Consumer medicine information

Ranitidine Sandoz Injection

Ranitidine

BRAND INFORMATION

Brand name

Ranitidine Sandoz Injection 50 mg/5 mL

Active ingredient

Ranitidine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Ranitidine Sandoz Injection.

What is in this leaflet

This leaflet answers some common questions about Ranitidine Sandoz Injection.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you having Ranitidine Sandoz Injection against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Ranitidine Sandoz Injection is used for

The name of your medicine is Ranitidine Sandoz Injection. It contains the active ingredient ranitidine (as hydrochloride).

Ranitidine Sandoz Injection is used to treat a variety of conditions. If you are unsure why you have been prescribed Ranitidine Sandoz Injection, talk to your doctor.

Ranitidine Sandoz Injection is used to treat peptic ulcers.

Depending on the position of the ulcer it is called a gastric or duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out of the stomach.

These can be caused in part by too much acid being made in the stomach.

Ranitidine Sandoz Injection is also used to help stop ulcers from coming back.

Ranitidine Sandoz Injection is used to treat reflux oesophagitis or reflux disease. This can be caused by "washing back" (reflux) of food and acid from the stomach into the food pipe, also known as the oesophagus.

Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn.

Ranitidine Sandoz Injection is also used to treat a rare condition called Zollinger-Ellison syndrome, where the stomach produces very large amounts of acid, much more than in ulcers and reflux disease.

Ranitidine Sandoz Injection may be used to treat scleroderma oesophagitis. Scleroderma is a rare condition, and in scleroderma oesophagitis the food pipe is abnormal and there is reflux.

Ask your doctor if you have any questions about why Ranitidine Sandoz Injection was prescribed for you. Your doctor may have prescribed it for another reason.

How Ranitidine Sandoz Injection works

Ranitidine Sandoz Injection belongs to a group of medicines called H2-antagonists or H2-blockers.

It works by decreasing the amount of acid made by the stomach. This helps reduce the pain and also allows the ulcer to heal in most people.

There is no evidence that Ranitidine Sandoz Injection is addictive.

Before you are given Ranitidine Sandoz Injection

When you must not be given it

Do not use Ranitidine Sandoz Injection if:

  • you are allergic to the active ingredient or any of the inactive ingredients mentioned at the end of this leaflet under Product Description
  • it is past it's expiry date or the packaging appears to have been tampered with.

Before you are given it

Tell your doctor if you have allergies to:

  • any other medicines, especially if they are in the same drug class as ranitidine
  • any other medicines, foods, preservatives or dyes.

Tell your doctor if you are pregnant or plan to become pregnant or will be breast feeding while you are using Ranitidine Sandoz Injection. Ranitidine passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of using Ranitidine Sandoz Injection during pregnancy and breastfeeding.

Tell your doctor if you are over 40 years of age, and it is the first time you have experienced symptoms of reflux or indigestion, or that these symptoms have recently changed.

Tell your doctor if you have or have had any of the following medical conditions:

  • peptic, duodenal, or stomach ulcer
  • symptoms like vomiting, diarrhoea, passage of blood, "coffee ground" like substance in vomit or faeces, or unintended weight loss
  • acute porphyria, an inherited blood condition
  • stomach cancer
  • stomach ulcers before and you are taking NSAID medicines
  • kidney problems
  • liver problems
  • lung disease
  • diabetes
  • heart disease
  • over 65 years of age
  • any condition where your immune system may be affected.

Tell your doctor if you have had to stop having this or any other medicine for your ulcer or reflux.

Taking other medicines

Tell your doctor if you are taking any other medicine, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Ranitidine Sandoz may interfere with each other. These include:

  • sucralfate, another medicine used to treat reflux and ulcers
  • warfarin, a medicine used to prevent blood clots
  • triazolam and midazolam, medicines used as sedatives
  • ketoconazole, an anti-fungal medicine
  • atazanavir and delavirdine, medicines used to treat HIV
  • glipizide, a medicine used for diabetics
  • gefitinib, a medicine used in the treatment of cancer
  • NSAID medicines, for pain and inflammation
  • Procainamide or n-acetylprocainamide, used to treat heart problems.

