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Package leaflet: Information for the patient 10 mg/ml Solution for Injection/Infusion Atracurium besilate

Read all of this leaflet carefully before you aminoglycosides, polymyxins, spectinomycin, start using this medicine because it contains tetracyclines, lincomycin and clindamycin; important information for you. - anti-arrhythmic drugs (used to treat heart - Keep this leaflet. You may need to read it again. rhythm disorders), such as propranolol, - If you have any further questions, ask your oxprenolol, calcium channel blockers, doctor or nurse. lidocaine, procainamide and quinidine; - If you get any side effects, talk to your doctor - water pills (diuretics), such as furosemide, or nurse. This includes any possible side effects mannitol, thiazide diuretics and acetazolamide; not listed in this leaflet. See section 4. - magnesium salts (used to prevent low levels of magnesium in the body); What is in this leaflet - medicines used to treat mental disorders, such 1. What Atracurium Besilate is and what it is used as lithium or chlorpromazine; for - medicines used to treat high blood pressure 2. What you need to know before you receive (hypertension), such as trimetaphan and Atracurium Besilate ; 3. How to use Atracurium Besilate - medicines used to treat joint inflammation 4. Possible side effects (anti-rheumatic drugs), such as chloroquine and 5. How to store Atracurium Besilate penicillamine; 6. Contents of the pack and other information - medicines used to treat Alzheimer´s disease, such as ; - steroids (used to treat inflammations or 1. What Atracurium Besilate is and what it is asthma), such as prednisolone; used for - medicines used to treat fits (epilepsy), such as phenytoin. Atracurium Besilate belongs to a group of medicines called muscle relaxants. and breast-feeding Atracurium Besilate is used during to If you are pregnant or breast-feeding, think you relax muscles and to assist with inserting a may be pregnant or are planning to have a baby, breathing tube and with artificial breathing. It is ask your doctor for advice before administration also used to help with artificial breathing at of this medicine. Your doctor will consider the patients in intensive care units. benefit of your therapy against the risk of administration of Atracurium Besilate for your child. 2. What you need to know before you receive Atracurium Besilate Atracurium Besilate can be used to maintain relaxation of muscle tension during caesarean Atracurium Besilate cannot be administered: section. - if you are allergic to atracurium besilate, cisatracurium or any of the other ingredients of Driving and using machines this medicine (listed in section 6). Atracurium Besilate has major influence on the ability to drive and use machines. Ask the doctor If you think that this applies to you talk to your for advice on when it is safe to drive and use doctor before Atracurium Besilate is administered machines again. to you. Do not drive or use machines if you feel unwell. Warnings and precautions Talk to your doctor or nurse before using 3. How to use Atracurium Besilate Atracurium Besilate - if you have an or bronchial asthma; Atracurium Besilate is used during procedures - if you have ever had an allergic reaction to which require you to be anaesthetised other medicines similar to Atracurium Besilate (unconscious) or heavily sedated. It will be that blocks the transmission of impulses always administered under the supervision of an between a nerve and muscle; experienced doctor. - if you suffer from muscle weakness, tiredness or difficulty in coordination of movements What quantity is administered (); Your doctor will determine the correct dose of - if you suffer from a neuromuscular disease; Atracurium Besilate depending on: - if you have a heart disease or you are sensitive - your body weight; to a drop in blood pressure; - the extent and duration of required relaxation of - if you have severe electrolyte disorders muscle tension; (unusual levels of ions such as sodium, - your expected response (reaction) to the drug potassium or chloride in your blood); administration. - if you have recently suffered severe burns that required medical attention. How Atracurium Besilate is administered Atracurium Besilate will be given to you by a If you think that any of the above can apply to single injection into your vein or as a continuous you, talk to your doctor. infusion (usually using an infusion pump) into your vein. In this case the medicine is given Children slowly over a certain period of time. This medicine is not intended for use in infants up to1 month of age. Instruction of ampoule opening: 1) Turn the ampoule with coloured point up. If Other medicines and Atracurium Besilate there is any solution in the upper part of the Tell your doctor if you are taking, have recently ampoule, gently tap with your finger to get all taken or might take any other medicines. This the solution to the lower part of the ampoule. also applies to medicines available without a 2) Use both hands to open; while holding the prescription. lower part of the ampoule in one hand, use the other hand to break off the upper part of the Some medicines may influence the effects of ampoule in the direction away from the Atracurium Besilate. Tell your doctor if you are coloured point (see the pictures below). taking any of the following: - anaesthetics (used to reduce consciousness and pain during surgical procedure), such as , , or ; - antibiotics (used to treat infections), such as

