranitidine (as the hydrochloride) in 2 mL
aqueous solution
(25 mg/mL) for injection .
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection
ZANTAC Injection is a clear, colourless to pale yellow liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS_ _
ZANTAC Injection is indicated in adults for the short-term treatment
of duodenal ulcer,
benign
gastric
ulcer,
post-operative
ulcer,
reflux
oesophagitis,
Zollinger-Ellison
syndrome, and the following conditions where a reduction of gastric
secretion and acid
output is desirable: the prophylaxis of upper gastrointestinal
haemorrhage from stress
ulceration in seriously ill patients, the prophylaxis of recurrent
haemorrhage in patients
with bleeding peptic ulcers and before general anaesthesia in patients
considered to
be at risk of acid aspiration (Mendelson's) syndrome, particularly
obstetric patients
during labour. For appropriate cases ZANTAC Tablets are also available
(see
ZANTAC Tablet Data Sheet).
4.2
DOSE AND METHOD OF ADMINISTRATION_ _
Dose
Adults
ZANTAC Injection may be given as:-
-
a slow (over 2 minutes) intravenous injection of 50 mg, diluted to a
volume of 20
mL, every 6-8 hours.
-
an intermittent intravenous infusion at 25 mg/hour for two hours,
repeated at 6-8
hour intervals.
-
an intramuscular injection of 50 mg every 6-8 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 a continuous intravenous infusion of 0.125-0.250 mg/kg/h may be
preferred.
In the prophylaxis of haemorrhage from stress ulceration in seriously
ill patients or
prophylaxis of recurrent haemorrhage in patients bleeding from peptic
ulceration
parenteral administration may be continued until oral feeding
commences. Patients
_ _
2
consi