CISATRACURIUM 5 mg /Ml Solution

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Cisatracurium Accord, 2 mg/ml, solution for injection/infusion
3. Cisatracurium Accord, 5 mg/ml, solution for injection/infusion
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Cisatracurium Accord and what is it used for
5. Important information before taking Cisatracurium Accord
   1. When not to use Cisatracurium Accord
   2. Warnings and precautions
   3. Cisatracurium Accord and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
6. How to take Cisatracurium Accord
   1. How the injection is administered
   2. Use of a higher than recommended dose of Cisatracurium Accord
7. Possible side effects
   1. Allergic reactions (occurring less frequently than in 1 in 10,000 patients)
   2. Common (occurring less frequently than in 1 in 10 patients)
   3. Uncommon (occurring less frequently than in 1 in 100 patients)
   4. Rare (occurring less frequently than in 1 in 10,000 patients)
   5. Reporting side effects
8. How to store Cisatracurium Accord
9. Contents of the packaging and other information
   1. What Cisatracurium Accord contains
   2. What Cisatracurium Accord looks like and contents of the packaging
   3. Cisatracurium Accord 2 mg/ml:
   4. Cisatracurium Accord 5 mg/ml:
   5. Responsible entity
   6. Manufacturer/Importer
   7. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   8. Date of last revision of the leaflet: December 2023
   9. Information intended for healthcare professionals only:

Leaflet accompanying the packaging: information for the user

Cisatracurium Accord, 2 mg/ml, solution for injection/infusion

Cisatracurium Accord, 5 mg/ml, solution for injection/infusion

Cisatracurium

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Cisatracurium Accord and what is it used for
• 2. Important information before taking Cisatracurium Accord
• 3. How to take Cisatracurium Accord
• 4. Possible side effects
• 5. How to store Cisatracurium Accord
• 6. Contents of the packaging and other information

1. What is Cisatracurium Accord and what is it 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 the insertion of an endotracheal tube (endotracheal intubation), if the patient requires respiratory support;
• to relax muscles in patients in intensive care units.

To obtain additional information on the use of the medicine, consult a doctor.

2. Important information before taking Cisatracurium Accord

When not to use Cisatracurium Accord

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

Do not use Cisatracurium Accord if any of the above situations apply to the patient.
In case of doubts, consult a doctor, nurse, or pharmacist before starting to use Cisatracurium Accord.

Warnings and precautions

Before starting to take Cisatracurium Accord, consult a doctor, pharmacist, or nurse if:

• the patient has muscle weakness, fatigue, or difficulty coordinating movements (myasthenia gravis);
• the patient has neuromuscular disorders, such as muscle atrophy, paralysis, motor neuron disease, or cerebral palsy;
• the patient is burned and requires treatment;

In case of doubts whether any of the above situations apply to the patient, consult a doctor, nurse, or pharmacist before starting to use Cisatracurium Accord.

Cisatracurium Accord and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take, including herbal medicines and those available without a prescription.
Particularly, inform the doctor about the use of the following medicines:

• anesthetics (used to relieve pain during surgical procedures),
• antibiotics (used to treat infections),
• antiarrhythmic medicines (used to control heart rhythm),
• medicines used to treat high blood pressure,
• diuretics, such as furosemide,
• medicines used to treat rheumatism, such as chloroquine or D-penicillamine,
• corticosteroids,
• antiepileptic medicines, such as phenytoin or carbamazepine,
• medicines used to treat mental illnesses, such as lithium, monoamine oxidase inhibitors (MAOIs), or chlorpromazine
• medicines containing magnesium,
• medicines used to treat Alzheimer's disease (acetylcholinesterase inhibitors, such as donepezil).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
It cannot be excluded that cisatracurium has a harmful effect on the breastfed child, however, it is not expected to have an effect if breastfeeding is resumed after the effect of the medicine has ceased.
Cisatracurium is rapidly eliminated from the body. The woman should not breastfeed for 3 hours after the administration of the medicine has ended.

