ROCURONIO 10 mg /Ml Infusion Solution

Зміст інструкції

1. Rocuronio B. Braun 10 mg/ml injectable solution or for infusion
   1. What is Rocuronio B. Braun 10 mg/ml and what is it used for
   2. What you need to know before using Rocuronio B. Braun 10 mg/ml
   3. How to use Rocuronio B. Braun 10 mg/ml
   4. Possible side effects
   5. How to store Rocuronio B. Braun 10 mg/ml
   6. Package Contents and Other Information

Rocuronio B. Braun 10 mg/ml injectable solution or for infusion

Rocuronium bromide

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Rocuronio B. Braun 10 mg/ml is and what it is used for.
• 2. What you need to know before using Rocuronio B. Braun 10 mg/ml.
• 3. How to use Rocuronio B. Braun 10 mg/ml.
• 4. Possible side effects.
• 5. How to store Rocuronio B. Braun 10 mg/ml.
• 6. Contents of the pack and other information.

1. What is Rocuronio B. Braun 10 mg/ml and what is it used for

Rocuronio B. Braun 10 mg/ml belongs to a group of medicines called muscle relaxants.
Under normal circumstances, nerves send messages to muscles via impulses. Rocuronio B. Braun
10 mg/ml works by blocking these impulses, so that the muscles relax.
When undergoing a surgical operation, the muscles need to be completely relaxed.
This allows the surgeon to perform the operation more easily.
In adults and childrenundergoing general anesthesia, Rocuronio B. Braun 10 mg/ml can be
used to facilitate the insertion of a tube into the trachea to aid mechanical ventilation
(mechanically assisted breathing) and to ensure that the muscles are relaxed during
the operation.
In adults, the doctor may use this medicine for a short period as an adjunct
in the intensive care unit (ICU) (e.g. to facilitate the insertion of a tube into the trachea). Furthermore,
this medicine is also used in emergency situations where it is necessary to insert a tube into the trachea very
quickly before a surgical operation.

2. What you need to know before using Rocuronio B. Braun 10 mg/ml

Do not use Rocuronio B. Braun 10 mg/ml

• if you are allergicto rocuronium bromide or to 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 kidney, liver or biliary disease
• if you have heart disease or a condition affecting blood circulation
• if one or more areas of your body are swollen due to fluid accumulation (e.g. in the ankles)
• if you have a disease affecting the nerves and muscles (neuromuscular diseases, e.g. polio, myasthenia gravis, Eaton-Lambert syndrome)
• if you have previously experienced abnormally low body temperature during anesthesia (hypothermia)
• if you have a low level of calcium in your blood (hypocalcemia), (caused for example by massive transfusions)
• if you have a low level of potassium in your blood (hypopotassemia), (caused for example by severe vomiting, diarrhea or diuretic therapy)
• if you have a high level of magnesium in your blood (hypermagnesemia)
• if you have a low level of protein in your blood (hypoproteinemia)
• if you are suffering from dehydration
• if you have an increased amount of acid in your blood (acidosis)
• if you have an increased amount of carbon dioxide in your blood (hypercapnia)
• if you have excessive weight loss (cachexia)
• if you are overweight or elderly
• if you have burns.

Other medicines and Rocuronio B. Braun 10 mg/ml
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, such as:

• antibiotics
• antidepressant medicines containing lithium
• medicines used for the treatment of heart disease or high blood pressure (e.g. quinidine, calcium-channel blockers, adrenergic blockers such as beta-blockers, alpha-blockers)
• diuretics (medicines that increase the amount of urine produced)
• some laxatives such as magnesium salts
• quinine (used to treat pain and infections)
• medicines used for the treatment of epilepsy (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)
• other medicines used for the treatment or prevention of a viral infection (protease inhibitors).

