ZANTAC INJECTION (50MG/2ML)
Active substance: RANITIDINE HYDROCHLORIDE
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10000000084905
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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, Zantac 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 mg/kg or 2.5 mg/kg, maximum 50 mg) 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 min, or following dilution with normal saline to 20 ml. Maintenance of pH > 4 can be achieved by intermittent infusion of 1.5 mg/kg every 6 h to 8 h. Alternatively treatment can be continuous, administering a loading dose of 0.45 mg/kg followed by a continuous infusion of 0.15 mg/kg/hr. Prophylaxisofstressulcerationinseriously ill patients The recommended dose for prophylaxis of stress ulceration is 1 mg/kg (maximum 50 mg) every 6 h to 8 h. Alternatively treatment can be continuous, administering 125 - 250 micrograms/kg/hr as continuous infusion. Neonates(under1month) (SeeSPCsection5.2Pharmacokineticproperties - Special patient populations.) Renal Impairment: Accumulation of ranitidine with resulting elevated plasma concentrations will occur in patients with severe renal impairment (creatinine clearance less than 50 ml/min). Accordingly, it is recommended in such patients that ranitidine be administered in doses of 25 mg. Routeofadministration Intravenous or intramuscular injection.
Shelf Life
36 months unopened. . . .
Information for Heathcare Professionals
. . .
Zantac Injection 50 mg/2 ml
Special Precautions for Storage
Storebelow25C,protectfromlight. Zantac Injection should not be autoclaved.
ranitidine hydrochloride
Please refer to the Summary of Product Characteristics (SPC) for further details on this product. intramuscular injection of 50 mg (2 ml) every 6 to 8 hours. Prophylaxisofhaemorrhagefromstress ulceration or recurrent haemorrhage: 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 untiloralfeedingcommences.Patients considered to be still at risk may then be treated with Zantac Tablets 150 mg twice daily. 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. ProphylaxisofMendlesonssyndrome: In patients considered to be at risk of developing acid aspiration syndrome, Zantac Injection 50 mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia. Children/infants(6monthsto11years) (SeeSPCsection5.2Pharmacokineticproperties - Special patient populations.) Zantac Injection may be given as a slow (over 2 minutes) i.v. injection up to a maximum of 50 mg every 6 to 8 hours. Pepticulceracutetreatmentand gastro-oesophageal reflux
Instructions for Use/Handling
Zantac Injection has been shown to be compatible with the following intravenous infusion fluids:0.9%SodiumChlorideBP 5%DextroseBP 0.18%SodiumChlorideand4%DextroseBP 4.2%SodiumBicarbonateBP Hartmanns Solution. All unused admixtures of Zantac Injection with infusion fluids should be discarded 24 hours after preparation. Although compatibility studies have only been undertaken in polyvinyl chloride infusion bags(inglassforSodiumBicarbonateBP) and a polyvinyl chloride administration set it is considered that adequate stability would be conferred by the use of a polyethylene infusion bag. InformationforHealthcareProfessionalsLeaflet date: January 2009 Zantac is a registered trademark of the GlaxoSmithKline group of companies 2009 GlaxoSmithKline group of companies
Qualitative and Quantitative Composition
RanitidinehydrochlorideHSE56mg/2ml equivalent to ranitidine 50 mg/2 ml.
Pharmaceutical Form
Injection (Aqueous solution) A clear colourless to pale yellow liquid, practically free from particles
Posology and Method of Administration
(SeeSPCsection5.2Pharmacokineticproperties - Special patient populations.) Adults(includingelderly)/adolescents (12 years and over) Zantac Injection may be given as a slow (over 2 minutes) intravenous injection up to a maximum of 50 mg, after dilution to a volume of 20 ml per 50 mg dose, which may be repeated every 6 to 8 hours; or as an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at 6 to 8 hour intervals, or as an
Package Leaflet: Information for the User
Different doses may also be given to you as a slow infusion or continuous infusion, depending on what condition you are being treated for. Childrenandinfants(6monthsto11years): YourdoctorwillgiveZantacbyaslowinjection 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 YourdoctorornursewillgiveyouZantac 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.
Zantac Injection 50 mg/2 ml
reasttendernessand/orbreast b enlargement breastdischarge. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
ranitidine hydrochloride
Read all of this leaflet carefully before you start taking this medicine. eepthisleaflet.Youmayneedto K read it again. fyouhaveanyfurtherquestions,askyour I doctor or pharmacist. hismedicinehasbeenprescribedforyou. T Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. fanyofthesideeffectsgetsserious,orifyou I notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1 What Zantac is and what it is used for 2 BeforeyouhaveZantac 3 How to have Zantac Injection 4 Possiblesideeffects 5 How to store Zantac 6 Further information ouhaveanyproblemswithyour y immune system. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before having this medicine. Taking other medicines Pleasetellyourdoctororpharmacistifyou are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Zantac can affect the way some other medicines work. Also some other medicines can affect the way Zantac works. In particular tell your doctor or pharmacist if you are taking any of the following medicines: lidocaine,alocalanaesthetic propranolol,procainamideor n-acetylprocainamide, for heart problems diazepam,forworryoranxiety problems phenytoin,forepilepsy theophylline,forbreathingproblems (asthma) warfarin,forthinningyourblood glipizide,forloweringbloodglucose atazanavirordelaviridine,fortreating HIV infection triazolam,forinsomnia gefitnib,forlungcancer ketoconazole,anantifungalmedicine, sometimes used for treating thrush. Midazolamisamedicinethatmaybegiven to you just before you have an operation. Tell the doctor you are taking Zantac before your operation in case he or she wants to give you midazolam. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before having Zantac. Pregnancy and breast-feeding If you are pregnant, might become pregnant or are breast-feeding, you should not take this medicine unless your doctor advises it is essential. Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding. Important information about some of the ingredients of Zantac Zantac Injection contains less than 23 mg of sodium and is therefore essentially sodium-free.
