IKERVIS ciclosporin 1 mg/mL eye drops emulsion ampoule

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

ciclosporin, Quantity: 1 mg/mL

Boleh didapati daripada:

Seqirus Pty Ltd

Borang farmaseutikal:

Eye Drops, emulsion

Komposisi:

Excipient Ingredients: medium chain triglycerides; cetalkonium chloride; glycerol; tyloxapol; poloxamer; sodium hydroxide; water for injections

Laluan pentadbiran:

Ophthalmic

Unit dalam pakej:

30 (5 connected ampoules per pouch, 6 pouches per carton)

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

Treatment of severe keratitis in adult patients with dry eye disease which has not improved despite treatment with tear substitutes.

Ringkasan produk:

Visual Identification: A milky white liquid; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status kebenaran:

Registered

Tarikh kebenaran:

2020-12-15

Risalah maklumat

IKERVIS
®
Consumer Medicine Information (CMI)
1
IKERVIS®
_ _
_ _
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.
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING IKERVIS®?
IKERVIS® contains the active ingredient ciclosporin. IKERVIS® is
used to treat severe keratitis in adult patients with dry eye
disease which has not improved despite treatment with artificial
tears.
For more information, see Section 1. Why am I using IKERVIS®?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE IKERVIS®?
Do not use if you have ever had an allergic reaction to IKERVIS® 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, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
IKERVIS®?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with IKERVIS® 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 IKERVIS®?
•
The usual dose of IKERVIS® is one drop, once daily, to be applied to
the affected eye(s) at bedtime.
•
FOLLOW ALL DIRECTIONS GIVEN TO YOU BY YOUR DOCTOR, OPTOMETRIST OR
PHARMACIST CAREFULLY. They may differ from the information
contained in this leaflet.
More instructions can be found in Section 4. How do I use IKERVIS®?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING IKERVIS®?
THINGS YOU
SHOULD DO
•
Tell your doctor immediately if you become pregnant.
•
Tell any doctor, dentist, optometrist or pharmacist who treat you that
you are using IKERVIS®.
•
Tell your doctor immediately if you develop any signs of an allergic
reaction after use.
THINGS YOU
SHOULD NOT DO
•
Do not start using any other medicine i

Ciri produk

IKERVIS
® CICLOSPORIN 0.1% OPHTHALMIC EMULSION
Page
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This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to report
any suspected adverse events at www.tga.gov.au/reporting-problems
AUSTRALIAN PRODUCT INFORMATION – IKERVIS
®
(CICLOSPORIN) EYE DROPS, EMULSION
1
NAME OF THE MEDICINE
Ciclosporin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL of IKERVIS
®
emulsion contains 1 mg (0.1%) of ciclosporin.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Eye drops, emulsion.
Milky white liquid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of severe keratitis in adult patients with dry eye disease
which has not improved
despite treatment with tear substitutes.
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment should be initiated by an ophthalmologist or appropriately
qualified healthcare
professional with expertise in the diagnosis, assessment and treatment
of keratitis associated
with dry eye disease (see Section 4.4 SPECIAL PRECAUTIONS AND WARNINGS
FOR
USE).
DOSAGE
_Adults _
▼
IKERVIS
® CICLOSPORIN 0.1% OPHTHALMIC EMULSION
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The recommended dose is one drop of IKERVIS
®
once daily to be applied to the affected
eye(s) at bedtime.
Response to treatment should be reassessed at least every 6 months.
If a dose is missed, treatment should be continued on the next day as
normal. Patients should
be advised not to instil more than one drop in the affected eye(s).
_Paediatric Patients _
IKERVIS
®
has not been studied in patients below 18 years of age.
_Elderly Patients _
The elderly population has been studied in clinical studies. No dosage
adjustment is required.
_Renal Impairment _
The effect of IKERVIS has not been studied in patients with renal
impairment. However, no
special considerations are needed in these populations.
_Hepatic Impairment _
The effect of IKERVIS has not been studied in patients with hepatic
impairment. Ho