USER INFORMATION PAMPHLET Suero Fisiológico Vitulia 0.9% solution for perfusion Sodium chloride

Transcription

1 USER INFORMATION PAMPHLET Suero Fisiológico Vitulia 0.9% solution for perfusion Sodium chloride Read the whole of this prospectus in detail, because it contains information that will be important to you. This medication can be obtained without a prescription for the treatment of minor afflictions without the intervention of a doctor. However, you must use Suero Fisiológico Vitulia with care to obtain the best results. -Keep this prospectus; you may need to read it again. -If you have any doubts, consult your doctor or pharmacists. This medicine has been prescribed to you and must not be given to others. It may harm them, even when their symptoms are the same as yours. In this prospectus: 1. What are Suero Fisiológico Vitulia and what are they used for? 2. Before using Suero Fisiológico Vitulia 3. How to use Suero Fisiológico Vitulia 4. Possible adverse effects 5. Storage of Suero Fisiológico Vitulia 1. WHAT IS Suero Fisiológico Vitulia AND WHAT IS IT USED FOR? Suero Fisiológico Vitulia belongs to the intravenous group of medicines. Suero Fisiológico Vitulia is used to replenish water and sodium and chloride salts that can be low as a consequence of different alterations or disorders. It is also used as a transport solution for other compatible medicines. 2. BEFORE USING Suero Fisiológico Vitulia Do not use Suero Fisiológico Vitulia - If you are allergic to (hypersensitive) the principal component of Suero Fisiológico Vitulia. If you present: - Excess water in the body (hyperhydration), excess sodium (hypernatremia) or chloride (hyperchloremia). - Acidosis (a lower ph than the normal range). - Oedematous states in patients with cardiac, hepatic or renal alterations or serious hypertension. In the same way it should not be administered to patients with low sodium levels (hypokalemia) above all in those with cardiovascular sicknesses. Be especially careful with Suero Fisiológico Vitulia

2 If you have disorders where a restriction on the consumption of sodium is indicated, such as cardiac insufficiency, generalised retention of liquids oedema, retention of liquid in the lungs, (lung oedema), hypertension (high blood pressure), hypertension during pregnancy (eclampsia), serious kidney insufficiency. Salt in serum needs to be checked regularly as does the water balance and the acid-base equilibrium. In prolonged therapies and in patients with an acid-base disequilibrium, cardiac, hepatic and/or renal alterations, or if you are being treated with corticoids or the adrenocorticotropic hormone frequent checks on the electrolytes in the blood need to be done. In the case that your suffer a case of hypertonic dehydration (loss of water with an excess of salts) a high perfusion speed needs to be avoided as it can provoke an increase in the plasma s osmolarity (concentration of salts in the plasma), and specifically, an increase in the concentration of sodium in the plasma (the quantity of sodium in the blood). In preterm infants and those breast feeding the administration of sodium chloride must only be done after determining the levels of sodium in the serum. Use of other medicines Inform your doctor or pharmacist if you are taking or have recently taken other medicines, including those acquired without prescription. The administration of sodium chloride accelerated the renal excretion of lithium, leading to its reduced therapeutic effectiveness. It must be administered with care to those being treated with corticoids or the adrenocorticotropic hormone as they can retain water and sodium. Before mixing with other medicines the compatibility tables must be checked, the ph born in mind and the ions controlled. Pregnancy and while breast feeding Consult your doctor or pharmacist before using any medicine. Suero Fisiológico Vitulia can be used when indicated during pregnancy and when breast feeding. Until now there is no relevant epidemiological data and so it is recommended that if used it be used with precaution. Driving and the use of machines This is not appropriate in the context of treatment with this medicine.

3 3. HOW TO USE Suero Fisiológico Vitulia Follow the administration instructions for Suero Fisiológico Vitulia given by your doctor exactly. Consult your doctor or pharmacist if you have doubts. The standard dose is up to 40ml per kg of body weight. The velocity of perfusion recommended is of some 5ml per kg of body weight per hour, which corresponds to 1.7 drops per kg of body weight per minute. Your doctor will decide the dose and frequency with which the solution is administered, it will depend on your age, weight and clinical situation. A greater quantity of solution must be administered and at a higher speed in those patients who manifest a deficit of plasma volume (hypovolemic shock). If you use more Suero Fisiológico Vitulia than you should It is very unlikely that this will happen as your doctor will determine your daily doses. However, if you did receive an overdose, it could provoke an excess concentration of sodium in the blood, chloride and electrolytes in general or have an excess of hydration and related manifestations like metabolic acidosis (inferior blood ph to normal), overcharging of the heart and the formation of oedemas. In such a case, the perfusion must be interrupted, and diuretic medicines administered in order to eliminate the excess liquid, as well as a check on the electrolytes in the blood and the acid-base equilibrium. If you are not checked in to hospital go to the nearest one or consult the Toxicology Information Service. Telephone: , indicating the medicine and the amount ingested. If you have any doubt about the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS As with all medicines, Suero Fisiológico Vitulia can produce side effects, though not everyone suffers them. If large quantities of the solution are administered, the levels of sodium and chloride in the plasma may increase. If it is administered continuously in the same perfusion location it can produce pain, fever, infections and phlebitis which extends from the point of injection, extravasation and hypervolaemia. If it is used as a vehicle for the administration of other drugs, the nature of the other drugs administered will determine the probability of other side effects. In the case of side effects the perfusion must be interrupted.

4 If you consider any of the side effects you suffer to be serious, or if you notice any other side effect not mentioned in this pamphlet, inform your doctor or pharmacist. 5. CONSERVATION OF Suero Fisiológico Vitulia Keep out of reach and sight of children. It does not require special conditions for its conservation. Do not use Suero Fisiológico Vitulia after the expiry date which appears on the container. The expiry date is the last day of the month indicated. Do not use Suero Fisiológico Vitulia if it is cloudy or shows sedimentation (presence of particles at the bottom of the container) or if the container shows signs of deterioration. Medicines must not be disposed of in the drains or thrown away. Leave unwanted medicines and containers at the SIGRE point in a chemist. Ask your pharmacist how to dispose of any containers or unneeded medicines. This way you will help look after the environment. 6. ADDITIONAL INFORMATION Composition of Suero Fisiológico Vitulia The principal component is: Principal component Per 100ml Sodium chloride 0.9g Electrolytes mmol/l meq/l Sodium Chlorides Theoretical osmolarity 308 mosm/l Acidity (up to ph 7.4) <0.3 mmol/l ph The other components are: water for injections. Product appearance and container contents Suero Fisiológico Vitulia is a solution for perfusion, transparent and colourless, which is presented in plastic jars (Ecoflac Plus ) of 50, 100, 250, 500 and 1000 ml (it is possible that not all sizes are commercialised). Clinical box: ml jars ml jars ml jars ml jars ml jars

5 Holder of the authorisation for the commercialisation and fabrication of the product. LABORATORIOS ERN, S.A. Pedro IV, Barcelona, España This pamphlet was revised in June This information is for doctors and health professionals only: Single use containers. Dispose of any remaining content not used after finishing the perfusion. The solution must only be used if the seal is not damaged and the solution is clear. Use the sterile administration set for its administration. Detailed and updated information about this product is available on the webpage of the Spanish Agency for Medicines and Health Products (AEMPS)