Cisatracurium accord

Package leaflet: Information for the user

Cisatracurium Accord, 2 mg/ml, solution for injection/infusion
Cisatracurium Accord, 5 mg/ml, solution for injection/infusion
Cisatracurium
Please read all of this leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Cisatracurium Accord is and what it is used for
2. What you need to know before using Cisatracurium Accord
3. How to use Cisatracurium Accord
4. Possible side effects
5. How to store Cisatracurium Accord
6. Contents of the pack and other information

1. What Cisatracurium Accord is and what it is used for

Cisatracurium Accord contains the active substance cisatracurium, which belongs to a group of medicines called muscle relaxants.
Cisatracurium Accord is used:

• to relax skeletal muscles during surgical procedures, including heart surgery, in adults and children over 1 month of age;
• to facilitate endotracheal intubation (endotracheal intubation) if the patient requires assisted ventilation;
• to relax muscles in patients in intensive care units.

For additional information regarding the use of this medicine, please consult your doctor.

2. Important information before using Cisatracurium Accord

When not to use Cisatracurium Accord

• if the patient is allergic to cisatracurium, any other muscle relaxant medicine, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously had a bad reaction to anaesthesia.

Do not use Cisatracurium Accord if any of the above situations apply to the patient.
If in doubt, consult a doctor, nurse, or pharmacist before starting treatment with Cisatracurium Accord.

Warnings and precautions

Before starting treatment with Cisatracurium Accord, consult a doctor, pharmacist, or nurse if:

• the patient has muscle weakness, fatigue, or difficulties with motor coordination (myasthenia gravis);
• the patient has neuromuscular disorders such as muscle atrophy, paralysis, motor neuron disease, or cerebral palsy;
• the patient has burns and requires treatment.

If in doubt whether any of the above conditions apply to the patient, consult a doctor, nurse, or pharmacist before starting treatment with Cisatracurium Accord.

Cisatracurium Accord and other medicines

Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including herbal medicines and those available without a prescription.

In particular, inform the doctor if the patient is taking any of the following medicines:

• anaesthetics (used to prevent pain during surgical procedures),
• antibiotics (used to treat infections),
• antiarrhythmics (used to control heart rhythm),
• medicines for high blood pressure,
• diuretics (water tablets), such as furosemide,
• medicines used to treat rheumatism, such as chloroquine or D-penicillamine,
• steroid medicines,
• antiepileptic medicines, such as phenytoin or carbamazepine,
• medicines used to treat psychiatric conditions, such as lithium, monoamine oxidase inhibitors (MAOIs), or chlorpromazine,
• medicines containing magnesium,
• medicines used in Alzheimer's disease (acetylcholinesterase inhibitors, such as donepezil).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

A harmful effect of cisatracurium on the breastfed infant cannot be excluded; however, such an effect is not expected if breastfeeding is resumed after the effect of the drug has worn off.
Cisatracurium is rapidly eliminated from the body. A woman should not breastfeed for 3 hours after the end of drug administration.

Driving and operating machinery

If the patient is staying in hospital for only one day, the doctor will inform the patient when they may leave the hospital or drive a vehicle. Driving too soon after surgery may be dangerous.

3. How to take Cisatracurium Accord

How the injection is administered
The patient will never receive this medicine on their own. The medicine will always be administered to the patient by a qualified healthcare professional.

Cisatracurium Accord can be given as:

• a single intravenous injection (rapid intravenous bolus),
• continuous intravenous infusion. The medicine is slowly administered into the patient's vein over a longer period of time.

The method of administration and dose of Cisatracurium Accord will be determined by the doctor based on:

• the patient's body weight,
• the required degree and duration of muscle relaxation,
• the expected response of the patient to the medicine.

This medicine should not be used in children under 1 month of age.

Administration of a higher than recommended dose of Cisatracurium Accord
Cisatracurium Accord will always be administered under strict control.
However, if there is suspicion that the patient may have received too much medicine, the doctor or nurse should be informed immediately.
If you have any further doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If you notice any adverse reactions, you should immediately inform your doctor, nurse or pharmacist.
This also applies to adverse reactions not listed in this leaflet.

