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ROCURONIUM HIKMA 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

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About the medicine

How to use ROCURONIUM HIKMA 10 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

Rocuronium Hikma 10 mg/ml Solution for Injection and Perfusion EFG

rocuronium bromide

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 pack and other information

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

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

This medicine belongs to a group of medicines called muscle relaxants.

Muscle relaxants are used during an operation as part of a general anaesthetic. When you are having an operation, your muscles must be completely relaxed. This makes it easier for the surgeon to perform the operation.

Normally, nerves send messages to your muscles through impulses. This medicine works by blocking these impulses so that your muscles relax. Because your respiratory muscles also relax, you will need help with your breathing (artificial ventilation) during and after the operation until you can breathe on your own again.

During the operation, your anaesthetist will control the effect of the muscle relaxant and, if necessary, give you more. At the end of the surgery, the effects of the medicine are allowed to wear off and you will start breathing on your own again. Sometimes, the anaesthetist will give you another medicine to help speed up this process.

This medicine can also be used in the intensive care unit to keep your muscles relaxed.

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 Rocuronium Hikma

Do not use Rocuronium Hikma

  • If you are allergic (hypersensitive) to rocuronium bromide, bromide ion or any of the other ingredients of this medicine (listed in section 6).

Tell your anaesthetist if this applies to you.

Warnings and precautions

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

  • If you are allergic to other muscle relaxants
  • If you have kidney, heart, liver or gallbladder disease
  • If you have a disease that affects your nerves and muscles
  • If you have fluid retention (oedema)
  • If you have a history of malignant hyperthermia (sudden fever with palpitations, rapid breathing and stiffness, pain and/or muscle weakness).

Tell your anaesthetist if you are in any of these situations.

Some conditions may influence the effects of this medicine, for example:

  • low calcium levels in the blood
  • low potassium levels in the blood
  • high magnesium levels in the blood
  • low protein levels in the blood
  • increased carbon dioxide levels in the blood
  • dehydration
  • loss of too much water from the body, for example, due to illness, diarrhoea or sweating
  • breathing too quickly, leading to a decrease in carbon dioxide levels in the blood (alkalosis)
  • poor general health
  • burns
  • being severely overweight (obesity)
  • body temperature too low (hypothermia)

If you have any of these conditions, your anaesthetist will take them into account when deciding the correct dose of this medicine for you.

Children and Elderly

This medicine can be used in children (newborns and adolescents) and elderly patients, but your anaesthetist must assess your medical history first.

Other medicines and Rocuronium Hikma

Tell your doctor if you are using, have recently used or might use any other medicines.

This includes medicines or herbal products that you have bought without a prescription.

This medicine may affect other medicines or be affected by them.

Medicines that increase the effect of rocuronium:

  • certain antibiotics
  • certain medicines used to treat heart diseases or high blood pressure (diuretics, calcium channel blockers, beta-blockers and quinidine)
  • certain anti-inflammatory medicines (corticosteroids)
  • medicines used to treat manic depression (bipolar disorder)
  • magnesium salts
  • certain medicines for the treatment of malaria

Medicines that decrease the effect of rocuronium:

  • certain medicines used to treat epilepsy
  • calcium chloride and potassium chloride
  • certain protease inhibitors called gabexate and ulinastatin.

You may be given other medicines during the procedure that may have an influence on the effects of rocuronium. These include certain anaesthetics, other muscle relaxants, medicines such as phenytoin and medicines that reverse the effects of this medicine. Rocuronium may make certain anaesthetics work more quickly. Your doctor will take this into account when deciding the correct dose of rocuronium for you.

Pregnancy and breast-feeding

Tell your anaesthetist if you are pregnant, might be pregnant or are breast-feeding.

Your anaesthetist may still give you this medicine, but will first discuss it with you. 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 using this medicine.

You may be given this medicine if you are having a caesarean section.

Breast-feeding should be discontinued for 6 hours after use of this medicine.

Driving and using machines

Do not drive or use machines until you have been told it is safe to do so. Because this medicine is given as part of a general anaesthetic, you may feel tired, weak or dizzy for some time after the operation. Your doctor will be able to advise you how long the effects are likely to last.

Rocuronium Hikma contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per vial/ampoule; this is essentially “sodium-free”.

