Ranitidine 50mg/2ml Solution for Injection and Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

RANITIDINE HYDROCHLORIDE

Available from:

Alliance Pharmaceuticals Ltd.

ATC code:

A02BA; A02BA03

INN (International Name):

RANITIDINE HYDROCHLORIDE

Dosage:

50/2 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection/infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

H2-receptor antagonists; famotidine

Authorization status:

Marketed

Authorization date:

2008-11-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE
PROFESSIONALS ONLY:
RANITIDINE 50MG/2ML SOLUTION FOR INJECTION AND INFUSION
ranitidine hydrochloride
RANITIDINE 50MG/2ML SOLUTION FOR INJECTION AND INFUSION
PLEASE READ THIS INFORMATION CAREFULLY BEFORE GIVING RANITIDINE
50MG/2ML SOLUTION FOR INJECTION AND INFUSION (REFERRED TO AS
RANITIDINE
INJECTION THROUGHOUT THIS LEAFLET). PLEASE REFER TO THE SUMMARY OF
PRODUCT CHARACTERISTICS FOR FURTHER DETAILS ON THIS PRODUCT.
PRESENTATION
Each 2ml ampoule of Ranitidine Injection contains 50mg of ranitidine
as
ranitidine hydrochloride. Product provided in amber glass ampoules,
5 ampoules in a carton.
PHARMACEUTICAL FORM
Solution for Injection and Infusion.
Clear, colourless solution.
INDICATIONS
Ranitidine
Injection
is
indicated
for
the
treatment
of duodenal
ulcer, benign gastric ulcer, post-operative ulcer and of Zollinger -
Ellison Syndrome.
In the management of conditions where reduction of g
astric secretion
and acid output is desirable, such as reflux oesophagitis.
As prophylaxis against:
•
gastrointestinal haemorrhage from stress ulceration in seriously ill
patients
• recurrent
haemorrhage
in patients with
bleeding
peptic
ulcers
• acid aspiration (Mendelson's Syndrome) before anaesthesia in
patients at risk, particularly obstetric patients during labour.
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.
DOSAGE AND METHOD OF ADMINISTRATION See SPC section 5.2
Pharmacokinetic Properties - Special Patient Populations
.
Recommended
rates
of
administration
should
not
be
exceeded
as
bradycardia in association with rapid administration of ranitidine has
been reported rarely.
Adults (including elderly) and adolescents (12 years and older)
Ranitidine Injection may be given as:
• a slow (over two minutes) intravenous injection up to a maximum of
50
mg after dilution

Summary of Product characteristics

Health Products Regulatory Authority
19 October 2018
CRN008L3J
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ranitidine 50mg/2ml Solution for Injection and Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each one ml of solution contains 25mg ranitidine as ranitidine
hydrochloride. Each
2ml ampoule contains 50mg ranitidine.
Excipient(s) with known effect:
Each ampoule contains 0.55mg (0.014mmol) of Potassium and 2.23mg
(0.097mmol)
of Sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection and Infusion
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults
Ranitidine Solution for Injection is indicated for the treatment of
duodenal ulcer,
benign gastric ulcer, post - operative ulcer, and of Zollinger -
Ellison Syndrome.
In the management of conditions where reduction of gastric secretion
and acid
output is desirable, such as reflux oesphagitis.
As prophylaxis against:

gastrointestinal haemorrhage from stress ulceration in seriously ill
patients

recurrent haemorrhage in patients with bleeding peptic ulcers

acid aspiration (Mendelson's Syndrome) before anaesthesia in patients
at
risk, particularly obstetric patients during labour.
Children (6 months to 18 years)

short term treatment of peptic ulcer
Health Products Regulatory Authority
19 October 2018
CRN008L3J
Page 2 of 10

treatment of gastro-oesophageal reflux, including reflux oesophagitis
and
symptomatic relief of gastro-oesophageal reflux disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
See section 5.2 Pharmacokinetic Properties – Special Patient
Populations
Posology
Adults (including elderly) and adolescents (12 years and older)
Ranitidine Solution for Injection may be given as:

a slow intravenous injection (over two minutes) up to a maximum of 50
mg,
after dilution to a volume of 20 ml per 50 mg dose. This dose may be
repeated every 6 to 8 hours or

as an intermittent intravenous infusion at a rate of 25 mg per hour
fo