Rocuronium Accord

PACKAGE LEAFLET

Package leaflet: information for the patient

Rocuronium Accord 10 mg/mL solution for injection in pre-filled syringe

rocuronium bromide
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Rocuronium Accord is a muscle relaxant used in adults and children from the age of 2 years.
Muscle relaxants are used during surgical procedures to assist general anaesthesia.
During surgery, muscles must be completely relaxed. This facilitates the surgeon’s work during the procedure.
Normally, nerves send signals to the muscles. Rocuronium Accord can temporarily block these signals, causing muscle relaxation. Since the muscles required for breathing also become relaxed, artificial ventilation will be provided until you are able to breathe independently again. During surgery, the effect of the muscle relaxant will be continuously monitored and, if necessary, additional doses of Rocuronium Accord will be administered. At the end of the procedure, the effect of Rocuronium Accord will be allowed to wear off, after which you will be able to breathe independently again. Sometimes, another medicine is given to speed up this recovery. Rocuronium Accord may also be used in intensive care therapy.

2. What you need to know before using Rocuronium Accord

Rocuronium Accord must not be administered

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

Tell your doctor if any of the following apply to you.
Warnings and precautions
Your medical history may affect how Rocuronium Accord is given to you. Inform your doctor if you have or have ever had any of the following:

• allergy to muscle relaxants
• poor kidney function (renal impairment) or kidney disease
• cardiovascular disease
• development of oedema (fluid accumulation, e.g. in the ankles)
• liver disease, gallbladder or biliary tract disease, or poor liver function
• neuromuscular disorders
• a history of malignant hyperthermia (sudden fever with rapid heartbeat, fast breathing, and muscle stiffness, pain and/or weakness)

Certain medical conditions may affect how Rocuronium Accord works. For example:

• low levels of potassium in the blood (hypokalaemia)
• high levels of magnesium in the blood (hypermagnesaemia), for example when treating pregnancy toxemia with magnesium salts
• low levels of calcium in the blood (hypocalcaemia)
• low levels of protein in the blood (hypoproteinaemia)
• lack of fluids (dehydration)
• too much acid in the blood (acidosis)
• too much carbon dioxide in the blood (hypercapnia)
• general poor health condition
• being overweight
• burns

If you have any of the conditions listed above, your doctor will take them into account when determining the appropriate dose of Rocuronium Accord for you.

Children and adolescents
Rocuronium Accord can be used in children (2–11 years) and adolescents (12–17 years).
However, maintenance dosing is not established in pediatric patients under 12 years of age.
Rocuronium Accord must not be administered to children under 2 years of age because the subdivisions on the pre-filled syringes do not allow accurate dosing in this population.

Other medicines and Rocuronium Accord
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
This will help your doctor determine the correct dose of Rocuronium Accord for you.
The following medicines may affect the effect of Rocuronium Accord:

Medicines that increase the effect of Rocuronium Accord:

• certain anaesthetics
• medicines used to relax muscles (suxamethonium)
• certain medicines used to treat bacterial infections (antibiotics)
• certain medicines used for bipolar disorder (lithium)
• certain medicines for heart disease or high blood pressure (quinidine, calcium antagonists, beta-blockers)
• certain medicines used to treat malaria (quinine)
• diuretics
• magnesium salts
• local anaesthetics (lidocaine and bupivacaine)
• short-term use of medicines for epilepsy (phenytoin), for example during surgery.

Medicines that reduce the effect of Rocuronium Accord:

• long-term use of corticosteroids (anti-inflammatory medicines) or medicines for epilepsy (phenytoin and carbamazepine)
• medicines for pancreatitis, blood clotting disorders, and acute blood loss (protease inhibitors: gabexate, ulinastatin)
• Calcium chloride, potassium chloride.

Medicines with variable effects on Rocuronium Accord:

• Other medicines used to relax muscles. Rocuronium Accord may affect the effect of the following medicines:
• the effect of local anaesthetics (lidocaine) may be increased.

Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breast-feeding, consult your doctor before using this medicine.
There is very limited data on the use of rocuronium bromide during human pregnancy and no data available for breastfeeding women. Rocuronium Accord should be administered to pregnant or breast-feeding women only if the doctor decides that the benefits outweigh the risks.
This medicine may be administered during caesarean section.

Driving and using machines
Your doctor will advise you when you may resume driving or operating dangerous machinery after receiving Rocuronium Accord.

Rocuronium Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release tablet, i.e. essentially ‘sodium-free’.

3. How to use Rocuronium Accord

Dosage
Your doctor will determine the dose of Rocuronium Accord based on:

• the type of anaesthetic being used
• the expected duration of the surgical procedure
• other medicines you are taking
• your age and your overall health status.

A healthcare professional will administer Rocuronium Accord to you before and/or during surgery.
The usual dose is 0.6 mg of rocuronium bromide per kilogram of body weight, and the effect lasts between 30 and 40 minutes.
During the procedure, it will be checked whether Rocuronium Accord is still effective. Additional doses will be administered if necessary.

How Rocuronium Accord is administered
Rocuronium Accord is not intended for self-administration. Rocuronium Accord will be injected as an intravenous solution. It will be given as a single injection.

