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Document: leaflet MAH GENERIC_PL 03551-0111 change

• leaflet MAH GENERIC_PL 03551-0111
• leaflet MAH GENERIC_PL 08828-0182
• leaflet MAH GENERIC_PL 25215-0018

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What is in this leaflet:

1.    What Rocuronium 10 mg/ml solution for injection/infusion is and what it is used for

2.    What you need to know before you use Rocuronium 10 mg/ml solution for injection/ infusion

3.    How to use Rocuronium 10 mg/ml solution for injection/infusion

4.    Possible side effects

5.    How to store Rocuronium 10 mg/ml solution for injection/infusion

6.    Contents of the pack and other information

1. What Rocuronium 10 mg/ml solution for injection/infusion is and what it is used for_

Rocuronium 10 mg/ml solution for injection/ infusion belongs to a group of medicines called muscle relaxants.

Under normal circumstances your nerves send messages to the muscles by impulses. Rocuronium 10 mg/ml solution for injection/infusion acts by blocking these impulses so that the muscles become relaxed.

When you have an operation your muscles must be completely relaxed. This makes it easier for the surgeon to perform the operation.

In adults and children, if you are under general anaesthesia, Rocuronium 10 mg/ml solution for injection/infusion may be used to ease the insertion of a tube into your windpipe (trachea) to help you breath (mechanical assistance of breathing) and to assure that your muscles are relaxed during surgery.

If you are an adult your doctor may also use this medicine for a short time as an additional medicine in the intensive care unit (ICU) (e.g. to ease the insertion of a tube into your windpipe). In addition you may also receive this medicine whenever there is an emergency situation and you need to receive a tube into your windpipe very quickly to prepare for surgery.

2. What you need to know before you use Rocuronium 10 mg/ml solution for injection/infusion

Do not use Rocuronium 10 mg/ml solution for injection/infusion

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using this medicine

-    if you are allergic to any muscle relaxant

-    if you have a kidney, a liver or a biliary disease

-    if you have a heart disease or a disease affecting your blood circulation

-    if you have one of your body areas is swelling due to water incorporation (oedema e.g. in the ankle area)

-    if you have a disease affecting the nerves and muscles (neuromuscular diseases, e.g. polio (poliomyelitis), myasthenia gravis, Eaton-Lambert syndrome)

-    if you ever developed a too low body temperature during an anaesthesia (hypothermia)

-    if you have a low calcium level in the blood (hypocalcaemia), (caused for example by massive transfusions)

-    if you have a low potassium level in the blood (hypokalaemia), (caused for example by severe vomiting, diarrhoea or diuretic therapy)

-    if you have a high magnesium level in the blood (hypermagnesaemia)

-    if you have a low level of proteins in the blood (hypoproteinaemia)

-    if you suffer from dehydration

-    if you have an increased amount of acids in the blood (acidosis)

-    if you have an increased amount of carbon dioxide in the blood (hypercapnia)

-    if you suffer from an excessive loss of weight (cachexia)

-    if you are overweight or elderly

-    if you have burns

Other medicines and Rocuronium 10 mg/ ml solution for injection/infusion

Your doctor or pharmacist has to know if you are taking, have recently taken or might take any other medicines, such as:

-    antibiotics

-    anti-depressant medicines containing lithium

-    medicines used for the treatment of heart diseases or high blood pressure (e.g. qui-nidine, calcium channel blocking agents, adrenergic blocking agents (e.g. beta blockers, alpha-blockers)

-    diuretics or water pills (medicines which increase the amount of urine),

-    some laxatives such as magnesium salts

-    quinine (used to treat pain and infections)

-    medicines used for epilepsy treatment (e.g. phenytoin, carbamazepine)

-    long term use of corticosteroids in the ICU

-    medicines used for the treatment of myasthenia gravis (neostigmine, pyridostigmine, edrophonium, aminopyridine),

-    theophylline (used for the treatment of asthma)

-    medicines used for the treatment or prevention of a virus infection (protease inhibitors)

Please note:

You may be given other medicines during the procedure which can influence the effects of rocuronium. These include certain anaesthetics (e.g. local anaesthetics, inhalational anaesthetics), other muscle relaxants, protamine which reverses the anticoagulant effect (prevention of blood clots) of heparin. Your doctor will take this into account when he is deciding the correct dose of rocuronium for you.

