PACKAGE LEAFLET: INFORMATION FOR THE USER. CALCICLO STEROP 11 meq 10 ml Solution for injection. Dihydrated Calcium Chloride

Transcription

1 PACKAGE LEAFLET: INFORMATION FOR THE USER CALCICLO STEROP 11 meq 10 ml Solution for injection Dihydrated Calcium Chloride 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, or pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. What is in this leaflet 1. What CALCICLO STEROP 11 meq 10 ml is and what it is used for 2. What you need to know before you use CALCICLO STEROP 11 meq 10 ml 3. How to use CALCICLO STEROP 11 meq 10 ml 4. What are the possible side effects 5. How to store CALCICLO STEROP 11 meq 10 ml 6. Contents of the pack and other information 1. WHAT IS CALCICLO STEROP 11 meq 10 ml AND WHAT IT IS USED FOR CALCICLO STEROP is a solution of electrolytes, source of calcium. CALCICLO STEROP for injection is indicated as: - treatment of severe calcium depletion; - emergency treatment of potassium and magnesium excessive levels in the blood; - treatment of heart failure only in case of potassium excess in the blood, severe calcium depletion or administration of too high doses of a cardiac antagonist (group of medicines against too high blood pressure). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CALCICLO STEROP 11 meq 10 ml? Do not use CALCICLO STEROP 11 meq 10 ml in case of : - if you are allergic to dihydrated calcium chloride or any of the other ingredients of this medicine (listed in section 6). - increase of calcium levels in the blood and/or urines, - formation of calcic stones, calcifications into kidneys and arteries, - digitalized patients (strictly contra-indicated), - sarcoidosis, - prolonged immobilization of the patient with sometimes an increased calcium level in the urines and/or in the blood. The administration of calcium must be stopped, to be continued when the patient is able to move again. - by subcutaneous or intramuscular way. Warnings and precautions Talk to your doctor or, pharmacist or nurse before using CALCICLO STEROP 11mEq 10ml. - THE INTRAVENOUS INJECTION HAS TO BE EXTREMELY SLOW (10 ml in 5 MINUTES); It must be done in the patient in supine position, and the cardiac rhythm must be monitored. - Calcium chloride can be irritating at the injection site. The prudence is therefore needed in order to avoid the product spilling out of the vein, especially with children whose veins are still delicate. - Never inject calcium to a digitalized patient (see "Do not use CALCICLO STEROP 11 meq 10 ml"). - Caution must be exercised with patients having a renal insufficiency or forming stones in the kidneys. - Extreme caution is needed with the patients presenting an insufficiency or a respiratory acidosis, a cardiac insufficiency or a ventricular fibrillation. - It is necessary to check regularly the calcium levels in the plasma and in the urines as an excess of calcium is much more dangerous than a lack. Page 1 sur 5