If you receive more Rocuronium Accord than you should
Since medical staff will closely monitor your condition, it is unlikely that you will receive an excessive dose of Rocuronium Accord. However, if this occurs, artificial ventilation will be continued until you are able to breathe independently again. The effects of (excessive) Rocuronium Accord can be counteracted and your recovery accelerated by administering a medicine that reverses the effects of Rocuronium Accord.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If these side effects occur during anaesthesia, they will be seen and treated by the doctor.

The following side effects may occur:

Uncommon/rare (may affect less than 1 in 100/1,000 people)

• Fast heartbeat (tachycardia)
• Low blood pressure (hypotension)
• Rocuronium Accord has no effect, or is too effective or not effective enough
• Pain at the injection site
• Redness or itching at the injection site
• Prolonged muscle relaxant effect of Rocuronium Accord
• Delayed recovery from anaesthesia

Very rare (may affect less than 1 in 10,000 people)

• Allergic reactions, such as breathing difficulties, changes in blood pressure or heart rate, shock (sudden drop in blood pressure) due to insufficient blood circulation or skin changes (e.g. fluid accumulation, redness or rash)
• Excessive and prolonged contraction of the airway muscles causing breathing difficulties (bronchospasm)
• Muscle weakness or paralysis
• Sudden fluid accumulation in the skin and mucous membranes (e.g. throat or tongue), breathing difficulties and/or itching or rash, often as an allergic reaction (angioedema)
• Fluid accumulation (edema) in the face
• Airway problems due to anaesthesia
• Skin rash, sometimes with severe itching and raised bumps (urticaria)
• Skin redness
• Flushing

Not known (frequency cannot be estimated from the available data)

• Acute allergic spasm of the coronary blood vessels (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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rocuronium Accord

Keep this medicine out of sight and reach of children.
Rocuronium Accord is stored in hospital. Store in a refrigerator (2°C - 8°C).
Storage outside the refrigerator: Rocuronium Accord may also be stored outside the refrigerator
at a maximum temperature of 30°C for up to 12 weeks, after which it must be discarded. The product must not be returned to the refrigerator once stored outside. The product must not be used after the expiry date stated on the packaging.
The pre-filled syringe is for single use only.
Do not use this medicine after the expiry date which is stated on the box (Twist box) and on the syringe label after EXP. The expiry date refers to the last day of that month.
Do not use Rocuronium Accord if you notice particles in the solution or if the solution is not clear.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Rocuronium Accord contains
The active substance is rocuronium bromide: each ml of solution contains 10 mg of rocuronium bromide.
Each 5 ml pre-filled syringe contains 50 mg of rocuronium bromide.
Each 10 ml pre-filled syringe contains 100 mg of rocuronium bromide.
The other ingredients are: sodium chloride, sodium acetate trihydrate, glacial acetic acid (for pH adjustment) and water for injections.

Description of the appearance of Rocuronium Accord and contents of the pack
Rocuronium Accord is a sterile, clear solution, ranging from colourless to light yellowish-brown, filled into a transparent glass pre-filled syringe free from visible foreign particles.
5 ml transparent glass pre-filled syringe with protective cap, plunger stopper (grey bromobutyl rubber stopper) and plunger rod (polypropylene). Graduations for 0.1 ml are present on the barrel of the syringe.
10 ml transparent glass pre-filled syringe with protective cap, plunger stopper (grey bromobutyl rubber stopper) and plunger rod (polypropylene). Graduations for 0.2 ml are present on the barrel of the syringe.
Pack size: one pre-filled syringe.
The pre-filled syringe is supplied without a needle, packaged in an outer plastic box (Twist box).

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp.z.o.o.
Ul. Lutomierska 50,
95-200, Pabianice, Poland
OR
Laboratori Fundació Dau
Pol. Ind. Consorci Zona Franca. c/ C, 12-14
08040 BARCELONA (Barcelona), Spain

The following information is intended for healthcare professionals only:
Pre-filled syringes are not suitable for accurate administration of the product in children under 2 years of age.
The user must be aware of the different scale graduations of the two available pre-filled syringes (graduations for 0.1 ml on the 5 ml syringe and graduations for 0.2 ml on the 10 ml syringe).
The pre-filled syringe is for single-patient use only. Dispose of the syringe after use. Do not reuse.

Appearance of the solution
The product should be inspected visually for particulate matter and discoloration prior to administration. Only use a clear, colourless or pale yellowish-brown solution free from particles or precipitates. Do not use this medicinal product if visible signs of deterioration are observed.

Incompatibilities of the solution
Rocuronium bromide is physically incompatible with solutions of the following medicinal products: amphotericin, amoxicillin, azathioprine, cefazolin, cloxacillin, dexamethasone, diazepam, enoximone, erythromycin, famotidine, furosemide, hydrocortisone sodium succinate, insulin, metoclopramide, methylprednisolone, prednisolone sodium succinato, thiopental, trimethoprim and vancomycin. Rocuronium bromide is also incompatible with Intralipid.

Use of the pre-filled syringe
The pre-filled syringe is for single use only.
The pre-filled syringe is not suitable for use with syringe pump drivers. The pre-filled syringe is a ready-to-administer product and is not suitable for dilution in an infusion bag.
Any unused product or waste material must be disposed of in accordance with local regulations.