Important note:
During the procedure you may be given other medicines that can affect the effects
of rocuronium. These include some anesthetics (e.g. local anesthetics, inhalation anesthetics),
other muscle relaxants, protamine which reverses the anticoagulant effect (prevention of blood clots)
of heparin. Your doctor will take this into account when deciding the correct dose of rocuronium for you.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
Data on the use of Rocuronio B. Braun 10 mg/ml during pregnancy in humans are very
limited and there are no data on women who are breastfeeding. Rocuronio B. Braun 10 mg/ml should be
administered to pregnant and breastfeeding women only when the doctor decides that the benefits
outweigh the risks. Rocuronio B. Braun 10 mg/ml may be administered during a Cesarean section.
There are no data on the effects of this medicine on fertility.

Driving and operating machinery
Rocuronio B. Braun 10 mg/ml has a strong influence on the ability to drive and operate machinery.
Therefore, it is not recommended to drive a car or use potentially dangerous machinery
until 24 hours have passed since the complete remission of the effects of this medicine.
Your doctor will tell you when you can start driving and using machinery again. You should always
be accompanied home by a responsible adult after your treatment.

Rocuronio B. Braun 10 mg/ml contains sodium
This medicinal product contains less than 1 mmol of sodium (23 mg) per dose, which is
essentially ‘sodium-free’.

3. How to use Rocuronio B. Braun 10 mg/ml

Rocuronio B. Braun 10 mg/ml will be administered to you by the anesthesiologist. It will be administered via
intravenous injection as a single injection or as a continuous infusion (over a prolonged period of time) into a vein.

Adults
The usual dose is 0.6 mg per kg of body weight and its effect lasts from 30 to 40 minutes. During
surgery, the effect of Rocuronio B. Braun 10 mg/ml will be continuously monitored.
Therefore, the doctor may administer a larger amount of this medicine to you based on your
specific situation.
If necessary, additional doses may be administered to you. The dose will be adjusted to your
needs by the anesthesiologist. This depends on many factors, such as drug interactions (their
cross-activity), consideration of the estimated duration of the surgery, as well as the age and health status of the patient.
This medicinal product is for single use only.

Use in children and adolescents
This medicine can be administered to newborns (from 0 to 27 days), infants (from 28 days to 2
months) and young children (from 3 months to 23 months), children (from 2 to 11 years) and adolescents (from 12 to ≤ 17
years). The anesthesiologist will adjust the dose according to your child's needs. The doctor will take into account that
higher infusion rates may be necessary in children.
Experience with rocuronium bromide in a particular anesthesia technique, called rapid sequence induction, is limited in children and adolescents. Therefore, rocuronium bromide is not
recommended for this purpose in children and adolescents.

Elderly patients, obese or overweight patients and patients with liver and/or biliary diseases and/or with

renal impairment:
The doctor may adjust the dosage you receive based on your specific situation.

If you receive more Rocuronio B. Braun 10 mg/ml than you should
The anesthesiologist will keep you under close monitoring while you are under the effects of Rocuronio B. Braun 10
mg/ml, so it is unlikely that you will be given too much Rocuronio B. Braun 10 mg/ml. If
this should happen, however, muscle relaxation may increase. In this case,
the anesthesiologist may give you medicines to reverse this effect and will ensure that anesthesia and
artificial ventilation are continued until you are able to breathe
autonomously.

Further information
If you have any questions about the use of this medicine, ask your doctor, pharmacist or
nurse.
For information for doctors and healthcare professionals, see the relevant section further on.

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 you experience any side effect, please contact your doctor or nurse:
Very rare (may affect up to 1 in 10,000 people):
Hypersensitivity reactions (allergic reactions) and symptoms associated with them. A hypersensitivity reaction may include skin rash, itching, difficulty breathing, low blood pressure,
rapid heartbeat, circulatory collapse, shock or swelling of the face, lips, throat or
tongue, urticaria, rash, skin redness.
Also, during anesthesia you may have more difficulty breathing (anesthetic respiratory complication).
Not known (frequency cannot be estimated from the available data):

• Cessation of breathing
• Respiratory failure

Other side effects:
Uncommon/rare (may affect up to 1-10 patients per 1,000):

