KETOROLAC TROMETAMOL ROMPHARM 30 MGML

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

KETOROLAC TROMETAMOL

Verfügbar ab:

A.L. MEDI-MARKET LTD.

ATC-Code:

M01AB15

Darreichungsform:

SOLUTION FOR INJECTION

Zusammensetzung:

KETOROLAC TROMETAMOL 30 MG / 1 ML

Verabreichungsweg:

I.M, I.V

Verschreibungstyp:

Required

Hergestellt von:

S.C. ROMPHARM COMPANY S.R.L., ROMANIA

Therapiebereich:

KETOROLAC

Anwendungsgebiete:

Ketorolac Trometamol 30 mg/ml, solution for injection is indicated for the short-term management of moderate to severe acute post-operative pain. The maximum duration of treatment is two days.

Berechtigungsdatum:

2020-10-21

Fachinformation

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ketorolac Trometamol Rompharm 30 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre of solution for injection contains 30 mg of ketorolac
trometamol.
Excipient with known effect:
Each millilitre of solution contains 100 mg of ethanol (96%) and less
than 1 mmol (23 mg) of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, slightly yellow solution, free of visible particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ketorolac Trometamol Rompharm 30 mg/ml, solution for injection is
indicated for the short-term
management of moderate to severe acute post-operative pain. The
maximum duration of treatment is
two days.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
The time to onset of analgesic effect following both intramuscular and
the intravenous administration
is similar and is approximately 30 minutes, the maximum analgesia
occurring within 1 - 2 hours.
The median duration of the analgesia is generally four to six hours.
Dosage should be adjusted individually, according to the severity of
pain and the patient's response.
The administration of continuous multiple daily doses of ketorolac
intramuscularly or intravenously
should not exceed 2 days because adverse events may increase with
prolonged usage. There has been
limited experience with dosing for longer periods since the vast
majority of patients have transferred
to oral medication, or no longer require analgesic therapy after this
time.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
Posology
The product is not approved for use after heart surgeries.
_Adults and adolescents over 16 years _
Page 2 of 13
The recommended initial dose is 10 mg of ketorolac trometamol,
followed by 10 to 30 mg every 4 to 6
hours, as required.
The minimum effective dose is recommended.
The recommended maximum daily dose is 90