CISATRACURIO HIKMA 2 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

2. What you need to know before you use Cisatracurium Hikma

Do not use Cisatracurium Hikma

• if you are allergic to cisatracurium or other muscle relaxants or any of the other ingredients of this medicine (listed in section 6).
• if you have had a bad reaction to an anaesthetic in the past.

Cisatracurium should not be given to you if you have any of the above conditions. If you are not sure, talk to your doctor, nurse or pharmacist before you are given this medicine.

Warnings and precautions

Tell your doctor, pharmacist or nurse before you start using this medicine if:

• you have muscle weakness, tiredness or difficulty coordinating your movements (myasthenia gravis);
• you have a nerve disease that causes muscle wasting, paralysis, motor neurone disease or cerebral palsy;
• you have burns that need medical treatment;
• you have ever had an allergic reaction to any muscle relaxant that you have been given during 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 this medicine.

Other medicines and Cisatracurium Hikma

Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular, tell your doctor if you are taking any of the following medicines:

• anaesthetics (used to reduce feeling and pain during surgery);
• antibiotics (used to treat infections);
• medicines used to treat irregular heartbeats (anti-arrhythmics);
• medicines used to treat high blood pressure;
• medicines that help get rid of fluids (diuretics), such as furosemide;
• medicines for joint inflammation, such as chloroquine or D-penicillamine;
• corticosteroids;
• medicines for epilepsy (seizures), such as phenytoin or carbamazepine;
• medicines for mental illness, such as lithium, monoamine oxidase inhibitors (MAOIs) or chlorpromazine (which can also be used for nausea);
• medicines that contain magnesium;
• medicines for Alzheimer's disease (anticholinesterases, such as donepezil).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.

A harmful effect of cisatracurium on the baby cannot be excluded; however, it is unlikely to occur if breast-feeding is restarted after the effects of the substance have disappeared. Cisatracurium is rapidly eliminated from the body. Women should not breast-feed for 3 hours after the end of treatment.

Driving and using machines

If you are going to be in hospital for just one day, your doctor will tell you how long to wait before you can leave hospital or drive. It may be dangerous to drive soon after you have had an operation.

3. How to use Cisatracurium Hikma

Never try to give yourself this medicine. It should always be given by a person who is qualified to do so. Cisatracurium can be given:

• as a single injection into a vein (intravenous bolus injection);
• as a continuous infusion into a vein. This is when the medicine is given slowly over a long period of time.

Your doctor will decide how and how much of the medicine you will be given. This will depend on:

• your body weight;
• how much and how long you need muscle relaxation;
• how you are expected to respond to the medicine.

This medicine should not be given to children under 1 month old.

If you have been given too much Cisatracurium Hikma

This medicine will always be given in carefully controlled conditions. However, if you think you have been given too much, tell your doctor or nurse immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Allergic reactions (may affect up to 1 in 10,000 people)

If you get an allergic reaction, tell your doctor or nurse immediately. The signs may include:

• sudden wheezing, chest pain or tightness;
• swelling of the eyelids, face, lips, mouth or tongue;
• skin rash or hives anywhere on the body;
• collapse and anaphylactic shock.

Tell your doctor, nurse or pharmacist if you notice any of the following:

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)

• skin rash or redness;
• wheezing or coughing.

Rare (may affect up to 1 in 10,000 people)

• muscle weakness or pain.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website (http://www.aemps.gob.es/). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cisatracurium Hikma

• 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 after “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 to protect from light.

• If diluted, store the infusion solution at 25°C or 2-8°C and use within 24 hours. Any unused infusion solution should be discarded 24 hours after preparation.

• Medicines should not be disposed of via wastewater or household waste. Your doctor or nurse will dispose of any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

What Cisatracurium Hikma contains

• The active substance is 2 mg/ml cisatracurium (as besilate).
• The other ingredients are benzenesulfonic acid (for pH adjustment) and water for injections.

Appearance and packaging

Cisatracurium Hikma 2 mg/ml Solution for Injection and Infusion is a colourless to pale yellow or yellowish-green solution, practically free from visible particles, and is available in:

• Boxes of 5 and 10 glass ampoules of 2.5 ml (each 2.5 ml ampoule contains 5 mg of cisatracurium).
• Boxes of 5 and 10 glass ampoules of 5 ml (each 5 ml ampoule contains 10 mg of cisatracurium).
• Boxes of 5 and 10 glass ampoules of 10 ml (each 10 ml ampoule contains 20 mg of cisatracurium).

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó, 8, 8A e 8B - Fervença

2705-906 Terrugem SNT

Portugal

Manufacturer

Hikma Italia S.P.A.

Viale Certosa 10

27100 Pavia

Italy

You can obtain further information on this medicine from the representative of the marketing authorisation holder:

Hikma España, S.L.U.

Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2

28108 - Alcobendas, Madrid

Spain

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

Austria: Cisatracurium Hikma 2 mg/ml Injektionslösung oder Infusionslösung

Germany: Cisatracurium Hikma 2 mg/ml Injektionslösung /Infusionslösung

Belgium: Cisatracurium Hikma 2 mg/ml Injektions/Infusionslösung/Solution injectable/pour perfusion/ Oplossing voor injectie / infusie

Spain: Cisatracurio Hikma 2 mg/ml solución inyectable y para perfusión EFG

France: Cisatracurium Hikma 2 mg/ml Solution injectable/pour perfusion

Italy: Cisatracurio Hikma 2 mg/ml Soluzione iniettabile infusione

Netherlands: Cisatracurium Hikma 2 mg/ml Oplossing voor injectie/ infusie

Portugal: Cisatracúrio Hikma

United Kingdom: Cisatracurium 2 mg/ml Solution for injection/infusion

Date of last revision of this leaflet: July 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/).

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This information is intended only for healthcare professionals:

This product is for single use only. Use only clear and almost colourless or slightly yellowish/greenish solutions. The product should be inspected visually before use, and if the appearance has changed or the container is damaged, the product should be discarded.

Diluted Cisatracurium Hikma remains physically and chemically stable for at least 24 hours at 2-8°C and 25°C at concentrations between 0.1 and 2 mg/ml in the following infusion fluids, either in polyvinyl chloride or polypropylene containers.

Intravenous infusion of sodium chloride (0.9% w/v).

Intravenous infusion of glucose (5% w/v).

Intravenous infusion of sodium chloride (0.18% w/v) and glucose (4.5% w/v) (one-fifth of the usual concentration of glucose).

Intravenous infusion of sodium chloride (0.45% w/v) and glucose (5% w/v).

In any case, since the product does not contain antimicrobial preservatives, dilution should be made immediately before use or, if this is not possible, it can be stored according to section 5 of the leaflet.

Cisatracurium Hikma has been shown to be compatible with the following drugs commonly used in surgical procedures, when mixed under conditions simulating intravenous infusion through a "Y" device: alfentanil hydrochloride, droperidol, fentanyl citrate, midazolam hydrochloride and sufentanil citrate. When other drugs are administered through the same needle or cannula as cisatracurium, it is recommended that each drug be flushed through with a suitable volume of an intravenous fluid, such as sodium chloride 0.9% w/v infusion.

As with other drugs administered intravenously, when a small vein is selected as the injection site, this medicine should be flushed through the vein with a suitable intravenous fluid, for example, sodium chloride 0.9% w/v infusion.