ROCURONIUM TAMARANG 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION, Generic

Introduction

Package Leaflet: Information for the User

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

Rocuronium, bromide

Read all of this leaflet carefully before you are given 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 anesthesiologist or another doctor.
• If you experience any side effects, talk to your anesthesiologist or another doctor, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is Rocuronium Tamarang and what is it used for
2. What you need to know before you start using Rocuronium Tamarang
3. How Rocuronium Tamarang is administered
4. Possible side effects
5. Storage of Rocuronium Tamarang
6. Contents of the pack and further information

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

Rocuronium Tamarang belongs to a group of medicines called muscle relaxants. Muscle relaxants are used during an operation as part of a general anesthetic. When you undergo an operation, your muscles must be completely relaxed. This makes it easier for the surgeon to perform the operation. Normally, nerves send messages to muscles through impulses. Rocuronium Tamarang works by blocking these impulses so that the muscles relax. Because your respiratory muscles also relax, you will need help breathing (artificial ventilation) during and after the operation until you can breathe on your own again.

During the operation, your anesthesiologist 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. Sometimes, the anesthesiologist will give you another medicine to help speed up this process.

Rocuronium Tamarang can also be used in the Intensive Care Unit for short-term use to keep your muscles relaxed.

2. What you need to know before you start using Rocuronium Tamarang

You must not be given Rocuronium Tamarang

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

Tell your anesthesiologist if this applies to you

Warnings and precautions

Talk to your anesthesiologist before you are given Rocuronium Tamarang

• If you are allergicto other muscle relaxants
• If you have a kidney, liver, or bile ductdisease
• If you have a disease that affects the nerves and muscles(poliomyelitis, myasthenia gravis)
• If you have fluid retention(edema)
• If you have a history of malignant hyperthermia(sudden fever with palpitations, rapid breathing, and muscle stiffness, pain, and/or weakness).

Some conditions may affect the effects of Rocuronium Tamarang, 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
• too much carbon dioxide in the blood (acidosis)
• loss of too much water from the body, for example, due to illness, diarrhea, or sweating (dehydration)
• breathing too much, causing a decrease in the amount of carbon dioxide in the blood (alkalosis)
• Poor overall health
• Suffering from severe obesity (obesity)
• Burns
• Body temperature too low (hypothermia)

If you have any of these conditions, your anesthesiologist will take them into account when deciding the correct dose of Rocuronium Tamarang for you.

Children and elderly

Rocuronium Tamarang can be used in children (newborns and adolescents) and the elderly, but your anesthesiologist must evaluate your medical history first.

Other medicines and Rocuronium Tamarang

Tell your anesthesiologist if you are taking,have recently taken, or might take any other medicines. Rocuronium Tamarang may affect other medicines or be affected by them.

Medicines that increase the effect of Rocuronium Tamarang:

• some antibiotics
• some medicines used for heart diseasesor high blood pressure(diuretics, calcium channel blockers, beta-blockers, and quinidine)
• certain anti-inflammatory(corticosteroids)
• magnesium salts
• some medicines used to treat bipolar disorder(lithium salts)
• some medicines used to treat malaria(quinine)
• some medicines used to help you sleep (anesthetics)
• some medicines that cause an increase in urine volume(diuretics)
• some local anesthetics(lidocaine, bupivacaine)
• some medicines used to treat epilepsyduring an operation (phenytoin)
• some medicines used to induce short-term muscle relaxationin anesthesia and intensive care (suxamethonium)

Medicines that decrease the effect of Rocuronium Tamarang:

• long-term use of medicines for the treatment of epilepsy(phenytoin and carbamazepine)
• some protease inhibitorscalled gabexate and ulinastatin
• acetylcholinesterase inhibitors, medicines for the treatment of myasthenia gravis(neostigmine, edrophonium, pyridostigmine)
• calcium chlorideand potassium chloride

Additionally, you may be given other medicines before or during surgery that may alter the effects of rocuronium. These include certain anesthetics, other muscle relaxants, medicines such as phenytoin, and medicines that reverse the effect of Rocuronium Tamarang. Rocuronium may make certain anesthetics work more quickly. Your anesthesiologist will take this into account when deciding the correct dose of Rocuronium Tamarang for you.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your anesthesiologist before you are given this medicine.

