Naropin

מדינה: ניו זילנד

שפה: אנגלית

מקור: Medsafe (Medicines Safety Authority)

מרכיב פעיל:

Ropivacaine hydrochloride monohydrate 5.29 mg/mL equivalent to 5 mg/mL Ropivacaine hydrochloride anhydrous;  

זמין מ:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (שם בינלאומי):

Ropivacaine hydrochloride monohydrate 5.29 mg/mL (equiv to 5 mg/mL Ropivacaine hydrochloride anhydrous)

כמות:

5 mg/mL

טופס פרצבטיות:

Solution for injection

הרכב:

Active: Ropivacaine hydrochloride monohydrate 5.29 mg/mL equivalent to 5 mg/mL Ropivacaine hydrochloride anhydrous   Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide Water for injection

יחידות באריזה:

Ampoule, plastic, polypropylene 5x10ml, 50 mL

סיווג:

Prescription

סוג מרשם:

Prescription

תוצרת:

BASF Pharma (Evionnaz) SA

leaflet_short:

Package - Contents - Shelf Life: Ampoule, plastic, polypropylene 5x10ml - 50 mL - 36 months from date of manufacture stored at or below 30°C - Ampoule, plastic, polypropylene 5x20ml - 100 mL - 36 months from date of manufacture stored at or below 30°C

תאריך אישור:

2000-04-17

מאפייני מוצר

Naropin Data Sheet
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
Naropin 2mg/mL Solution for Injection
Naropin 7.5mg/mL Solution for Injection
Naropin 10mg/mL Solution for Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution for injection contains 2mg, 7.5mg or 10mg of
ropivacaine hydrochloride.
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
N
AROPIN
solution for injection is a sterile, isotonic, isobaric, aqueous
solution.
Clear, colourless solution.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
N
AROPIN
is indicated for:
SURGICAL ANAESTHESIA
•
Epidural block for surgery, including Caesarean Section
•
Intrathecal block
•
Major nerve block
•
Field block (minor nerve block and infiltration)
ACUTE PAIN MANAGEMENT
•
Continuous epidural infusion (Naropin alone or in combination with
Fentanyl) or
intermittent bolus administration e.g. postoperative or labour pain
•
Field block (minor nerve block and infiltration)
•
Intra-articular injection
•
Continuous peripheral nerve block infusion or intermittent injections,
e.g. postoperative
pain management
•
Continuous wound infusion for postoperative pain management (adults
only)
ACUTE PAIN MANAGEMENT IN PAEDIATRICS (CHILDREN AGED 0 – 12 YEARS)
•
Caudal epidural block in neonates, infants and children up to and
including 12 years
•
Peripheral nerve block in children aged 1 up to and including 12 years
•
Continuous epidural infusion in neonates, infants and children up to
and including 12
years
For peri- and postoperative pain management.
4.2
DOSE AND METHOD OF ADMINISTRATION
N
AROPIN
should only be used by or under the supervision of clinicians
experienced in
regional anaesthesia.
Naropin Data Sheet
Copyright
2
ADULTS AND CHILDREN ABOVE 12 YEARS OF AGE:
The following table is a guide to dosage for the more commonly used
blocks. The clinician’s
experience and knowledge of the patient’s physical status are of
importance when deciding
the dose.
In general, surgical anaesthesia (e.g. epidural administration)
re