Rocuronium Kabi 10 mg/ml solution for injection / infusion (2.5 ml vial)

País: Malta

Língua: inglês

Origem: Malta Medicines Authority

Disponível em:

Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy

Código ATC:

M03AC09

DCI (Denominação Comum Internacional):

ROCURONIUM BROMIDE 10 mg/ml

Forma farmacêutica:

SOLUTION FOR INJECTION/INFUSION

Composição:

ROCURONIUM BROMIDE 10 mg/ml

Tipo de prescrição:

POM

Área terapêutica:

MUSCLE RELAXANTS

Resumo do produto:

Licence number in the source country: NOT APPLICAPABLE

Status de autorização:

Withdrawn

Data de autorização:

2022-03-15

Folheto informativo - Bula

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ROCURONIUM KABI 10 MG/ML SOLUTION FOR INJECTION / INFUSION
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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possibile
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Rocuronium Kabi is and what it is used for
2.
What you need to know before you use Rocuronium Kabi
3.
How to use Rocuronium Kabi
4.
Possible side effects
5.
How to store Rocuronium Kabi
6.
Contents of the pack and other information
1.
WHAT ROCURONIUM KABI IS AND WHAT IT IS USED FOR
Rocuronium Kabi belongs to a group of medicines called muscle
relaxants.
Normally the nerves send messages to the muscles by impulses.
Rocuronium Kabi 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.
Rocuronium Kabi may also be used if you are having an anaesthesia to
ease the insertion of a tube
into your trachea (windpipe) for artificial ventilation (mechanical
assistance of breathing).
Rocuronium Kabi is indicated in adults and in neonates (0-27 days)
infants and toddlers aged 28 days
to 23 months, children aged 2 to 11 years and adolescents aged 12 to
17 years.
Rocuronium Kabi may also be used in adults only as an adjunct in the
intensive care unit (ICU) (e.g.
to ease the insertion of a tube into your windpipe) for short term
use.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ROCURONIUM KABI
DO NOT USE ROCURONIUM KABI
-
if you are
ALLERGIC
to rocuronium bromide, the bromide ion 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 Ro

Características técnicas

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Rocuronium Kabi 10 mg/ml solution for injection / infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for injection / infusion contains 10 mg rocuronium
bromide.
Each vial with 2.5 ml contains 25 mg rocuronium bromide.
Each vial with 5 ml contains 50 mg rocuronium bromide.
Each vial with 10 ml contains 100 mg rocuronium bromide.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection / infusion
Clear, colourless to pale brownish-yellow solution
pH of the solution: 3.8 to 4.2
Osmolality: 270– 310 mOsmol/kg.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rocuronium Kabi is indicated in adult and paediatric patients (from
term neonates to adolescents (0
to < 18 years) as an adjunct to general anaesthesia to facilitate
tracheal intubation during routine
sequence induction and to provide skeletal muscle relaxation, during
surgery. In adults Rocuronium
Kabi is also indicated to facilitate tracheal intubation during rapid
sequence induction and as an
adjunct in the intensive care unit (ICU) (e.g. to facilitate
intubation), for short term use.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Rocuronium bromide should be administered only by an experienced staff
familiar with the use of
neuromuscular blocking agents. Adequate facilities and staff for
endotracheal intubation and artificial
ventilation have to be available for immediate use.
As with other neuromuscular blocking agents, the dosage of rocuronium
bromide should be
individualised in each patient. The method of anaesthesia and the
expected duration of surgery, the
method of sedation and the expected duration of mechanical
ventilation, the possible interaction with
other medicinal products that are administered concomitantly and the
condition of the patient should
be taken into account when determining the dose. The use of an
appropriate neuromuscular
monitoring technique is recommended for the evaluation of the
neuromuscul