CONSUMER MEDICINE INFORMATION

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1 CONSUMER MEDICINE INFORMATION What is in this leaflet This leaflet answers sme cmmn questins abut CEFTRIAXONE lcp. It des nt cntain all the available infrmatin. It des nt take the place f talking t yur dctr r pharmacist. All medicines have risks and benefits. Yur dctr has weighed the risks f yu using CEFTRIAXONE ICP against the benefits it will have fr yu. If yu have any cncerns abut using this medicine, ask yur dctr r pharmacist. Keep this leaflet with the medicine. Yu may need t read it again' What CEFTRIAXONE ICP is used fr CEFTRIAXONE ICP cntains the active ingredient ceftriaxne sdium. CEFTRIAXONE ICP is an antibitic used t treat bacterial infectins in different parts f the bdy. CEFTRIAXONE ICP is als used t prevent infectins befre, during and after surgery. CEFTRIAXONE ICP belngs t a grup f antibitics called cephalsprins, which wrk by killing the bacteria that are causing yur infectin. Yur dctr may have prescribed CEFTRIAXONE ICP fr anther reasn. Ask yur dctr if yu have any questins abut why CEFTRIAXONE ICP has been prescribed fr yu. This medicine is available nly with a dctr's prescriptin. Befre yu are given CEFTRIAXONE ICP D nt use CEFTMAXONE ICP if: 1. Yu have an allergy t ceftriaxne, r any ther cephalsprins Sme f the slnnptms f an allergic reactin may include skin rash, itching r hives, asthma, wheezing, shrtness f breath, swelling f the face, lips r tngue which may cause difficulty in swallwing r breathing; 2. Yu have had a serius allergic reactin t any penicillins; 3. The packaging is trn r shws any signs f tampering;

2 4. The use by date r expiry date printed n the pack has passed. If this medicine is used after the expiry date has passed, it may nt wrk as well. Befre yu start t take r are given CEFTMAXONE ICP yu must tell yur dctr rf: 1. Yu have had any type f allergic reactin t any cephalsprin r penicillin medicines. Yu may have an increased chance f being allergic t CEFTRIAXONE ICP if yu are allergic t any cephalsprins r penicillins; 2.Yu are allergic t ligncaine, which may be mixed with CEFTRIAXONE ICP befre intramuscular injectin, r ther lcal anaesthetics; 3. Yu have allergies t any ther medicines r any ther substances, such as fds, preservatives r dyes; 4. Yu are pregnant, r intend t becme pregnant. Yur dctr will discuss the risks and benefrts f using CEFTRIAXONE ICP during pregnancy; 5. Yu are breast-feeding r intend t breast-feed. CEFTRIAXONE ICP passes int breast milk and may affect yur baby. Yur dctr will discuss the risks and benefits f using it when breast-feeding. 6. If yu have r have had any medical cnditins, including kidney disease, stmach r bwel prblems, liver disease r bleeding prblems. If yu have nt tld yur dctr(s) abut any fthe abve, tell them befre yu are given CEFTRIAXONE ICP. Use in children Yur child's dctr will discuss the risks and benefits f yur child using CEFTRIAXONE ICP. Taking ther medicines Tell yur dctr if yu are taking any ther medicines, including medicines that yu buy withut a prescriptin frm yur pharmacy, superrnarket r health fd shp. Sme medicines may interfere with CEFTRIAXONE ICP. These include chlramphenicl.

3 'l'his medicine may be affected by CEFTRIAXONE lcp, r may affect hw well it wrks. Yu may need t use different amunts f yur medicine, r yu may need t use dilferent medicines. Yur dctr will advise yu. Sme antibitics may decrease the effectiveness f sme birth cntrl pills. Yur dctr and pharmacist have mre infrmatin n medicines t be careful with r avid while using CEFTRIAXONE ICP. Hw CEFTRIAXONE ICP is given CEFTRIAXONE ICP must nly be given by a dctr r nurse. CEFTRIAXONE ICP may be given in tw ways:- as a slw injectin int a vein;?s a deep injectin int a large muscle. Hw much will yu be given Yur dctr will decide what dse and hw lng yu will receive CEFTRIAXONE ICP. This depends n yur cnditin and whether yu are taking any ther medicines. Fr mst infectins, CEFTRIAXONE ICP is usually given nce r twice a day. The length f treatment is usually between 4 days and 2 weeks. Smetinres nly a single dse f CEFTRIAXONE ICP is required fr the treatment and preventin f certain infectins. While yu are using CEFTRIAXONE ICP Things yu must d If the symptms f yur infectin d nt imprve within a few days, r if they becme wrse, tell yur dctr.. If yu get severe diarrhea tell yur dctr, pharmacist r nurse immediately. D this even if it ccurs several weeks after CEFTRIAXONE ICP has been stpped. Diarrhea may mean that yu have a serius cnditin affecting yur bwel. Yu may need urgent rnedical care. D nt take any diarrhea medicine withut first checking with yur dctr.. If yu get a sre rvhite muth r tngue while using r sn after stpping CEFTRIAXONE ICP, tell yur dctr. Als tell yur dctr if yu get vaginal