The following information is intended for Atracurium Besilate is a hypotonic solution and healthcare professionals only: thus it must not be administered into the same venous access as a blood transfusion. For single use only. Once opened, the product should be used immediately. Atracurium Besilate is compatible with the following solutions for infusion. From a microbiological point of view, unless the method of dilution precludes the risk of microbial Infusion solution Period of stability contamination, the product should be used Sodium chloride intravenous 24 hours immediately. If not used immediately, in-use infusion (9 mg/ml) storage times and conditions are the responsibility Glucose intravenous infusion 8 hours of the user. (50 mg/ml) Atracurium besilate is inactivated by high pH, Ringer intravenous infusion 8 hours thus it must not be mixed in the same syringe with Sodium chloride (1.8 mg/ml) and 8 hours solutions of thiopental or any other alkaline glucose (40 mg/ml) intravenous solutions. infusion Ringer lactate intravenous 4 hours After injecting Atracurium Besilate into a small infusion vein, physiological saline solution should be flushed through the vein. When other medicines When diluted in these solutions to give atracurium are administered through the same indwelling besilate concentrations of 0.5 mg/ml and above, the needle or cannula as Atracurium Besilate, it is resultant solutions will be stable in daylight for the necessary to rinse it with a sufficient volume of stated periods at temperatures of up to 25°C. physiological saline after administration of each medicine. the EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2°C – 8°C). Do not freeze. Store in the original package in order to protect from light. For single use only. Once opened, the product should be used immediately. The solution is to be visually inspected prior to Use in children use. Only clear solutions practically free from Infants aged up to 1 month should not receive this particles should be used. medicine. Do not throw away any medicines via wastewater If you are given more Atracurium Besilate or household waste. Ask your pharmacist how to than you should throw away medicines you no longer use. These This medicine will only be used by doctors who measures will help protect the environment. are appropriately skilled in its administration. As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too 6. Contents of the pack and other information little or too much, however tell your doctor or a healthcare professional immediately if you have What Atracurium Besilate contains any concerns. In the case of administration of too large dose the appropriate measures will be - The active substance is atracurium besilate. implemented immediately. 1 ml of solution contains 10 mg of atracurium besilate. Each ampoule (2.5 ml) contains 25 mg of 4. Possible side effects atracurium besilate. Each ampoule (5 ml) contains 50 mg of Like all medicines, this medicine can cause side atracurium besilate. effects, although not everybody gets them. - The other ingredients are benzenesulfonic acid If any of the following happen, tell the doctor (for pH adjustment), water for injections. immediately: - severe allergic reaction – you may get a sudden What Atracurium Besilate looks like and itchy rash (hives), swelling of the hands, feet, contents of the pack ankles, face, lips, mouth or throat (which may Clear colourless or yellowish solution for cause difficulty in swallowing or breathing), injection/infusion, free from visible particles. and you may feel you are going to faint; - shock; 2.5 ml or 5.0 ml of solution filled in 5.0 ml type I - heart failure; colourless glass ampoules. - cardiac arrest. Pack size: 1 or 5 ampoules. The above are very rare, serious side effects. You may need urgent medical attention. Not all pack sizes may be marketed. If you experience any of the following tell your Marketing Authorisation Holder doctor as soon as possible: AS KALCEKS Krustpils iela 53, Rīga, LV-1057, Latvia Common side effects (may affect up to 1 in 10 Tel.: +371 67083320 people): E-mail: [email protected] - low blood pressure (hypotension), usually mild and transient; Manufacturer - skin redness. Akciju sabiedrība “Kalceks” Krustpils iela 71E, Rīga, LV-1057, Latvia Uncommon side effects (may affect up to 1 in 100 people): This medicinal product is authorised in the - difficulty in breathing and whistling Member States of the EEA under the following (bronchospasm). names: Bulgaria Atracurium Kalceks 10 mg/ml инжекционен/инфузионен Not known (frequency cannot be estimated from разтвор the available data): Czech Republic Atracurium Kalceks - convulsions; Estonia Atracurium b esilate Kalceks - muscle disorders (myopathy), muscle weakness. France ATRACURIUM KALCEKS 10 mg/ml, solution injectable/pour perfusion Reporting of side effects Hungary Atracurium besilate Kalceks If you get any side effects, talk to your doctor or 10 mg/ml oldatos injekció/infúzió nurse. This includes any possible side effects not Ireland Atracurium Besilate 10 mg/ml listed in this leaflet. You can also report side Solution for Injection/Infusion effects directly via the national reporting system: Latvia Atracurium besilate Kalceks United Kingdom - Yellow Card Scheme. Website: 10 mg/ml šķīdums injekcijām/ www.mhra.gov.uk/yellowcard or search for infūzijām MHRA Yellow Card in the Google Play or Apple Lithuania Atracurium besilate Kalceks App Store. 10 mg/ml injekcinis ar infuzinis Ireland - HPRA Pharmacovigilance, Earlsfort tirpalas Terrace , IRL - Dublin 2. Tel: +353 1 6764971 The Netherlands Atracurium Kalceks 10 mg/ml Fax: +353 1 6762517. Website: www.hpra.ie. oplossing voor injectie/infusie e-mail: [email protected]. Poland Atracurium Kalceks By reporting side effects you can help provide Romania Atracurium Kalceks 10 mg/ml more information on the safety of this medicine. soluție injectabilă/perfuzabilă Slovakia Atracurium Kalceks 10 mg/ml injekčný/infúzny roztok 5. How to store Atracurium Besilate Sweden Atracurium Kalceks 10 mg/ml injektions-/infusionsvätska, Keep this medicine out of the sight and reach of lösning children. United Kingdom Atracurium Besilate 10 mg/ml Do not use this medicine after the expiry date Solution for Injection/Infusion which is stated on the label and on the carton after This leaflet was last revised in 08/2019

02.10.2019 HIE-UK/I/10/2