국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
Zinc chloride; Copper chloride 2H2O; Manganese chloride 4H2O; Sodium selenite anhydrous; Sodium fluoride; Potassium iodide
Fresenius Kabi Deutschland GmbH
B05XA; B05XA31
Zinc chloride; Copper chloride 2H2O; Manganese chloride 4H2O; Sodium selenite anhydrous; Sodium fluoride; Potassium iodide
. percent volume/volume
Concentrate for solution for infusion
Electrolyte solutions; electrolytes in combination with other drugs
Marketed
1995-11-13
PACKAGE LEAFLET: INFORMATION FOR THE USER PEDITRACE® 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 your 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® YOUR CHILD SHOULD NOT RECEIVE PEDITRACE : • if they are allergic to Peditrace or any of the other ingredients of this medicine (listed in section 6). IF YOUR CHILD DEVELOPS A RASH OR OTHER ALLERGIC REACTIONS (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. WARNINGS 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. HO 전체 문서 읽기
Health Products Regulatory Authority 18 April 2019 CRN008S1S Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Peditrace concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of Peditrace contains: Zinc chloride 521 micrograms Copper chloride 2H 2 O 53.7 micrograms Manganese chloride 4H 2 O 3.60 micrograms Sodium selenite anhydrous 4.38 micrograms Sodium fluoride 126 micrograms Potassium iodide 1.31 micrograms The active ingredients in 1 ml correspond to: Zinc 250 micrograms 3.82 micromol Copper 20 micrograms 0.315 micromol Manganese 1 micrograms 18.2 nmol Selenium 2 micrograms 25.3 nmol Flouride 57 micrograms 3.0 micromol Iodine 1 micrograms 7.88 nmol For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion A sterile, clear, colourless solution for addition to certain infusion fluids. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Peditrace is intended to meet the basal requirements for trace elements during intravenous nutrition of infants and children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Paediatric population_ The basal requirements for infants and children of the included trace elements are met by 1 ml of Peditrace per kg body weight per day to a maximum daily dose of 15 ml. A daily dose of 15 ml Peditrace should also meet the basic needs of trace elements in children weighing 15-40 kg. Above 40 kg the adult preparation Additrace should be used. Method of administration Peditrace should not be given undiluted. Health Products Regulatory Authority 18 April 2019 CRN008S1S Page 2 of 4 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Wilson’s disease. Administration should be carried out but only under specialist surveillance, especially in patients with pre-existing imbalances, in renal failure or hepatic disease. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Peditrace should be used with caution in conditio 전체 문서 읽기