ROPIVACAINE BIOAVENIR 10 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ROPIVACAINE HYDROCHLORIDE

Available from:

BIOAVENIR LTD, ISRAEL

ATC code:

N01BB09

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

ROPIVACAINE HYDROCHLORIDE 10 MG/ML

Administration route:

EPIDURAL, PERINEURAL

Prescription type:

Required

Manufactured by:

L.MOLTENI & C. DEI F.LLI ALITTI,ITALY

Therapeutic area:

ROPIVACAINE

Therapeutic indications:

Ropivacaine 10 mg/ml is indicated in adults and adolescents above 12 years of age for:Surgical anaesthesia: - Lumbar Epidural Administration for surgery

Authorization date:

2019-12-31

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ropivacaine BioAvenir 2 mg/ml solution for infusion
Ropivacaine BioAvenir 2 mg/ml solution for injection
Ropivacaine BioAvenir 7.5 mg/ml solution for injection
Ropivacaine BioAvenir 10 mg/ml solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Ropivacaine BioAvenir 2 mg/ml solution for infusion:
1 ml solution for infusion contains ropivacaine hydrochloride 2 mg.
1 bag of 100 ml contains ropivacaine hydrochloride 200 mg.
1 bag of 200 ml contains ropivacaine hydrochloride 400 mg.
Ropivacaine BioAvenir 2 mg/ml solution for injection:
1 ml solution for injection contains ropivacaine hydrochloride 2 mg.
1 ampoule of 10 ml contains ropivacaine hydrochloride 20 mg.
1 ampoule of 20 ml contains ropivacaine hydrochloride 40 mg.
Ropivacaine BioAvenir 7.5 mg/ml solution for injection:
1 ml solution for injection contains ropivacaine hydrochloride 7.5 mg.
1 ampoule of 10 ml contains ropivacaine hydrochloride 75 mg.
1 ampoule of 20 ml contains ropivacaine hydrochloride 150 mg.
Ropivacaine BioAvenir 10 mg/ml solution for injection:
1 ml solution for injection contains ropivacaine hydrochloride 10 mg.
1 ampoule of 10 ml contains ropivacaine hydrochloride 100 mg.
1 ampoule of 20 ml contains ropivacaine hydrochloride 200 mg.
Excipients: 1 ml contains 3 mg sodium.
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Ropivacaine BioAvenir 2 mg/ml solution for infusion
2
Ropivacaine Bioavenir 2 mg/ml, 7.5 mg/ml, 10 mg/ml solution for
injection for epidural and
perineural administration
Solution for injection - Sterile, clear, colourless, isotonic, aqueous
solution with pH between 4.0-6.0.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ropivacaine BioAvenir 2mg/ml solution for injection is indicated for
acute pain management:
In adults and adolescents above 12 years of age for:
Continuous epidural infusion or intermittent bolus administration
during post operative or labour
pain.
Field blocks.
Peripheral nerve block via continuous