2 - The first symptoms of an excess of calcium in the blood are: strong constipation, dry mouth, headaches, thirst sensation, irritability, anorexia, mental depression, metallic taste, weakness or extreme fatigue. Then the following manifestations arise: confusion, drowsiness, hypertension, increased sensitivity of the eyes or of the skin to the light, in particular in hemodialyzed patient, cardiac arrhythmias, vomiting and polyuria. - For the measures to take in case of excess of calcium in the blood: refer to the section "If you use more CALCICLO STEROP 11 meq 10 ml than you should". - Do not administer if the solution is not limpid. - CALCICLO STEROP 11 meq 10 ml contains no conservative. The microbes can therefore develop after the opening of the ampoules. The medicinal solution and any syringe that would contain it are for unique and individual use, they cannot be reused in any case. - The solution will be taken in the cleanest way possible, with a sterile syringe, immediately after the opening of the ampoules. It is necessary to prevent the entrance of microbes. Any unused or remaining quantity of solution must be eliminated following the regulation in force. - In a general way, a risk of irritation or necrosis exists at the injection site in case of too fast administration or injection of a too important volume. In order to reduce the risk of thrombophlebitis, it is recommended to change the injection site every 24 hours. Tell your doctor if one of the precautions is usable for you, or if it was the case in the past. Children and adolescents Calcium chloride can be irritating at the injection site. The prudence is therefore needed in order to avoid the product spilling out of the vein, especially with children whose veins are still delicate. Other medicines and CALCICLO STEROP 11 meq 10 ml Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. The plasmatic calcium and magnesium concentrations can increase when the calcium chloride is administered simultaneously with another calcium or magnesium salts. The calcium chloride neutralizes the effect of the magnesium sulphate if simultaneously administered. If two salts are mixed in a solution, a deposit of calcium sulfate appears. Serious disruptions of the heart rhythm can appear if the calcium chloride is used with digitalized medicines. The thiazidic diuretics are able, by diminishing the excretion of the calcium by the kidneys, to provoke an increase of its level in the blood. The calcium chloride can diminish the response to the calcium antagonists. Cardiotonic glycosides. The inotropic and toxic effects of the cardiotonic glycosides and calcium salts are synergic and arrhythmias can arise in case of simultaneous administrations. An I.V. calcium administration is contraindicated. Physical incompatibilities The calcium chloride solutions can form a precipitate in the presence of phosphates, carbonates and bicarbonates. Although calcium chloride is compatible with most of the solutions for infusion, the supplement of calcium chloride must be done by infusion after having consulted their compatibility data and after the research of a potential precipitate or an eventual crystallization, principally with phosphates. Calcium forms some complexes with tetracycline and a mix of these composites in infusion is excluded. CALCICLO STEROP 11mEq 10ml with food and, drink and alcohol Not applicable. Pregnancy and, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy The intravenous administration is to be avoided during pregnancy, except if a quick correction of the calcium quantity in the blood is necessary. Breast-feeding Calcium crosses the placental barrier and can be found in the maternal milk. The intravenous administration is to be avoided during lactation, except if a quick correction of the calcium quantity in the blood is necessary. Fertility No data available. Page 2 sur 5

3 Driving and using machines No relevance. Important information about some of the ingredients of CALCICLO STEROP 11mEq 10ml No relevance. CALCICLO STEROP 11 meq 10 ml contains dihydrated calcium chloride and water for injection. 3. HOW TO USE CALCICLO STEROP 11 meq 10 ml? Solution for slow intravenous injection. The injection of calcium (chloride) WILL BE DONE EXCLUSIVELY BY SLOW INTRAVENOUS WAY (in a sufficiently large vein and through a fine needle), in a manner to avoid a too fast increase of calcium in the blood and an extravasation (injection of the product outside of the vein); which in fact can provoke a destruction of the tissues. The dose will be adapted individually, according to the blood results (ionogram). An excess of calcium in the blood being even more dangerous than a lack of calcium, any overdose will be avoided by a regular check of the calcium levels in the blood, which will be maintained between 9 and 10.4 mg/dl (4.5 and 5.2 meq/l), and will not go beyond 12 mg/dl. Adults: - In case of lack of calcium in the blood (hypocalcaemia) : inject 500 mg to 1g of calcium chloride (or 3.4 to 6.8 meq of calcium) by SLOW INTRAVENOUS WAY, at a speed of 0.5 to 1 ml per minute. This dose will be repeated with an interval of 1 to 3 days if necessary. - In case of excess of potassium in the blood (hyperkaliemia) : the dosage will be given according to the plasmatic levels and watching the changes of the electrocardiogram during the administration. - In case of magnesium excess in the blood (hypermagnesaemia): initial dose of 500 mg of calcium chloride (or 3.4 to 6.8 meq calcium). This dose will be able to be repeated if necessary. Use in children In case of lack of calcium in the blood (hypocalcaemia) : 25 mg/kg of body weight by SLOW intravenous way. Nevertheless, the calcium chloride is rarely used in pediatrics, where a less irritating calcium salt will be preferred for the small-caliber vessels of the children. Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. If you use more CALCICLO STEROP 11mEq 10ml than you should If you used too much CALCICLO STEROP 11mEq 10ml, immediately contact your doctor, your pharmacist or the Poisons control center. Calcium excess must be avoided by regular check of its level in the blood during the treatment, especially in patients suffering from a chronic kidney insufficiency. Normal calcium levels in the blood are between 9 and 10.4 mg/dl (is between 4.5 and 5.2 meq/l) and in case of hypercalcemia (excess of calcium) seric calcium levels are superior to 10.5 mg/dl. Symptoms of an overdose : dry mouth, sensation of thirst, headaches, irritability, mental depression, metallic taste, lack of appetite, nauseas, vomitings, thirst, important constipation, abdominal pain, confusion, muscular weakness or extreme fatigue, drowsiness, hypertension, increase of the sensitiveness of the eyes or skin to the light, in particular in hemodialyzed patients, increase of the quantity of urines, disturbances of the cardiac rhythm and life-threatening coma. If the first signs of an overdose, stop immediately the administration of calcium and call immediately the consulting physician who will choose a treatment according to the seriousness of the intoxication. The levels of potassium, magnesium and calcium in the blood must be determined regularly in order to adjust the treatment and prevent complications. Information to the attention of the doctor A brutal stop of calcium administration and possibly of other medicines able to increase the serum calcium levels are generally sufficient to stop a moderate hypercalcemia (seric levels of calcium between 10.5 and 12 mg/dl) in asymptomatic patients having a normal renal function. Page 3 sur 5

