ROPIVACAINE FRESENIUS 2 MGML SOLUTION FOR INJECTION

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

ROPIVACAINE AS HYDROCHLORIDE

MAH:

NEOPHARM (ISRAEL) 1996 LTD

ATC_code:

N01BB09

pharmaceutical_form:

SOLUTION FOR INJECTION

composition:

ROPIVACAINE AS HYDROCHLORIDE 2 MG/ML

administration_route:

PERINEURAL, EPIDURAL

prescription_type:

Required

manufactured_by:

FRESENIUS KABI NORGE AS, NORWAY

therapeutic_area:

ROPIVACAINE

therapeutic_indication:

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 a continuous infusion or intermittent bolus injections, e.g. postoperative pain management.

authorization_date:

2022-05-31

SPC

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ropivacaine Fresenius 2 mg/ml solution for infusion
Ropivacaine Fresenius 2 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ropivacaine Fresenius 2 mg/ml solution for infusion:
1 ml solution for infusion contains ropivacaine hydrochloride (as
ropivacaine base) 2 mg (1.77mg).
1 bag of 100 ml contains ropivacaine hydrochloride 200 mg.
1 bag of 200 ml contains ropivacaine hydrochloride 400 mg.
1 ampoule of 20 ml contains ropivacaine hydrochloride 40 mg.
Excipients: 1 ml contains 3.4 mg sodium.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Ropivacaine Fresenius 2 mg/ml solution for infusion for epidural and
perineural administration
Ropivacaine Fresenius 2 mg/ml solution for injection for epidural and
perineural administration
Solution for injection/infusion - Clear , colorless and free from
visible particles
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ropivacaine Fresenius
2 mg/ml solution for injection or infusion 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
Ropivacaine Fresenius 2 mg/ml solution for injection:
1 ml solution for injection contains ropivacaine hydrochloride (as
ropivacaine base)2 mg(1.77mg).
1 ampoule of 10 ml contains ropivacaine hydrochloride 20 mg.
1 ampoule of 20 ml contains ropivacaine hydrochloride 40 mg.
2
pain management.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For epidural and perineural use.
Ropivacaine Hydrochloride should only be used by, or under the
supervision of, clinicians
experienced in regional anaesthesia.
ADULTS AND ADOLESCENT ABOVE 12 YEARS OF AGE
POSOLOGY
The following table is a guide to dosage for the more commonly used
blocks. The smallest dose
required to produce an effective block sho