Driving and using machines

In the case where the patient is in the hospital for only one day, the doctor will inform the patient when they can leave the hospital or drive a car. Driving a car too soon after surgery may be dangerous.

3. How to take Cisatracurium Accord

How the injection is administered

The patient will never take this medicine on their own. The medicine will always be administered to the patient by a qualified healthcare professional.
Cisatracurium Accord can be administered as:

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

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

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

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

Use of a higher than recommended dose of Cisatracurium Accord

Cisatracurium Accord will always be administered under close supervision.
However, if the patient suspects that they may have received too much medicine, they should immediately inform their doctor or nurse.
In case of any further doubts related to the use of this medicine, consult a doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In case of observing any side effects, inform the doctor, nurse, or pharmacist immediately. This also applies to side effects not listed in this leaflet.

Allergic reactions (occurring less frequently than in 1 in 10,000 patients)

If the patient experiences an allergic reaction, they should immediately inform their doctor or nurse.
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 rash on the body,
• collapse and shock.

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

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

• slow heart rate,
• low blood pressure.

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

• -rash or redness of the skin,
• cough or wheezing.

Rare (occurring less frequently than in 1 in 10,000 patients)

• weakness or lack of muscle strength.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, inform the doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be gathered on the safety of the use of the medicine.

5. How to store Cisatracurium Accord

Keep the 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 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 solution should be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Cisatracurium Accord contains

The active substance of the medicine is cisatracurium (as besylate).
The other ingredients are: benzenesulfonic acid and water for injections.

What Cisatracurium Accord looks like and contents of the packaging

Cisatracurium Accord 2 mg/ml:

Ampoules of 2.5 ml contain 5 mg of cisatracurium (as cisatracurium besylate) and are packaged in packs of 1 and 5 ampoules.
Ampoules of 5 ml contain 10 mg of cisatracurium (as cisatracurium besylate) and are packaged in packs of 1 and 5 ampoules.
Ampoules of 10 ml contain 20 mg of cisatracurium (as cisatracurium besylate) and are packaged in packs of 1 and 5 ampoules.
Ampoules of 25 ml contain 50 mg of cisatracurium (as cisatracurium besylate) and are packaged in packs of 1 and 2 ampoules.

Cisatracurium Accord 5 mg/ml:

Ampoules of 30 ml contain 150 mg of cisatracurium (as cisatracurium besylate) and are packaged in packs of 1 and 5 ampoules.
Not all pack sizes may be marketed.

Responsible entity

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

Manufacturer/Importer

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

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

Date of last revision of the leaflet: December 2023

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Information intended for healthcare professionals only:

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

This product is intended for single use only.
Only a colorless, pale yellow, or greenish-yellow clear solution should be used. Before use, the product should be visually inspected for any change in appearance or damage to the container; if so, the product should be discarded.
The diluted solution of Cisatracurium Accord in concentrations from 1.0 to 2 mg/ml is stable at 5°C for 24 hours, stored in polyvinyl chloride or polypropylene bags, in the following infusion solutions:

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

Since the product does not contain antimicrobial preservatives, it should be diluted immediately before administration. If the diluted solution is not administered immediately, it should be stored as indicated below.
From a microbiological point of view, the solution should be used immediately. If the product is not used immediately, the storage conditions and storage time are the responsibility of the user. The storage time should not exceed 24 hours at 2°C-8°C, unless dilution has taken place in controlled, validated aseptic conditions.
It has been shown that the medicinal product Cisatracurium Accord is compatible with the following commonly used medicines during the perioperative period, when combined during simultaneous administration into the infusion line through a "Y" connector: 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 flush the needle or cannula thoroughly with an appropriate infusion solution, e.g., sodium chloride for intravenous infusion (0.9% w/v). As with other intravenously administered products, if a small vein is chosen for injection, the vein should be flushed with an appropriate infusion solution, e.g., sodium chloride for intravenous infusion (0.9% w/v), after administration of the medicinal product Cisatracurium Accord.