4 But when the calcium seric levels go beyond 12 mg/dl, supplementary measures can be necessary, among which: - Hydratation of the patient by an intravenous 0.9% NaCl administration. If case of overdose of saline, a diuresis forced by the administration of furosemide can be implemented to increase quickly the sodium and calcium excretion. - Supervision and, if necessary, immediate adjustment of the seric potassium and magnesium levels in order to prevent any complication. - Electrocardiographic supervision and potential administration of β-blocking agents in order to protect the heart against any serious arrhythmia. - Possibly: Hemodialysis and I.M. administration of calcitonine, I.V. etidronate disodium, I.V. plicamycine (over a short period) or of corticosteroids. - Frequent determinations of the seric levels of calcium and adjustment of the treatment consequently. If you forget to use CALCICLO STEROP 11mEq 10ml Do not use a double dose to make up for a forgotten dose. If you stop to using CALCICLO STEROP 11mEq 10ml No data available. 4. WHAT ARE THE POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. - The intravenous administration of calcium (chloride) can provoke an irritation at the site of injection. The patient can also complain about pain, tingling, redness, rash or transpiration, a sensation of oppression or hot flush, a "chalky taste", nauseas, or vomitings. - The tingling can be the sign of too quick administration, while redness, rash and hot feeling can be the sign of an extravasation (injection of the product outside the vein). - A too fast intravenous administration can also provoke the following symptoms: vasodilatation, hypotension, bradycardia (slowdown of heart beatings), disturbances of the heart rhythm, syncope and heart failure. - In case of extended administration, there is a risk of subcutaneous or visceral vascular calcification. - The undesirable effects of a hypercalcaemia are : lack of appetite, nauseas, vomitings, constipation, excessive thirst, abdominal pain, muscular weakness, confusion, increased excretion of urine, disturbances of the cardiac rhythm, tissue calcification and coma. Additional side effects in children Irritation of the vessels of small caliber. If you get any side effects, talk to your doctor or, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. 5. HOW TO STORE CALCICLO STEROP 11mEq 10ml STEROP Keep this medicine out of the sight and reach of children in the packaging of origin, at ambient temperature (15-25 C). Do not use this medicine after the expiry date which is stated on the carton after the mention EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION What CALCICLO STEROP 11mEq 10ml contains The active substance is dihydrated calcium chloride 0.803g/10ml. The other ingredient is water for injection. Ionic composition: 10 ml of solution contain 11 meq Ca + + and 11 meq Cl -. Page 4 sur 5

5 What CALCICLO STEROP 11mEq 10ml looks like and contents of the pack. Solution for injection for slow intravenous injection. Glass ampoules type I of 10 ml. Boxes of 10 ampoules and 100 ampoules (for hospital use). Marketing Authorisation Holder and Manufacturer Sterop Laboratories - Avenue de Scheut Brussels - BELGIUM Delivery: Medicine under medical prescription. N of registration: BE This leaflet was last revised in 05/2009 Page 5 sur 5