5 How to store Zantac
eepoutofthereachandsightofchildren. K onotuseZantacaftertheexpirydatewhich D is stated on the label. The expiry date refers to the last day of that month. Donotstoreabove25C Protectfromlight edicinesshouldnotbedisposedofvia M household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
4 Possible side effects
Likeallmedicines,Zantaccancausesideeffects, although not everybody gets them. The following side effects may happen with this medicine. Stop taking Zantac and see a doctor straight away, if you notice any of the following serious side effects, you may need urgent medical treatment: allergicreactions,thesignsmayinclude: - rash, itching or hives on the skin - swelling of your face, lips, tongue or other parts of the body - chest pain, shortness of breath, wheezingorhavingtroublebreathing - unexplained fever and feeling faint, especially when standing up kidneyproblems,whichcanleadto back pain, fever, pain when passing urine, blood in the urine and changes in blood tests everestomachpain,thismaybeasignof s something called pancreatitis sloworirregularheartbeat a Checkwithyourdoctorat your next visit if you notice any of the following: Uncommon (affects less than 1 in 100 people) stomachpain constipation feelingsick(nausea) Rare side effects that may show up in bloodtests: ncreaseofserumcreatinineintheblood i (kidney function test) alseresultsinbloodtestscalledliver f function tests rashonitsown a Checkwithyourdoctoras soon as possible if you notice any of the following: Very rare (affect less than 1 in 10,000 people) herecanbechangesinthelevelofcertain t substances in your blood. This can lead to you feeling unusually tired or short of breath and being more likely to bruise or get an infection eelingdepressed,confused,seeingor f hearing unexplained things (hallucinations) eadache(sometimessevere) h eelingdizzyorhavingblurredvision f ourjointsormusclesarepainfulorswollen y or you cannot control their movement oursmallbloodvesselscanbecomeswollen y (known as vasculitis). Signs of this can include: a rash, swollen joints or kidney problems ourlivercanbecomeswollen.Thiscanlead y to: nausea (feeling sick) or vomiting (being sick), loss of appetite or generally feeling unwell, itching, fever, yellowing of the skin and eyes or dark coloured urine lushingormarksonyourskinthatlooklike f targets unexplainedhairloss diarrhoea impotence
6 Further information
What Zantac contains: heactivesubstanceisranitidine(asthe T hydrochloride) 50 mg heotheringredientsaresodiumchloride, T potassium dihydrogen orthophosphate, disodium hydrogen orthophosphate and Water for Injections. What Zantac looks like and contents of the pack Zantac Injection is a clear, colourless to pale yellowliquid.Youshouldntbeabletoseeany particles in it. Cartonscontainfive2mlglassampoules. Marketing Authorisation Holder and Manufacturer Product licence held by GlaxoSmithKline UK,StockleyParkWest,Uxbridge, MiddlesexUB111BT. Manufactured by GlaxoSmithKline S.p.A., SanPolodiTorrile,Parma,Italy. The information provided applies only to Zantac Injection 50 mg/2 ml Other formats: To listen to or request a copy of this leaflet inBraille,largeprintoraudiopleasecall, free of charge:
1 What Zantac is and what it is used for
Zantac contains a medicine called ranitidine. This belongs to a group of medicines called H2-receptor antagonists. It lowers the amount of acid in your stomach. For adults (including the elderly) Zantac is used to: ealandstopulcersinthestomach, h or the part of the gut it empties into (the duodenum) stopulcersfrombleeding mproveproblemscausedbyacidinthefood i pipe (oesophagus) or too much acid in the stomach.Bothofthesecancausepainor discomfort sometimes known as indigestion, dyspepsia or heartburn topacidcomingupfromthestomachwhile s under anaesthetic during an operation. For children (6 months to 18 years) Zantac is used to: healulcersinthestomach,orthepartofthe gut it empties into (the duodenum) healandstopproblemscausedbyacidin the food pipe (oesophagus) or too much acidinthestomach.Bothofthesecancause pain or discomfort sometimes known as indigestion, dyspepsia or heartburn.
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Pleasebereadytogivethefollowing information: Product name Zantac Injection 50 mg/2 ml Referencenumber10949/0109 ThisisaserviceprovidedbytheRoyalNational InstituteoftheBlind. Leafletdate:July2010 Zantac is a registered trademark of the GlaxoSmithKline group of companies 2010 GlaxoSmithKline group of companies
2 Before you have Zantac
Do not have Zantac if: ouareallergic(hypersensitive)toranitidine y or any of the other ingredients of Zantac (listed in Section 6). If you are not sure, talk to your doctor or pharmacist before having Zantac. Take special care with Zantac Checkwithyourdoctororpharmacistbefore having your medicine if: ouhavestomachcancer y ouhavekidneyproblems.Youwillneedto y have a different amount of Zantac youhavehadstomachulcersbefore youhaveahistoryofhearttrouble youhavearareconditioncalledacute porphyria youareover65yearsold youhavelungdisease youarediabetic
3 How to have Zantac Injection
Youwillneverbeexpectedtogiveyourselfthis 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: asasingleinjectionintoamuscle saslowinfusionintoavein.Thisiswhere a the drug is slowly given to you over a few minutes sacontinuousinfusionintoavein.Thisis a 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.
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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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

