Zantac 25 mg/ml Solution for Injection/Infusion

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Ranitidine

Disponibil de la:

GlaxoSmithKline (Ireland) Limited

Codul ATC:

A02BA; A02BA02

INN (nume internaţional):

Ranitidine

Dozare:

25 milligram(s)/millilitre

Forma farmaceutică:

Solution for injection/infusion

Tip de prescriptie medicala:

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

Zonă Terapeutică:

H2-receptor antagonists; ranitidine

Statutul autorizaţiei:

Not marketed

Data de autorizare:

1983-11-23

Prospect

3
HOW TO HAVE ZANTAC SOLUTION FOR INJECTION/
INFUSION
You will never be expected to give yourself this medicine.
It will always be given to you by a person who is trained
to do so.
HAVING THIS MEDICINE
Zantac Injection will be given to you either:
•
as a single injection into a muscle
•
as a slow infusion into a vein. This is where the drug
is slowly given to you over a few minutes
•
as a continuous infusion into a vein. This is where the
drug is slowly given to you over a few hours.
The usual dose for an adult (including the elderly)
and adolescents (12 years and older) is 50 mg every
6 to 8 hours, as a single injection into a muscle.
Different doses may also be given to you as a slow
infusion or continuous infusion, depending on what
condition you are being treated for.
USE IN CHILDREN AND INFANTS (6 MONTHS TO 11 YEARS):
Your doctor will give Zantac by a slow injection into a
vein. The maximum dose is 50 mg every 6 or 8 hours. It
is usually only given while your child is unable to take
Zantac by mouth.
IF YOU ARE GIVEN MORE ZANTAC THAN YOU SHOULD
Your doctor or nurse will give you Zantac injection so it
is unlikely that you will receive too much. If you think
you have been given too much or have missed a dose,
tell your doctor or nurse.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.
4 POSSIBLE SIDE EFFECTS
Like all medicines, the medicine can cause side effects,
although not everybody gets them.
CONDITIONS YOU NEED TO LOOK OUT FOR
SEVERE ALLERGIC REACTION: These are rare in people taking
Zantac. Signs include:
•
raised and itchy rash (_hives_)
•
swelling, sometimes of the face or mouth (_angioedema_)
•
chest pain, shortness of breath, unexplained fever,
wheezing or difficulty in breathing
•
feeling faint, especially when standing up
•
collapse
CONTACT A DOCTOR IMMEDIATELY if you get any of these
symptoms. Stop taking Zantac.
SERIOUS SKIN REACTIONS: these are very rare in people
taking Zantac. Signs include:
•
Skin rash, which may blister, a

Caracteristicilor produsului

Health Products Regulatory Authority
17 December 2019
CRN009FKJ
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zantac 25 mg/ml Solution for Injection/Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains ranitidine hydrochloride equivalent to 50 mg
ranitidine in 2 ml i.e. 25 mg/ml.
Each ampoule also contains 2.9 mg (0.09 mmol) of sodium and 0.6 mg
(0.015 mmol) of potassium.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection/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)
Zantac Injection may be given either as a slow (over 2 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 infusio