These medicines may be affected by Ranitidine Sandoz Injection, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.

How Ranitidine Sandoz Injection is given

The injection will be administered by your doctor or a nurse.

The usual dose is 50 milligrams of ranitidine every six to eight hours either by injection into a vein or through a 'drip'.

Use in children

Ranitidine Sandoz Injection has not been studied fully in children. However, it has been used successfully in children aged 8 to 18 years in doses up to 150mg twice daily. Your child’s doctor will discuss the risks and benefits of your child taking Ranitidine Sandoz Injection.

If you are given too much (overdose)

As your doctor is administering the dose, overdose is unlikely to occur. However, if at any time you do not feel well and are worried, telephone your doctor or the Poisons Information Centre (telephone Australia 13 11 26 or New Zealand 0800 POISON or 0800 764766) for advice, or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have been given too much Ranitidine Sandoz Injection. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are being treated with Ranitidine Sandoz Injection

Things you must do

  • Always follow your doctors instructions carefully.
  • Tell your doctor if you become pregnant while being treated with Ranitidine Sandoz Injection.
  • If you are about to start taking a new medicine, tell your doctor and pharmacist that you are taking Ranitidine Sandoz Injection.

Things to be careful of

Be careful driving or operating machinery until you know how Ranitidine Sandoz Injection affects you. Ranitidine Sandoz Injection may cause dizziness or light-headedness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Be careful when drinking alcohol while you are given this medicine. If you drink alcohol, dizziness or light-headedness may be worse.

Things that may help your condition

Some self help measures suggested below may help your condition. Talk to your doctor or pharmacist about these measures and for more information.

Alcohol -
your doctor may advise you to limit your alcohol intake.

Aspirin and similar medicines used to treat arthritis, period pain or headaches -
these medicines may irritate the stomach and may make your condition worse. Your doctor or pharmacist can suggest other medicines you can take.

Caffeine -
your doctor may advise you to limit the number of drinks which contain caffeine, such as coffee, tea, cocoa and cola drinks, because they contain ingredients that may irritate your stomach.

Eating habits -
eat smaller, more frequent meals. Eat slowly and chew your food carefully. Try not to rush at meal times.

Smoking -
your doctor may advise you to stop smoking or at least cut down.

Weight -
if you are overweight, your doctor may suggest losing some weight to help your condition.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Ranitidine Sandoz Injection.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • constipation, diarrhoea, nausea (feeling sick) and vomiting
  • abdominal pain or discomfort.

These are the more common side effects of Ranitidine Sandoz Injection. Mostly, these are mild and short-lived.

  • breast tenderness and/or breast enlargement
  • breast discharge
  • headache, sometimes severe
  • hair loss
  • sexual problems
  • tiredness, dizziness or drowsiness, insomnia (sleeplessness)
  • muscle and joint pain
  • pain or flaking skin where you had the injection
  • abdominal uncontrolled movements, muscle twitching or spasms.

These are rare side effects of Ranitidine Sandoz Injection.

Tell your doctor or pharmacist immediately if you notice any of the following:

  • chest infection
  • depression, hallucination or mental confusion
  • general illness associated with weight loss
  • blurred vision
  • skin troubles such as rash (red spots), itching, skin lumps or hives
  • yellowing of the skin and/or eyes, also called jaundice
  • signs of frequent infections such as fever, chills, sore throat or mouth ulcers
  • bleeding or bruising more easily than normal.

These are serious side effects of Ranitidine Sandoz Injection. You may need urgent medical attention. Serious side effects are rare.

If any of the following happen, stop taking Ranitidine Sandoz Injection, and tell your doctor immediately, or go to Accident and Emergency at your nearest hospital:

  • swelling of the face, eyelids, lips, mouth or throat, which may cause difficulty in swallowing or breathing, itchy skin or hives. These are the symptoms of an allergic reaction.
  • severe upper stomach pain together with nausea and vomiting or a change in the type of pain
  • wheezing, chest pain or tightness, unusual heart beat (fast, slow or irregular).

