Rocuronium Hikma 10 mg/ml solution for injection and infusion EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Rocuronium Hikma 10 mg/ml solution for injection and infusion 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
Contents of this leaflet:
- What Rocuronium Hikma is and what it is used for
- What you need to know before you start using Rocuronium Hikma
- How to use Rocuronium Hikma
- Possible side effects
- How to store Rocuronium Hikma
- Contents of the pack and other information
1. What Rocuronium Hikma is and what it is used for
This medicine belongs to a group of medicines called muscle relaxants.
Muscle relaxants are used during surgery as part of general anaesthesia. When you undergo an operation, your muscles need to be completely relaxed. This makes it easier for the surgeon to perform the procedure.
Normally, nerves send messages to muscles through impulses. This medicine works by blocking these impulses, causing the muscles to relax. Because your respiratory muscles also become relaxed, you will need assistance with breathing (mechanical ventilation) during and after the operation until you are able to breathe on your own again.
During the operation, your anaesthetist will monitor the effect of the muscle relaxant and, if necessary, administer additional doses. At the end of surgery, the effects of the medicine are allowed to wear off, and you will begin breathing independently again. Sometimes, the anaesthetist may give you another medicine to help speed up this process.
This medicine may also be used in the intensive care unit to maintain muscle relaxation.
2. What you need to know before using Rocuronium Hikma
Do not use Rocuronium Hikma
- If you are allergic (hypersensitive) to rocuronium bromide, bromide ions, or any of the other components of this medicine (listed in section 6).
Inform your anesthesiologist if this applies to you.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using this medicine if:
- You are allergic to other muscle relaxants
- You have kidney, heart, liver, or gallbladder disease
- You have a condition affecting nerves and muscles
- You have fluid retention (edema)
- You have a history of malignant hyperthermia (sudden fever with palpitations, rapid breathing, and muscle stiffness, pain, and/or weakness)
- You have or have had a rare tumor of the adrenal glands (pheochromocytoma); this may increase the risk of severe high blood pressure.
Inform your anesthesiologist if you are in any of these situations.
Certain conditions may affect 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 levels of carbon dioxide in the blood
- Dehydration
- Excessive loss of body water, for example due to illness, diarrhea, or sweating
- Breathing too rapidly, leading to reduced levels of carbon dioxide in the blood (alkalosis)
- Poor general health
- Burns
- Severe overweight (obesity)
- Abnormally low body temperature (hypothermia)
If you have any of these conditions, your anesthesiologist will take them into account when deciding the correct dose of this medicine for you.
Children and Elderly
This medicine may be used in children (newborns and adolescents) and elderly patients, but your anesthesiologist must first evaluate your medical history.
Other medicines and Rocuronium Hikma
Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.
This includes herbal medicines or products purchased 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 conditions 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 used to treat 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 could influence the effects of rocuronium. These include certain anesthetics, other muscle relaxants, drugs such as phenytoin, and medicines that reverse the effects of this medicine. Rocuronium may cause certain anesthetics to act more quickly. Your doctor will take this into account when determining the correct dose of rocuronium for you.
Pregnancy and breastfeeding
Inform your anesthesiologist if you are pregnant, think you may be pregnant, or are breastfeeding.
Your anesthesiologist may still administer this medicine, but only after careful consideration. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
This medicine may be administered if you are undergoing a caesarean section.
Breastfeeding should be suspended for 6 hours after using this medicine.
Driving and using machines
Do not drive or operate machinery until you are told it is safe to do so. Since this medicine is given as part of general anesthesia, you may feel tired, weak, or dizzy for some time afterward. Your doctor can advise you on how long these effects are likely to last.
Rocuronium Hikma contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial/ampoule; essentially “sodium-free”.
3. How to use Rocuronium Hikma
Dosage
Your anaesthetist will calculate the dose of this medicine you need based on:
- the type of anaesthetic,
- the expected duration of the operation,
- other medicines you are taking,
- your health status.
The usual dose is 0.6 mg per kg of body weight, and its effect lasts between 30 and 40 minutes.
How Rocuronium Hikma is administered
This medicine will be given to you intravenously (into a vein) as a single injection or as a continuous infusion (drip).
