PACKAGE LEAFLET: INFORMATION FOR THE USER
Cisatracurium [MAH] 2 mg/ml solution for injection/infusion
Cisatracurium
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 Cisatracurium [MAH] is and what it is used for 2. What you need to know before Cisatracurium [MAH] is given 3. How Cisatracurium [MAH] is given 4. Possible side effects 5. How to store Cisatracurium [MAH] 6. Contents of the pack and other information
1. WHAT CISATRACURIUM [MAH] IS AND WHAT IT IS USED FOR
Cisatracurium [MAH] belongs to a group of medicines called muscle relaxants.
Cisatracurium [MAH] is used: to relax muscles during a wide range of surgical procedures in adults and children over 1 month of age, to help insert a tube into the windpipe (tracheal intubation), if a person needs help to breathe, to relax the muscles of adults in intensive care.
2. WHAT YOU NEED TO KNOW BEFORE CISATRACURIUM [MAH] IS GIVEN
Cisatracurium [MAH] must not be used if you are allergic to cisatracurium, atracurium or benzenesulfonic acid.
Warnings and precautions Talk to your doctor, pharmacist or nurse before you are given, Cisatracurium [MAH] if you have: - muscle weakness, tiredness or difficulty in co-ordination of your movements (myasthenia gravis), - a neuromuscular disease, such as a muscle wasting disease, paralysis, motor neurone disease or cerebral palsy, - a burn which requires medical treatment, - a severe acid-base and/or electrolyte disorder, - ever had an allergic reaction to any muscle relaxant which was given as part of an operation.
If you are not sure if any of the above applies to you, talk to your doctor, nurse or pharmacist before you are given Cisatracurium [MAH].
Children Children under the age of one month (new-born infants) should not receive Cisatracurium [MAH].
Other medicines and Cisatracurium [MAH]. Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This is especially important with the following medicines as they may interact with your Cisatracurium [MAH]: - anaesthetics (used for sedation and pain reduction during surgical procedures, such as enflurane, isoflurane, halothane, ketamine) - other muscle relaxants, such as suxamethonium - antibiotics (used to treat infections, such as aminoglycosides, polymyxins, spectinomycin, tetracyclines, lincomycin and clindamycin) - antiarrhythmics (used to control the heart rhythm, such as propranolol, oxprenolol, calcium channel blockers, lidocaine, procainamide and quinidine) - medicines to treat high blood pressure, such as trimethaphan and hexamethonium - diuretics (water tablets, such as furosemide, thiazides, mannitol and acetazolamide) - medicines to treat rheumatism, such as chloroquine or d-penicillamine - steroids - anti-epileptic medicines, such as phenytoin or carbamazepine - medicines to treat mental illness, such as lithium, or chlorpromazine - medicines containing magnesium - medicines to treat Alzheimer’s disease (anticholinesterases e.g. donepezil)
It may still be all right for you to receive Cisatracurium [MAH] and your doctor will be able to decide what is suitable for you.
Pregnancy, breast-feeding and fertility There is little experience in the use of Cisatracurium [MAH] in pregnant or breast- feeding women. Therefore, it is not recommended to use Cisatracurium [MAH] during pregnancy or breast-feeding. An influence on the suckling child is not to be expected if you restart breast-feeding after the effects of the substance have worn off. As a precaution breast-feeding should be discontinued during treatment and for at least 12 hours after administration of Cisatracurium [MAH]. 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 this medicine is given to you.
Driving and using machines Cisatracurium [MAH] is administered under general anaesthesia. General anaesthesia has a major influence on your ability to drive and use machinery. It can be dangerous to drive, operate machinery or work in dangerous situations too soon after having had an operation. Your doctor will tell you when you can start driving and using machinery again.
3. HOW CISATRACURIUM [MAH] IS GIVEN
How your injection is given Cisatracurium [MAH] must only be given to you by or under the supervision of an experienced doctor who is familiar with the use and action of this type of medicine. It will always be given under carefully controlled conditions, where emergency equipment is available.
Dosage Your doctor will decide on the dose of Cisatracurium you will be given. The amount of Cisatracurium [MAH] you need depends on: your body weight the amount and duration of muscle relaxation required your expected response to the medicine
Method of administration Cisatracurium [MAH] will be given to you as a single injection into your vein (intravenous bolus injection), as a continuous infusion into your vein (intravenous infusion or “drip”). This is where the drug is slowly given to you over a longer period of time.
If you receive more Cisatracurium [MAH] than you should As Cisatracurium [MAH] will always be given to you under carefully controlled conditions, it is unlikely that you will be given too much.
If you have received too much, or if it is suspected, that you may have received too much, appropriate action will be taken promptly by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
As all muscle relaxants cisatracurium can cause allergic reactions although serious allergic reactions are very rare (may affect up to 1 in 10,000 people ). Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips and rash or itching (especially affecting your whole body) should be reported to a doctor immediately.
