KETOROLAC DROPS PHARMA-Q #N/A

Ország: Dél-afrikai Köztársaság

Nyelv: angol

Forrás: South African Health Products Regulatory Authority (SAHPRA)

Beszerezhető a:

Pharma-Q Holdings (Pty) Ltd

Adagolás:

Not Indicated

Gyógyszerészeti forma:

#N/A

Összetétel:

None

Engedélyezési státusz:

Registered

Betegtájékoztató

PATIENT INFORMATION LEAFLET
PHARMA-Q HOLDINGS (PTY) LTD.
KETOROLAC DROPS PHARMA-Q (KETOROLAC TROMETAMOL, EYE DROPS)
page
1 of 8
SCHEDULING STATUS
S3
KETOROLAC DROPS PHARMA-Q, 0,5 % EYE DROPS, SOLUTION
KETOROLAC TROMETAMOL
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING KETOROLAC
DROPS PHARMA-Q
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health
care provider.
•
Ketorolac Drops Pharma-Q has been prescribed for you personally and
you should
not share your medicine with other people. It
may harm them, even if their symptoms
are the same as yours.
WHAT IS IN THIS LEAFLET
1. What Ketorolac Drops Pharma-Q is and what it is used for
2. What you need to know before you use Ketorolac Drops Pharma-Q
3. How to use Ketorolac Drops Pharma-Q
4. Possible side effects
5. How to store Ketorolac Drops Pharma-Q
6. Contents of the pack and other information
1. WHAT KETOROLAC DROPS PHARMA-Q IS AND WHAT IT IS USED FOR
Ketorolac Drops Pharma-Q belongs to a group of medicines known as
non-steroidal anti-
inflammatory drugs (NSAIDs). The active ingredient in Ketorolac Drops
Pharma-Q is ketorolac
trometamol.
PATIENT INFORMATION LEAFLET
PHARMA-Q HOLDINGS (PTY) LTD.
KETOROLAC DROPS PHARMA-Q (KETOROLAC TROMETAMOL, EYE DROPS)
page
2 of 8
Ketorolac Drops Pharma-Q is used to relieve inflammation following
surgery on the eye in adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE KETOROLAC DROPS PHARMA-Q
Do not use Ketorolac Drops Pharma-Q:
•
if you are allergic (hypersensitive) to ketorolac trometamol or any of
the other ingredients of
Ketorolac Drops Pharma-Q (listed in section 6).
•
if you are allergic to aspirin or any other similar medicine
•
if you are a child as the safety and effectiveness in children have
not been established.
•
if you are pregnant or breastfeeding your baby.
•
Ketorolac Drops Pharma-Q should not be used while wearing soft contact
lenses.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR BEFORE USING KET

Termékjellemzők

PROFESSIONAL INFORMATION
PHARMA-Q HOLDINGS (PTY) LTD.
KETOROLAC DROPS PHARMA-Q (KETOROLAC TROMETAMOL, EYE DROPS)
SCHEDULING STATUS
S3
1. NAME OF THE MEDICINE
KETOROLAC DROPS PHARMA-Q, 0,5 % EYE DROPS, SOLUTION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Ketorolac Drops Pharma-Q contains ketorolac trometamol 5 mg/ mL.
_Preservatives: _
Benzalkonium chloride 0,01 % _m/v_
Disodium edetate 0,1 % _m/v_
Sugar free.
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless to pale yellow solution practically free from
particles.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ketorolac Drops Pharma-Q is indicated for the relief of inflammation
following ocular surgery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
One drop instilled into the eye three times daily starting 24 hours
before surgery and continuing
post-operatively.
SPECIAL POPULATIONS
_PAEDIATRIC POPULATION: _
_ _
page
2 of 9
The safety and efficacy of Ketorolac Drops Pharma-Q in children have
not been established (see
section 4.3)._ _
METHOD OF ADMINISTRATION
Ophthalmic use.
Instil one drop of the solution into the inferior conjunctival sac of
the eye to be treated, while
pulling the lower eyelid gently downwards and looking upwards. If used
with other eye drops there
must be an interval of 5 minutes between applications.
4.3 CONTRAINDICATIONS
•
Known hypersensitivity to ketorolac trometamol or to any of the
excipients listed in section 6.1.
•
The potential exists for cross-sensitivity to acetylsalicylic acid and
other non-steroidal anti-
inflammatory medicines.
•
Ketorolac Drops Pharma-Q is contraindicated in individuals who have
previously exhibited
sensitivities to these medicines.
•
Safety and effectiveness in children have not been established.
•
Safety of use in pregnant women has not been established (see section
4.6).
•
Ketorolac Drops Pharma-Q is not recommended for nursing mothers.
Ketorolac trometamol is
secreted in human milk after systemic administration (see section
4.6).
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