Ropivacaine Kabi 2 mg/ml solution for infusion - 100ml

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Medicines Authority

सक्रिय संघटक:

ROPIVACAINE HYDROCHLORIDE

थमां उपलब्ध:

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

ए.टी.सी कोड:

N01BB09

INN (इंटरनेशनल नाम):

ROPIVACAINE HYDROCHLORIDE 2 mg/ml

फार्मास्यूटिकल फॉर्म:

SOLUTION FOR INFUSION

रचना:

ROPIVACAINE HYDROCHLORIDE 2 mg/ml

प्रिस्क्रिप्शन प्रकार:

POM

चिकित्सीय क्षेत्र:

ANESTHETICS

उत्पाद समीक्षा:

Licence number in the source country: NOT APPLICAPABLE

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2021-12-22

सूचना पत्रक

PL112303102,7
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Ropivacaine Kabi 2 mg/ml solution for infusion
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 name of your medicine is “Ropivacaine Kabi 2 mg/ml solution for
infusion, in the rest of the
leaflet it will be 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 infusion 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.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ROPIVACAINE KABI
YOU MUST NOT BE GIVEN ROPIVACAINE KABI
-
If you are
ALLERGIC
(hypersensitive) TO ROPIVACAINE HYDROCHLORIDE
or any of the other ingredients
of this medicine (listed in section 6).
-
If you are allergic to any other local anaesthetics of the same class
(such as lidocaine or
bupivacaine).
-
If you have been told that you have
DECREASED VOLUME OF BLOOD
(hypovolaemia).
-
INTO A
BLOOD VESSEL
to numb a specific area of your body,
-
OR INTO THE NECK OF THE WOMB
to relieve pain during childbirth.
If you are not sure if any of the above apply to you, talk to your
doctor before you are given
Ropivacaine

उत्पाद विशेषताएं

SPC112303102,7
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ropivacaine Kabi 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.
Excipient with known effect:
Each 100 ml bag contains 14.8 mmol (or 340 mg) of sodium.
Each 200 ml bag contains 29.6 mmol (or 680 mg) of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless solution with a pH of 4.0 to 6.0 and an osmolality
between 255 and 305 mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ropivacaine Kabi 2 mg/ml solution for infusion 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
intermittent bolus
injections, e.g. postoperative pain management
•
In infants from 1 year and children up to and including 12 years of
age (per- and postoperative)
for
-
Single and continuous peripheral nerve block
•
In neonates, infants and children up to and including 12 years of age
(per- and postoperative) for
-
Caudal epidural block
-
Continuous epidural infusion
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Ropivacaine Kabi should only be used by, or under the supervision of,
clinicians experienced in
regional anaesthesia.
SPC112303102,7
2
Posology
_ _
_Adults and adolescents 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.
CONCENTRATION
MG/ML
VOLUME
ML
DOSE
MG
ONSET
MINUTES
DURATION
HOURS
ACUTE PAIN MAN