KETOROLAC

Main information

  • Trade name:
  • KETOROLAC APOTEX ketorolac trometamol 10 mg/1 mL solution for injection ampoule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • KETOROLAC APOTEX ketorolac trometamol 10 mg/1 mL solution for injection ampoule
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217074
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217074

KETOROLAC APOTEX ketorolac trometamol 10 mg/1 mL solution for injection ampoule

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

27/10/2014

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. KETOROLAC APOTEX ketorolac trometamol 10 mg/1 mL solution for injection ampoule

Product Type

Single Medicine Product

Effective date

31/03/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Ketorolac is indicated for the short-term management of moderately severe, acute pain following surgical procedures. The total duration of ketorolac use

should not exceed five days.

It is recommended that ketorolac parenteral be used in the immediate post-operative period. Patients can then be converted to an oral formulation

(dependent on their analgesic needs), as outlined in the Dosage and Administration Section (Refer to Conversion from Parenteral to Oral Therapy). The

total period of treatment utilising the oral and/or intramuscular route of administration is not to exceed five days.

General

Ketorolac is not recommended for use as an obstetrical pre-operative medication or for obstetrical analgesia because it has not been adequately studied

for use in these circumstances and because of the known effects of drugs that inhibit prostaglandin biosynthesis on uterine contraction and fetal

circulation. There is no satisfactory evidence for the use of ketorolac in acute exacerbations of chronic painful inflammatory conditions (e.g. rheumatoid

or osteoarthritis).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Ampoule

Glass Type I Clear

24 Months

Store below 30

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

5 ampoules

(S4) Prescription Only Medicine

Components

1. KETOROLAC APOTEX ketorolac trometamol 10 mg/1 mL solution for injection ampoule

Dosage Form

Injection, solution

Route of Administration

Intramuscular

Visual Identification

A clear and slightly yellow coloured solution.

Active Ingredients

Ketorolac trometamol

10 mg/mL

© 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 26.11.2017 at 07:00:16 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

KETOROLAC APOTEX

Solution for Injection

Contains the active ingredient ketorolac trometamol

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully for

information on your medicine.

This leaflet answers some common

questions about KETOROLAC

solution for injection. It does not

contain all the available information.

It does not take the place of talking to

your doctor or pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. More recent information on

this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

You can also download the most up

to date leaflet from

www.apotex.com.au.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using this medicine

against the benefits they expect it

will have for you.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with you. You may

want to read it again.

What this medicine is

used for

The name of your medicine is

KETOROLAC APOTEX solution

for injection. It contains the active

ingredient ketorolac trometamol.

Ketorolac belongs to a family of

medicines called Non-Steroidal Anti-

Inflammatory Drugs (NSAIDs).

Ketorolac relieves pain and reduces

inflammation (swelling and soreness)

that may occur following surgery.

Although ketorolac can relieve the

symptoms of pain and inflammation,

it will not cure your condition.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you. Your

doctor may have prescribed this

medicine for another reason.

This medicine is available only with

a doctor's prescription.

There is no evidence that ketorolac is

addictive.

Use in children

Do not give ketorolac to a child

under 16 years of age.

The safety and effectiveness in

children under 16 have not been

established.

Before you are given

this medicine

When you must not be given

it

Do not use ketorolac if:

You have an allergy to:

ketorolac or any ingredients listed

at the end of this leaflet

aspirin or any other NSAID

medicine

Many medicines used to treat

headache, period pain and other

aches and pains contains aspirin

or NSAID medicines. If you are

not sure if you are taking any of

these medicines, ask your doctor

or pharmacist.

If you are allergic to aspirin or

NSAID medicines and use

ketorolac, these symptoms may

be severe.

You are pregnant or intend to

be pregnant.

Ketorolac may affect your

developing baby if you take it

during pregnancy.

You are breastfeeding or intend

to breastfeed.

Ketorolac may pass into human

breast milk.

You have or have had any of

the following:

kidney disease

severe heart failure

high blood pressure

KETOROLAC APOTEX SOLUTION FOR INJECTION

a peptic ulcer (stomach or

duodenal ulcer), a recent history

of one, or have had peptic ulcers

before

any bleeding disorders

asthma

you suffer dehydration

nasal polyps syndrome,

angioedema or bronchospasm

(breathing difficulties)

a history of Stevens-Johnsons

Syndrome (a rare skin condition

with severe blisters and bleeding

in the lips, eyes, mouth, nose and

genitals).