3. How to use Rocuronium Hikma

Dose

Your anaesthetist will calculate the dose of this medicine that you need based on:

  • the type of anaesthetic,
  • the expected duration of the operation,
  • other medicines that you are taking,
  • your state of health.

The usual dose is 0.6 mg per kg of body weight and its effect lasts for 30 to 40 minutes.

How Rocuronium Hikma is given

This medicine will be given to you by injection into a vein as a single injection or as a continuous infusion (a drip)

If you use more Rocuronium Hikma than you should

Your anaesthetist will closely monitor you while you are under this medicine, so it is unlikely that you will be given too much rocuronium. If this happens, your anaesthetist will make sure that you continue to receive anaesthesia and artificial ventilation until you can breathe on your own again.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone 91 562 04 20.

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 these side effects occur while you are under anaesthesia, your anaesthetist will see them and treat them.

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

  • Increased or decreased effect of the medicine
  • Prolonged muscle relaxant effect of the medicine
  • Decrease in blood pressure
  • Increased heart rate
  • Pain at the injection site

Very rare(may affect up to 1 in 10,000 people):

  • Allergic reactions (hypersensitivity) (such as difficulty breathing, collapse of the circulation and shock),
  • Wheezing in the chest
  • Muscle weakness
  • Sudden fever with rapid heartbeats, rapid breathing and stiffness, pain and/or muscle weakness
  • Swelling, itching or skin rash

Frequency not known (cannot be estimated from the available data):

  • Severe allergic spasm of the coronary blood vessels (Kounis syndrome) causing chest pain (angina) or heart attack (myocardial infarction)

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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: www.notificaram.es. By reporting side effects you can help provide more information on the safety of this medicine.

5. Storage of Rocuronium Hikma

Keep in the refrigerator (2°C - 8°C).

Storage outside the refrigerator

This medicine can be stored at a temperature not above 25°C for a maximum of 16 weeks, after which it must be discarded. Once removed from the refrigerator, the product must not be returned to it. The storage period must not exceed the shelf-life.

The hospital will store this medicine under the correct storage conditions and will ensure that it is within its expiry date.

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 is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Rocuronium Hikma contains

  • The active substance is rocuronium bromide.
  • The other ingredients are sodium acetate trihydrate, sodium chloride, sodium hydroxide (for pH adjustment), acetic acid (for pH adjustment), water for injections.

Each ml of this medicine contains 10 mg of rocuronium bromide.

Each vial/ampoule of 5 ml contains 50 mg of rocuronium bromide.

Appearance and packaging

Rocuronium Hikma is a clear, colourless to slightly yellow/orange solution for injection.

It is available in vials containing 50 mg (10 vials per pack) of rocuronium bromide.

Marketing Authorisation Holder and Manufacturer

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó, nº8, 8A, 8B, Fervença

2705-906 Terrugem SNT

Portugal

You can ask for more information about this medicine from the local 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

Date of last revision of this leaflet:08/2021

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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The following information is intended for healthcare professionals only:

  • Incompatibilities

Physical incompatibility has been documented for rocuronium when added to solutions containing the following medicines: amphotericin, amoxicillin, azathioprine, cefazolin, cloxacillin, dexamethasone, diazepam, enoximone, erythromycin, famotidine, furosemide, sodium hydrocortisone succinate, insulin, prednisolone sodium succinate, thiopental, trimethoprim and vancomycin.

This medicine must not be mixed with other medicines except those mentioned in section 6.6.

If this medicine is administered through the same infusion line that is also used for other medicines, it is important that this infusion line is properly flushed (e.g. with NaCl 0.9%) between the administration of rocuronium and the medicines for which incompatibility with this medicine has been demonstrated or for which compatibility with this medicine has not been established.

  • Duration

Unopened vial: 2 years provided that it is stored in the prescribed conditions (see Special precautions for storage). The date mentioned on the carton and on the label of the vial is the expiry date; this is the date until which this medicine may be used.

Storage outside the refrigerator:

The medicine can be stored at a temperature not above 25°C for a maximum of 16 weeks, after which it must be discarded. The medicine must not be returned to the refrigerator after it has been removed. The storage period must not exceed the shelf-life.

After first opening:

Since this medicine does not contain preservatives, the solution must be used immediately after opening the vial.

After dilution with infusion fluids (see section 6.6), chemical and physical stability has been demonstrated for 24 hours at room temperature (15°C to 25°C). From a microbiological point of view, the diluted product must be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and would normally not exceed 24 hours at 2°C to 8°C.

