ROPIVACAINE KABI ropivacaine hydrochloride 150 mg/20 mL solution for injection ampoule

Main information

  • Trade name:
  • ROPIVACAINE KABI ropivacaine hydrochloride 150 mg/20 mL solution for injection ampoule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ROPIVACAINE KABI ropivacaine hydrochloride 150 mg/20 mL solution for injection ampoule
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 195807
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

195807

ROPIVACAINE KABI ropivacaine hydrochloride 150 mg/20 mL solution for injection ampoule

ARTG entry for

Medicine Registered

Sponsor

Fresenius Kabi Australia Pty Ltd

Postal Address

Level 2, 2 Woodland Way,Mount Kuring-gai, NSW, 2080

Australia

ARTG Start Date

13/06/2013

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. ROPIVACAINE KABI ropivacaine hydrochloride 150 mg/20 mL solution for injection ampoule

Product Type

Single Medicine Product

Effective date

4/05/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Surgical anaesthesia (adults and children over 12 years of age); epidural block for surgery including caesarean section; intrathecal anaesthesia; field

block (minor nerve block and infiltration); major nerve block. Analgesia (adults and children over 12 years of age); continuous epidural infusion or

intermittent bolus epidural administration for analgesia in postoperative pain or labour pain; field block (minor nerve block and infiltration); continuous

peripheral nerve block infusion or intermittent injections for post operative pain management; continuous wound infusion for postoperative pain

management (adults only). Analgesia (children aged 0 - 12 years); caudal epidural block in neonates (> 37 weeks gestation and over 2500 g weight),

infants and children up to and including 12 years. continous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and

including 12 years; peripheral nerve block in children aged 1 up to and including 12 years. For peri- and postoperative pain management. There are no

safety or efficacy data to support the use of ropivacaine hydrochloride for analgesia for longer than 72 hours. (Data for peripheral nerve block

administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Ampoule

36 Months

Store below 25

degrees Celsius

Not recorded

Do not Freeze

Do not Refrigerate

Pack Size/Poison information

Pack Size

Poison Schedule

5 x 20 mL ampoules

(S4) Prescription Only Medicine

Components

1. ROPIVACAINE KABI ropivacaine hydrochloride 150 mg/20 mL solution for injection ampoule

Dosage Form

Injection, solution

Route of Administration

Intrathecal

Epidural

Visual Identification

Clear solution

Active Ingredients

Ropivacaine hydrochloride

150 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 28.11.2017 at 03:35:15 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

CMI for Ropivacaine Kabi

Feb, 2016

Page 1 of 3

Ropivacaine Kabi

Ropivacaine hydrochloride Solution for Injection

Consumer Medicine Information

What is in this leaflet

This leaflet answers some of the

common

questions

about

Ropivacaine

Kabi.

does

contain

available

information.

It does not take the place of talking

to your doctor or pharmacist.

medicines

have

risks

benefits. Your doctor has weighed

the risks of you taking Ropivacaine

Kabi

against

benefits

they

expect it will have for you.

If you have any concerns about

taking

this

medicine,

ask

your

doctor or pharmacist.

Keep this leaflet.

You may need to read it again.

What Ropivacaine Kabi

is used for

Ropivacaine

Kabi

local

anaesthetic

(an-es-thet-ic).

injected

into

body

where

makes the nerves unable to pass

messages to the brain. Depending

on the amount used, ropivacaine

will either totally stop pain or will

cause a partial loss of feeling.

Ropivacaine

Kabi

used

anaesthetic

stop

pain

surgery and/or to make childbirth

less

painful.

Ropivacaine

Kabi

also

used

after

surgery

treat

post-operative pain.

Your

doctor

will

have

explained

being

treated

with

Ropivacaine

Kabi

told

what dose you will be given.

Follow all directions given to you by

your doctor carefully.

They

differ

from

information contained in this leaflet.

Your

doctor

prescribe

this

medicine for another use. Ask your

doctor

want

more

information.

Ropivacaine Kabi is not addictive.

Before you are given

Ropivacaine Kabi

When you must not take it

Ropivacaine Kabi must not be used

1. you have any allergies to

any ingredient listed at the end

of this leaflet

any other local anaesthetics

2. you have problems controlling

your low blood pressure

3. you have inflammation and/or

an

infection

at

the

site

of

injection

Before you start to take it

You must tell your doctor if

1. you

have

any

allergies

to

other substances

2. you

have

any

of

these

medical conditions

problems

with

your

blood

pressure or circulation

blood poisoning

problems

with

clotting

your blood

acidosis, or too much acid in the

blood

nerve problems

liver, kidney or heart problems

disease of the brain or spine,

including

meningitis,

polio,

cancer or infections

muscle

disease

weakness

(e.g. myasthenia gravis)

3. you are pregnant, are breast

feeding or intend to breast-

feed.

Your

doctor

will

discuss

possible risks and benefits of using

Ropivacaine Kabi during pregnancy

and breast-feeding.

It may not be safe for you to be

given Ropivacaine Kabi if you have

any of these conditions.

Ropivacaine Kabi will only be used

if the solution is clear, the package

undamaged

(expiry) date marked on the pack

has not been passed.

Taking other medicines

You must tell your doctor if you

are taking any other medicines,

including

medicines

that

control

your

heart beat

medicines

used

thin

blood, including aspirin

low molecular weight heparin or

other medicines used to prevent

blood clots

fluvoxamine, a medicine used to

treat depression.

enoxacin, a medicine used to

treat bacterial infections.

ketoconazole, a medicine used

to treat fungal infections

cimetidine, a medicine used to

treat

stomach

ulcers

heartburn

medicines for depression

CMI for Ropivacaine Kabi

Feb, 2016

Page 2 of 3

medicines that you buy at the

pharmacy,

supermarket

health food shop

These

medicines

affect

way Ropivacaine Kabi works.

