Summary of Product Characteristics

Transcription

1 Summary f Prduct Characteristics 1 NAME OF THE MEDICINAL PRODUCT 0.9% Sdium Chlride Intravenus Infusin Slutin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sdium Chlride 9g per litre. Fr a full list f excipients, see Sectin PHARMACEUTICAL FORM Slutin fr infusin. Clurless t faintly straw-clured slutin withut visible particles in bags, individually verwrapped. ph 5. Osmlarity apprx 300mOsm/kgH 2 O. 4 CLINICAL PARTICULARS 4.1 Therapeutic Indicatins 0.9% istnic saline slutin is indicated: fr fluid replacement and prvisin f extracellular ins in near physilgical cncentratin in cnditins f extracellular-vlume depletin, dehydratin and electrlyte imbalance such as sdium depletin as an istnic medium fr intravenus administratin f medicinal prducts knwn t be cmpatible with 0.9% sdium chlride. 4.2 Pslgy and methd f administratin Fr intravenus infusin under medical supervisin. Single use nly. The pathphysilgical respnse t dehydratin, t electrlyte lss and t sdium chlride infusin will vary with the age f the patient being treated and this shuld be taken int accunt during rehydratin therapy. Fluid replacement therapy shuld be administered with cautin t very yung and elderly patients. The vlume f istnic saline slutin needed t replenish fluid deficits varies with age, bdy weight, cmplementary treatment and severity f the clinical cnditin. The dse and rate f administratin are subject t clinical and labratry assessment in each case. Date Printed 23/06/2011 CRN page number: 1

2 4.3 Cntraindicatins Sdium chlride infusin slutin shuld be administered with cautin t : patients with cnditins f impaired sdium excretin such as impaired renal functin, cardiac failure, cardipulmnary disease, peripheral r pulmnary edema, hypertensin, cirrhsis f the liver, pre-eclampsia, severe hepatic insufficiency; hypernatraemia patients receiving drugs which may prmte salt retentin, and very yung and t elderly patients wh have reduced capacity t cmpensate fr fluctuatins in fluid and electrlyte balance. 4.4 Special warnings and precautins fr use Electrlytes shuld be mnitred prir t and during infusin. 4.5 Interactin with ther medicinal prducts and ther frms f interactin Check cmpatibility f medicinal prducts with 0.9% sdium chlride befre administratin with the slutin. See Sectin 6.2 Incmpatibilities. 4.6 Fertility, pregnancy and lactatin Administratin f intravenus fluids t pregnant r lactating wmen requires special cnsideratin f the cnsequences f pssible unwanted effects in relatin t the desired therapeutic bjective. 4.7 Effects n ability t drive and use machines Nt relevant 4.8 Undesirable effects Infusin f 0.9% sdium chlride infusin may lead t fluid and electrlyte imbalances such as metablic acidsis, hypkalaemia, sdium retentin, hypertensin, tachycardia, edema and gastrintestinal effects. Prlnged intravenus infusin may lead t venus irritatin and thrmbphlebitis at the infusin site.in the event f adverse reactin, stp infusin immediately. 4.9 Overdse Excessive administratin may give rise t sdium accumulatin and hypernatraemia with resultant dehydratin f rgans particularly the brain, and edema, hypervlemic haemdilutin, and hypkalaemia. 5 PHARMACOLOGICAL PROPERTIES 5.1 Pharmacdynamic prperties Slutin fr Infusin. ATC cde B05BB Pharmackinetic prperties Nt applicable. Date Printed 23/06/2011 CRN page number: 2

