CISATRACURIUM MYLAN PHARMA

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Cisatracurium Mylan Pharma 2 mg/ml, injection or infusion solution, 5 mg/ml, injection or infusion solution

cisatracurium
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Cisatracurium Mylan Pharma is and what it is used for

2. What you need to know before taking Cisatracurium Mylan Pharma

3. How to take Cisatracurium Mylan Pharma

4. Possible side effects

5. How to store Cisatracurium Mylan Pharma

6. Contents of the pack and other information.

1. What Cisatracurio Mylan Pharma is and what it is used for

Cisatracurio Mylan Pharma contains a substance called cisatracurium which belongs to a group of medicines known as muscle relaxants.
Cisatracurio Mylan Pharma is used for:

• relaxing muscles during surgical procedures in adults and children over one month of age, including cardiac surgery;
• assisting in the insertion of a tube into the trachea (endotracheal intubation), when a person needs help with breathing;
• relaxing muscles in adults undergoing intensive care treatment.

Ask your doctor if you would like more information about this medicine.

2. What you need to know before taking Cisatracurium Mylan Pharma.

Do not take Cisatracurium Mylan Pharma:

• if you are allergic (hypersensitive) to cisatracurium, to any other muscle relaxant, or to any of the other components of Cisatracurium Mylan Pharma (listed in section 6);
• if you have previously had an adverse reaction to an anaesthetic.

You must not use Cisatracurium Mylan Pharma if any of the above conditions apply to you. If you are unsure, talk to your doctor, nurse, or pharmacist before taking Cisatracurium Mylan Pharma.
Warnings and precautions
Talk to your doctor, nurse, or pharmacist before taking this medicine if:

• you experience muscle weakness, fatigue, or difficulty coordinating movements (myasthenia gravis);
• you suffer from a neuromuscular disease, such as a degenerative muscle disorder, paralysis, motor neuron disease, or cerebral palsy;
• you have a burn requiring medical treatment;
• you have previously had an allergic reaction to any muscle relaxant administered during a surgical procedure.

If you are unsure whether any of these conditions apply to you, talk to your doctor or pharmacist before taking Cisatracurium Mylan Pharma.
Other medicines and Cisatracurium Mylan Pharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• anaesthetics (used to reduce sensitivity and pain during surgical procedures);
• antibiotics (used to treat infections);
• medicines for irregular heartbeats (antiarrhythmics);
• medicines for high blood pressure;
• diuretics, such as furosemide;
• medicines for joint inflammation, such as chloroquine or d-penicillamine;
• steroids;
• medicines for seizures (epilepsy), such as phenytoin or carbamazepine;
• medicines for mental illnesses, such as lithium, monoamine oxidase inhibitors (MAO inhibitors), or chlorpromazine (which may also be used for nausea and vomiting);
• medicines containing magnesium;
• medicines for Alzheimer's disease (anticholinesterases, e.g. donepezil).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.
Driving and using machines
If you are staying in hospital for only one day, your doctor will advise you how long to wait before leaving the hospital or driving a vehicle. Driving too soon after surgery may be dangerous.

3. How to take Cisatracurium Mylan Pharma

How the injection is administered
You are not expected to use this medicine yourself. It will always be given by a qualified
healthcare professional.
Cisatracurium Mylan Pharma can be administered:

• as a single intravenous injection (intravenous bolus injection)
• as a continuous intravenous infusion. In this case, the medicine is given slowly over a prolonged period of time.

Your doctor will decide the route of administration and the dose to be given.
The dose will depend on:

• your body weight;
• the required intensity and duration of muscle relaxation;
• your expected response to the medicine.

Children under one month of age must not be treated with this medicine.
If you receive more Cisatracurium Mylan Pharma than you should
Cisatracurium Mylan Pharma will always be administered under closely monitored conditions.
However, if you think that you have been given more than the correct amount, inform your doctor or nurse immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The frequency of the possible side effects listed below is defined according to the following convention:
very common (affects more than 1 in 10 people)
common (affects 1 to 10 people in 100)
uncommon (affects 1 to 10 people in 1,000)
rare (affects 1 to 10 people in 10,000)
very rare (affects less than 1 in 10,000)
not known (frequency cannot be estimated from the available data)

Contact your doctor, nurse or pharmacist if you notice any of the following reactions.

