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RANITIDINE 50MG/2ML SOLUTION FOR INJECTION AND INFUSION

Active substance: RANITIDINE HYDROCHLORIDE

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Artwork Information
Product Title:

Ranitidine PIL

Date:

03/04/2013

Product Size:

170mm x 330mm

Label Number:

12-480

Colours Used:

Black, PMS 273

Fonts Used:

Arial Narrow

Font size (min):

8 point

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ranitidine 50mg/2ml Solution for Injection and Infusion
Ranitidine 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 or nurse.
• This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their symptoms are
the same as yours.
• If you get any side effects talk to your doctor or nurse. This
includes any possible side effects not listed in this leaflet.
The name of this medicine is Ranitidine 50mg/2ml Solution
for Injection and Infusion (referred to as Ranitidine Injection
throughout this leaflet).
What is in this leaflet:
1. What Ranitidine Injection is and what it is used for
2. What you need to know before you use Ranitidine Injection
3. How to use Ranitidine Injection
4. Possible side effects
5. How to store Ranitidine Injection
6. Contents of the pack and other information
1. WHAT RANITIDINE INJECTION IS AND WHAT IT IS
USED FOR
Ranitidine Injection is a solution for injection or infusion into a
vein, or injection into a muscle. It contains ranitidine as the
active ingredient. Ranitidine is one of a group of medicines
called H2-antagonists that reduce the amount of acid in the
stomach.
It is used in adults (including the elderly) to:
• Treat ulcers of the stomach or duodenum (the stomach
empties into this part of the intestine)
• Treat problems caused by acid in the gullet (oesophagus)
• Prevent ulcers from bleeding
• Prevent acid coming up from the stomach during the
anaesthetic given before a surgical operation.
It is used in children (6 months to 18 years) for:
• short term treatment of stomach or duodenal ulcers
• treatment of problems caused by acid in the gullet (oesophagus)
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
RANITIDINE INJECTION
Do not use Ranitidine Injection if:
• You are allergic (hypersensitive) to ranitidine or to any of the
other ingredients (listed in Section 6, overleaf).

Warnings and precautions
Before receiving Ranitidine Injection, tell your doctor if:
• Your kidneys are not working properly
• You have stomach cancer
• You have a current heart problem or a history of heart trouble
• You are pregnant or think you may be pregnant
• You are breast-feeding your baby
• You have a rare condition called porphyria
• You have had stomach ulcers before
• You have any unintentional weight loss associated with acid
indigestion
• you are over 65 years old
• you have lung disease
• you are diabetic
• you have a lowered immune system.
Talk to your doctor or nurse if any of these statements are
currently applicable or were previously applicable to you.
Other medicines and Ranitidine Injection
Tell your doctor if you are taking or have recently taken any
other medicines, including those obtained without a prescription.
In particular tell your doctor if you are taking:
• lidocaine, a local anaesthetic
• warfarin, used to thin the blood
• propranolol, procainamide or n-acetylprocainamide, for heart
problems
• diazepam, for worry or anxiety problems
• phenytoin, for epilepsy
• theophylline, for breathing problems
• glipizide, used to lower blood glucose
• atazanavir or delaviridine, for treating HIV infection
• gefitnib for lung cancer
• ketoconazole for fungal infections or thrush
• triazolam or midazolam for insomnia. Midazolam may also be
given before an operation. Tell your doctor you are taking
ranitidine before you have an operation.
Pregnancy and breast-feeding
As with other medicines it is not recommended that Ranitidine
Injection be used during pregnancy or breast-feeding unless
absolutely necessary.
Driving and using machines
Ranitidine Injection is unlikely to affect your ability to drive or
operate machinery.
Ranitidine Injection contains Sodium
This medicinal product contains less than 1 mmol sodium (23 mg)
per 50 mg, i.e essentially sodium-free.
3. HOW TO USE RANITIDINE INJECTION
Your doctor will decide the correct dose of Ranitidine Injection for you.

----------------------------------- -----------------------The following information is intended for medical or healthcare professionals only:
Ranitidine 50mg/2ml Solution for Injection and Infusion
Please read this information carefully before using Ranitidine
50mg/2ml Solution for Injection and Infusion (referred to as
Ranitidine Injection throughout this leaflet). Further information is
contained in the Summary of Product Characteristics.
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.
Indications
Ranitidine Solution for Injection is indicated for the treatment of
duodenal ulcer, benign oesophageal or 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 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 Whenever solution and
container permit, parenteral drug products should be inspected
visually for particulate matter and discolouration prior to administration.

