Ropivacaine Kabi 2 mg/ml solution for injection - 20ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ROPIVACAINE HYDROCHLORIDE

Available from:

Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy

ATC code:

N01BB09

INN (International Name):

ROPIVACAINE HYDROCHLORIDE 2 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

ROPIVACAINE HYDROCHLORIDE 2 mg/ml

Prescription type:

POM

Therapeutic area:

ANESTHETICS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-12-22

Patient Information leaflet

PL112303101,4,5,6,8,9PL112303101,4,5,6,8,9
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Ropivacaine Kabi 2 mg/ml solution for injection
Ropivacaine Kabi 7.5 mg/ml solution for injection
Ropivacaine Kabi 10 mg/ml solution for injection
Ropivacaine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, nurse or any other
healthcare professional.
-
If you get any side effects, talk to your doctor, nurse or any other
healthcare professional. This
includes any possible side effects not listed in this leaflet. See
section 4.
The full names of the medicines covered by this leaflet are:
Ropivacaine Kabi 2 mg/ml solution for injection
Ropivacaine Kabi 7.5 mg/ml solution for injection
Ropivacaine Kabi 10 mg/ml solution for injection
In this leaflet they are jointly referred to as Ropivacaine Kabi.
WHAT IS IN THIS LEAFLET
1.
What Ropivacaine Kabi is and what it is used for
2.
What you need to know before you are given Ropivacaine Kabi
3.
How to use Ropivacaine Kabi
4.
Possible side effects
5.
How to store Ropivacaine Kabi
6.
Contents of the pack and other information
1.
WHAT ROPIVACAINE KABI IS AND WHAT IT IS USED FOR
•
Ropivacaine Kabi contains a medicine called ropivacaine hydrochloride.
•
It belongs to a group of medicines called local anaesthetics.
Ropivacaine Kabi 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.
Ropivacaine Kabi 7.5 mg/ml solution for injection is used in adults
and children above 12 years to
numb (anaesthetise) parts of the body. It is used to stop pain
happening or to provide pain relief. It can
be used to:
-
Numb parts of the body during surgery, including having a baby by
Caesarean section.
-
Relieve pain during childbirth, after surgery, or after an accident.
Ropivacaine Kabi 10 mg/ml solution for i

Summary of Product characteristics

SPC112303101,4,5,6,8,9
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ropivacaine Kabi 2 mg/ml solution for injection
Ropivacaine Kabi 7.5 mg/ml solution for injection
Ropivacaine Kabi 10 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Ropivacaine Kabi 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.
_Ropivacaine Kabi 7.5 mg/ml: _
Each ml solution for injection contains 7.5 mg ropivacaine
hydrochloride.
Each 10 ml ampoule contains 75 mg ropivacaine hydrochloride.
Each 20 ml ampoule contains 150 mg ropivacaine hydrochloride.
_Ropivacaine Kabi 10 mg/ml: _
Each ml solution for injection contains 10 mg ropivacaine
hydrochloride.
Each 10 ml ampoule contains 100 mg ropivacaine hydrochloride.
Each 20 ml ampoule contains 200 mg ropivacaine hydrochloride.
Excipient with known effect:
_Ropivacaine Kabi 2 mg/ml: _
Each 10 ml ampoule contains 1.48 mmol (or 34 mg) of sodium.
Each 20 ml ampoule contains 2.96 mmol (or 68 mg) of sodium.
_Ropivacaine Kabi 7.5 mg/ml: _
Each 10 ml ampoule contains 1.3 mmol (or 29.9 mg) of sodium.
Each 20 ml ampoule contains 2.6 mmol (or 59.8 mg) of sodium.
_Ropivacaine Kabi 10 mg/ml: _
Each 10 ml ampoule contains 1.2 mmol (or 28 mg) of sodium.
Each 20 ml ampoule contains 2.4 mmol (or 56 mg) of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution with a pH of 4.0 to 6.0 and an osmolality
between 255 and 305 mOsmol/kg.
SPC112303101,4,5,6,8,9
2
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ropivacaine Kabi 2 mg/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 postoperative
or labour pain
-
Field blocks
-
Continuous peripheral nerve block via a continuous infusion or
inter