These are very serious side effects. You may need urgent medical attention or hospitalisation. All these side effects are rare.

Tell your doctor if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

Some health problems or complications may arise from the condition being treated itself. For this reason, contact your doctor immediately if you notice any of the following:

  • ongoing stomach pain or indigestion
  • passing black or blood-stained motions
  • vomiting
  • unexpected weight loss.

After using Ranitidine Sandoz Injection

Storage

Keep your medicine in the original container.

If you take it out of its original container it may not keep well.

Keep your medicine in a cool dry place where the temperature stays below 25°C. Protect from light.

Do not store Ranitidine Sandoz Injection or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

The solution for injection should be clear and colourless to pale yellow in colour. The injection should not be used if it is discoloured or cloudy.

Product description

What it looks like

Ranitidine Sandoz Injection: brown glass ampoules containing a solution for injection. Available in boxes of five ampoules.

Ingredients

Active ingredient:

Each 5mL ampoule contains 50mg of ranitidine (as hydrochloride).

Inactive ingredient:

  • water for injection
  • sodium hydroxide.

Supplier

Ranitidine Sandoz Injection is supplied in Australia by:

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park, NSW 2113
Australia
Tel: 1800 726 369

Novartis New Zealand Ltd
PO Box 99102
Newmarket
Auckland 1149
New Zealand
Tel: 0800 354 335

This leaflet was revised in December 2017

Australian Register Number(s)
Ranitidine Sandoz Injection: AUST R 75771

Published by MIMS October 2019

BRAND INFORMATION

Brand name

Ranitidine Sandoz Injection 50 mg/5 mL

Active ingredient

Ranitidine

Schedule

S4

 

1 Name of Medicine

Ranitidine hydrochloride.

6.7 Physicochemical Properties

Ranitidine hydrochloride is a histamine H2-receptor antagonist. It is an aminoalkyl-substituted furan and is structurally different from cimetidine, lacking the imidazole ring and the cyanoguanidine group. Ranitidine hydrochloride is a white to pale or slightly yellow crystalline powder, freely soluble in water and in methanol, sparingly soluble in ethanol, very slightly soluble in methylene chloride. It exhibits polymorphism.
Chemical name: N-(2-(((5- [(dimethylamino) methyl]-2-furanyl) methyl) thio) ethyl)-N'-methyl-2-nitro- 1,1-ethenediamine hydrochloride.
Molecular Formula: C13H23ClN4O3S.
Molecular Weight: 350.9.

Chemical structure.


CAS number.

66357-59-3.

2 Qualitative and Quantitative Composition

Each Ranitidine Sandoz concentrated injection ampoule contains 56 mg of ranitidine hydrochloride equivalent to 50 mg of ranitidine in 5 mL ampoules.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Ranitidine Sandoz concentrated injection is clear brownish-yellow solution.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Animal experiments both in vitro and in vivo have established that ranitidine is a selective, competitive antagonist of histamine at H2-receptor sites. Ranitidine has no significant interaction at histamine H1-receptors, muscarinic receptors or beta-adrenoreceptors. Ranitidine is a potent inhibitor of gastric secretion in the rat and dog.
All the evidence from human studies is compatible with a selective, competitive antagonism of histamine H2-receptors by ranitidine in humans. Oral or intravenous administration of ranitidine inhibits both basal gastric secretions and gastric acid secretion induced by histamine, pentagastrin and other secretagogues. On a weight basis ranitidine is between four and nine times more potent than cimetidine.
After oral administration of ranitidine, the plasma concentrations of ranitidine achieved are directly related to the dose administered. A plasma ranitidine concentration of 50 to 100 nanogram/mL has an inhibitory effect upon stimulated gastric acid secretion of approximately 50%.
Inhibition of pentagastrin induced gastric acid secretion increases with dose, being approximately 90% two hours after an oral 150 mg dose and a significant effect is still evident 12 hours after this dose. In ten patients with duodenal ulcer, ranitidine 150 mg given orally every 12 hours significantly reduced mean 24 hour hydrogen ion activity by 69% and nocturnal gastric acid output by 90%, whereas cimetidine (200 mg three times daily and 400 mg at night) reduced mean 24 hour hydrogen ion activity by 48% and nocturnal gastric acid output by 70%.
Pepsin secretion is also inhibited by ranitidine, but secretion of gastric mucus is not affected. Ranitidine does not alter the secretion of bicarbonate or enzymes from the pancreas in response to secretin and pancreozymin.
Reduction in gastric acid secretion induced by ranitidine 150 mg twice daily for seven days did not cause bacterial overgrowth in the stomach.
Pulse rate, blood pressure, ECG and EEG were not significantly affected in humans following recommended doses of ranitidine.
Chronic ranitidine therapy (300 mg/day for 28 days) had no effect on serum prolactin, gastrin, thyroid stimulating hormone, follicle stimulating hormone, luteinising hormone, gonadotrophins, testosterone, oestriol, progesterone or cortisol levels.
One study in 30 male patients with duodenal ulcer showed a significant decrease in basal thyroxine levels after four weeks of treatment with ranitidine 300 mg daily, but no significant change in thyroid stimulating hormone was noted.
Acute administration of 50 mg of ranitidine intravenously had no effect on plasma aldosterone in healthy male volunteers whereas it caused a significant reduction in vasopressin. Cimetidine 200 mg intravenously had a similar effect on vasopressin.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