The following side effects have been reported:
Common (may affect up to 1 in 10 people) - decrease in heart rate - decrease in blood pressure
Uncommon (may affect up to 1 in 100 people) - a rash or redness of your skin - bronchospasm (asthma-like symptoms)
Very rare (may affect up to 1 in 10,000 people) - muscles weakness or failure
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE CISATRACURIUM [MAH]
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after “Exp.”. The expiry date refers to the last day of that month.
Storage conditions Before opening: Store in a refrigerator (2 ºC and 8 °C). Do not freeze. Keep the ampoules in the outer carton in order to protect from light.
After opening and/or after dilution For single use only. Cisatracurium [MAH] should be used immediately after opening and/or dilution. Any unused solution should be discarded. Do not use this medicine if you notice the solution is not clear and free of particles or if the container is damaged.
Do not throw away any medicines via wastewater. 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 Cisatracurium [MAH] contains
The active substance is cisatracurium. 1 ml of Cisatracurium [MAH] contains 2.68 mg cisatracurium besilate, equivalent to 2 mg cisatracurium.
The other ingredients are benzenesulfonic acid 1% and water for injections.
What Cisatracurium [MAH] looks like and the content of the pack Cisatracurium [MAH] is a clear, colourless to pale yellow or greenish yellow solution for injection/infusion.
Cisatracurium [MAH] is available in packs of: 1 (5, 10, 50) clear glass ampoule(s), each containing 2.5 ml, 5 ml or 10 ml of solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder [to be completed nationally]
Manufacturer [to be completed nationally]
This medicinal product is authorised in the Member States of the EEA under the following names:
Cisatracurium Kabi 2 mg/ml Injektions- DE /Infusionslösung BE Cisatracurium Fresenius Kabi 2 mg/ml oplossing voor injectie/infusie CZ Cisatracurium Kabi 2 mg/ml
DK Cisatracurium Fresenius Kabi
EE Cisatracurium Kabi 2 mg/ml
EL Cisatracurium/Kabi 2mg/ml, Διάλυμα για ένεση/έγχυση ES Cisatracurio Kabi 2mg/ml solución inyectable y para perfusión EFG FI Cisatracurium Fresenius Kabi 2 mg/ml
Cisatracurium Kabi 2 mg/ml, solution FR injectable/pour perfusion
Cisatracurium Kabi 2 mg/ml oldatos HU injekció vagy infúzió
IT Cisatracurio Kabi 2mg/ml
Cisatracurium Kabi 2mg/ml šķīdums LV injekcijām/infūzijām
Cisatracurium Kabi 2 mg/ml injekcinis ar LT infuzinis tirpalas Cisatracurium Kabi 2 mg/ml Injektions- LU /Infusionslösung NL Cisatracurium Fresenius Kabi 2 mg/ml oplossing voor injectie/infusie PL Cisatracurium Kabi
PT Besilato de Cisatracúrio Kabi
UK Cisatracurium 2 mg/ml solution for injection/infusion
This leaflet was last revised in 05/2016. [to be completed nationally]
------The following information is intended for healthcare professionals only:
PREPARATION GUIDE FOR
Cisatracurium [MAH] 2 mg/ml solution for injection/infusion
It is important that you read the entire contents of this guide prior to the preparation of this medicinal product.
This is a summary of the information regarding the preparation of Cisatracurium [MAH]. Please refer to the Summary of Product Characteristics for full information.
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned below.
Since cisatracurium is stable only in acidic solutions it should not be mixed in the same syringe or administered simultaneously through the same needle with alkaline solutions, e.g., sodium thiopentone.
It is not compatible with ketorolac, trometamol or propofol injectable emulsion.
Dilution Instructions
Diluted to concentrations between 0.1 and 2 mg cisatracurium/ml Cisatracurium [MAH] 2 mg/ml is physically and chemically stable for 24 hours at 25°C in sodium chloride 9 mg/ml (0.9%) solution; in sodium chloride 9 mg/ml (0.9%) and glucose 50 mg/ml (5%) solution; and in glucose 50 mg/ml (5%) solution.
Chemical and physical in-use stability have been demonstrated for 24 hours at 25°C.From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C.
Posology and method of administration Please see the Summary of Product Characteristics.
Precautions for Disposal and other Handling
The product should be visually inspected prior to use. The solution should only be used if it is clear and colourless or almost colourless up to slightly yellow/greenish yellow, practically free from particles and if the container is undamaged. If the visual appearance has changed or if the container is damaged, the product must be discarded.
For single use only. The product should be used immediately after opening the ampoule. Any unused product or waste material should be disposed of in accordance with local requirements.
Cisatracurium has been shown to be compatible with the following commonly used peri-operative medicinal products, when mixed in conditions simulating administration into a running intravenous infusion via a Y-site injection port: alfentanil hydrochloride, droperidol, fentanyl citrate, midazolam hydrochloride and sufentanil citrate. Where other agents are administered through the same indwelling needle or cannula as cisatracurium, it is recommended that each medicinal product be flushed through with an adequate volume of a suitable intravenous fluid, e.g., sodium chloride 9 mg/ml (0.9%) solution.