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CISATRACURIO HIKMA 2 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

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About the medicine

How to use CISATRACURIO HIKMA 2 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Cisatracurium Hikma 2 mg/ml Solution for Injection and Infusion EFG

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 or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

Cisatracurium Hikma contains a medicine called cisatracurium. This belongs to a group of medicines called muscle relaxants.

Cisatracurium is used to:

  • relax muscles during surgical operations, including heart surgery, in adults and children over 1 month old;
  • help insert a tube into the windpipe (tracheal intubation), if a person needs help with breathing;
  • relax muscles in adults in intensive care.

Ask your doctor if you need more information about this medicine.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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.

Online doctors for CISATRACURIO HIKMA 2 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

Discuss questions about CISATRACURIO HIKMA 2 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
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  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
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He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Doctor

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
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  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Doctor

Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

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  • Chest pain, shortness of breath, arrhythmias (tachycardia, bradycardia, palpitations).
  • Leg swelling, chronic fatigue, reduced exercise tolerance.
  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
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  • Individual treatment plans including oral medications and insulin therapy.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
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General internal medicine and preventive care:
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Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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Frequently Asked Questions

Is a prescription required for CISATRACURIO HIKMA 2 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION?
CISATRACURIO HIKMA 2 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in CISATRACURIO HIKMA 2 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION?
The active ingredient in CISATRACURIO HIKMA 2 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION is cisatracurium. This information helps identify medicines with the same composition but different brand names.
Who manufactures CISATRACURIO HIKMA 2 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION?
CISATRACURIO HIKMA 2 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION is manufactured by Hikma Farmaceutica (Portugal) S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of CISATRACURIO HIKMA 2 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether CISATRACURIO HIKMA 2 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to CISATRACURIO HIKMA 2 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION?
Other medicines with the same active substance (cisatracurium) include CISATRACURIO ACCORDPHARMA 2 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION, CISATRACURIO ACCORDPHARMA 5 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION, CISATRACURIO KALCEKS 2 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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