MARCAINE SPINAL 0.5 % HEAVY

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

BUPIVACAINE HYDROCHLORIDE

MAH:

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_indication:

Spinal anaesthesia for surgery, e.g. urological and lower limb surgery, lasting 2-3 hours, abdominal surgery lasting 45-60 minutes.

authorization_date:

2014-09-30

SPC

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Marcaine Spinal 0.5% Heavy
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_1 ml solution for injection contains_
: 5 mg bupivacaine hydrochloride.
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, e.g. urological and lower limb
surgery, lasting 2-3 hours,
abdominal surgery lasting 45-60 minutes.
4.2.
Posology and method of administration
Marcaine Spinal Heavy 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 and the dose must be
adjusted for the
individual patient.
The dose must be reduced in the elderly and patients in the late
stages of pregnancy.
Indication
Dose
ml
Dose
mg
Onset time
minutes
(approx.)
Duration
hours
(approx.)
Urological
surgery
1.5-3 ml
7.5-15 mg
5-8 min
2-3 hours
Surgery in the lower
extremities, including
hip surgery
2-4 ml
10-20 mg
5-8 min
2-3 hours
Abdominal surgery
(including caesarean
section)
2-4 ml
10-20 mg
5-8 min
45-60 min
The recommended injection is in the L3-L4 intervertebral space.
There is currently no clinical experience of doses higher than 20 mg.
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
2
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 i