Ropivacaine 400mg/200ml infusion bags

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Ropivacaine hydrochloride

Commercializzato da:

Advanz Pharma

Codice ATC:

N01BB09

INN (Nome Internazionale):

Ropivacaine hydrochloride

Dosaggio:

2mg/1ml

Forma farmaceutica:

Infusion

Via di somministrazione:

Perineural; Epidural

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 15020100; GTIN: 5099602996205

Foglio illustrativo

READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START USING THIS MEDICINE.
• Keep this leaflet. 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 leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
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 Ropiv-
acaine 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 medicine called local anaesthetic.
Ropivacaine 2 mg/ml solution for infusion
is used in adults and children of all ages for
acute pain management. It numbs (anaes-
thetises) 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 ROP-
IVACAINE HYDROCHLORIDE, other so called
local anaesthetics of the amide type or
any of the other ingredients of Ropiv-
acaine,
• if you have a DECREASE IN BLOOD VOLUME
(hypovolaemia).
This
is
measured
by
healthcare personnel.
• for INFUSION INTO A BLOOD VESSEL to numb
a specific area of your body,
• for INFUSION 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 injections
of Ropivacaine in order to numb parts of
the body are not established in younger
children.
Special care should be taken to AVOID ANY
ADMINISTRATION
of
Ropivacaine
DIRECTLY
INTO A BLOOD VESSEL to prevent any immedi-
ate toxic effects. Administration should not
be performed in inflamed areas.
Please tell your doctor

Scheda tecnica

ROPIVACAINE 2 MG / ML SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 24-Sep-2014 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Ropivacaine 2 mg / ml solution for infusion
2. Qualitative and quantitative composition
Each ml solution for infusion contains 2 mg ropivacaine hydrochloride.
Each 100 ml bag contains 200 mg ropivacaine hydrochloride.
Each 200 ml bag contains 400 mg ropivacaine hydrochloride.
Each 250 ml bag contains 500 mg ropivacaine hydrochloride.
Excipient:
Each 100 ml bag contains 14.7 mmol (or 339 mg) of sodium.
Each 200 ml bag contains 29.5 mmol (or 678 mg) of sodium.
Each 250 ml bag contains 36.8 mmol (or 847.5 mg) of sodium.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for infusion.
Clear, colourless, sterile, isotonic, isobaric aqueous solution for
infusion with a pH of 4.0 to 6.0.
4. Clinical particulars
4.1 Therapeutic indications
Ropivacaine 2 mg/ml solution for infusion is indicated foracute pain
management
Iin 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 decidin