For intravenous or intramuscular injection or, after dilution, for
intravenous infusion Ranitidine Injection should be injected either as a
slow bolus injection or as a short term infusion lasting 15 minutes,
directly into a large vein through a large-gauge needle or intravenous
catheter.
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 at least two minutes)
intravenous injection of 50 mg after dilution to a volume of 20 ml per 50mg
dose, which may be repeated every six to eight hours; an intermittent
intravenous infusion at a rate of 25 mg per hour for two hours, which may
be repeated at six to eight hour intervals; as an intramuscular injection of
50 mg (2ml) every six to eight hours.
In the prophylaxis of haemorrhage from stress ulceration in seriously ill
patients or the prophylaxis of recurrent haemorrhage in patients bleeding
from peptic ulceration, parenteral administration may be continued until
oral feeding commences.
In the prophylaxis of upper gastro-intestinal 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/hr may be preferred.
In patients considered to be at risk of developing acid aspiration
(Mendelson’s) syndrome, Ranitidine Solution for Injection 50 mg may be
given intramuscularly or by slow intravenous injection (over 2 minutes)
45 to 60 minutes before induction of general anaesthesia.

Adults (including the elderly) and adolescents (12 years and
older): The usual dose is 50mg every 6 or 8 hours
This can be given by the doctor or nurse in one of three ways:
• By slow injection into a vein over 2 minutes (after dilution to a
volume of 20mls)
• By means of a ‘drip’ (infusion) into a vein (given over 2 hours)
• By injection into a muscle
For patients at risk of acid coming up from the stomach during
anaesthesia, Ranitidine Injection may be given by injection into
a muscle or by slow injection into a vein, 45 to 60 minutes
before the anaesthetic.
Children and infants (6 months to 11 years): The dose will be
given by a slow injection into a vein. The maximum dose is
50mg every 6 or 8 hours. It is usually only given if your child is
unable to take ranitidine by mouth.
Kidney impairment: If your kidneys are not working properly
your doctor may give you a lower dose.
If you have the impression that the effect of Ranitidine Injection
is too strong or too weak, talk to your doctor. If you receive too
much it is unlikely to cause any problems.
If you have any further questions on the use of this product, ask
your doctor or nurse. Some discolouration of the solution may
occur on exposure to light. The solution should be inspected
for this deterioration when drawing a dose from the ampoule.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ranitidine Injection can cause side effects,
although not everybody gets them.
A few people can be allergic to some medicines. If any of
the following happen, tell your doctor or nurse immediately:
• Severe itching of the skin, rash
• Swelling of the hands, feet, ankles, face, lips, tongue, mouth or
throat, which may cause difficulties in swallowing or breathing
• Chest tightness
• Collapse
You may have had a serious allergic reaction to Ranitidine Injection.
Tell your doctor if you notice any of the following:
Uncommon side effects (less than 1 in 100)
• stomach pain
• constipation
• feeling sick (nausea) .
Rare side effects (less than 1 in 1,000)
• skin rash
Rare side effects that may show up in blood tests:
• increase of serum creatinine in blood (kidney function test)
• changes to liver function
Very rare side effects (less than 1 in 10,000)
• Depression
• Confusion, hallucinations (mainly reported in severely ill or
elderly patients)
• Blood disorders that may result in unusual tiredness,
shortness of breath, more infections than usual, bruising
more easily

• Uncontrolled movements
• Heart problems (slow or irregular heart rhythm)
• Inflammation of the blood vessels which may cause reddening
of areas of skin, localised pain and tenderness
• Headaches (sometimes severe), dizziness
• Diarrhoea
• Blurred vision
• Inflammation of the pancreas (which may cause severe
stomach pain)
• Liver problems which may lead to jaundice (yellow colour of
skin and the whites of eyes)
• Red blotches or lumps on the skin, hair loss
• Pain in the joints or muscles
• Kidney problems that may cause changes in the amount and
colour of water you pass
• If you are a man, sexual impotence that is normally reversible,
tenderness of the breast, breast discharge and/or breast
enlargement.
Many of these side effects are reversible and go away once
ranitidine treatment is stopped.
If any of the side effects gets serious, or if you notice any side
effect not listed in this leaflet, please tell your doctor or nurse.
5. HOW TO STORE RANITIDINE INJECTION
Do not store above 25ºC
Keep ampoules in the carton to protect them from light.
Keep out of the reach and sight of children.
Ranitidine Injection should not be used after the expiry date on
the ampoule and carton. The expiry date refers to the last day of
that month.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help to protect the
environment.
6. FURTHER INFORMATION
What Ranitidine Injection contains
The active substance is ranitidine. One 2ml ampoule contains
50mg of ranitidine as ranitidine hydrochloride.
Other ingredients are sodium chloride, potassium dihydrogen
phosphate, disodium hydrogen phosphate dihydrate and water
for injections.
What Ranitidine Injection looks like and contents of the pack
Ranitidine Injection is a clear, colourless liquid in amber glass
ampoules.
Each carton of Ranitidine Injection contains 5 ampoules.
Marketing Authorisation Holder
Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road,
Chippenham, Wiltshire, SN15 2BB, UK.
Manufacturer: Kleva S A, 189 Parnithos Avenue, 136 71
Acharnai, Athens, Greece.
This leaflet was last revised in
Alliance and associated devices are registered trademarks of
Alliance Pharmaceuticals Limited
© Alliance Pharmaceuticals Limited 2013

- - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - - - - - - Special Patient Populations
Children/infants (6 months and above): limited pharmacokinetic data
show that there were no significant differences in half-life (range for
children 3 years and above: 1.7 - 2.2 h) and plasma clearance (range for
children 3 years and above: 9 - 22 ml/min/kg) between children and
healthy adults receiving intravenous ranitidine when correction is made for
body weight. Pharmacokinetic data in infants is extremely limited but appears
to be in line with that for older children.
Patients over 50 years of age: In patients over 50 years of age, half-life is
prolonged (3-4 h) and clearance is reduced, consistent with the age-related
decline of renal function. However, systemic exposure and accumulation
are 50% higher. This difference exceeds the effect of declining renal
function, and indicates increased bioavailability in older patients
Neonates (under 1 month): limited pharmacokinetic data from term
babies undergoing treatment with Extracorporeal Membrane
Oxygenation (EMCO) suggests that plasma clearance following
i.v.administration may be reduced (1.5-8.2 ml/min/kg) and the
half-life increased in the new-born. Clearance of ranitidine appeared
to be related to the estimated glomerular filtration rate in the neonates.
Pharmaceutical Information
Excipients: Sodium chloride, Potassium dihydrogen
phosphate, Disodium hydrogen phosphate dihydrate, Water for injections.
Incompatibilities: None known. Shelf-life: 2 years. Storage Precautions:
Do not store above 25ºC. Keep ampoules in the outer carton to protect
from light. Nature of Container: 2 ml solution in amber, type 1 glass
ampoules. Instructions for Use and Handling: Please refer to
‘Dosage and method of administration’.
This leaflet was last revised:
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Patients with renal impairment: Ranitidine is excreted via the kidney and
so plasma levels of the drug are increased in patients with severe renal
impairment (creatinine clearance less than 50ml/min). Accordingly, it is
recommended in such patients that ranitidine be administered in doses
of 25 mg.
Children and infants (6 months to 11 years): May be given as a slow
(over 2 minutes) i.v. injection up to a maximum of 50mg every 6 to 8
hours. Intravenous therapy in children with peptic ulcer disease is
indicated only when oral therapy is not possible. For acute treatment of
peptic ulcer disease and gastro-oesophageal reflux in paediatric
patients, Ranitidine injection may be administered at doses that have
been shown to be effective for these diseases in adults and effective for
acid suppression in critically ill children.
The initial dose (2.0 mg/kg or 2.5 mg/kg, maximum 50mg) may be
administered as a slow intravenous infusion over 10 minutes, either with
a syringe pump followed by a 3 ml flush with normal saline over 5
minutes, or following dilution with normal saline to 20ml. Alternatively
treatment can be continuous, after administering a loading dose of 0.45
mg/kg followed by a continuous infusion of 0.15 mg/kg/hr. The
recommended dose for prophylaxis of stress ulceration is 1mg/kg
(maximum 50 mg) every 6h to 8h. Alternatively treatment can be
continuous, administering 125 - 250 micrograms/kg/hr as continuous
infusion.
Ranitidine Injection has been shown to be compatible with the following
intravenous infusion fluids: 0.9% Sodium Chloride BP, 5% Dextrose
BP, 0.18% Sodium Chloride and 4% Dextrose BP, 4.2% Sodium
Bicarbonate BP, Hartmann's solution.
All unused mixtures of Ranitidine Solution for Injection with infusion
fluids should be discarded.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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