No data available.

Distribution.

Serum protein binding of ranitidine in humans is in the range of 10 to 19%.

Metabolism.

The metabolites are N-oxide, S-oxide and desmethyl.

Excretion.

The elimination half-life is approximately two hours.
Ranitidine is excreted via the kidneys mainly as unchanged drug and in minor amounts as the N-oxide, S-oxide and desmethyl metabolites. The 24 hour urinary recovery of free ranitidine and its metabolites is about 40% after oral administration of the drug.
Impairment of renal function requires a reduction in dosage (see Section 4.4 Special Warnings and Precautions for Use).
Impairment of hepatic function may increase the bioavailability of ranitidine but has no significant effect on the elimination half-life. However, in the presence of normal renal function, no dosage reduction for intravenous ranitidine appears necessary in patients with hepatic impairment.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

Short-term treatment of proven duodenal ulcer and gastric ulcer, including intravenous use for prophylaxis against recurrent haemorrhage.
Maintenance treatment to reduce the risk of relapse in duodenal ulcer.
Maintenance treatment for periods up to one year to reduce the risk of relapse in patients with documented healing of benign gastric ulcer.
Treatment of gastrinoma (Zollinger-Ellison syndrome).
Short-term symptomatic treatment of reflux oesophagitis unresponsive to conservative anti-reflux measures and simple drug therapies such as antacids.
Maintenance treatment to reduce the risk of relapse of reflux oesophagitis.
Treatment of scleroderma oesophagitis.
The intravenous injection is indicated where oral treatment is inappropriate.

4.3 Contraindications

Known hypersensitivity to ranitidine or any of the ingredients in this product.

4.4 Special Warnings and Precautions for Use

Gastric ulcer.

Treatment with a histamine H2-antagonist may mask symptoms associated with carcinoma of the stomach and therefore may delay diagnosis of the condition. Accordingly, where gastric ulcer is suspected, the possibility of malignancy should be excluded before therapy with Ranitidine Sandoz Injection is instituted.

Long-term use.

The risk of ulcer recurrence is determined by many factors. In some cases, long periods of treatment may be necessary and/or repeated. Evidence from controlled clinical trials of up to 18 months of continuous treatment with ranitidine has not revealed any undue untoward effects.

Bradycardia.

In association with rapid administration of ranitidine injection has been rarely reported, usually in patients with factors predisposing to cardiac rhythm disturbances. Recommended rates of administration should not be exceeded.

Higher doses.

The use of higher than recommended doses of intravenous H2-antagonists has been associated with rises in liver enzymes when treatment has been extended beyond five days.

Porphyria.

Rare clinical reports suggest that ranitidine may precipitate acute porphyric attacks. Ranitidine Sandoz Injection should therefore be avoided in patients with a history of acute porphyria.

