Ketorolac-Claris

Main information

  • Trade name:
  • Ketorolac-Claris ketorolac trometamol 30 mg/1 mL solution for injection ampoule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Ketorolac-Claris ketorolac trometamol 30 mg/1 mL solution for injection ampoule
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218877
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218877

Ketorolac-Claris ketorolac trometamol 30 mg/1 mL solution for injection ampoule

ARTG entry for

Medicine Registered

Sponsor

Claris Lifesciences Australia Pty Ltd

Postal Address

PO Box 1290,BURWOOD, NSW, 1805

Australia

ARTG Start Date

19/12/2014

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-Claris ketorolac trometamol 30 mg/1 mL solution for injection ampoule

Product Type

Single Medicine Product

Effective date

12/10/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Ketorolac-Claris 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 the 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-Claris 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 the known effects of drugs that inhibit prostaglandin biosynthesis on

uterine contraction and foetal circulation.,There is no satisfactory evidence for the use of Ketorolac-Claris 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

Child resistant closure

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

25 ampoule

(S4) Prescription Only Medicine

5 ampoule

(S4) Prescription Only Medicine

10 ampoule

(S4) Prescription Only Medicine

Components

1. Ketorolac-Claris ketorolac trometamol 30 mg/1 mL solution for injection ampoule

Dosage Form

Injection, solution

Route of Administration

Intramuscular

Visual Identification

Clear slightly yellow solution

Active Ingredients

Ketorolac trometamol

30 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 04:14:23 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

Ketorolac-Claris

Ketorolac trometamol 10 mg/1 mL and 30 mg/1 mL, solution for injection

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Ketorolac-Claris injection. It does not contain all

the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using Ketorolac-Claris

injection against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Ketorolac-Claris is used for

Ketorolac trometamol belongs to a family of medicines called Non-Steroidal Anti-Inflammatory

Drugs (NSAIDs).

Ketorolac-Claris relieves pain and reduces inflammation (swelling and soreness) that may occur

following surgery. Although Ketorolac-Claris can relieve the symptoms of pain and inflammation, it

will not cure your condition.

Your doctor may have prescribed Ketorolac-Claris for another purpose. Ask your doctor if you have

any questions why Ketorolac-Claris has been prescribed for you.

This medicine is available only with a doctor's prescription. Ketorolac-Claris is not addictive

Before you are given Ketorolac-Claris

When you must not be given it

You should not be given Ketorolac-Claris if:

1.

you have an allergy to:

ketorolac trometamol 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 contain

aspirin or NSAID medicines. If you are not sure if you are taking any of these medicines, ask

your doctor or pharmacist.

Symptoms of an allergic reaction to these medicines may include:

asthma, wheezing or shortness of breath

swelling of the face, lips or tongue which may cause difficulty in swallowing or

breathing

hives, itching or skin rash

fainting

If you are allergic to aspirin or NSAID medicines and use Ketorolac-Claris, these symptoms

may be severe.

2.

you are pregnant, or intend to become pregnant

Ketorolac-Claris may affect your developing baby if you use it during pregnancy.

3.

you are breast-feeding or intend to breast-feed

Ketorolac-Claris passes into breast milk. The effect on the baby is not known.

4.

you have kidney disease

5.

you have severe heart failure

6.

you have a peptic ulcer (stomach or duodenal ulcer), a recent history of one, or have had

peptic ulcers before

7.

you have had any bleeding disorders

8.

you have asthma

9.

you suffer dehydration

10.

you have nasal polyps syndrome, angioedema or bronchospasm (breathing difficulties)

11.

you have a history of Stevens-Johnsons Syndrome (a rare skin condition with severe

blisters and bleeding in the lips, eyes, mouth, nose and genitals).

12.

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

13.

the packaging is torn or shows signs of tampering.

14.

the expiry date (EXP) printed on the pack has passed.

If you use this medicine after the expiry date has passed, it may not work as well.

Do not give Ketorolac-Claris to a child under 16 years of age. The safety and effectiveness in

children under 16 have not been established.

If you are not sure if you should be given Ketorolac-Claris, contact your doctor.

Before you are given it

1.

you have any allergies to:

any other medicines

any other substances, such as foods, preservatives or dyes

2.

you intend to become pregnant

Ketorolac-Claris may impair fertility and is not recommended in women attempting to

conceive. If it is necessary for you to be given Ketorolac-Claris, your doctor will discuss the

risks and benefits of receiving it during pregnancy.

