PACKAGE LEAFLET: INFORMATION FOR THE USER. SODIPHOS 22mEq / 10ml Concentrate for solution for infusion. Disodium phosphate dihydrate

Transcription

1 PACKAGE LEAFLET: INFORMATION FOR THE USER SODIPHOS 22mEq / 10ml Concentrate for solution for infusion Disodium phosphate dihydrate Read all of this leaflet carefully before you start using this medicine. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What SODIPHOS is and what it is used for 2. What you need to know before you use SODIPHOS 3. How to use SODIPHOS 4. Possible side effects 5. How to store SODIPHOS 6. Further information 1. WHAT SODIPHOS IS AND WHAT IT IS USED FOR Pharmacotherapeutic group: Electrolyte solution {= solution that can be decomposed into ions: sodium and phosphate (= kind of salt)}. Source of phosphate (by infusion). Ionic composition by 10ml ampoule: Na + 2- HPO 4 meq mmol Therapeutic indication: Sodium phosphate, administered by infusion after dilution, is used to treat too low levels of phosphate in the blood. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SODIPHOS Do not use SODIPHOS - If you are allergic (hypersensitive) to disodium phosphate dihydrate. - If you have too high levels of phosphates in the blood. - If your kidney function is impaired. - If you have too low levels of calcium in the blood. - If you have too low levels of potassium in the blood. Page 1 sur 6

2 - If you have too high levels of sodium in the blood. - If you suffer from Addison's disease. - If you suffer from congestive heart failure. - If you suffer from unstable angina pectoris. Take special care with SODIPHOS - Do not administer the product as it is. Dilute before administration using an appropriate solution for infusion. - Do not use the solution if it is not clear. - In case of prolonged administration, hypokalaemia should be avoided (= a too low potassium levels in the blood) by administration of a potassium supplement. - The administration of phosphates must be avoided in patients with markedly reduced kidney function and monitoring of serum creatinine levels and blood urea is indicated during intravenous administration of phosphates. In patients (adults as well as children) with mild to moderate kidney function impairment, careful monitoring of phosphates and other ions should be carried out. This will be done via a blood electrolyte evaluation (= table indicating the concentration of the main ions present in the blood). - Intravenous administration of phosphates if there is a decrease in phosphate levels in the blood is only indicated in serious life-threatening situations. - Extreme caution is recommended in case of concomitant administration of medicines that prolong the QT interval and in case of acute myocardial infarction or recent heart surgery (less than 3 months ago). - SODIPHOS does not contain an antimicrobial preservative and germs can therefore develop in it after opening of the ampoules. The medicinal solution and any syringe that contains this solution are for single-use and can in no case be reused. - The solution for infusion should be prepared under aseptic conditions, i.e. without allowing any germs to enter it. To do this, a sterile syringe must be used and the solution must be taken up immediately after opening the ampoule. Any amount of the unused product SODIPHOS must be eliminated in compliance with current regulations. - Like with any administration for infusion, the solution and the infusion equipment must be kept away from any contamination by germs during the entire duration of the infusion. At the end of the infusion, any remaining medicinal solution must be eliminated along with all of the equipment that contained the solution in compliance with current regulations. Outside of the hospital, it is recommended that an infusion not be used for more than 4 to 6 hours. - The infusion speed should be controlled. - There is a risk of irritation, necrosis (= destruction of cells or tissue) at the injection site or thrombophlebitis (= inflammation of the veins) in case of prolonged or too rapid administration. In order to reduce the risk of thrombophlebitis, the site of administration should be changed every 24 hours. - In case of administration of large volumes, it is important to regularly check the blood electrolyte balance. It is important to avoid any circulatory overload, especially in subjects with cardiac or renal insufficiency. - It should be kept in mind that hypomagnesaemia (= too low levels of magnesium in the blood) can occur during treatment of hypophosphatemia by intravenous administration of phosphates. Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Page 2 sur 6

3 Before any mixing, the compatibility of the medicines to be mixed must be ensured. Phosphates solutions are incompatible with the following: certain calcium or magnesium salts; certain solutions for intravenous administration; certain preparations for total parenteral nutrition (i.e. in the form of an injection); substances such as ciprofloxacin, deferoxamine mesylate or dobutamine. Using SODIPHOS with food and drink Not applicable. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. Pregnancy There are no adequate and well-controlled studies in humans. However, no harmful effects have been documented in case of daily administration of normal recommended amounts. Breast-feeding Distribution of phosphates in breast milk is not known. However, no harmful effects have been reported in breast-fed infants in case of daily administration at normal recommended doses. Driving and using machines There are no data concerning the effect of the medicine on these activities. Important information about some of the ingredients of SODIPHOS Not applicable. 3. HOW TO USE SODIPHOS Always use this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Concentrate for solution for infusion (ex.: in a 5% glucose solution). Cannot be injected undiluted. It is only for administration by slow infusion or for administration using a continuous infusion pump. The dose and speed of administration should be determined according to the patient s weight, age, and clinical state. Administration of phosphates via the intravenous route is recommended in cases of severe deficiency of phosphates in the blood, i.e. elemental phosphorus levels of less than 1mg/dl or 0.32mmol/l. Posology for adults In case of severe lack of phosphates in the blood, the following system is recommended for patients having a normal potassium levels in the blood and a normal renal function: 9mmol of phosphorus element (about 300mg) in a semi-normal saline solution, by continuous infusion during 12 hours, and repeated every 12 hours, until phosphorus serum rates exceed 1mg/dl. Another alternative consists in administering an initial dose of 0.08mmol/kg of body weight (or 2.5mg/kg of body weight) in case of a recent and uncomplicated decrease of phosphate in the blood. In case of a prolonged drop of phosphate levels in blood and for multiple causes, Page 3 sur 6

