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Patient Information Leaflet Polifleks 60 Mg/Ml Dextran

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Patient Information Leaflet Polifleks 60 Mg/Ml Dextran PATIENT INFORMATION LEAFLET POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE SOLUTION FOR I.V. INFUSION Used intravenously Active ingredients: Each 100 ml of parenteral solution contains 6g of DEXTRAN 70, 0,9 g of sodium chloride. Excipients: Sterile water for injection Please read this PATIENT INFORMATION LEAFLET carefully before starting to use the drug; because important information is included here. • Keep these PATIENT INFORMATION LEAFLET. You may need to re-read it later. • In case you have additional questions, please consult your doctor or pharmacist. • This drug is prescribed personally for you, do not give to others. • During the use of this drug, please tell your doctor that you are using this drug when you visit your doctor or a hospital. • Please follow these instructions strictly. Do not use dosages higher or lower than the dosage recommended to you. The following topics are included in this PATIENT INFORMATION LEAFLET: 1. What is POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE and what is it used for? 2. Before you are given POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE 3. How you will be given POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE? 4. Possible side effects 5. How to store POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE? 1 1. What is POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE and what is it used for? The POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE is a sterile solution to be given you by your doctor or other healthcare officer. The POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE is a part of the group of drugs called “blood substitutes and plasma protein fractions”. The POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE is a colorless, clear, particle-free, odorless, sterile and apyrogen solution. The POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE is used in the following conditions: For protecting the patient from shocks which may arise from operations or other traumas, bleeding or burns and during treatment of resulting shocks, For preventing vein occlusion caused by traumas, For preventing coagulation of blood in the vein or heart after surgery and lung occlusion. 2. Before you are given POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE DO NOT USE POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE under following conditions: Do not use the POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE; if you have excessive sensitivity to DEXTRAN, in critical kidney diseases with decrease in widdling or absence of widdling, in massive bleeding patients, in clinical cases with a possible harm of sodium and chloride, in heart related failures, in decrease in number of blood-platelet or decrease in number of fibrinogens in blood. Use POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE CAREFULLY under following conditions: Use the POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE carefully if you have: 2 heart failure; kidney failure. ‘If these warnings are applicable to you even in a past period, please consult with your doctor.’ Use of POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE with foods or drinks The POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE has no interaction with foods and drinks. Pregnancy Consult your doctor or pharmacist before using this drug. If you are pregnant or you believe that you are pregnant, inform your doctor. When the POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE is administered to pregnant women, it is not known to be harmful to embryo, therefore its use is not recommended. In case you become aware that you are pregnant during treatment, immediately consult your doctor or pharmacist. Lactation Consult your doctor or pharmacist before using this drug. It is not known if the POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE is discharged with the breast milk. You should consult with your doctor before breastfeeding your baby. Driving and use of machines Driving is not practically possible during use of the solutions administered through infusion. It has no known effect on the driving and use of machine after use. Important information about some ingredients of POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE No warning is required as it contains injection water as the auxiliary agent. Taking other medicines Samples must be taken before treatment for cross-matching, Ph and blood group designation to prevent wrong results and some of the samples must be kept for future assessments to be performed during treatment. While the saline agglutination and indirect antiglobulin methods may be used for cross matching and blood group designations of additional blood samples after start of infusion, use of proteolytic enzyme techniques may be difficult for cross-matching test. 3 Blood glucose measurements performed by using sulphuric acid or acetic acid hydrolysis after administration of the DEXTRAN 70 Isotonic Solution may give high values and laboratory tests performed by using the measures for refraction of light in serum may be higher than the normal values. Blood samples must be taken for these tests before start of infusion of the DEXTRAN 70 Isotonic Solution. If it is given with heparin, there is a risk of bleeding. The DEXTRAN may cause turbidity in the tests for bilirubin volume measurement by using alcohol and total protein quantity measurement by using biuret and may cause problem in quantity measurement for this reason. Attention must be paid to I.V. treatments for sodium in corticosteroid and corticotrophin tests. If you are currently using any prescribed drug or OTC, or if you have used them recently, please inform your doctor or pharmacist about these. 3. How POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE will be given? Instructions for proper use and dosage/application intervals: Your doctor shall designate dose of your drug depending on your disease and administer it to you accordingly. Route and method of administration: The POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE is administered by specialized healthcare personnel through infusion in vein. Different age groups Pediatric use: There is no sufficient data for use of the POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE in children. Use in the elderly: The POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE must be used in the elderly carefully. Conditions of special use: Renal Insufficiency In case of renal insufficiency, your doc tor shall determine the dose that you shall use and administer it accordingly. 4 Liver Insufficiency: In case of liver insufficiency, your doc tor shall determine the dose that you shall use and administer it accordingly. If you have the impression that the effects of POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE are too powerful or too weak, consult your doctor or pharmacist. In case you have used greater amount of POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE then you should: As this drug shall be administered by your doctor or experienced healthcare personnel at the hospital, this section does not apply to you. In case you forget to take POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE: As this drug shall be administered by your doctor or experienced healthcare personnel at the hospital, this section does not apply to you. Possible effects related to the termination of the treatment with POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE: As the POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE shall be used under supervision of a specialized doctor, your doctor shall decide the time to finalize your treatment. Do not finalize the treatment without approval of your doctor. 4. Possible side effects Like all drugs, POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE can cause adverse effects in individuals who are sensitive to the contents. If you notice any of the followings, inform your doctor promptly or visit the emergency division of the closest hospital: Hypernatremia (increase in the sodium quantity in blood above the normal level) Vein occlusion Vein inflammatory Observing increase in total blood volume Difficulty in breathing, face, tongue, lip or throat swelling, allergic reactions such as hives All of them are the side effects. Urgent medical intervention may be required. If you notice any of the followings, inform your doctor: Fever 5 Sting, itching, distention, pain feel, inflammation in the injection place Leakage of the drug to the out of vein Chest wheezing or tightness Less widdling or no widdling Distention in feet and hands Extraordinary bleeding or non-stop bleeding Feel of faint Nausea, vomiting, stomachache Mild itching, skin redness Joint ache Nasal blockage They are the slight side effects of the POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE. If you suffer from a side effect which is not mentioned in these PATIENT INFORMATION LEAFLET, inform your doctor or pharmacist. 5. How to store POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE Store POLİFLEKS 60 MG/ML DEXTRAN 70 9 MG/ML ISOTONIC SODIUM CHLORIDE in places out of sight and reach of children and within the original packaging.
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