If you use more Rocuronium Hikma than you should
Your anaesthetist will carefully monitor you while you are receiving this medicine, so it is unlikely that you will be given too much rocuronium. If this does happen, your anaesthetist will ensure that anaesthesia and artificial ventilation are continued until you are able to breathe on your own again.
In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If these side effects occur while you are under anesthesia, your anesthetist will see and treat them.
Rare (may affect up to 1 in 1,000 people):
- Increase or decrease in the drug's effect
- Prolongation of the drug's muscle-relaxing effect
- Decreased 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, circulatory collapse, and shock)
- Wheezing in the chest
- Muscle weakness
- Sudden fever with rapid heartbeat, fast breathing, and muscle stiffness, pain, and/or weakness
- Swelling, itching, or skin rash
Frequency not known (cannot be estimated from 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 adverse effects worsen, or if you notice any adverse effects not mentioned in this leaflet, inform your anesthetist or another doctor.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Rocuronium Hikma
Store in a refrigerator (2 °C - 8 °C).
Storage outside the refrigerator
This medicine can be stored at a temperature not exceeding 25°C for a maximum period 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 expiry date.
The hospital will store this medicine under appropriate storage conditions and ensure it is used within its expiry date.
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 the month indicated.
Medicines should not be disposed of via wastewater or household waste. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Package contents and other information
Composition of Rocuronium Hikma
-
The active substance is rocuronium bromide.
-
The other components are sodium acetate trihydrate, sodium chloride, sodium hydroxide (to adjust pH), acetic acid (to adjust pH), water for injections.
Each ml of this medicinal product contains 10 mg of rocuronium bromide.
Each 5 ml vial/ampoule contains 50 mg of rocuronium bromide.
Appearance of the product and pack contents
Rocuronium Hikma is a clear, colourless to slightly yellow/orange injectable solution.
It is available in vials containing 50 mg (10 vials per pack) of rocuronium bromide.
Marketing Authorization Holder and Manufacturer
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, nº8, 8A, 8B, Fervença
2705-906 Terrugem SNT
Portugal
Further information about this medicine can be requested from the local representative of the Marketing Authorization Holder:
Hikma España, S.L.U.
Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2
28108 - Alcobendas, Madrid
Spain
Date of the most recent review of this leaflet: 02/2026
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es
The following information is intended for healthcare professionals only:
- Incompatibilities
Physical incompatibility of rocuronium has been documented when added to solutions containing the following medicinal products: amphotericin, amoxicillin, azathioprine, cefazolin, cloxacillin, dexamethasone, diazepam, enoximone, erythromycin, famotidine, furosemide, hydrocortisone sodium succinate, insulin, intralipid, prednisolone sodium succinate, **thiopental, trimethoprim and vancomycin.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
If this medicinal product is administered through the same infusion line used for other medicinal products, it is important that the infusion line is adequately flushed (e.g., with 0.9% NaCl) between the administration of rocuronium and those medicinal products with which incompatibility has been demonstrated or for which compatibility has not been established.
• Duration
Unopened vial: 2 years, provided it is stored under the recommended conditions (see Special precautions for storage). The date stated on the carton and vial label is the expiry date; this is the date until which the medicinal product may be used.
Storage outside the refrigerator:
The medicinal product may be stored at a temperature not exceeding 25 °C for up to 16 weeks, after which it must be discarded. The medicinal product must not be returned to refrigerated storage after removal from the refrigerator. The storage period must not exceed the product's shelf life.
After first opening:
Since this medicinal product does not contain preservatives, the solution should be used immediately after opening the vial.
After dilution with infusion fluids (see section 6.6), chemical and physical stability in use has been demonstrated for 24 hours at room temperature (15°C to 25°C). From a microbiological standpoint, the diluted product should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user/administrator and normally should not exceed 24 hours between 2°C and 8°C.
- Special precautions for disposal and other handling
Compatibility studies have been carried out with the following infusion fluids: at nominal concentrations of 1 mg/ml, this medicinal product has been shown to be compatible with: 0.9% NaCl, 5% dextrose, 5% dextrose in saline, sterile water for injectable preparations and Ringer's lactate. Administration should begin immediately after mixing and should be completed within 24 hours.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.