ROPIVACAINE B.BRAUN 10 MGML

দেশ: ইস্রায়েল

ভাষা: ইংরেজি

সূত্র: Ministry of Health

সক্রিয় উপাদান:

ROPIVACAINE HYDROCHLORIDE

থেকে পাওয়া:

LAPIDOT MEDICAL IMPORT AND MARKETING LTD

এটিসি কোড:

N01BB09

ফার্মাসিউটিকাল ফর্ম:

SOLUTION FOR INJECTION

রচনা:

ROPIVACAINE HYDROCHLORIDE 10 MG/ML

প্রশাসন রুট:

PERINEURAL, EPIDURAL

প্রেসক্রিপশন টাইপ:

Required

Manufactured by:

B.BRAUN MELSUNGEN AG, GERMANY

থেরাপিউটিক এলাকা:

ROPIVACAINE

থেরাপিউটিক ইঙ্গিত:

Ropivacaine B. Braun 10 mg/ml is indicated in adults and adolescents aged above 12 years of age for:Surgical anaesthesiaLumbar epidural administration for surgery

অনুমোদন তারিখ:

2021-07-31

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
Ropivacaine B. Braun 2 mg/ml, Ropivacaine B. Braun 10 mg/ml
_ropivacaine hydrochloride _
Solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Name of the
medicinal
product
1 ml contains:
ropivacaine
hydrochloride
(mg)
10ml ampoule
contains:
ropivacaine
hydrochloride
(mg)
20ml ampoule
contains:
ropivacaine
hydrochloride
(mg)
Ropivacaine B.
Braun solution
for
injection
2 mg/ml
2.0
20
40
10 mg/ml
10.0
100
200
Excipients with known effect:
Ropivacaine B. Braun 2 mg/ml solution for injection contains 3.3 mg/ml
sodium
Ropivacaine B. Braun 10 mg/ml solution for injection contains 2.7
mg/ml
sodium.
For full list of excipients see _section 6.1._
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution
with a pH of 4
–
6 and an osmolality of 270
–
320
mOsmol/kg.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ROPIVACAINE B. BRAUN 10 MG/ML IS INDICATED IN ADULTS AND ADOLESCENTS
AGED ABOVE 12 YEARS OF AGE FOR:
Surgical anaesthesia
Lumbar epidural administration for surgery
ROPIVACAINE B. BRAUN 2MG/ML IS INDICATED FOR:
Acute pain management:
In adults and adolescents above 12 years of age for:
• Continuous epidural infusion or intermittent bolus administration
during
postoperative or labour pain.
• Field blocks.
• Peripheral nerve block via continuous infusion or intermittent
bolus injections, e.g.
postoperative pain management.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Ropivacaine B. Braun should only be used by or under the supervision
of
clinicians experienced in regional anaesthesia.
_ADULTS AND CHILDREN ABOVE 12 YEARS OF AGE: _
The following table is a guide to dosage for the more commonly used
blocks.
The smallest dose required to produce an effective block should be
used. The
clinician’s experience and knowledge of the patient’s physical
status are of
importance when deciding the dose.
DOSAGE RECOMMENDATIONS FOR ROPIVACAINE B. BRAUN IN ADULTS AND
ADOLESCENTS
ABOVE 12 YEARS OF AGE
Conc.
mg/
ml
Volume
ml
Dose