Ropivacaine 20mg/10ml solution for injection ampoules

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Ropivacaine hydrochloride

Tillgänglig från:

Advanz Pharma

ATC-kod:

N01BB09

INN (International namn):

Ropivacaine hydrochloride

Dos:

2mg/1ml

Läkemedelsform:

Solution for injection

Administreringssätt:

Perineural; Epidural

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 15020100; GTIN: 5099602996267

Bipacksedel

R1
11-04-2012
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Corpo 10 pt
Interlinea 10 pt
020D461018
38 X 143
ROPIVACAINE 2 MG/ML SOLUTION FOR INJECTION
FORMATO CHIUSO (mm)
286/143 X 420/38
DIMENSIONI (mm)
Grammatura
carta 40 gr/mq
NERO
BOZZA
MOLTENI S.P.A.
PACKAGE LEAFLET: INFORMATION FOR THE USER
ROPIVACAINE 2 MG/ML SOLUTION FOR INJECTION
Ropivacaine hydrochloride
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
- Keep this leafl et. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side
effects not listed in this leafl et,
please tell your doctor or pharmacist.
IN THIS LEAFL ET:
1. What Ropivacaine is and what it is used for
2. Before you use Ropivacaine
3. How to use Ropivacaine
4. Possible side effects
5. How to store Ropivacaine
6. Further information
This product will be referred to as Ropivacaine from here on.
1. WHAT ROPIVACAINE IS AND WHAT IT IS USED FOR
Ropivacaine contains the active substance ropivacaine hydrochloride
which is a type of medi-
cine called local anaesthetic.
Ropivacaine 2 mg/ml solution for injection is used in adults and
children of all ages for acute
pain management. It numbs (anaesthetises) parts of the body e.g. after
surgery.
2. BEFORE YOU USE ROPIVACAINE
YOU MUST NOT BE GIVEN ROPIVACAINE
- if you are ALLERGIC (hypersensitive) TO ROPIVACAINE HYDROCHLORIDE,
other so called local an-
aesthetics of the amide type or any of the other ingredients of
Ropivacaine,
- if you have a DECREASE IN BLOOD VOLUME (hypovolaemia). This is
measured by healthcare
personnel.
- for INJECTION INTO A BLOOD VESSEL to numb a specifi c area of your
body,
- for INJECTION INTO THE NECK OF THE WOMB to relieve pain during
childbirth.
TAKE SPECIAL CARE WITH ROPIVACAINE
- In newborn children as they are more susceptible to Ropivacaine.
- In children < 12 years as some

Produktens egenskaper

ROPIVACAINE 2 MG / ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 24-Sep-2014 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Ropivacaine 2 mg / ml solution for injection
2. Qualitative and quantitative composition
Ropivacaine 2 mg/ml:
Each ml solution for injection contains 2 mg ropivacaine
hydrochloride.
Each 10 ml ampoule contains 20 mg ropivacaine hydrochloride.
Each 20 ml ampoule contains 40 mg ropivacaine hydrochloride.
Excipient:
Ropivacaine 2 mg/ml:
Each 10 ml ampoule contains 1.47 mmol (or 33.9 mg) of sodium.
Each 20 ml ampoule contains 2.95 mmol (or 67.8 mg) of sodium.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection
Clear, colourless, sterile, isotonic, isobaric aqueous solution for
injection with a pH of 4.0 to 6.0.
4. Clinical particulars
4.1 Therapeutic indications
Ropivacaine 2 mg/ml solution for injection is indicated for acute pain
management
In adults and children above 12 years of age:
- Continuous epidural infusion or intermittent bolus administration
during postoperative or labour pain
- Field blocks
- Continuous peripheral nerve block via a continuous infusion or
intermittent bolus injections, e.g.
postoperative pain management
In infants from 1 year and children up to and including 12 years for:
- Single and continuous peripheral nerve block
In neonates, infants and children up to and including 12 years for
(per- and postoperative)
- Caudal epidural block
- Continuous epidural infusion
4.2 Posology and method of administration
Ropivacaine should only be used by, or under the supervision, of
clinicians experienced in regional
anaesthesia.
POSOLOGY
_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.
INDICATION
CONCENTRATION
MG/ML
VOLUME
ML
DOSE
MG