4 itching r discharge. This may mean yu have a fungal infectin called thrush. Smetimcs the use f CEFTRIAXONE ICP allws fungi t grw and the abve symptms t ccur. CEFTRiAXONE ICP des nt wrk against fungi.. If yu becme pregnant while yu are using CEFTRIAXONE ICP, tell yur dctr immediately. If yu are abut t start taking any new medicine, tell yur dctr and pharmacist that yu are using CEFTRIAXONE ICP. If yu have t test yur urine fr sugar while yu are being given CEFTRIAXONE ICP, make sure yur dctr knws which type f test yu use. CEFTRIAXONE ICP may affect the results f sme f these tests. If yu have t have any bld tests, tell yur dctr yu are being given CEFTRIAXONE ICP. CEFTRIAXONE ICP may affect the results f sme bld tests. Tell all the dctrs, dentists and pharmacists wh are treating yu that yu are using CEFTRIAXONE ICP. Things yu must nt d D nt give CEFTRIAXONE ICP t anyne else, even if they havethe same cnditin as yu. D nt use CEFTRIAXONE ICP t treat any ther cmplaints unless yur dctr tells yu t. Things t be careful f Be careful driving r perating machinery until yu knw hw CEFTRIAXONE ICP affects yu. CEFTRIAXONE ICP may cause dizziness in sme peple. Make sure yu knw hw yu react t CEFTRIAXONE ICP befre yu drive a car, perate machinery r d anything else that may be dangerus if yu are affected. Side effects Tell yur dctr, nurse r pharmacist as sn as pssible if yu d nt feel well while yu are being given CEFTRIAXONE ICP. All medicines can have side effects. Smetimes they are serius, mst f the time they are nt. Yu may need medical

5 treatment if yu get sme f the side effects. Ask yur dctr r pharmacist answer any questins yu may have. While using CEFTRIAXONE ICP tell yur dctr r nurse if yu ntice any f the fllwing and they wrry yu:-. ral thrush - white, fu*y, sre tngue and muth. vaginal thrush - sre and itchy vagina smetimes with a white discharge pain r swelling at the injectin site. diarrhea. nausea (feeling sick) r vmiting headache r dizziness taste disturbances. fever These side effects are usuallv mild. Tell yur dctr r nurse immediately r g t Accident and Emergency at yur nearest hspital if yu ntice any f the fllwing:. severe abdminal cramps r stmach cramps watery and severe diarrhea, rvhich may als be bldy. skin rash, itching r hives. severe peeling r flaking f the skin swelling f the face, lips r tngue which may cause difficulty in swallwing r breathing wheezing r shrtness f breath swelling f the hands, feet r ankles. bleeding r bruising mre easily than nrmal signs f frequent infectins such as fever, severe chills, sre thrat r muth ulcers. signs f anaemia such as, tiredness, being shrt f breath when exercising, lking pale yellwing f the skin r eyes fast r irresular heart beat

6 passing less urine than is nrmal pain when passing urine These are serius side effects. Yu may need urgent medical attentin. Serius side effects are rare. After using CEFTRIAXONE ICP Tell yur dctr immediately if yu ntice any f the fllwing side effects, even if they ccur several weeks after stpping treatment with CEFTRIAXONE ICP:-. severe abdminal cramps r stmach cramps watery and severe diarrhea, which may als be bldy fever, in cmbinatin vr,ith ne r bth f the abve These are rare but serius side effects. Yu may have a serius cnditin affecting yur bwel. Yu may necd urgent medical attentin. Hwever, this side effect is rare. D nt take any diarrhea medicine withut first checking with yur dctr. Other side effects nt listed abve may als ccur in sme patients. Tell yur dctr if yu ntice anything else that is making yu feel unwell. D nt be alarmed by this list f pssible side effects. Yu may nt experience any f them. Strage CEFTRIAXONE ICP will be stred in the phannacy r n the ward. The pwder fr injectin is kept in a cl, dry place prtected frm light and misture, where the temperature stays belw 25C. The recnstituted slutin can be kept in a refrigeratr between 2 and 8C fr nt mre than 24 hurs aftcr mixing. D nt freeze. Prduct descriptin I(hat it lks like CEFTRIAXONE ICP is a white t pale yellw crystalline pwder in a glass vial r bttle. When recnstituted fr injectin, the clur f the slutin ranges frm pale yellw t amber. Ingredients

7 I he actrve rngredient in ctsf'i'rlaxne ICP is ceftriaxne sdium. Aus tra I ia n regis t rat irt numbers : CtsF'I'RIAXONE ICP 500 mg vial: AUST R CEFTRIAXONE ICP I g vial: AUST R CEFTRIAXONE ICP 2 g infusin bttle: AUST R Manufacturer CEFTRIAXONE ICP is distributed by the spnsr f the prduct:- Intensive Care Prducts Pty Ltd Level 1. APP Huse 14 Rdbrugh Rad Frenchs Frest, NSW 2086 Phne: Fax: Date f Infrmatin: I March.2004 Updated: 19 June,2005

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