  • Special precautions for disposal and other handling

Compatibility studies have been performed with the following infusion fluids: at nominal concentrations of 1 mg/ml, this medicine has been shown to be compatible with: NaCl 0.9%, Dextrose 5%, Dextrose 5% in saline, Water for Injection and Ringer’s lactate. Administration should be started immediately after mixing and must be completed within 24 hours.

Any unused medicine or waste material should be disposed of in accordance with local requirements.

Online doctors for ROCURONIUM HIKMA 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

Discuss questions about ROCURONIUM HIKMA 10 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

Daniel Cichi

Family medicine 24 years exp.

Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance. His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation. Patients commonly consult Dr Daniel Cichi for: 

  • acute symptoms: fever, infections, flu-like illness, cough, sore throat, shortness of breath;
  • chest discomfort, palpitations, dizziness, fatigue, and blood pressure concerns;
  • digestive problems: abdominal pain, nausea, diarrhoea, constipation, reflux;
  • sexually transmitted infections, erectile dysfunction;
  • muscle, joint, and back pain, minor injuries, post-traumatic symptoms;
  • chronic conditions: hypertension, diabetes, high cholesterol, thyroid disorders, weight loss, hair loss;
  • review and interpretation of lab tests, imaging reports, and medical documents;
  • medication review and treatment adjustment;
  • medical advice while travelling or living abroad;
  • second opinions and guidance on whether in-person care is needed.

Dr Cichi’s consultations are structured and practical. He focuses on clear explanations, risk assessment, and actionable recommendations, helping patients understand their symptoms and make informed decisions about their health.

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€55
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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
  • nausea, diarrhoea, abdominal pain, digestive infections
  • 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)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
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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€58
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Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns

Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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€80
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Doctor

Andrei Popov

General medicine 7 years exp.

Dr. Andrei Popov is a family physician with specialized training in the management of chronic pain. He provides video consultations for adults in Spain and across Europe: whether you have been living with pain for months that no one has been able to properly explain, or you need to resolve a health issue without waiting weeks for an appointment.

His approach is clear: to listen, organize your case, and provide you with a practical roadmap based on evidence-based medicine and adapted to your medical history and personal needs.

Pain: how he can help

  • Chronic pain (more than 3 months
  • Migraine and recurrent or high-intensity headaches
  •  Neck, lower back, back and joint pain
  •  Post-traumatic pain after injuries or surgeries
  •  Pain of neurological origin: neuralgia, neuropathic pain, fibromyalgia

General medicine

  • Frequent respiratory infections (cold, flu, persistent cough)
  • Hypertension, diabetes and metabolic disorders
  • Review of laboratory tests and MRI/CT reports (explained in clear language)
  • Preventive medicine and health monitoring
  • Second opinions and treatment adjustments (when clinically appropriate)

What the consultation is like
 Each session lasts up to 30 minutes. We review symptoms, medical history, medications and any tests you provide, and you finish the consultation with a clear treatment plan, defined next steps, and criteria to understand when follow-up may be needed. If warning signs are detected, he will clearly advise whether you need in-person care or urgent medical attention.

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€80
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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:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
  • 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:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • 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.
  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
  • Metabolic syndrome – obesity, lipid disorders, insulin resistance.
Gastroenterology – Digestive health:
  • Abdominal pain, nausea, heartburn, gastroesophageal reflux (GERD).
  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
  • Cancer prevention – screening strategies and risk assessment.
  • Holistic approach – symptom relief, complication prevention, and quality of life improvement.
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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€60

Frequently Asked Questions

Is a prescription required for ROCURONIUM HIKMA 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION?
ROCURONIUM HIKMA 10 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 ROCURONIUM HIKMA 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION?
The active ingredient in ROCURONIUM HIKMA 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION is rocuronium bromide. This information helps identify medicines with the same composition but different brand names.
Who manufactures ROCURONIUM HIKMA 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION?
ROCURONIUM HIKMA 10 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 ROCURONIUM HIKMA 10 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 ROCURONIUM HIKMA 10 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 ROCURONIUM HIKMA 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION?
Other medicines with the same active substance (rocuronium bromide) include ESMERON 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION, ROCURONIUM AGUETTANT 10 mg/mL Injectable Solution in Pre-filled Syringe, ROCURONIUM B. BRAUN 10 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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