Package leaflet: Information for the user. Fragmin 10,000 IU/1 ml and 10,000 IU/4 ml Solution for injection dalteparin sodium

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1 Package leaflet: Infrmatin fr the user Fragmin 10,000 IU/1 ml and 10,000 IU/4 ml Slutin fr injectin dalteparin sdium Read all f this leaflet carefully befre yu start using this medicine because it cntains imprtant infrmatin fr yu. Keep this leaflet. Yu may need t read it again. If yu have any further questins, ask yur dctr, pharmacist r nurse. If yu get any side effects talk t yur dctr, pharmacist r nurse. This includes any pssible side effects nt listed in this leaflet. See sectin 4. What is in this leaflet: 1. What Fragmin is and what it is used fr 2. What yu need t knw befre yu are given Fragmin 3. Hw Fragmin is given t yu 4. Pssible side effects 5. Hw t stre Fragmin 6. Cntents f the pack and ther infrmatin 1. What Fragmin is and what it is used fr Fragmin cntains the active ingredient dalteparin sdium. It is available in 2 strengths: 10,000 IU/ 1 ml slutin fr injectin. 10,000 IU/ 4 ml slutin fr injectin. Abbreviatin: IU = Internatinal units Fragmin belngs t a grup f medicines called lw mlecular weight heparins r antithrmbtics, which help prevent the frmatin f bld clts by thinning the bld. Yu may be given Fragmin fr the fllwing cnditins: Haemdialysis/Haemfiltratin: Fragmin may be used in patients having haemdialysis r haemfiltratin. Fragmin prevents bld clts being frmed in the tubes f the equipment. Haemdialysis and haemfiltratin are methds f remving excessive natural waste prducts frm the bld f peple whse kidneys are n lnger able t perfrm this functin. The 10,000 IU/1 ml can als be used t treat cnditins such as venus thrmbemblism and unstable crnary artery disease. Page 1 f 7

2 Venus thrmbemblism: Venus thrmbemblism is a cnditin where bld clts develp in the legs (deep vein thrmbsis) r the lungs (pulmnary emblism). This can happen fllwing surgery, pregnancy r lng perids f bed rest. Unstable crnary artery disease: In patients with crnary artery disease, the crnary arteries (bld vessels t the heart) are furred up and narrwed by patches f fatty depsits. Unstable crnary artery disease means that a furred up bit f the artery has ruptured and a clt has frmed n it, reducing the flw f bld t the heart. Fragmin helps t prevent mre clts being frmed. Ask yur dctr if yu are unsure why yu have been given Fragmin. 2. What yu need t knw befre yu are given Fragmin Yu shuld nt be given Fragmin: if yu are allergic (hypersensitive) t the active ingredient dalteparin sdium r a similar prduct r any f the ther ingredients f this medicine (listed in sectin 6). if yu have a stmach ulcer r ulcer f the dudenum (small intestine). if yu have suffered frm a brain haemrrhage (bleeding in yur brain). if yu suffer frm any cnditin which may cause yu t bleed mre easily (e.g. haemphilia, liver failure). Ask yur dctr if yu are unsure. if yu have a cnditin called septic endcarditis (an infectin and inflammatin f the lining f the heart and heart valves). Yur dctr will have tld yu if yu have this. if yu have an injury t, r are abut t have an peratin invlving yur spine, head, eyes r ears. If yu are suffering frm thrmbcytpenia (a cnditin where there are fewer cltting cells knwn as platelets in the bld, causing yu t bruise and bleed mre easily). Yur dctr will have tld yu if yu have this. If yu are receiving Fragmin t treat bld clts, yu shuld nt have a lcal, spinal r epidural anaesthetic. Warnings and precautins Talk t yur dctr, pharmacist r nurse befre yu take Fragmin: if yu have cnditins which make yu mre susceptible t bleeding e.g.: after an peratin r trauma a strke caused by a bleed severe liver r kidney failure abnrmal r lw numbers f platelets (cltting cells) eye disease caused by bld pressure r diabetes taking ther medicines that thin the bld (e.g. aspirin, warfarin, dipyridamle) uncntrlled high bld pressure. Page 2 f 7

