MARCAINE 0.5 %

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BUPIVACAINE HYDROCHLORIDE

Available from:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC code:

N01BB01

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

BUPIVACAINE HYDROCHLORIDE 5 MG/ML

Administration route:

EPIDURAL, CAUDAL, PUDENTAL, SACRAL, INTERCOSTAL, PARACERVICAL

Prescription type:

Required

Manufactured by:

RECIPHARM MONTS, FRANCE

Therapeutic group:

BUPIVACAINE

Therapeutic area:

BUPIVACAINE

Therapeutic indications:

Long acting local anaesthetic.

Authorization date:

2015-08-31

Patient Information leaflet

דומע
1
ךותמ
2 ךיראת
2102/10/
01 םש םושירה רפסמו תילגנאב רישכתה
)
046 89 23721 01
(
Marcaine 0.5% םושירה לעב םש
Libra Ltd
-
Pharm
-
O
-
Tec
!דבלב תורמחהה טורפל דעוימ הז ספוט
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
Retro- and peribulbar
injections with local
anaesthetics may involve
some risk of persistent
ocular muscle dysfunction.
Retrobulbar and peribulbar injections
with local anaesthetic agents may involve
some risk of persistent ocular muscle
dysfunction.
There have been post-marketing reports
of chondrolysis in patients who have
received continuous intra-articular
infusion of local anaesthetics
postoperatively. The majority of the cases
reported involved chondrolysis in the
shoulder joint. It has not been possible to
establish a clear causal link due to several
contributory factors. There is also
inconsistency in the scientific literature
regarding the mechanism of action.
Continuous intra-articular infusion is not
an approved indication for Marcaine.
Paediatric population
The safety and efficacy of Marcaine in
children aged < 1 year has not been
established. Only limited data are
available.
Use of bupivacaine for intra-articular
block in children aged 1 to 12 years has
not been documented.
Use of bupivacaine for major nerve block
in children aged 1 to 12 years has not
been documented.
For epidural anaesthesia, children should
be administered gradually increasing
דומע
2
ךותמ
2
doses proportional to their age and
weight, since thoracic epidural
anaesthesia in particular can result in
severe hypotonia and decreased
respiratory function.
UNDESIRABLE EFFECTS
Paediatric population
Side effects in children are similar to
those in adults, but early signs of local
anaesthetic toxicity in children may be
difficult to detect in cases where the
blockade is given under sedation or
general anaesthesia.
If circulatory depression
occurs, give intravenous
fluids, dobutamine and if
necessary
nora

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Marcaine 0.5%
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml Marcaine contains 5 mg bupivacaine hydrochloride.
Excipient with known effect: Sodium 3.1 mg/ml.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection.
4
CLINICAL PARTICULARS
4.1 Therapeutic indications
Long acting local anaesthetic.
4.2 Posology and method of administration
Marcaine should only be used by physicians with experience of regional
anaesthesia or
under the supervision
of such a physician. The lowest possible dose for adequate
anaesthesia should be sought.
It is important to observe particular caution in order to prevent
inadvertent intravascular
injections. Thorough aspiration before and during injection of the
main dose is
recommended. The main dose should be injected slowly at 25-50
mg/minute or in divided
doses, while keeping continuous verbal contact with the patient and
monitoring the heart
rate. In epidural injection, the administration of high doses, a test
dose of 3-5 ml Marcaine
with adrenaline is recommended. An inadvertent intravascular injection
can cause
symptoms such as a transient increase in heart rate and an inadvertent
intrathecal injection
can cause signs of spinal block. The injection should be discontinued
immediately if there
are any toxic symptoms.
The following doses are guidelines; the dosage should be adjusted
according to the scope
of the block and the patient's overall health status.
In _infiltration anaesthesia_, administer Marcaine 5 mg/ml, 5-30 ml
(25-150 mg bupivacaine
hydrochloride).
_ _
For _diagnostic and therapeutic blocks_: Marcaine 5 mg/ml, 0.5-20 ml
(2.5-100 mg
bupivacaine hydrochloride). For example, for trigeminal block 0.5-2.5
ml (2.5-12.5 mg) and
for stellatum block 5-10 ml (25-50 mg) should be given.
In _intercostal block_, administer Marcaine 5 mg/ml, 2-3 ml (10-15 mg
bupivacaine
hydrochloride) per nerve, up to a total of ten nerves.
In _major blocks_ (such as epidural, sacral and brachial