4 this dose can be increased to 0.16mmol/kg body weight (or 5mg/kg of body weight). The initial dose is to be increased from 25% to 50% in symptomatic patients and decreased from 25% to 50% in patients with high levels of calcium in the blood. Each dose is to be administered over a time period of 6 hours. The risks related to the intravenous administration of phosphates are: decrease in blood pressure, dehydration, increase in blood sodium levels, decrease in blood calcium levels, metastatic calcifications and increase in blood phosphate levels. Whatever the chosen dose and speed of administration, calcium, potassium and phosphorus levels in the blood must be controlled every 12h to 24h. Given the frequency of the occurrence of a drop in blood magnesium levels accompanying the decrease in phosphate levels, routine monitoring of serum magnesium levels is also recommended. If a decrease in blood magnesium levels is detected, it must be corrected simultaneously. Paediatric posology The recommended dosage is 0.15 to 0.33mmol/kg/dose of phosphate diluted in a solution for infusion. Administration should take place over 6 hours, at a speed not exceeding 0.2mmol/kg/h. This dose is to be repeated if necessary, so that serum phosphorus levels are maintained above 2mg/dl. The recommended maintenance dose is 0.5 to 1.5mmol/kg/24 hours. Posology for patients with renal insufficiency In adults as well as in children, administration of phosphates is not recommended in patients with marked renal insufficiency. In addition, careful monitoring of phosphate levels and other electrolytes levels must be performed in patients with mild to moderate renal insufficiency. If you use more SODIPHOS than you should If you used too much SODIPHOS, contact immediately your doctor, your pharmacist or the Poison center (070/ ). A too fast administration and/or an administration of too large quantities can provoke a too high potassium levels in the blood, a too low calcium levels, a paralysis due to prolonged contraction of the muscles, a low blood pressure, an acceleration of heart rate, fever, an accumulation of fluid in the body (= oedema) and an acute renal insufficiency. In these cases, administration must be reduced or stopped and a doctor informed. In order to prevent too high blood phosphate levels, parenteral administration of phosphates (i.e. in the form of an injection) should be replaced by oral administration as soon as elemental phosphorus levels reaches 2mg/dl. In patients undergoing dialysis, the risk of mortality increases when elemental phosphorus levels exceed values of 6.6mg/dl. Symptoms The signs of hyperphosphataemia are similar to those of hypocalcaemia, which causes: increase in neuromuscular excitability, muscle cramps, spasms in the hands and feet, tetanus and seizures. If hyperphosphataemia is associated with high levels of calcium in the blood, it may form extra-skeletal calcium precipitations, mainly in the kidneys. Treatment Reduce or discontinue administration. It is possible to orally administer products that bind to phosphates (aluminium or calcium salts, polymers). In case of very acute overdose with Page 4 sur 6

5 tetanus, calcium must be immediately administered parenterally. In case of severe kidney failure, haemodialysis should be initiated. If you forget to use SODIPHOS Do not use a double dose of SODIPHOS to make up for a forgotten dose. If you stop using SODIPHOS Discontinuation of treatment with SODIPHOS can cause a decrease in blood phosphate levels and the resulting symptoms can then reappear. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, SODIPHOS can cause side effects, although not everybody gets them. The following adverse effects may occur: A. Cardiovascular effects Significant decrease in blood pressure as well as acute myocardial infarction in rare cases. B. Endocrine/metabolic effects - The most common toxic effect is a decrease in blood calcium levels with a risk of cramps. This decrease in blood calcium levels can occur regardless of the route of administration, but it is more common during intravenous administration. A symptomatic decrease in blood calcium levels can be worsened in case of administration of phosphates in patients with a magnesium deficiency in the blood. - A decrease in blood magnesium levels can also occur during intravenous administration of phosphates in patients with very low blood phosphate levels. Monitoring of magnesium levels is therefore indicated during treatment with phosphates and a possible decrease in magnesium is to be corrected at the same time. - An extra-skeletal calcification can also occur, particularly in case of intravenous administration. - An excess of phosphate in the blood can also occur during administration of phosphates, but this is rare, except in patients with renal insufficiency. Injection of phosphates is to be discontinued as soon as serum elemental phosphorus levels exceed 0.65mmol/l (or 2.0mg/dl). C. Renal/urogenital effects Acute renal insufficiency has been reported following intravenous administration of phosphates in a patient with excessive activity of the parathyroid gland. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE SODIPHOS Keep the medicine out of the reach and sight of children. Store in the original package at ambiant temperature. Page 5 sur 6

6 Do not use SODIPHOS after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What SODIPHOS contains - The active substance is disodium phosphate dihydrate (197mg/ml). - The other ingredient is water for injection. What SODIPHOS looks like and contents of the pack 10ml ampoules, packed in boxes of 10 ampoules and 100 ampoules (for hospital use). Marketing Authorisation Holder and Manufacturer Laboratoires STEROP S.A., avenue de Scheut 46-50, 1070 Brussels. Delivery: Medical prescription. Registration number: BE This leaflet was last approved in 12/2009 Page 6 sur 6