3 if yu have been tld by yur dctr that yu have a lt f ptassium in yur bld r have a lw bld ph. Yur dctr will mnitr yur bld regularly befre and during treatment. if yu have ever had an peratin t insert artificial heart valves. if yu need any ther injectins. Yu may need t have bld tests t mnitr the effects f Fragmin: if yu have kidney failure r liver prblems if yu are very thin r mrbidly bese if yu are pregnant if yu are at increased risk f bleeding r rethrmbsis (mre bld clts) if yu are a child. Yur dctr will mnitr yur bld regularly befre and during treatment. Children and adlescents Dsing recmmendatins in children are based n clinical experience; there are limited data frm clinical trials, which will help yur dctr calculate the dse f Fragmin. Other medicines and Fragmin Tell yur dctr, pharmacist r nurse if yu are taking, have recently taken r are planning t take r use any ther medicines. This includes medicines that yu have bught fr yurself. Sme medicines can affect the way Fragmin wrks. Fragmin can reduce the effectiveness f ther medicines taken at the same time. Medicines that increase the effect f Fragmin include; Thse used t thin yur bld (e.g. aspirin, dipyridamle, glycprtein receptr antagnists and warfarin) Medicines called nn-steridal anti-inflammatry drugs (NSAIDs) used t reduce pain and inflammatin (e.g. indmetacin) Sme medicines fr gut (e.g. sulfinpyrazne and prbenecid) Etacrynic acid (a water retentin tablet (diuretic)) Slutins given t increase bld vlume (e.g. dextrans) Medicines knwn as cytstatics (used in cancer treatment) Thrmblytic medicatins fr treating transmural heart attack (e.g. TPA-tissue plasmingen activatr). Medicines that can reduce the effect f Fragmin, include: Thse fr allergy and hay fever (e.g. antihistamines) Thse used fr heart r circulatin prblems (e.g. digxin r digitxin) Antibitics knwn as tetracyclines which are used t treat bacterial infectins Vitamin C (e.g. sme vitamin supplements). Other medicines that may interfere with Fragmin include: Thse used t treat angina ( e.g. intravenus nitrglycerine) Antibitics such as high dse penicillin which are used t treat bacterial infectins Anti-malarials (e.g. quinine) Tbacc smking. Page 3 f 7

4 Please nte that if yu are being treated with Fragmin fr unstable crnary artery disease yur dctr may adjust yur dse f aspirin accrdingly. Please tell yur dctr r pharmacist if yu are taking r have recently taken any ther lw mlecular weight heparins r anti-thrmbtics. Please tell yur dctr r pharmacist if yu are taking r have recently taken any ther medicines, including medicines btained withut a prescriptin. Pregnancy and breast-feeding Fragmin has nt been fund t cause harmful effects during pregnancy. The pssibility f harm t the baby appears remte. Tell yur dctr if yu are pregnant and they will advise yu. Hwever, if yu have an artificial heart valve and are pregnant, the usual dse f Fragmin might nt be enugh t prevent a bld clt. Yur dctr will discuss this with yu. If yu are receiving Fragmin t treat bld clts, yu shuld nt have a lcal, spinal r epidural anaesthetic. Ask yur dctr r pharmacist fr advice befre taking this medicine whilst breast-feeding. Driving and using machines Fragmin des nt affect the ability t drive and perate machinery. 3. Hw Fragmin is given t yu Yur medicine will be administered by a dctr r nurse. Fragmin is given either as an injectin int a vein r as subcutaneus injectin, which means it is injected beneath the skin. It is usually injected int a skin fld in yur abdmen (stmach), r the uter aspects f yur thigh. The amunt f Fragmin yu receive will depend n yur particular cnditin. Haemdialysis/Haemfiltratin Use in adults and the elderly: If yu are underging haemdialysis r haemfiltratin, the medicine will be injected int the tubes f the haemdialysis machine. Fr patients with chrnic (lng term) kidney prblems, wh are being given treatment lasting lnger than 4 hurs, a starting dse f IU fr each kg f bdyweight will usually be given. This is fllwed by an infusin (slw injectin) f IU/kg every hur. The same dse may be given if the treatment lasts less than 4 hurs, r a single injectin f 5000 IU may be given. Fr patients with acute (rapid r severe) kidney failure, r patients wh are mre likely t bleed, the usual dse is 5-10 IU fr each kg f bdy weight, fllwed by 4-5 IU/kg every hur. Deep Vein Thrmbsis Use in adults and the elderly: If yu are having treatment fr deep vein thrmbsis yu will be given an injectin beneath the skin. The site f this injectin will usually be the stmach Page 4 f 7

