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

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

ketorolac trometamol, Quantity: 30 mg/mL

Disponible depuis:

Baxter Healthcare Pty Ltd

DCI (Dénomination commune internationale):

Ketorolac trometamol

forme pharmaceutique:

Injection, solution

Composition:

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

Mode d'administration:

Intramuscular

Unités en paquet:

25 ampoule, 10 ampoule, 5 ampoule

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

Ketorolac-Baxter 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 section 4.2 Dose and method of administration (Refer to "Conversion from Intramuscular 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-Baxter 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-Baxter in acute exacerbations of chronic painful inflammatory conditions (e.g. rheumatoid or osteoarthritis).

Descriptif du produit:

Visual Identification: Clear slightly yellow solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Statut de autorisation:

Licence status A

Date de l'autorisation:

2014-12-19

Notice patient

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 medi

Résumé des caractéristiques du produit

Keterolac-Baxter (Ketorolac Trometamol)
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AUSTRALIAN PRODUCT INFORMATION
KETOROLAC-BAXTER (KETOROLAC TROMETAMOL)
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Ketorolac trometamol (synonym ketorolac tromethamine 10 mg/mL and 30
mg/mL, solution
for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipients with known effect:
•
Contains Ethanol ~12.3%v/v
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ketorolac-Baxter 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. _
WARNING
Ketorolac-Baxter 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-Baxter beyond the recommendations in
the product
information will not provide better efficacy but will result in
increasing risk of developing
serious adverse effects.
Keterolac-Baxter (Ketorolac Trometamol)
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GENERAL
Ketorolac-Baxter 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-Baxter in
acute exacer