3 5.3 Preclinical safety data Nn-clinical data reveal n special hazard fr humans based n cnventinal studies f safety pharmaclgy, repeated dse txicity, gentxicity, carcingenic ptential, txicity t reprductin. 6 PHARMACEUTICAL PARTICULARS 6.1 List f excipients Water fr Injectins 6.2 Incmpatibilities N studies fr cmpatibility have been cnducted with this prduct. Cnfirm additive cmpatibility befre use. 6.3 Shelf life 2 years Use immediately n remval frm verwrap. 6.4 Special precautins fr strage D nt stre abve 25C. D nt freeze. Stre in the uter cntainer. 6.5 Nature and cntents f cntainer Macflex and Macflex N cntainers: Macflex flexible PVC cntainer with a PVC infusin site, r Macflex N flexible ethylene and plyprpylene cplymer cntainer and infusin site; and plycarbnate-plyisprene injectin site fr additin f medicinal prducts. Bags are individually verwrapped in transparent plyprpylene laminate. Bags cntain 50ml, 100ml, 250ml, 500ml r 1000ml slutin. Easyflex N and Easyflex + cntainers: flexible ethylene and plyprpylene cplymer cntainer with a plycarbnatesilicn needleless access site fr additin f medicinal prducts r fr use as a luer lck cnnectin fr infusin. Bags are individually verwrapped in transparent plyprpylene laminate. Bags cntain 50ml, 100ml, 250ml, 500ml r 1000ml slutin. Macperf and Macperf N cntainers: The clsed infusin system Macperf and Macperf N flexible cntainers incrprate an integral infusin set fr direct cnnectin t a luer (e.g. catheter) in the patient. The infusin set cmprises a plycarbnate breakaway, PVC infusin chamber and tubing, plyprpylene regulatr, plycarbnate male luer and plyprpylene male luer. Bags are individually verwrapped in transparent plyprpylene laminate. Bags cntain 50ml, 100ml, 250ml r 500ml slutin. 6.6 Special precautins fr dispsal f a used medicinal prduct r waste materials derived frm such medicinal prduct and ther handling f the prduct Fr single use nly. D nt use unless the slutin is clear and the cntainer undamaged. Discard any unused slutin. Any unused prduct r waste material shuld be dispsed f in accrdance with lcal requirements. Macflex and Macflex N bags: Remve the bag frm the plastic verwrap. Remve the prtectr and cnnect by clamping t the administratin set. Macperf and Macperf N bags : Date Printed 23/06/2011 CRN page number: 3

4 Remve the bag frm the plastic verwrap. Mve the rller clamp dwn 1 cm befre clamping the tubing. Prime the line : Break the in-line cannula by flexing the tubing in ne directin then the ther Fill the drip chamber with slutin by squeezing the bag Gradually pen the flw regulatr and prime the line fully Clamp the tubing and cnnect t a luer as apprpriate The flw rate must be checked regularly during infusin. Additin f medicinal prducts: Cnfirm additive cmpatibility befre use. Clean the injectin site using antiseptic slutin. Carefully intrduce the sterile needle int the sterile chamber in the injectin site, attach the needle t the cntainer with the medicinal prduct, intrduce the needle thrugh the secnd membrane int the bag and inject the medicine. Carefully withdraw the needle. Mix thrughly with the slutin. Use immediately. Easyflex N and Easyflex + bags: Remve the bag frm the plastic verwrap. D nt use needles r spikes t gain access t the needleless cnnectr site Cnnectin f syringes t the needleless cnnectr fr the injectin f a medicine r aspiratin f slutins 1. Cnfirm additive cmpatibility befre use. 2. Clean the injectin site using antiseptic slutin. 3. Attach the male luer-lck cnnectr f the syringe with the bag s needleless cnnectr by pushing in and twisting the syringe clckwise t secure the cnnectin. 4. Aspirate the IV slutin ut f the bag, r inject the fluid r medicine int the bag. Mix thrughly with the slutin. Use immediately. 5. Discnnect the syringe frm the needleless cnnectin site by twisting anti-clckwise. 6. The needleless cnnectin site clses autmatically. 7. The needleless cnnectin site can be recnnected several times by repeating steps 1 t 3. Cnnectin f an IV giving set with a spike fr the administratin f an IV slutin: Easyflex N: - Remve the prtective cver (twist-ff); - Cnnect the giving set t the bag by piercing the prt and fully insert the giving set using a rtating mvement. - Administer IV fluid r medicine. Easyflex +: - Remve the infusin site prtectr by breaking it; - Cnnect the giving set t the bag by piercing the prt withut rtating mvement. - Administer IV fluid r medicine Cnnectin f an IV giving set with a male luer-lck cnnectr t the needleless cnnectr fr the administratin f an IV slutin Use the needleless cnnectr t infuse an IV slutin with a giving set fitted with a male luerlck cnnectr. 1. Clean the injectin site using antiseptic slutin. Attach the male luer-lck cnnectr f the IV giving set with the female luer f the bag s needleless cnnectin site by pushing in and twisting the set clckwise t secure the cnnectin. 2. Administer IV fluid r medicine in the usual manner 3. Discnnect the giving set frm the needleless cnnectin site by twisting the luer-lck cnnectin anti-clckwise. 4. The needleless cnnectin site clses autmatically. Date Printed 23/06/2011 CRN page number: 4

5 7 MARKETING AUTHORISATION HOLDER Mac Pharma (UK) Ltd 8 th Flr- Regal Huse 70 Lndn Rad Twickenham Middlesex TW1 3QS United Kingdm 8 MARKETING AUTHORISATION NUMBER PA 0931/001/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date f first authrisatin: 31 May 1999 Date f last renewal: 15 March DATE OF REVISION OF THE TEXT June 2011 Date Printed 23/06/2011 CRN page number: 5