Pregnancy and breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

There are very limited data on the use of Rocuronium 10 mg/ml solution for injection/infusion during human pregnancy and no data on breast-feeding women. Rocuronium 10 mg/ml solution for injection/infusion should only be given to pregnant and nursing women when the doctor decides that the benefits outweigh the risks. Rocuronium 10 mg/ml solution for injection/infusion may be given during Caesarean section.

There are no data available on the influence of this medicine on your fertility.

Driving and using machines

Rocuronium 10 mg/ml solution for injection/ infusion has a major influence on driving and using machines.

Therefore, it is not recommended to drive a car or use potentially dangerous machines during the first 24 hours after full recovery from the effect of this medicine.

Your doctor should advise you when you can start driving and using machines again. You should always be accompanied home by a responsible adult after your treatment.

Rocuronium 10 mg/ml solution for injection/infusion contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 'sodium-free'.

3. How to use Rocuronium 10 mg/ml solution for injection/infusion

Rocuronium 10 mg/ml solution for injection/ infusion will be given to you by your anaesthetist. It is given to you intravenously either as a single injection or as a continuous infusion (over a longer period of time) into a vein.

Adults

The usual dose is 0.6 mg per kg body weight and its effect will last 30 to 40 minutes. During surgery the effect of Rocuronium 10 mg/ ml solution for injection/infusion is controlled continously. Therefore your doctor may administer further amounts of this medicine to you depending on your individual situation.

If necessary, additional doses could be administered to you. The dose is adjusted to your needs by your anaesthetist. It depends on many factors, such as drug interactions (their cross activity), taking into consideration the estimated length of surgery as well as your age and clinical condition.

This medicinal product is for single use only.

Use in children and adolescents This medicine may be given to neonates (0 - 27 days), infants (28 days to 2 months) and toddlers (3 months to 23 months), children (2-11 years) and adolescents (12 to <17 years). The anaesthetist will adjust the dose according to the needs of your child. Your doctor will take into account that for children higher infusion rates might be necessary.

The experience with rocuronium bromide in a special type of anaesthetic technique called rapid sequence induction is limited in children and adolescents. Rocuronium bromide is therefore not recommended for this purpose in children and adolescents.

Older patients, obese/overweight patients and patients with liver and/or bile diseases and/or kidney failure:

Your doctor might need to adapt the dosage you will receive depending on your individual situation.

If you receive more Rocuronium 10 mg/ ml solution for injection/infusion than you should

Your anaesthetist will carefully monitor you when you are under medication of Rocuronium 10 mg/ml solution for injection/infusion, therefore it is unlikely that you will be given too much Rocuronium 10 mg/ml solution for injection/infusion. If it happens, muscle relaxation might increase. Then your anaesthetist may give you medicines to reverse this effect and will make sure that anaesthesia and artificial ventilation will be continued until you breathe on your own again.

Further questions

If you have any further questions on the use of this medicine, please ask your doctor or pharmacist or nurse.

For information intended for medicinal or healthcare professionals please see accordant section below.

4. Possible side effects_

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may be serious. If any of the following side effects occur, inform your doctor or nurse immediately:

Very rare (may affect up to 1 in 10 000 people): Hypersensitivity reactions (allergic reactions) and symptoms associated with it. A hypersensitivity reaction may include rash, itching, difficulty in breathing, low blood pressure, fast heart beat, circulatory collapse, shock or swelling of the face, lips, throat or tongue, hives, welt, reddening of the skin. In addition during anaesthesia there might occur the situation that you get other difficulties with your breathing system (airway complication of anaesthesia).

