Riik: Malta
keel: inglise
Allikas: Medicines Authority
POTASSIUM IODIDE, COPPER CHLORIDE, ZINC CHLORIDE, MANGANESE CHLORIDE, SODIUM FLUORIDE, SODIUM SELENITE
Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy
B05XA31
POTASSIUM IODIDE 1.31 µg/ml COPPER CHLORIDE 53.7 µg/ml ZINC CHLORIDE 521 µg/ml MANGANESE CHLORIDE 3.6 µg/ml SODIUM FLUORIDE 126 µg/ml SODIUM SELENITE 4.38 µg/ml
CONCENTRATE FOR SOLUTION FOR INFUSION
POTASSIUM IODIDE 1.31 µg/ml COPPER CHLORIDE 53.7 µg/ml ZINC CHLORIDE 521 µg/ml MANGANESE CHLORIDE 3.6 µg/ml SODIUM FLUORIDE 126 µg/ml SODIUM SELENITE 4.38 µg/ml
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Authorised
2006-12-21
Package Leaflet: Information for the User PEDITRACE R CONCENTRATE FOR SOLUTION FOR INFUSION Read all of this leaflet carefully before this medicine is given. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse. If you notice any side effects, including those not listed in this leaflet, please tell your doctor, pharmacist or nurse. What is in this leaflet: 1. What Peditrace is and what it is used for 2. What you need to know before yur child receives Peditrace 3. How your child will be given Peditrace 4. Possible side effects 5. How to store Peditrace 6. Contents of the pack and other information 1. WHAT PEDITRACE IS AND WHAT IT IS USED FOR Peditrace is especially designed for babies and children. It provides trace elements to your child when they cannot eat normally. It is usually used as part of a balanced intravenous diet, together with proteins, fats, carbohydrates, salts and vitamins. 2. WHAT YOU NEED TO KNOW BEFORE YOUR CHILD RECEIVES PEDITRACE R Your child should not receive Peditrace. If they are allergic to Peditrace or the other ingredients of this medicine (listed in section 6). IF YOUR CHILD DEVELOPS A RASH OR OTHER ALLERGIC REACTION (LIKE ITCHING, SWOLLEN LIPS OR FACE OR SHORTNESS OF BREATH), PLEASE INFORM THEIR DOCTOR, PHARMACIST OR NURSE. If they suffer from Wilson’s DISEASE (AN INHERITED DISORDER WHERE THERE IS EXCESSIVE AMOUNT OF COPPER IN THE BODY’S TISSUE). Peditrace must be diluted before use. It will be added to another solution before it is given to your child. Your doctor or nurse will make sure it is prepared correctly. WARNING AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before Peditrace is given to your child if they: Have liver or kidney problems Your doctor may want to do regular blood tests to check your child’s condition. OTHER MEDICINES AND PEDITRACE Tell your doctor or pharmacist if your child is taking, have recently taken or might take any other medicines. 3. HOW YOUR CH Lugege kogu dokumenti
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Peditrace concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of Peditrace contains: Active Ingredients Quantity Zinc Chloride 521 µ g Copper Chloride 2H 2 0 53.7 µ g Manganese Chloride 4 H 2 0 3.60 µ g Sodium Selenite anhydrous 4.38 µ g Sodium Fluoride 126 µ g Potassium Iodide 1.31 µ g The active ingredients in 1 ml correspond to Zn 250 µ g 3.82 µ mol Cu 20 µ g 0.315 µ mol Mn 1 µ g 18.2 nmol Se 2 µ g 25.3 nmol F 57 µ g 3.00 µ mol I 1 µ g 7.88 nmol Product Properties Osmolality: 38 mosm/kg water pH: 2.0 For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for infusion. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Peditrace is an integral part of the complete intravenous nutrition of infants and children. It is intended to meet basal requirements for trace elements and should be used in conjunction with amino acid or glucose solutions or other paediatric admixtures. 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and elderly: _ The trace element solution Additrace should be used in adults and elderly. _ _ _Paediatric population: _ _Infants and children (weighing 15kg or less): _ Basal requirements of the included trace elements are covered by 1 ml Peditrace per kg body weight per day to a maximum daily dose of 15 ml. Children (weighing 15 kg or more): A daily dose of 15 ml Peditrace should meet basal trace element requirements. However, for patients weighing more than 40 kg the adult preparation Additrace should be used. Method of administration Peditrace should not be given undiluted. Peditrace administration should not be started until kidney function is established – usually during the second day of life. The infusion should be given at a very slow rate (minimum infusion period is 8 hours) and is best done with an appropriate pump or an automatic drop rate counter. As the requirements of trace elements may vary in different clinical conditi Lugege kogu dokumenti