Ropivacaine Kabi 5 mg/ml solution for injection - 10ml

Negara: Malta

Bahasa: Inggris

Sumber: Medicines Authority

Bahan aktif:

ROPIVACAINE HYDROCHLORIDE

Tersedia dari:

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

Kode ATC:

N01BB09

INN (Nama Internasional):

ROPIVACAINE HYDROCHLORIDE 5 mg/ml

Bentuk farmasi:

SOLUTION FOR INJECTION

Komposisi:

ROPIVACAINE HYDROCHLORIDE 5 mg/ml

Jenis Resep:

POM

Area terapi:

ANESTHETICS

Ringkasan produk:

Licence number in the source country: NOT APPLICAPABLE

Status otorisasi:

Authorised

Tanggal Otorisasi:

2021-12-22

Selebaran informasi

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Ropivacaine Kabi 5 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 name of your medicine is “Ropivacaine Kabi 5 mg/ml solution for
injection, 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 5 mg/ml solution for injection is used
•
in adults and adolescents above 12 years of age to NUMB (anaesthetise)
the area of the body
where surgery is going to be performed.It it injected in the lower
part of your spine. This
quickly stops pain from your waist down for a limited period of time
(usually 1 to 2 hours). This
is known as a “spinal block” (or “spinal”).
•
in children aged 1-12 years to NUMB (anaesthetise) parts of the body.
It is used to stop pain
happening or to provide pain relief.
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 l

Karakteristik produk

SPC112303103
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ropivacaine Kabi 5 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml solution for injection contains 5 mg ropivacaine
hydrochloride.
Each 10 ml ampoule contains 50 mg ropivacaine hydrochloride.
Excipient with known effect:
Each 10 ml ampoule contains 1.38 mmol (or 31.7 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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ropivacaine Kabi 5 mg/ml is indicated in adults and adolescents above
12 years of age for:
•
Intrathecal administration for surgical anaesthesia .
In infants from 1 year and children up to and including 12 years of
age for acute pain management
(per and post operative):
•
Single peripheral nerve block
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Ropivacaine Kabi should only be used by, or under the supervision of,
clinicians experienced in
regional anaesthesia.
INTRATHECAL ADMINISTRATION OF SURGICAL ANAESTHESIA
POSOLOGY_ _
_ _
_ADULTS AND ADOLESCENTS _
_(ABOVE _
_12 YEARS OF AGE_
_)_
_ _
The following table is a guide to dosage for intrathecal block in
adults. 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.
SPC112303103
2
_DOSAGE FOR THE INTRATHECAL BLOCK IN ADULTS _
CONCENTRATION
MG/ML
VOLUME
ML
DOSE
MG
ONSET
MINUTES
DURATION
HOURS
SURGICAL
ANAESTHESIA
INTRATHECAL
ADMINISTRATION
Surgery
5.0
3-5
15-25
1-5
2-6
_The doses in the table are those considered to be necessary to
produce a successful block and should _
_be regarded as guidelines for use in adults. Individual variations in
onset and duration occur. The _
_figures in the column 'Dose' reflect the expected average dose range
needed. Standard textbooks _
_should be consulted for both