BBRAUN

809/12620353/0215

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

•    Stopping breathing

•    respiratory failure

Other side effects include:

Uncommon/rare (may affect between to 1-10 in 1 000 people):

•    Increase in heart rate (tachycardia)*

•    Delayed recovery from anaesthesia

•    Lowering of blood pressure (hypotension)

•    Medicine was ineffective

•    Effect of the medicine in general was increased or decreased

•    Response of your body to this medicine may be increased or decreased

•    Pain at the injection site

•    Prolonged effect of muscle relaxation (prolonged neuromuscular block)

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

•    Increased level of histamine in the blood

•    Wheezing (bronchospasm)

•    Loss of movement (flaccid paralysis)

•    muscle weakness (after long-term use of this medicine in the ICU, especially if administered with cortisone)

*Clinical studies suggest that in paediatric patients an increase in heart rate is common and may affect up to 1 in 10 people.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance, Earlsfort Terrace,

IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie

5. How to store Rocuronium 10 mg/ ml solution for injection/infusion

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 label and carton after "EXP." The expiry date refers to the last day of that month.

Store in a refrigerator (2°C - 8°C).

After first opening: The product should be used immediately after opening the vial.

After dilution: Chemical and physical in-use stability of a 5 mg/ml and 0.1 mg/ml solution (diluted with sodium chloride 9 mg/ml (0.9%) and glucose 50 mg/ml (5%) solution for infusion) has been demonstrated for 24 hours at room temperature exposed to room light in glass, and plastic containers. From the microbiological point of view, the product should be used immediately. If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Do not use this medicine if you notice the solution is not clear or free from particles.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information_

What Rocuronium 10 mg/ml solution for injection/infusion contains

The active substance is rocuronium bromide.

1 ml contains 10 mg of rocuronium bromide. Each 2.5 ml vial contains a total content of 25 mg rocuronium bromide.

Each 5 ml vial contains a total content of 50 mg rocuronium bromide.

Each 10 ml vial contains a total content of 100 mg rocuronium bromide.

The other ingredients are sodium acetate trihydrate, sodium chloride, glacial acetic acid 100% and water for injections.

What Rocuronium 10 mg/ml solution for injection/infusion looks like and contents of the pack

Rocuronium 10 mg/ml solution for injection/ infusion is a clear, colourless to pale brownish-yellow solution for injection / injusion.

Pack size:

Rocuronium 10 mg/ml solution for injection/ infusion is available in packs of 10 vials containing 2.5 ml, 5 ml or 10 ml solution.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany

Postal address:

34209 Melsungen Germany

Phone: +49 5661/71-0 Fax: +49 5661/71-4567

Manufacturer:

hameln pharmaceuticals gmbh

Langes Feld 13

31789 Hameln, Germany

and

B. Braun Medical S.A.

Carretera de Terrassa, 121 08191 Rubi (Barcelona)

Spain

This medicinal product is authorised in the Member States of the EEA under the following names:

The following information is intended for healthcare professionals only:

Preperation guide for:

Rocuronium 10 mg/ml solution for injection/infusion

It is important that you read the entire contents of this guide prior to the preparation of this medicinal product.

Preparation for the intravenous administration

For single use only.

Rocuronium 10 mg/ml solution for injection/infusion is administered intravenously (i.v.) either as a bolus injection or as a continuous infusion.

Rocuronium 10 mg/ml solution for injection/infusion has been shown to be compatible with: sodium chloride 9 mg/ml (0.9%) and glucose 50 mg/ml (5%) solution.

Any unused solutions should be discarded.

This medicinal product must not be mixed with other medicinal products except those mentioned above.

Physical incompatibility has been documented for Rocuronium 10 mg/ml solution for injection/ infusion when added to solutions containing the following active substances: amphotericin, amoxicillin, azathioprine, cefazolin, cloxacillin, dexamethasone, diazepam, enoximone, erythromycin, famotidine, furosemide, hydrocortisone sodium succinate, insulin, intralipid, methohexital, methylprednisolone, prednisolone sodium succinate, thiopental, trimethoprim and vancomycin.

If Rocuronium 10 mg/ml solution for injection/infusion is administered via the same infusion line with other medicinal products, it is important that this infusion line is adequately flushed (e.g. with 0.9 % NaCl) between administration of Rocuronium 10 mg/ml solution for injection/infusion and medicinal products for which incompatibility with Rocuronium 10 mg/ml solution for injection/infusion has been demonstrated or for which compatibility with Rocuronium 10 mg/ml solution for injection/infusion has not been established.

B. Braun Melsungen AG

34209 Melsungen Germany

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