Gastric pH.

Agents that elevate gastric pH may increase the already present risk of nosocomial pneumonia in intubated intensive care unit patients receiving mechanical ventilation.

Use in renal impairment.

Ranitidine is excreted via the kidneys and in the presence of severe renal impairment, plasma levels of ranitidine are increased and prolonged. Accordingly, in the presence of significant renal impairment, serum levels should be monitored and dosage adjustments made. The clearance of ranitidine is increased during haemodialysis.

Use in the elderly.

In patients such as the elderly, persons with chronic lung disease, diabetes or the immunocompromised, there may be an increased risk of developing community acquired pneumonia. A large epidemiological study showed an increased risk of developing community acquired pneumonia in current users of H2-receptor antagonists versus those who had stopped treatment, with an observed adjusted relative risk of 1.63 (95% CI, 1.07-2.48).

Paediatric use.

Experience with ranitidine preparations in children is limited and such use has not been fully evaluated in clinical studies. Ranitidine has, however, been used successfully in children aged 8 to 18 years in doses up to 150 mg twice daily.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Ranitidine has the potential to affect the absorption, metabolism or renal excretion of other drugs. The altered pharmacokinetics may necessitate dosage adjustment of the affected drug or discontinuation of treatment.
Interactions occur by several mechanisms including:
1. Inhibition of cytochrome P450-linked mixed function oxygenase system. Ranitidine at usual therapeutic doses does not potentiate the actions of drugs which are inactivated by this enzyme system such as diazepam, lidocaine, phenytoin, propranolol and theophylline.
There have been reports of altered prothrombin time with coumarin anticoagulants (e.g. warfarin). Due to the narrow therapeutic index, close monitoring of increased or decreased prothrombin time is recommended during concurrent treatment with ranitidine.
2. Competition for renal tubular secretion. Since ranitidine is partially eliminated by the cationic system, it may affect the clearance of other drugs eliminated by this route. High doses of ranitidine (e.g. such as those used in the treatment of Zollinger-Ellison syndrome) may reduce the excretion of procainamide and N-acetylprocainamide resulting in increased plasma levels of these drugs.
3. Alteration of gastric pH. The bioavailability of certain drugs may be affected. This can result in either an increase in absorption (e.g. triazolam, midazolam, glipizide) or a decrease in absorption (e.g. ketoconazole, atazanavir, delavirdine, gefitinib).
If high doses (2 g) of sucralfate are coadministered with ranitidine, the absorption of the latter may be reduced. This effect is not seen if sucralfate is taken after an interval of two hours.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There are no data on the effects of ranitidine on human fertility. Reproduction studies performed in rats and rabbits have revealed no evidence of impaired fertility or harm to the foetus due to ranitidine.
(Category B1)
The safety of ranitidine in pregnancy has not been established. Ranitidine crosses the placenta. Ranitidine should only be used during pregnancy if considered essential. If the administration of ranitidine is considered to be necessary, its use requires that the potential benefits be weighed against possible hazards to the patient and to the foetus.
 Ranitidine is secreted in breast milk in lactating mothers but the clinical significance of this has not been fully evaluated. Ranitidine should only be used by nursing mothers if considered essential.

4.8 Adverse Effects (Undesirable Effects)

The following have been reported as events in clinical trials or in the routine management of patients treated with ranitidine. The relationship to ranitidine therapy has not been clear in many cases. Headache, sometimes severe, has been reported in a very small proportion of patients.

Central nervous system.

Rarely, malaise, dizziness, somnolence, insomnia and vertigo. Rare cases of reversible mental confusion, depression and hallucinations have been reported, predominantly in severely ill, in elderly and in nephropathic patients. In addition, reversible involuntary movement disorders have been reported rarely. There have been a few reports of reversible blurred vision suggestive of a change in accommodation. Reversible impotence has been reported rarely.

Cardiovascular.

As with other H2-receptor antagonists, rare reports of tachycardia, bradycardia, premature ventricular beats, atrioventricular block and asystole.

Gastrointestinal.