3.

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.

4.

you currently have an infection

Ketorolac-Claris 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.

5.

you plan to have surgery

6.

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-

Claris.

Taking other medicines

Tell your doctor if you are taking any other medicines including any that you buy without a

prescription from your pharmacy, supermarket or health food shop.

Some medicines and Ketorolac-Claris may interfere with each other. 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

diuretics, also called fluid or water tablets

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

medicines used to treat high blood pressure, including ACE inhibitors, angiotensin receptor

antagonists and beta-blockers.

certain antibiotics called aminoglycosides

These medicines may be affected by Ketorolac-Claris, or may affect how well it works. You may need

to use different amounts of your medicine, or you may need to use different medicines. Your doctor

will advise you.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while

taking Ketorolac-Claris.

Ask your doctor if you are not sure about this list of medicines

How Ketorolac-Claris is given

How much Ketorolac-Claris is given

Ketorolac-Claris 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).

Your doctor will decide what dose of Ketorolac-Claris 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 mg.

If you are over 65 years old or have reduced kidney function, your doctor may prescribe a lower

dose.

When Ketorolac-Claris is given

Ketorolac-Claris is given every 4 to 6 hours as required, up to a maximum daily dose of 90 mg.

How long Ketorolac-Claris is given for

You should not receive Ketorolac-Claris for longer than 5 days. Prolonged use may increase the

occurrence of side effects

If you receive too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice,

or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may

have taken too much Ketorolac-Claris. Do this even if there are no signs of discomfort or

poisoning. You may need urgent medical attention.

If you receive too much Ketorolac-Claris, you may have pain or tenderness in the stomach, stomach

upset including nausea (feeling sick), vomiting, heartburn, indigestion or cramps.

If you are not sure what to do, contact your doctor or pharmacist

While you are receiving Ketorolac-Claris

Things you must do

If you become pregnant while receiving Ketorolac-Claris, tell your doctor immediately.

Tell all doctors, dentists and pharmacists who are treating you that you have recently been given

Ketorolac-Claris.

If you are going to have surgery tell your doctor you are being given Ketorolac-Claris.

If you get an infection soon after receiving Ketorolac-Claris, tell your doctor. Ketorolac-Claris 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.

Things to be careful of

Be careful driving or operating machinery until you know how Ketorolac-Claris affects you. As with

other NSAID medicines, Ketorolac-Claris may cause dizziness or light-headedness in some people.

Make sure you know how you react to Ketorolac-Claris 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.

Storage

Ketorolac-Claris 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.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are receiving

Ketorolac-Claris.

Ketorolac-Claris helps most people with pain after surgery but it may have unwanted side effects in a

few people. All 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:

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.

These side effects of Ketorolac-Claris are usually mild.

Tell your doctor immediately if you notice any of the following:

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

These are serious side effects. You may need urgent medical attention. Serious side effects are rare.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at

your nearest hospital:

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

sudden or severe itching, skin rash or hives

fainting, seizures or fits

pain or tightness in the chest

These are very serious side effects. You may need urgent medical attention or hospitalisation. These

side effects are rare.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice

anything else that is making you feel unwell.

Ask your doctor or pharmacist if you do not understand anything in this list.

Do not be alarmed by this list of possible side effects. You may not experience any of them

Product Description

What Ketorolac-Claris looks like

Ketorolac-Claris is a clear to slightly yellow solution in 1 mL glass ampoules.

Ingredients

Active ingredient:

ketorolac trometamol

each 10 mg/1 mL Ketorolac-Claris contains 10 mg of ketorolac trometamol

each 30 mg/1 mL Ketorolac-Claris contains 30 mg of ketorolac trometamol

Inactive ingredients:

ethanol

sodium chloride

sodium hydroxide or hydrochloric acid (for pH adjustment)

water for injections

Ketorolac-Claris comes in packs of 5, 10 and 25 ampoules.

Distributor

AFT Pharmaceuticals Pty Ltd

113 Wicks Road

North Ryde

NSW 2113

Ketorolac-Claris 10 mg/1 mL: AUST R 218876

Ketorolac-Claris 30 mg/1 mL: AUST R 218877

This leaflet was prepared on: 09 September 2015