It is possible that your anesthesiologist will give you this medicine, but first, they must discuss it with you. You may be given Rocuronium Tamarang if you are having a cesarean section. Breastfeeding should be discontinued 6 hours after administration of this medicine.

Driving and using machines

Do not drive or use machines until you are told it is safe to do so. Because Rocuronium Tamarang is administered as part of a general anesthetic, you may feel tired, weak, or dizzy for some time after. Your anesthesiologist can advise you on the likely duration of the effects.

Rocuronium Tamarang contains sodium

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

3. How Rocuronium Tamarang is administered

Dosage

Your anesthesiologist will calculate the dose of this medicine based on:

• the type of anesthetic,
• the expected duration of the operation
• other medicines 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 Tamarang is administered

Your anesthesiologist will give you Rocuronium Tamarang by intravenous injection (into a vein), either as single injections or as a continuous infusion (a drip).

This medicine is for single use only. Any unused solution for injection/infusion must be discarded.

If you are given more Rocuronium Tamarang than recommended

Because your anesthesiologist will be carefully monitoring your condition, it is unlikely that you will be given too much Rocuronium Tamarang. However, if this happens, your anesthesiologist will keep you breathing artificially (with a ventilator) until you can breathe on your own again. You will remain asleep while this happens.

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 anesthesia, your anesthesiologist will see them and treat them.

Uncommon

(may affect up to 1 in 100 people):

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

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
• Swelling, rash, or hives, redness of the skin
• Chronic muscle disorder, usually observed after administration of rocuronium bromide and anti-inflammatory medicines (corticosteroids) in critically ill patients in the Intensive Care Unit (steroid myopathy)
• Respiratory complications due to anesthesia

Frequency not known

(cannot be estimated from the available data):

• Allergic spasm and severe coronary artery vasospasm (Kounis syndrome)causing chest pain (angina)or heart attack (myocardial infarction).
• Dilated pupils (mydriasis)or fixed pupils that do not change size with light or other stimuli.

If any of the side effects get worse, or if you notice any side effects not mentioned in this leaflet, tell your anesthesiologist or another doctor.

Reporting of side effects

If you experience any side effects, talk to your anesthesiologist or another doctor, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rocuronium Tamarang

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 shown.

Store in a refrigerator (2 °C - 8 °C).

Do not freeze.

Keep the vial/ampoule in the outer carton to protect it from light.

Rocuronium Tamarang can also be stored outside the refrigerator at a temperature not above 25° C for a maximum period of 12 weeks.

The medicine should be used immediately after opening the vial/ampoule.

Shelf-life of the diluted product: Chemical and physical in-use stability has been demonstrated after dilution with infusion fluids (see section 6.6) for 24 hours at 25 °C. From a microbiological point of view, the product should be used immediately.

If not used immediately, in-use storage times and conditions before use are the responsibility of the user and should not exceed 24 hours at 2-8 °C, unless the dilution has been carried out under validated aseptic conditions.

Do not use Rocuronium Tamarang if you notice that the solution is not clear or free of particles.

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

6. Contents of the pack and further information

Composition of Rocuronium Tamarang

The active substance is rocuronium bromide.

Each ml of solution for injection and infusion contains 10 mg of rocuronium bromide.

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

Each vial/ampoule of 10 ml contains 100 mg of rocuronium bromide.

The other ingredients are:

Sodium acetate trihydrate

Sodium chloride

Acetic acid 99% (for pH adjustment)

Acetic acid 30% (for pH adjustment)

Water for injection

Sodium hydroxide (for pH adjustment)

Appearance and packaging

Rocuronium Tamarang 10 mg/ml Solution for Injection and Infusion is a clear, colorless, or pale yellow-brown solution.

Vials/ampoules of 5 ml and 10 ml

Formats:

Packs of 10 vials/ampoules x 5 ml

Packs of 12 vials/ampoules x 5 ml

Packs of (6x 10) vials/ampoules x 5 ml

Packs of 10 vials/ampoules x 10 ml

Packs of (2x 10) vials/ampoules x 10 ml

Not all formats may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Tamarang, S.A.

Balmes 85 P 2

08008 Barcelona

Spain

Manufacturer

SOLUPHARM PHARMAZEUTISCHE ERZEUGNISSE GMBH

Industriestrasse 3

34212 Melsungen

Germany

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

Date of last revision of this leaflet:01/2024

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