Constipation, diarrhoea, nausea/ vomiting, abdominal discomfort/ pain.

Hepatic.

Transient and reversible changes in liver function tests can occur. In normal volunteers, ALT values were increased to at least twice the pretreatment levels in 6 of 12 subjects receiving 100 mg intravenously four times daily for 7 days and in 4 of 24 subjects receiving 50 mg intravenously four times daily for 5 days. There have been occasional reports of hepatitis, hepatocellular or hepatocanalicular or mixed, with or without jaundice. These were usually reversible.

Musculoskeletal.

Rare reports of arthralgias and myalgia.

Haematological.

Rare reports of agranulocytosis or pancytopenia, sometimes with marrow hypoplasia or aplasia, have been reported. Blood count changes (leucopenia, thrombocytopenia) have occurred in a few patients. These are usually reversible.

Endocrine.

Controlled studies in animals and humans have shown no stimulation of any pituitary hormone by ranitidine, no antiandrogenic activity, and cimetidine induced gynaecomastia and impotence in hypersecretory patients have resolved when ranitidine was substituted. However, occasional cases of gynaecomastia, galactorrhoea, impotence and loss of libido have been reported in male patients receiving ranitidine, but the incidence did not differ from that in the general population.

Dermatological.

Rash, including rare cases of mild erythema multiforme. Rare cases of vasculitis and alopecia have been reported.

Renal.

Very rare cases of acute interstitial nephritis have been reported.

Other.

Rare cases of hypersensitivity reactions (e.g. fever, bronchospasm, anaphylactic shock, urticaria, angioneurotic oedema, hypotension, chest pain, rash, eosinophilia), small increases in serum creatinine. Acute pancreatitis has been reported rarely. Dyspnoea has been reported.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

Dosage.

Ranitidine Sandoz Injection may be given as either a slow intravenous injection of 50 mg (e.g. 5 mL diluted to 20 mL 0.9% sodium chloride and given as a slow injection over not less than five minutes), which may be repeated every six to eight hours; or as an intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals.

Stability in intravenous infusion fluids.

Ranitidine Sandoz Injection has been shown to be physically and chemically compatible with the following intravenous infusion fluids: 0.9% Sodium Chloride BP, 5% Glucose BP, 0.18% Sodium Chloride and 4% Glucose BP, 4.2% Sodium Bicarbonate BP and Hartmann's solution, within minimum and maximum concentrations of ranitidine of 0.1 mg/mL (1 ampoule mixed with 495 mL of diluent) to 2.5 mg/mL (1 ampoule mixed with 15 mL of diluent).
However, Ranitidine Sandoz Injection does not contain any antimicrobial preservative. To reduce microbial contamination hazards, the admixture should be used as soon as practicable after preparation. If storage is necessary, keep the mixtures at 2-8°C for not more than 24 hours when diluted with 0.9% Sodium Chloride BP, 4.2% Sodium Bicarbonate BP or Hartmann's solution and for not more than 8 hours when diluted with 5% Glucose BP or 0.18% Sodium Chloride and 4% Glucose BP. All unused admixtures of Ranitidine Sandoz Injection with infusion fluids should be discarded after these storage periods. Ranitidine Sandoz Injection should not be autoclaved.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.9 Overdose

Symptoms.

There has been virtually no experience with overdosage of ranitidine injections and limited experience of overdosage with oral doses of ranitidine. Reported acute ingestions of up to 18 g orally have been associated with transient adverse effects similar to those encountered in normal clinical experience (see Section 4.8 Adverse Effects (Undesirable Effects)). Rapid bolus injection of 300 mg intravenous (six times the recommended dose which should be given slowly) caused dizziness and peripheral vasodilatation.

Treatment.

Symptomatic and supportive therapy should be given as appropriate. If need be, the drug may be removed from the plasma by haemodialysis.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Ranitidine Sandoz Injection contains water for injection and sodium hydroxide.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
For information on interactions with other medicines and other forms of interactions, see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light.

6.5 Nature and Contents of Container

Ranitidine Sandoz Injection is available in 5 mL ampoules in boxes of 5.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

Summary Table of Changes