• Increased heart rate (tachycardia)*
• Delayed recovery from anesthesia
• Low blood pressure (hypotension)
• Ineffectiveness of the medicine
• Increased or decreased efficacy of the medicine
• Increased or decreased reaction of the body to the medicine
• 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 the medicine in the ICU, especially if administered together with cortisone) *Clinical studies suggest that, in paediatric patients,an increased heart rate is common and may affect up to 1 in 10 subjects.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist or nurse. You can also report side effects directly
through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Rocuronio B. Braun 10 mg/ml

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date indicated on the label and on the packaging after
“EXP”. The expiry date refers to the last day of that
month.
Do not store at a temperature above 25°C.
After first opening: use the product immediately after opening the vial.
After dilution: the chemical and physical in-use stability of a 5 mg/ml and 0.1 mg/ml solution (diluted
with an infusion solution of sodium chloride 9 mg/ml (0.9%) and glucose 50 mg/ml (5%)) has been
demonstrated for 24 hours at room temperature, in artificial light conditions and in plastic and glass
containers. From a microbiological point of view, the product must be used immediately. If
not used immediately, the storage times and conditions before use are the responsibility of the user and
should not normally exceed 24 hours at 2-8°C, unless the dilution has been carried out under
controlled and validated aseptic conditions.
Do not use this medicine if you notice that the solution is not clear or contains particles.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Rocuronio B. Braun 10 mg/ml contains
The active substanceis rocuronium bromide.
1 ml contains 10 mg of rocuronium bromide.
Each vial of 5 ml contains a total of 50 mg of rocuronium bromide.
The other excipientsare gluconolactone, sodium acetate trihydrate, sodium citrate dihydrate and water for
injections.

Description of the appearance of Rocuronio B. Braun 10 mg/ml and contents of the pack
Rocuronio B. Braun 10 mg/ml is a clear solution for injection or infusion, from colourless to
slightly brownish-yellow.
Pack sizes:
Rocuronio B. Braun 10 mg/ml is available in packs of 20 plastic vials containing 5 ml of
solution.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:

• B. BRAUN MELSUNGEN AG Carl Braun Strasse, 1 34212 Melsungen Germany

Manufacturer
Hameln Pharmaceuticals GmbH
Langes Feld 13
31789 Hameln, Germany
and

• B. Braun Medical S.A. Carretera de Terrassa, 121 08191 Rubí (Barcelona) Spain

Manufacturing site

• B. Braun Medical S.A. Ronda de los Olivares Parcela 11 Poligone Industrial Los Olivares 23009 Jaén Spain This medicinal product is authorised in the Member States of the European Economic Area with the following denominations:

The following information is intended exclusively for doctors or healthcare professionals:
GUIDE TO PREPARATION OF:
Rocuronio B. Braun 10 mg/ml solution for injection or infusion

It is important to read the entire contents of this guide before preparing this
medicinal product.
PREPARATION FOR INTRAVENOUS ADMINISTRATION
For single use only.
Rocuronio B. Braun 10 mg/ml is administered intravenously (IV) both as a bolus injection and as a continuous infusion.
Rocuronio B. Braun 10 mg/ml has been shown to be compatible with: sodium chloride solution
9 mg/ml (0.9%) and glucose 50 mg/ml (5%).
Solutions not used should be discarded.
This medicine must not be mixed with other products except those mentioned
above.
Physical incompatibility has been documented for Rocuronium B. Braun 10 mg/ml 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 Rocuronio B. Braun 10 mg/ml is administered through the same infusion line as other
medicinal products, it is important that this infusion line is adequately flushed (e.g. with
0.9% NaCl) between the administration of Rocuronio B. Braun 10 mg/ml and the medicinal products for
which incompatibility with Rocuronio B. Braun 10 mg/ml has been demonstrated or for which no
compatibility with Rocuronio B. Braun 10 mg/ml has been established.