Ketorolac Kabi Contains the active ingredient ketorolac trometamol

Consumer Medicine Information

What is in this leaflet Kabi has been prescribed for  you are pregnant, or you. intend to become

pregnant This leaflet answers some This medicine is available only Ketorolac may affect common questions about with a doctor's prescription. your developing baby if Ketorolac Kabi. It does not you use it during contain all the available Ketorolac Kabi is not pregnancy. information. addictive.

It does not take the place of  you are breast-feeding talking to your doctor or or intend to breast- pharmacist. All medicines have Before you are given feed Ketorolac passes into risks and benefits. Your doctor Ketorolac Kabi has weighed the risks of you breast milk. The effect using Ketorolac Kabi against the on the baby is not When you must not use it benefits they expect it will have known. for you. Do not use ketorolac if:  You have or have had If you have any concerns any of the following about being given this  you have an allergy to: conditions: medicine, ask your doctor or pharmacist.  ketorolac or any  kidney disease ingredients listed at  severe liver disease Keep this leaflet with the the end of this leaflet  severe heart failure medicine.  aspirin or any other  you have recently had or You may need to read it again. NSAID medicine are about to have heart by-pass surgery Many medicines used to treat  you have a peptic ulcer What Ketorolac Kabi headache, period pain and other (stomach or duodenal is given for aches and pains contain aspirin ulcer), a recent history of or NSAID medicines. If you are one, or have previously Ketorolac Kabi belongs to a not sure if you are taking any of had peptic ulcers family of medicines called Non- these medicines, ask your doctor  you have had any Steroidal Anti-Inflammatory or pharmacist. bleeding disorders Drugs (NSAIDs). It contains the  you have asthma active ingredient Ketorolac Symptoms of an allergic reaction  you suffer dehydration Trometamol. to these medicines may include:  you have nasal polyps  asthma, wheezing or syndrome, angioedema Ketorolac Kabi relieves pain and shortness of breath or bronchospasm reduces inflammation (swelling  swelling of the face, lips (breathing difficulties) and soreness) that may occur or tongue which may  you have a history of following surgery. Although cause difficulty in Stevens-Johnsons Ketorolac Kabi can relieve the swallowing or breathing Syndrome (a rare skin symptoms of pain and  hives, itching or skin condition with severe inflammation, it will not cure your rash blisters and bleeding in condition.  fainting the lips, eyes, mouth, nose and genitals). Your doctor may have prescribed If you are allergic to aspirin or  You are receiving the Ketorolac Kabi for another NSAID medicines and use following medicines: purpose. Ketorolac Kabi these symptoms  other NSAID medicines may be severe.  probenecid, a medicine Ask your doctor if you have used to treat gout any questions why Ketorolac

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 lithium, a medicine used  heartburn, indigestion, to treat depression (such to treat some types of stomach ulcers or other as fluoxetine, paroxetine depression stomach problems or citalopram)  oxpentifylline, a  kidney or liver disease  thiothixene, a medicine medicine used to treat  heart failure used to treat psychosis certain blood disorders  high blood pressure or  diuretics, also called fluid heart problems or water tablets  The packaging is torn  swelling of the ankles or  phenytoin, a medicine or shows signs of feet used to treat epilepsy tampering.  inflammatory bowel  carbamazepine, a disease, such as medicine used to treat  The expiry date (EXP) Crohn's disease. epilepsy printed on the pack  methotrexate, a has passed. 4. You currently have an medicine used to treat infection arthritis and some If you use this medicine after the cancers expiry date has passed, it may Ketorolac may hide some of the  heparin, a medicine not work as well. signs of an infection (eg pain, used to treat blood fever) and may make you think disorders Do not give Ketorolac to a that the infection is not serious or  medicines used to treat child under 16 years of age. that you are better. high blood pressure, including ACE inhibitors, The safety and effectiveness in 5. You plan to have angiotensin receptor children under 16 have not been surgery antagonists and beta- established. blockers. 6. You have ever smoked  certain antibiotics called If you are not sure, if you or been a heavy aminoglycosides should be given ketorolac, alcohol drinker contact your doctor. These medicines may be If you have not told your affected by ketorolac or may Before you are given it doctor about any of the above, affect how well it works. You may tell them before you are given need to use different amounts of Before you are given this ketorolac. your medicine, or you may need medicine tell your doctor if: to use different medicines. Your Taking other medicines doctor will advise you. 1. You have any allergies to: Tell your doctor if you are Your doctor and pharmacist has taking any other medicines more information on medicines  any other medicines including any that you buy to be careful with or avoid while  any other substances, without a prescription from taking ketorolac. such as foods, your pharmacy, supermarket preservatives or dyes or health food shop. Ask your doctor if you are not

 any ingredients listed at sure about this list of medicines. Some medicines and ketorolac the end of this leaflet may interfere with each other.