Allergic reactions (affect less than 1 in 10,000 people)
If you experience an allergic reaction, inform your doctor or nurse immediately. Symptoms may include:

• sudden breathing difficulties, chest pain or tightness;
• swelling of the eyelids, face, lips, mouth or tongue;
• lumpy rash or hives anywhere on the body;
• collapse.

Common

• decreased heart rate;
• decreased blood pressure.

Uncommon

• skin rash or redness;
• asthma or cough.

Very rare

• muscle weakness or pain.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cisatracurium Mylan Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep in the original packaging to protect the medicine from light.
Chemical and physical in-use stability has been demonstrated for at least 24 hours at 5°C and at 25°C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and conditions of in-use storage are under the responsibility of the user and should normally not exceed 24 hours at a temperature between 2°C – 8°C, unless reconstitution has been carried out under controlled and validated aseptic conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Cisatracurium Mylan Pharma contains
The active substance is cisatracurium.
Each ml contains 2 mg of cisatracurium (as 2.68 mg of cisatracurium besilate).
Each ml contains 5 mg of cisatracurium (as 6.69 mg of cisatracurium besilate).
The other components are benzenesulfonic acid and water for injections.

Description of the appearance of Cisatracurium Mylan Pharma and contents of the pack
Colourless solution ranging from pale yellow to yellowish-green.

Cisatracurium Mylan Pharma 2 mg/ml solution for injection or infusion is supplied in transparent glass vials (type I) of 2.5 ml, 5 ml, and 10 ml, each containing 5 mg, 10 mg, or 20 mg of cisatracurium, respectively. The vials are packed in a cardboard box with the package leaflet.
Pack sizes of 1 and 5 vials.

Cisatracurium Mylan Pharma 5 mg/ml solution for injection or infusion is supplied in a transparent glass vial (type I) of 30 ml containing 150 mg of cisatracurium. The glass vial is sealed with a rubber stopper and an aluminium crimp cap and packed in a cardboard box containing the package leaflet.
Pack size: 1 vial.

Not all pack sizes may be marketed.

Marketing Authorization Holder:
Mylan S.p.a.
Via Vittor Pisani, 20
20124 Milano, Italy

Batch release responsible person:
Pharmathen S.A., 6 Dervenakion street, Pallini Attiki, 15351, Greece
Mylan S.A.S, 117, allée des Parcs, 69800 Saint-Priest, France

This package leaflet was last approved on

The following information is intended only for medical or healthcare professionals

Instructions for use
This product is intended for single use only. Use only clear, colourless solutions or solutions with a light yellow or yellowish-green tint. The product must be visually inspected before use; if the appearance is altered or the container is damaged, the product must be discarded.

Diluted Cisatracurium Mylan Pharma is physically and chemically stable for at least 24 hours at 5°C and 25°C at concentrations between 0.1 mg/ml and 2 mg/ml in the following infusion solutions, whether in polyvinyl chloride or polypropylene containers:

• Sodium Chloride (0.9% w/v), intravenous infusion.
• Glucose (5% w/v), intravenous infusion.
• Sodium Chloride (0.18% w/v) and Glucose (4% w/v), intravenous infusion.
• Sodium Chloride (0.45% w/v) and Glucose (2.5% w/v), intravenous infusion.

However, since the product does not contain antibacterial preservatives, dilution should be carried out immediately before use. Otherwise, the diluted solution must be stored as indicated in section 5 of this package leaflet.

Cisatracurium Mylan Pharma has been shown to be compatible with the following drugs

commonly used in the perioperative setting when mixed under conditions simulating intravenous infusion administration via a Y-site injection device:
alfentanil hydrochloride, droperidol, fentanyl citrate, midazolam hydrochloride, and sufentanil citrate.
If other drugs are administered through the same needle or cannula in addition to cisatracurium, each drug must be flushed through by washing the device with an appropriate volume of a suitable intravenous solution, e.g., Sodium Chloride for infusion (0.9% w/v).
As with other drugs administered intravenously, if a small-caliber vein is chosen as the injection site, Cisatracurium Mylan Pharma must be flushed with a suitable intravenous solution, e.g., sodium chloride for infusion (0.9% w/v).