KETOROLAC JUNO ketorolac trometamol 30 mg/1 mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

01-03-2022

Summary of Product characteristics (SPC)

01-03-2022

Public Assessment Report (PAR)

26-11-2017

Active ingredient:

ketorolac trometamol, Quantity: 30 mg

Available from:

Juno Pharmaceuticals Pty Ltd

INN (International Name):

Ketorolac trometamol

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intramuscular

Units in package:

5 ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Ketorolac trometamol 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 "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. Note that oral dosage form can be available from other brand/s.,General,Ketorolac trometamol 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 trometamol solution for injection in acute exacerbations of chronic painful inflammatory conditions (e.g. rheumatoid or osteoarthritis).

Product summary:

Visual Identification: Clear and colourless or slightly yellow solution; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2014-08-20

Patient Information leaflet

KETOROLAC JUNO
1
KETOROLAC JUNO
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.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING KETOROLAC JUNO?
Ketorolac Juno contains the active ingredient ketorolac trometamol.
Ketorolac 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 JUNO?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE KETOROLAC JUNO?
Do not use if you are pregnant or intend to become pregnant, or if you
are breastfeeding or intend to breastfeed. Do not use if
you have ever had an allergic reaction to ketorolac 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.
For more information, see Section 2. What should I know before I use
KETOROLAC JUNO?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ketorolac 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 JUNO?
Ketorolac Juno 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
JUNO?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING KETOROLAC JUNO?
THINGS YOU
SHOULD DO
•
Call your doctor straight away if you become pregnant while being
treated with ketorolac.
•
Tell your doctor if you get an infection soon after receiving
ketorolac.
THINGS YOU
SHOULD NOT DO
•
You should not receive ketorolac for longer than five days. Prolonged
use may increase the occurrence
of side effects.
DRIVING OR USING
MACHINES
•
B

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Summary of Product characteristics

Australian Product Information
Ketorolac JUNO Product Information v6.0
Page | 1
AUSTRALIAN PRODUCT INFORMATION
KETOROLAC JUNO _(KETOROLAC TROMETAMOL) _
_ _
WARNING
Ketorolac trometamol 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
trometamol
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.
1 NAME OF THE MEDICINE
Ketorolac trometamol
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
KETOROLAC
JUNO
solution
for
injection
contains
the
active
ingredient,
ketorolac
trometamol. Ketorolac trometamol (synonym ketorolac tromethamine) is a
non-narcotic
analgesic belonging to the non-steroidal anti-inflammatory drug
(NSAID) class of medicines
with analgesic, anti-inflammatory and antipyretic properties.
KETOROLAC JUNO solution for injection is available as a 30 mg/mL (3%)
sterile solution for
injection for intramuscular (IM) administration only. Excipients for
the solution for injection are:
ethanol, sodium chloride, water for injections and sodium hydroxide to
adjust pH.
3. PHARMACEUTICAL FORM
KETOROLAC JUNO solution for injection: 30 mg/mL clear and colourless
or slightly yellow in
colour, sterile solution in glass ampoules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
KETOROLAC JUNO 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 _

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