You are receiving the following

medicines:

other NSAID medicines

probenecid, a medicine used to

treat gout

lithium, a medicine used to treat

some types of depression

oxpentifylline, a medicine used to

treat certain blood disorders

You are hypersensitive to, or

have had an allergic reaction to,

ketorolac or any of the

ingredients listed at the end of

this leaflet.

Symptoms of an allergic reaction

may include: cough, shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, throat or other parts

of the body; rash, itching or hives

on the skin; fainting; or hay

fever-like symptoms.

If you think you are having an

allergic reaction, tell your

doctor immediately or go to the

Accident and Emergency

department at the nearest

hospital.

Do not give ketorolac to a child

under 16 years of age.

The safety and effectiveness in

children under 16 have not been

established.

Before you are given it

Before you are given this medicine,

tell your doctor if:

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

You have or have had any

medical conditions, especially the

following:

heartburn, indigestion, stomach

ulcers or other stomach problems

kidney or liver disease

heart failure

high blood pressure or heart

problems

swelling of the ankles or feet

inflammatory bowel disease, such

as Crohn's disease.

You currently have an infection

ketorolac may hide some of the

signs of an infection (e.g. pain,

fever) and may make you think

that the infection is not serious or

that you are better.

You intend to become pregnant

ketorolac may impair fertility and

is not recommended in women

attempting to conceive.

You are planning to have surgery.

You are currently receiving or are

planning to receive dental

treatment.

You are taking or are planning to

take any other medicines. This

includes vitamins and

supplements that are available

from your pharmacy, supermarket

or health food shop.

You have ever smoked or been a

heavy alcohol drinker.

If you have not told your doctor

about any of the above, tell them

before you are given ketorolac.

Some medicines may interact with

ketorolac. These include:

aspirin, salicylates or other

NSAID medicines (such as

ibuprofen or naproxen)

warfarin, a medicine used to stop

blood clots

probenecid, a medicine used to

treat gout

oxpentifylline, a medicine used to

treat certain blood disorders

lithium, a medicine used to treat

some types of depression

selective serotonin reuptake

inhibitors (SSRIs), medicines

used to treat depression (such as

fluoxetine, paroxetine or

citalopram)

thiothixene, a medicine used to

treat psychosis

phenytoin, a medicine used to

treat epilepsy

carbamazepine, a medicine used

to treat epilepsy

methotrexate, a medicine used to

treat arthritis and some cancers

heparin, a medicine used to treat

blood disorders

diuretics, also called fluid or

water tablets

medicines used to treat high

blood pressure, including ACE

inhibitors, angiotensin receptor

antagonists and beta-blockers

certain antibiotics called

aminoglycosides

If you are taking any of these you

may need a different dose or you

may need to take different medicines.

Your doctor will advise you.

Other medicines not listed above

may also interact with ketorolac.

How this medicine is

given

How much is given

Your doctor will decide what dose of

ketorolac you will receive. This

depends on your condition.

The usual dose for healthy adults is

10 mg to 30 mg every 4 to 6 hours,

up to a maximum daily dose of 90

If you are over 65 years old or have

reduced kidney function, your doctor

may prescribe a lower dose.

KETOROLAC APOTEX SOLUTION FOR INJECTION

How it is given

Ketorolac is given as an injection,

into a muscle by a doctor or trained

nurse.

The injection should not be injected

directly into the veins

(intravenously).

How long it is given for

Do not receive ketorolac for longer

than 5 days.

Prolonged use may increase the

occurrence of side effects.

If you receive too much

(overdose)

If you think that you or anyone

else may have been given too much

of this medicine, tell your doctor,

or go to the Accident and

Emergency department at your

nearest hospital.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

If you receive too much ketorolac,

you may have pain or tenderness in

the stomach, stomach upset including

nausea (feeling sick), vomiting,

heartburn or cramps.

If you are not sure what to do,

contact your doctor or pharmacist.

While you are being

given this medicine

Things you must do

Tell your doctor that you have been

given this medicine if:

you are about to be started on any

new medicine

you are pregnant or are planning

to become pregnant tell your

doctor immediately

you are breastfeeding or are

planning to breastfeed

you are about to have any blood

tests

you are going to have surgery or

an anaesthetic or are going into

hospital.

if you get an infection soon after

receiving ketorolac, tell your

doctor.

