BUPIVACAINE SPINAL PANPHARMA 5 MGML HEAVY

Ülke: İsrail

Dil: İngilizce

Kaynak: Ministry of Health

Aktif bileşen:

BUPIVACAINE AS HYDROCHLORIDE MONOHYDRATE

Mevcut itibaren:

PHARMALOGIC LTD

ATC kodu:

N01BB01

Farmasötik formu:

SOLUTION FOR INJECTION

Kompozisyon:

BUPIVACAINE AS HYDROCHLORIDE MONOHYDRATE 5 MG / 1 ML

Uygulama yolu:

INTRATHECAL

Reçete türü:

Required

Tarafından üretildi:

PANPHARMA, FRANCE

Terapötik alanı:

BUPIVACAINE

Terapötik endikasyonlar:

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

Yetkilendirme tarihi:

2021-10-26

Ürün özellikleri

BUPIVACAINE SPINAL PANPHARMA
5 MG/ML HEAVY
1
NAME OF THE MEDICINAL PRODUCT
Bupivacaine Spinal Panpharma 5 mg/ml heavy
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_1 ml solution for injection contains_
: bupivacaine hydrochloride 5 mg.
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 surgery and surgery,
on the lower limbs,
lasting 2-3 hours, abdominal surgery lasting 45-60 minutes.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Bupivacaine spinal heavy should only be used by clinicians with
experience of regional
anaesthesia or under their supervision. The lowest possible dose for
adequate anaesthesia
should be used.
The doses given below are guides for adults and the dosage should be
adjusted to the
individual patient.
The dose should be reduced in elderly patients and patients in late
stages of pregnancy.
INDICATION
DOSE
ML
DOSE
MG
TIME TO ONSET
OF EFFECT
IN MINUTES
(APPROX.)
DURATION
OF
EFFECT
IN
HOURS
(APPROX.)
Urological
surgery
1.5-3 ml
7.5-15 mg
5-8 min
2-3 hours
Surgery on
lower limbs,
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 experience of doses higher than 20 mg.
A spinal injection is given only after the subarachnoid space has been
clearly identified by
means of lumbar puncture (clear cerebrospinal fluid runs out via the
spinal needle or is seen
on aspiration). In the event of unsuccessful anaesthesia, a new
attempt to administer the
drug should only be made by injecting at a different level and with a
smaller volume. One
cause of lack of effect may be poor intrathecal distribution of the
drug, and this can be
helped by altering the patient’s position.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance, amide-type local anaesthetic
agents or to any of
the excipients listed