MARCAINE SPINAL 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:

SPINAL

Prescription type:

Required

Manufactured by:

CENEXI , FRANCE

Therapeutic group:

BUPIVACAINE

Therapeutic area:

BUPIVACAINE

Therapeutic indications:

Spinal anaesthesia for surgery.

Authorization date:

2014-10-31

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
MARCAINE SPINAL 0.5%
Solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_1 ml solution for injection 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
Spinal anaesthesia for surgery.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Marcaine Spinal 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.
The doses given below are guidelines for adults. The dose must be
adjusted for the
individual patient.
The dose must be reduced in the elderly patients and patients in the
late stages of
pregnancy.
Indication
Dose ml
Dose mg
Time to
onset of
effect in
minutes
(approx.)
Duration of
effect in
hours
(approx.)
Surgery on
lower limbs,
including
hip surgery
2-4 ml
10-20 mg
5-8 min
1.5-4 hours
The recommended injection site is the L
3
-L
4
intervertebral space.
There is currently no
clinical
experience of doses higher than 20 mg. Intravenous access
must be
established prior to
administration of Marcaine Spinal.
A spinal injection must not be given until the subarachnoid space has
been clearly
identified via lumbar puncture (clear cerebrospinal fluid exits via
the spinal needle or is
seen on aspiration). In the case of failed anaesthesia only one new
attempt should be
made to administer the medicinal product, which should be given at a
different level and
with a smaller volume. One reason for lack of effect may be poor
intrathecal distribution
of the medicinal product, which may be rectified by adjusting the
position of the patient
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance, amide-type local
anaesthetics or to any of the
excipients listed in section 6.1. Central nervous system disorders
(e.g. meningitis,
tumours, polio