KETOROLAC KABI ketorolac trometamol 30 mg/1 mL solution for injection, vial

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

ketorolac trometamol, Quantity: 30 mg/mL

Dostupno od:

Fresenius Kabi Australia Pty Ltd

INN (International ime):

Ketorolac trometamol

Farmaceutski oblik:

Injection, solution

Sastav:

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

Administracija rute:

Intramuscular

Jedinice u paketu:

5 vials

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

Ketorolac Kabi 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 "DOSE AND METHOD OF 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 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 in acute exacerbations of chronic painful inflammatory conditions (e.g. rheumatoid or osteoarthritis).

Proizvod sažetak:

Visual Identification: Clear, colourless to slightly yellow colour solution; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Status autorizacije:

Licence status A

Datum autorizacije:

2017-04-28

Uputa o lijeku

Filename: cmi-clean
Page 1 of 4
KETOROLAC KABI
_Contains the active ingredient ketorolac trometamol _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Ketorolac Kabi. 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 Kabi 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 KABI
IS GIVEN FOR
Ketorolac Kabi belongs to a
family of medicines called Non-
Steroidal Anti-Inflammatory
Drugs (NSAIDs). It contains the
active ingredient Ketorolac
Trometamol.
Ketorolac Kabi relieves pain and
reduces inflammation (swelling
and soreness) that may occur
following surgery. Although
Ketorolac Kabi can relieve the
symptoms of pain and
inflammation, it will not cure your
condition.
Your doctor may have prescribed
Ketorolac Kabi for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS WHY KETOROLAC
KABI HAS BEEN PRESCRIBED FOR
YOU.
THIS MEDICINE IS AVAILABLE ONLY
WITH A DOCTOR'S PRESCRIPTION.
KETOROLAC KABI IS NOT
ADDICTIVE.
BEFORE YOU ARE GIVEN
KETOROLAC KABI
_When you must not use 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 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 me

Svojstava lijeka

AUSTRALIAN PRODUCT INFORMATION-
KETOROLAC KABI (KETOROLAC TROMETAMOL)
SOLUTION FOR INJECTION
Australian PI May 2018
Page 1 of 23
\
1 NAME OF MEDICINE
Ketorolac trometamol
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of Ketorolac Kabi contains ketorolac trometamol 30 mg/ml
(3%).
Ketorolac trometamol is a member of the pyrrolo-pyrrole group of
NSAIDs. The medicine is
structurally and pharmacologically related to tolmetin and
indomethacin, however, unlike
these pyrrole acetic acid derivatives, ketorolac is a cyclic propionic
derivative.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Ketorolac trometamol 30 mg/mL solution for injection: Clear and
slightly yellow solution for
injection
WARNING
Ketorolac 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 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 KABI (KETOROLAC TROMETAMOL)
SOLUTION FOR INJECTION
Australian PI May 2018
Page 2 of 23
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ketorolac Kabi 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 "DOSE AND METHOD OF 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 a