Esmeron

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

ROCURONIUM BROMIDE

זמין מ:

N.V. Organon Kloosterstraat 6, NL-5349 AB Oss, Netherlands

קוד ATC:

M03AC09

INN (שם בינלאומי):

ROCURONIUM BROMIDE 10 mg/ml

טופס פרצבטיות:

SOLUTION FOR INJECTION

הרכב:

ROCURONIUM BROMIDE 10 mg/ml

סוג מרשם:

POM

איזור תרפויטי:

MUSCLE RELAXANTS

מצב אישור:

Withdrawn

תאריך אישור:

2006-04-18

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
ESMERON®
10 MG/ML
SOLUTION FOR INJECTION
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 anaesthetist or other
doctor.
• If you get any side effects, talk to your anaesthetist or other
doctor. This includes any possible
side effects not listed in this leaflet. See section 4.
_ _
_WHAT IS IN THIS LEAFLET _
1. What Esmeron is and what it is used for
2. What you need to know before Esmeron is given
3. How Esmeron is given
4. Possible side effects
5. How Esmeron is stored
6. Contents of the pack and other information
1. WHAT ESMERON IS AND WHAT IT IS USED FOR
Esmeron is one of a group of drugs called _muscle relaxants_.
Muscle relaxants are used during an operation as part of a general
anaesthetic. When you have an
operation your muscles must be completely relaxed. This makes it
easier for the surgeon to
perform the operation.
Normally, your nerves send messages called _impulses _to your muscles.
Esmeron acts by blocking
these impulses so that your muscles relax. Because your breathing
muscles also relax, you will
need help to breathe (_artificial ventilation_) during and after your
operation until you can breathe
on your own again.
During the operation your anaesthetist will keep a check on the effect
of the muscle relaxant, and
if necessary will give you some more. At the end of surgery, the
effects of the drug are allowed to
wear off and you will start breathing on your own. Sometimes the
anaesthetist will give you
another drug to help speed this up.
Esmeron can also be used in Intensive Care Units to keep your muscles
relaxed.
2. WHAT YOU NEED TO KNOW BEFORE ESMERON IS GIVEN
YOU SHOULD NOT RECEIVE ESMERON
• IF YOU ARE ALLERGIC (_hypersensitive_) to rocuronium, the bromide
ion or any of the other
ingredients of this medicine (listed in section 6).
—> TELL YOUR ANAESTHETIST IF

מאפייני מוצר

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Esmeron® 10 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml Esmeron contains 10 mg rocuronium bromide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
pH: 3.8-4.2
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Esmeron 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 Esmeron
is also indicated to facilitate tracheal
intubation during rapid sequence induction and as an adjunct in the
intensive care unit (ICU) to facilitate
intubation and mechanical ventilation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Like other neuromuscular blocking agents, Esmeron should only be
administered by, or under supervision
of, experienced clinicians who are familiar with the action and use of
these drugs.
As with other neuromuscular blocking agents, the dosage of Esmeron
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 drugs 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
neuromuscular block and recovery.
Inhalational anaesthetics do potentiate the neuromuscular blocking
effects of Esmeron. This potentiation
however, becomes clinically relevant in the course of anaesthesia,
when the volatile agents have reached the
tissue concentrations required for this interaction. Consequently,
adjustments with Esmeron should be
made by administering smaller maintenance doses at less frequent
intervals or by using low