Your doctor or pharmacist can tell

you what to do if you are taking any

of these medicines.

If you have not told your doctor

about any of these things, tell them

before you are given Ropivacaine

Kabi.

Using Ropivacaine

Kabi

How it will be given

Ropivacaine Kabi will be injected

by your doctor into the skin, near a

single nerve, or into an area which

contains a large number of nerves.

Ropivacaine

Kabi

also

directed

into

surgical

incision

after surgery by a tube.

This

will

result

area

numbness at or near the site of

administration, or in an area that

may seem unrelated to the site of

administration. The latter will be the

case

given

EPIDURAL

injection

injection

around the spinal cord).

Ropivacaine

Kabi

should

injected directly into the blood.

The dosage you will be given will

depend on your body size, age and

type

pain

relief

required.

Your doctor will have had a lot of

experience using Ropivacaine Kabi

or other local anaesthetics and will

choose the best dose for you. They

will

willing

discuss

this

decision with you.

Overdose

The

doctor

giving

you

Ropivacaine

Kabi

will

be

experienced in the use of local

anaesthetics, so it unlikely that

you will be given too much.

However,

particularly

sensitive to Ropivacaine Kabi, or

dose

accidentally

injected

directly into your blood, you may

develop problems with your sight,

hearing, and get a numb feeling in

or around the mouth, feel dizzy or

stiff, or have twitchy muscles.

In rare cases, these effects may be

followed by drowsiness and fits. In

extreme

cases

have

problems

with

your

breathing

your heart and you may become

unconscious.

While you are being

given Ropivacaine Kabi

Things to be careful of

Be careful driving or operating

machinery after you have been

given Ropivacaine Kabi.

drowsy

your

reflexes may be slow.

Do not drink alcohol while you

are

being

given

Ropivacaine

Kabi.

If you drink alcohol while you are

being given Ropivacaine Kabi your

blood pressure may drop making

you feel dizzy and faint.

Please

talk

your

doctor

pharmacist about these possibilities

if you think they may bother you.

Side Effects

Tell your doctor or pharmacist

as soon as possible if you do not

feel

well

while

you

are

taking

Ropivacaine Kabi.

Ropivacaine Kabi will help relieve

pain

most

people,

have

unwanted

side-effects.

medicines can have side effects.

Sometimes they are serious, most

of the time they are not.

You may need medical treatment if

you get some of the side effects.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you notice any

of the following and they worry

you:

nausea (feeling sick)

vomiting

headache

dizziness

irregular or slow heart beat

fever

tingling

feeling

("pins

needles")

shivering

difficulty passing urine

These are all mild side effects of

Ropivacaine Kabi.

Tell

your

doctor

nurse

immediately if you notice any of the

following:

stiff or twitching muscles

painful joints

difficulty breathing

extreme dizziness

slow heart beat

pain in the chest

fits

On rare occasions you may lose

consciousness.

These are all serious side effects.

need

urgent

medical

attention.

Serious side effects are rare.

Tell

your

doctor

if

you

notice

anything else that is making you

feel unwell.

Some people may get other side

effects

while

taking

Ropivacaine

Kabi.

After using

Ropivacaine Kabi

Storage

Ropivacaine Kabi will be stored by

your

doctor

pharmacist

under

recommended

storage

conditions.

CMI for Ropivacaine Kabi

Feb, 2016

Page 3 of 3

It should be kept in a cool dry place

where the temperature stays below

25°C.

Disposal

Any Ropivacaine Kabi which is not

used,

which

left

container, will be disposed of in a

safe manner by your doctor, nurse

or pharmacist.

Product Description

What it looks like

Ropivacaine

Kabi

(ropivacaine

hydrochloride solution for injection)

clear

colourless,

sterile

isotonic

ready-to-use

solution

injection.

The solution is filled into 100 mL or

(filling

volume

polyolefin bags (freeflex

) or into

polypropylene

ampoules (Ovalia).

Ingredients

The active ingredient is ropivacaine

hydrochloride.

Excipients:

Sodium chloride

Hydrochloric

acid

(for

adjustment)

Sodium

hydroxide

(for

adjustment)

Water for injections

Sponsor

Supplied in Australia by:

Fresenius Kabi Australia Pty

Limited

Level 2, 2 Woodland Way

Mount Kuring-gai NSW 2080

Australia

Telephone: (02) 9391 5555

Supplied in New Zealand by:

Fresenius

Kabi

Zealand

Limited

60 Pavilion Drive

Airport Oaks, Auckland

New Zealand

Freecall: 0800 144 892

Australian

Registration

Numbers

2 mg/mL in 10 mL ampoule:

AUST R 195796

2 mg/mL in 20 mL ampoule:

AUST R 195804

5 mg/mL in 10 mL ampoule:

AUST R 195805

7.5 mg/mL in 10 mL ampoule:

AUST R 195806

7.5 mg/mL in 20 mL ampoule:

AUST R 195807

10 mg/mL in 10 mL ampoule:

AUST R 195808

10 mg/mL in 20 mL ampoule:

AUST R 195809

2 mg/mL in 100 mL freeflex

bag AUST R 195810

2 mg/mL in 200 mL freeflex

bag AUST R 195811

® = Registered Trademark

This leaflet was updated in

Feb, 2016.