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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ketorolac trometamol, Quantity: 10 mg

Available from:

Medsurge Pharma Pty Ltd

Pharmaceutical form:

Injection

Composition:

Excipient Ingredients: sodium chloride; sodium hydroxide; water for injections; hydrochloric acid; ethanol

Administration route:

Intramuscular

Units in package:

5 x 1 mL ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

KETOROLAC MEDSURGE solution for injection 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 section 4.2 DOSE AND METHOD OF ADMINISTRATION (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. Note that oral dosage forms are available from other brands.,General,KETOROLAC MEDSURGE solution for injection 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 MEDSURGE solution for injection in acute exacerbations of chronic painful inflammatory conditions (e.g. rheumatoid or osteoarthritis).

Product summary:

Visual Identification: A clear and slightly yellow coloured solution free from visible particulate.; Container Type: Ampoule; Container Material: Glass; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-06-08

Patient Information leaflet

Ketorolac Medsurge CMI
1
KETOROLAC MEDSURGE
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING KETOROLAC MEDSURGE?
Ketorolac Medsurge contains the active ingredient ketorolac
trometamol. Ketorolac Medsurge is used to relieve pain and reduce
inflammation (swelling and soreness) that may occur following surgery.
For more information, see Section 1. Why am I using Ketorolac
Medsurge?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE KETOROLAC MEDSURGE?
Do not use if you have ever had an allergic reaction to Ketorolac
Medsurge or any of the ingredients listed at the end of the
CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO
BECOME PREGNANT OR ARE BREASTFEEDING
.
For more information, see Section 2. What should I know before I use
Ketorolac Medsurge?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Ketorolac Medsurge and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE KETOROLAC MEDSURGE?
•
Ketorolac Medsurge is given as an injection, into a muscle by a doctor
or trained nurse.
•
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.
More instructions can be found in Section 4. How do I use Ketorolac
Medsurge?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING KETOROLAC MEDSURGE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Ketorolac Medsurge.
•
Tell your doctor you are being given Ketorolac Medsurge if you are
going to have surgery.
•
Tell your doctor, if you get an infection soon after receiving
Ketorolac Medsurge. Signs of an infection
may include fever, pain, swelling and redness.
THINGS YOU
SHOULD NOT DO
•
Do not receive Ketorolac Medsurge for longer than 5 days. Pr

Summary of Product characteristics

KETOROLAC
PRODUCT INFORMATION
WARNING
KETOROLAC MEDSURGE solution for injection is a potent NSAID analgesic
and the resulting
NSAID-related adverse effects can be serious, for example
gastrointestinal haemorrhage,
surgical haemorrhage and renal impairment.
Increasing the dose of KETOROLAC MEDSURGE solution for injection
beyond the
recommendations in the product information will not provide better
efficacy but will result in
increasing risk of developing serious adverse effects.
AUSTRALIAN PRODUCT INFORMATION- KETOROLAC MEDSURGE
(KETOROLAC TROMETAMOL) SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Ketorolac trometamol
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
KETOROLAC MEDSURGE solution for injection is available as a 30 mg/mL
(3%) and 10 mg/mL
(1%) sterile solution for injection for intramuscular (IM)
administration only.
Excipients with known effect: alcohol present as 12% v/v ethanol.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
KETOROLAC MEDSURGE solution for injection: 10 mg/mL and 30 mg/mL clear
and slightly
yellow in colour, sterile solution in glass ampoules.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
KETOROLAC MEDSURGE solution for injection 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 SECTION 4.2 DOSE AND METHOD OF
ADMINISTRATION _
_(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. _
_ _
Note that oral dosage forms are available from other brands.
GENERAL
KETOROLAC MEDSURGE solution for injection is not recommended for use
as an obstetrical
pre-operative medication or for obstetrical a