Ketorolac may hide some of the signs

of an infection and may make you

think, mistakenly, that the infection

is not serious or that you are better.

Signs of an infection may include

fever, pain, swelling and redness.

Tell any other doctors, dentists and

pharmacists who are treating you that

you take this medicine.

Things to be careful of

Be careful when driving or operating

machinery until you know how this

medicine affects you.

As with other NSAID medicines,

ketorolac may cause dizziness or

light-headedness in some people,

Make sure you know how you react

to ketorolac before you drive a car,

operate machinery, or do anything

else that could be dangerous if you

are dizzy or light-headed. If this

occurs do not drive.

If you drink alcohol, dizziness or

light-headedness may be worse.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

receiving ketorolac or if you have

any questions or concerns.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them. All

medicines can have side effects.

Sometimes they are serious but most

of the time they are not.

Tell your doctor if you notice any

of the following:

stomach upset including nausea

(feeling sick), heartburn,

indigestion

pain in the stomach or wind

diarrhoea

dizziness

drowsiness

headache

sweating

skin rash or hives

aching muscles, muscle

tenderness or weakness, not

caused by exercise

pain at site of injection

dry mouth

feeling extremely thirsty

passing more or less urine than

normal.

Tell your doctor as soon as possible

if you notice any of the following.

These may be serious side effects and

you may need medical attention:

severe pain or tenderness in any

part of the stomach or back

severe dizziness, spinning

sensation

severe or persistent headache

abnormal vision

bleeding or bruising more easily

than normal, reddish or purplish

blotches under the skin

unusual weight gain, swelling of

ankles or legs

If you experience any of the

following, tell your doctor

immediately or go to the Accident

and Emergency department at

your nearest hospital.

These are very serious side effects

and you may need urgent medical

attention or hospitalisation:

vomiting blood or material that

looks like coffee grounds

bleeding from the back passage

(rectum), black sticky bowel

motions (stools) or bloody

diarrhoea

swelling of the face, lips or

tongue which may cause

difficulty in swallowing or

breathing

asthma, wheezing, shortness of

breath

KETOROLAC APOTEX SOLUTION FOR INJECTION

sudden or severe itching, skin

rash or hives

fainting, seizures or fits

pain or tightness in the chest

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to ketorolac tell

your doctor immediately or go to

the Accident and Emergency

department at your nearest

hospital.

Symptoms of an allergic reaction

may include some or all of the

following:

cough, shortness of breath,

wheezing or difficulty breathing

swelling of the face, lips, tongue,

throat or other parts of the body

rash, itching or hives on the skin

fainting

hay fever-like symptoms.

Storage and disposal

Storage

Ketorolac will be stored in the

pharmacy or on the hospital ward. It

is kept in a cool dry place where the

temperature stays below 30°C. It

should be protected from light.

Disposal

KETOROLAC solution for injection

is used for one dose in one patient

only. Any remaining contents should

be discarded.

Product description

What KETOROLAC APOTEX

Solution for Injection looks

like

10mg/mL and 30mg/ml solutions for

injection are clear and slightly yellow

in colour.

Blister pack of 5 ampoules

* Not all strengths, pack types and/or

pack sizes may be available.

Ingredients

Each ampoule contains 10 mg/mL

KETOROLAC Solution for injection

contains 10 mg of ketorolac

trometamol

Each 30 ampoules contain mg/mL

KETOROLAC Solution for injection

contains 30 mg of ketorolac

trometamol

It also contains the following inactive

ingredients:

ethanol

sodium chloride

sodium hydroxide or hydrochloric

acid

water for injections

This medicine is gluten-free, lactose-

free, sucrose-free, tartrazine-free and

free of other azo dyes.

Australian Registration

Numbers

KETOROLAC APOTEX 10mg/mL

solution for injection ampoules:

AUST R 217074

KETOROLAC APOTEX 30mg/mL

solution for injection ampoules:

AUST R 217079

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered

trade marks of Apotex Inc.

APO and APOTEX are registered

trade marks of Apotex Inc.

This leaflet was last updated in

February 2015.

KETOROLAC APOTEX SOLUTION FOR INJECTION