Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
POTASSIUM PHOSPHATE MONOBASIC ; SODIUM PHOSPHATE DIBASIC DIHYDRATE ; POTASSIUM HYDROXIDE
Fresenius Kabi Limited
B05XA30
POTASSIUM PHOSPHATE MONOBASIC ; SODIUM PHOSPHATE DIBASIC DIHYDRATE ; POTASSIUM HYDROXIDE
170. 133.5 14.0 g/20ml
Concentrate for Soln for Inf
Product subject to prescription which may not be renewed (A)
combinations of electrolytes
Not marketed
1983-04-01
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Addiphos is and what it is used for 2. What you need to know before you use Addiphos 3. How to use Addiphos 4. Possible side effects 5. How to store Addiphos 6. Contents of the pack and other information 1. WHAT ADDIPHOS IS AND WHAT IT IS USED FOR Addiphos provides salts into your blood stream when you cannot eat normally. Salts are chemicals required in small amounts for the body to work normally. Addiphos is usually used as part of a balanced intravenous diet, together with proteins, fats, carbohydrates, other salts and vitamins. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ADDIPHOS Do not use Addiphos: • if you are allergic to the active substance(s) or any other of the ingredients of this medicine (listed in section 6). If you develop a rash or other allergic reactions (like itching, swollen lips or face or shortness of breath), please inform your doctor, pharmacist or nurse. • have high potassium levels (hyperkalaemia) • have severely impaired kidneys • have problems with adrenal glands • are dehydrated (not enough water in your body) Warnings and precautions Talk to your doctor, pharmacist or nurse before using Addiphos if you suffer from: - impaired liver and/or kidney function - diabetes - heart problems Your doctor may want to do regular blood tests to check your condition. 01-58-01-017D Addiphos ® Concentrate for Solution for Infusion PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MASTER ARTWORK/LABEL SPECIFICATION Halden article number: FBV 1992 Label spec. number: 01-58-01-017D Code 128 653 Code lines: 1076 Colour coding: Black Size: 360 x 84 mm folded to 120 x Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Addiphos concentrate for solution for infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. A clear, colourless aqueous sterile solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a phosphate, potassium and sodium supplement during complete intravenous nutrition. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ The total daily dosage is dependent upon the age, weight, clinical state and degree of deficiency of the patient and must be determined on an individual basis. The usual daily dose is 5-20 ml of Addiphos. _Paediatric population_ Dosage should be reduced appropriately according to age and weight. Method of administration Intravenous infusion after dilution For instructions on dilution of the medicinal product before administration. See section 6.6. 4.3 CONTRAINDICATIONS Hypersensitvity to the active substance(s) or to any of the excipients listed in section 6.1. Each ml of Addiphos contains: Potassium Dihydrogen Phosphate 170.1 mg Disodium Phosphate Dihydrate 133.5 mg Potassium Hydroxide 14.0 mg One vial (20 ml Addiphos) provides the following: Phosphate 40 mmol Potassium 30 mmol Sodium 30 mmol For the full list of excipients, see section 6.1 H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _6_ _/_ _0_ _7_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _2_ _1_ _7_ _4_ _0_ _7_ _9_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ U Прочитайте повний документ