Allergic reactions (occurring less frequently than in 1 out of 10,000 patients)
If the patient experiences an allergic reaction, inform the doctor or nurse immediately.
Symptoms of an allergic reaction may include:

• sudden onset of wheezing, chest pain or shortness of breath,
• swelling of the eyelids, face, lips, mouth or tongue,
• hives or itchy rash on the body,
• collapse or shock.

Inform your doctor, nurse or pharmacist if the patient notices any of the following:

Common (occurring less frequently than in 1 out of 10 patients)

• slow heart rate,
• low blood pressure.

Uncommon (occurring less frequently than in 1 out of 100 patients)

• skin rash or redness,
• cough or wheezing.

Very rare (occurring less frequently than in 1 out of 10,000 patients)

• muscle weakness or lack of muscle strength.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Cisatracurium Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP.
The expiry date refers to the last day of the stated month.
Store in a refrigerator (2°C - 8°C). Do not freeze.
Store in the original packaging to protect from light.
The diluted solution should be stored at 2°C - 8°C and used within 24 hours. After 24 hours,
any unused portions of the solution must be discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Cisatracurium Accord contains
The active substance is cisatracurium (as besilate).
The other ingredients are: benzenesulfonic acid and water for injections.

What Cisatracurium Accord looks like and contents of the pack
Cisatracurium Accord 2 mg/ml:
Vials of 2.5 ml volume contain 5 mg cisatracurium (as cisatracurium besilate)
and are packed in packages containing 1 and 5 vials.
Vials of 5 ml volume contain 10 mg cisatracurium (as cisatracurium besilate)
and are packed in packages containing 1 and 5 vials.
Vials of 10 ml volume contain 20 mg cisatracurium (as cisatracurium besilate)
and are packed in packages containing 1 and 5 vials.
Vials of 25 ml volume contain 50 mg cisatracurium (as cisatracurium besilate)
and are packed in packages containing 1 and 2 vials.

Cisatracurium Accord 5 mg/ml:
Vials of 30 ml volume contain 150 mg cisatracurium (as cisatracurium besilate)
and are packed in packages containing 1 and 5 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Tel: + 48 22 577 28 00

Manufacturer/Importer
Accord Healthcare Polska Sp. z o.o.,
ul. Lutomierska 50
95-200 Pabianice
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
The Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Information intended exclusively for medical professionals:

This medicinal product must not be mixed with other medicinal products except those
listed in the section "Instructions for solution preparation and storage" below.
Since cisatracurium is stable only in acidic solutions, it must not be mixed in the same
syringe or administered through the same needle together with alkaline solutions, e.g. sodium thiopental.
The medicinal product shows pharmaceutical incompatibilities with ketorolac, trometamol, and
with propofol emulsion for injection.

Instructions for solution preparation and storage
This product is for single use only.
Only a colourless, pale yellow or greenish-yellow clear solution should be used. The product should be
visually inspected before use; if there is any change in appearance or if the container is damaged, the product
should be discarded.

The diluted solution of Cisatracurium Accord at concentrations from 1.0 to 2 mg/mL is stable
at 5°C for 24 hours when stored in polyvinyl chloride or polypropylene bags, in the following infusion fluids:

• Sodium chloride (0.9% w/v) for infusion
• Glucose (5% w/v) for infusion
• Sodium chloride (0.18%) and glucose (4% w/v) for infusion
• Sodium chloride (0.45%) and glucose (2.5% w/v) for infusion

Since the product does not contain antibacterial preservatives, it should be diluted immediately before use.
If the diluted solution is not administered immediately, it should be stored as indicated below.
From a microbiological standpoint, the solution should be used immediately. If not used immediately, the user
is responsible for conditions and duration of storage. The storage time should not exceed 24 hours at 2°C–8°C,
unless dilution was performed under controlled, validated aseptic conditions.

Cisatracurium Accord has been shown to be compatible with the following commonly used perioperative drugs
when co-administered via a Y-site infusion line: alfentanil hydrochloride, droperidol, fentanyl citrate,
midazolam hydrochloride, and sufentanil citrate. If other medicinal products are administered through the same needle or cannula, it is recommended to thoroughly flush the needle or cannula used for this product with an appropriate infusion fluid, e.g. sodium chloride 0.9% w/v for infusion.

As with other intravenously administered products, if a small vein is selected for injection, the vein should be flushed after administration of Cisatracurium Accord with an appropriate infusion fluid, e.g. sodium chloride 0.9% w/v for infusion.