5 (abdmen) r uter aspects f yur thigh. A dse f 200 IU fr each kg f bdy weight may be given nce a day, r 100 IU/kg twice a day. The single daily dse shuld nt exceed 18,000 IU. Fragmin can be used tgether with ther bld thinning medicines knwn as Vitamin K antagnists. Shuld this be desired, a minimum f five days wuld be required. Unstable Crnary Artery Disease Use in adults and the elderly: In the treatment f unstable crnary artery disease, a dse f 120 IU/kg f bdy weight is given every 12 hurs, as an injectin beneath the skin. If yu have an artificial heart valve, the nrmal dse fr preventin f bld clts is nt sufficient. Yur dctr will discuss this with yu. The maximum dse in a 12 hur perid is 10,000 IU. Extended use If yur dctr has recmmended a special prcedure t restre the bld supply t yur heart (angigraphy r crnary artery surgery), it may be necessary t cntinue t administer Fragmin fr up t 45 days. In this case, the dse shuld be either 5,000 IU (wmen less than 80 kg and men less than 70 kg) r 7,500 IU (wmen 80 kg and abve r men 70 kg and ver) every 12 hurs. These are typical dses fr adults, including elderly patients. Yur dctr will wrk ut the right dse fr yu. Sme f the liquid in the syringe may have t be expelled befre the injectin is given. Medical staff may take bld samples during yur treatment t mnitr the effects f Fragmin. Children and adlescents The dse will be based n bth the child s age and weight. Yunger children may need slightly mre Fragmin per kg than adults. Yur dctr will wrk ut the right dse fr yu. Medical staff may take bld samples during yur treatment t mnitr the effects f Fragmin. If yu are given mre Fragmin than yu shuld If yu feel that yu have been given mre Fragmin than yu shuld, infrm yur dctr r nursing staff immediately. Yur dctr may want t give yu an injectin f prtamine as an antidte. If yu have any further questins n the use f this medicine, ask yur dctr, pharmacist r nurse. 4. Pssible side effects Like all medicines, this medicine can cause side effects, althugh nt everybdy gets them. Stp using Fragmin and talk t a dctr r nurse at nce if yu get any signs f a severe allergic reactin (such as difficulty breathing, swelling f the lips, muth, thrat r eyes) - Cmmn side effects (may affect up t 1 in 10 peple): Page 5 f 7

6 A reversible decrease in the number f cltting cells (platelets) in yur bld (Type I thrmbcytpenia). This may make yu bruise mre easily Bleeding at any site Certain substances prduced by yur liver may increase Pain and reactins at the site f injectin Haematma cllectin f bld under the skin - Uncmmn side effects (may affect up t 1 in 100 peple): Increased levels f ptassium in yur bld (symptms may include temprary muscle weakness, lss f feeling and changes in yur heartbeat) Red skin rash and itchiness Itching Allergic reactins - Rare side effects (may affect up t 1 in 1,000 peple): An immune system prblem resulting in a severe decrease in the number f cltting cells (platelets) in yur bld (Type II thrmbcytpenia) Alpecia (hair lss) Painful skin lesins - Nt knwn (frequency cannt be estimated frm the available data): Bleeding inside r arund yur brain, symptms may include sudden severe headache Bleeding behind yur abdmen (stmach), symptms may include a feeling f tenderness and swelling arund yur stmach Bruising f the spine which may lead t back pain, tingling, numbness r weakness in yur legs, bwel r bladder prblems If yu have an artificial heart valve, treatment with Fragmin might nt be sufficient t prevent a bld clt, and yu might develp a clt in the heart valve. The adverse reactins in children are expected t be the same as in adults, hwever there is nly a little infrmatin abut the pssible side effects f lng term use in children. If yu get any side effects, talk t yur dctr, pharmacist r nurse. This includes any pssible side effects nt listed in this leaflet. Reprting f side effects If yu get any side effects, talk t yur dctr, pharmacist r nurse. This includes any pssible side effects nt listed in this leaflet. Yu can als reprt side effects directly via the Yellw Card Scheme at: By reprting side effects yu can help prvide mre infrmatin n the safety f this medicine. 5. Hw t stre Fragmin Keep this medicine ut f the sight and reach f children. Fragmin shuld nt be used after the expiry date which is printed n the label and cartn. The expiry date refers t the last day f that mnth. Page 6 f 7

7 Stre belw 30 C. Yur dctr r nurse will stre Fragmin in a safe place under the abve cnditins. D nt thrw away any medicines via wastewater r husehld waste. Ask yur pharmacist hw t thrw away medicines that yu n lnger use. These measures will help t prtect the envirnment. 6. Cntents f the pack and ther infrmatin What Fragmin cntains The active ingredient in Fragmin is dalteparin sdium. They cntain the fllwing: 4 ml ampule: 2,500 IU/ml (intl unit) 1 ml ampule: 10,000 IU (intl unit). The ther ingredients are water fr injectins and sdium chlride. What Fragmin lks like and cntents f the pack Fragmin is a clear clurless r straw clured slutin in a glass ampule. Each pack cntains 5 ampules. Marketing Authrisatin Hlder Pfizer Limited Ramsgate Rad Sandwich Kent CT13 9NJ, UK Manufacturer Pfizer Manufacturing Belgium NV Rijksweg 12 B-2870 Puurs Belgium This leaflet was last revised 03/2014. Ref: FR 12_0 Page 7 f 7

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