These include: How Ketorolac Kabi

2. You intend to become is given  aspirin, salicylates or pregnant other NSAID medicines How much is given Ketorolac may impair fertility and (such as ibuprofen or naproxen) Your doctor will decide what is not recommended in women dose of ketorolac you will  warfarin, a medicine attempting to conceive. receive. This depends on your used to stop blood clots If it is necessary for you to be condition. Ketorolac Kabi is  probenecid, a medicine given ketorolac, your doctor will given as an injection, into a used to treat gout discuss the risks and benefits of muscle by a doctor or trained  oxpentifylline, a receiving it during pregnancy. nurse. medicine used to treat

certain blood disorders 3. You have or have had The injection should not be any medical  lithium, a medicine used injected directly into the veins conditions, especially to treat some types of (intravenously). the following: depression  selective serotonin reuptake inhibitors (SSRIs), medicines used Filename: cmi-clean Page 2 of 4

The usual dose for healthy If you are going to have Tell your doctor if you notice adults is 10 mg to 30 mg every 4 surgery tell your doctor you any of the following and they to 6 hours, up to a maximum are being given ketorolac. worry you: daily dose of 90 mg. If you get an infection soon If you are over 65 years old or after receiving ketorolac, tell  stomach upset including have reduced kidney function, your doctor. nausea (feeling sick), your doctor may prescribe a heartburn, indigestion lower dose. Ketorolac may hide some of the  pain in the stomach or signs of an infection and may wind How it is given make you think, mistakenly, that  diarrhea Ketorolac Kabi is given every 4 the infection is not serious or that  dizziness to 6 hours as required, up to a you are better. Signs of an  drowsiness maximum daily dose of 90 mg. infection may include fever, pain,  headache swelling and redness.  sweating

How long is it given  skin rash or hives Things to be careful of Do not receive ketorolac for  aching muscles, muscle longer than 5 days. tenderness or weakness, Be careful driving or operating Prolonged use may increase the not caused by exercise occurrence of side effects. machinery until you know how ketorolac affects you.  pain at site of injection  dry mouth If you receive too much As with other NSAID medicines,  feeling extremely thirsty (overdose) ketorolac may cause dizziness or  passing more or less Immediately telephone your light-headedness in some urine than normal. doctor or Poisons Information people. Make sure you know Centre (telephone 13 11 26) for how you react to ketorolac These side effects of ketorolac advice, or go to Accident and before you drive a car, operate are usually mild. Emergency at your nearest machinery, or do anything else hospital, if you think that you or that could be dangerous if you Tell your doctor immediately if anyone else may have taken too are dizzy or light-headed. If this you notice any of the much ketorolac. occurs, do not drive. If you drink following: alcohol, dizziness or light- Do this even if there are no headedness may be worse.  severe pain or signs of discomfort or tenderness in any part of poisoning. Storage the stomach or back You may need urgent medical Ketorolac Kabi will be stored in  severe dizziness, attention. the pharmacy or on the hospital spinning sensation ward. It is kept in a cool dry  severe or persistent If you receive too much place where the temperature headache ketorolac, you may have pain or stays below 25°C. It should be  abnormal vision tenderness in the stomach, protected from light.  bleeding or bruising stomach upset including nausea more easily than normal, (feeling sick), vomiting, reddish or purplish heartburn, indigestion or cramps. Side effects blotches under the skin  unusual weight gain, If you are not sure what to do, Tell your doctor or pharmacist swelling of ankles or legs contact your doctor or as soon as possible if you do pharmacist. not feel well while you are These are serious side effects. receiving Ketorolac Kabi. You may need urgent medical attention. Serious side effects While you are Ketorolac helps most people with are rare. receiving Ketorolac pain after surgery but it may Kabi have unwanted side effects in a If any of the following happen, few people. All medicines can tell your doctor immediately or have side effects. Sometimes go to the Accident and Things you must do they are serious, most of the Emergency at your nearest If you become pregnant while time they are not. You may need hospital: receiving ketorolac, tell your medical treatment if you get doctor immediately. some of the side effects.  vomiting blood or Tell all doctors, dentists and material that looks like pharmacists who are treating Ask your doctor or pharmacist coffee grounds you that you have recently to answer any questions you  bleeding from the back been given ketorolac. may have. passage(rectum), black sticky bowel motions

Filename: cmi-clean Page 3 of 4 (stools) or bloody diarrhea Sponsor  swelling of the face, lips or tongue which may Fresenius Kabi Pty Limited cause difficulty in Level 2, 2 Woodland Way swallowing or breathing Mount Kuring-gai NSW 2080  asthma, wheezing, Australia shortness of breath Telephone: (02) 9391 5555  sudden or severe itching, skin rash or Ketorolac Kabi is supplied in hives New Zealand by:  fainting, seizures or fits  pain or tightness in the Fresenius Kabi New Zealand chest Limited 60 Pavilion Drive These are very serious side Airport Oaks, Auckland 2022 effects. You may need urgent New Zealand medical attention or Freecall: 0800 144 892 hospitalisation. These side effects are rare. Australian Registration Number Other side effects not listed above may also occur in some Ketorolac Kabi 30mg/mL – patients. Tell your doctor if AUST R 275273 you notice anything else that is making you feel unwell. This leaflet was prepared in April 2018. 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 it looks like

Ketorolac Kabi is a clear to slightly yellow solution in 1 mL glass vials.

Ingredients

Each 1mL vial contains 30 mg/mL ketorolac trometamol.

It also contains the following inactive ingredients:

 ethanol  sodium chloride  sodium hydroxide or hydrochloric acid  water for injections

Ketorolac Kabi does not contain sucrose, gluten, tartrazine or any other azo dyes.

Ketorolac Kabi comes in packs of 5 vials.

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