CEQUA ciclosporin 900 microgram/mL eye drops ampoule

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

ciclosporin, Quantity: 900 microgram/mL

Disponível em:

Sun Pharma ANZ Pty Ltd

Forma farmacêutica:

Eye Drops

Composição:

Excipient Ingredients: PEG-40 hydrogenated castor oil; octoxinol 40; monobasic sodium phosphate dihydrate; dibasic sodium phosphate; sodium chloride; povidone; water for injections; hydrochloric acid; sodium hydroxide

Via de administração:

Ophthalmic

Unidades em pacote:

60, 10 - sample pack

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

CEQUA is indicated to increase tear production in patients with moderate to severe keratoconjunctivitis sicca (dry eye) where prior use of artificial tears has not been sufficient.

Resumo do produto:

Visual Identification: Clear, colourless solution, practically free from visible particulates; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status de autorização:

Registered

Data de autorização:

2020-01-31

Folheto informativo - Bula

[MEDICINE NAME]
®
™
1

This medicine is subject to additional monitoring. This will allow
quick identification of new safety information. You can
help by reporting any side affects you may get. You can report side
effects to your doctor or directly at
www.tga.gov.au/reporting-problems.
CEQUA™
_Ciclosporin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CEQUA eye drops.
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 taking CEQUA
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CEQUA EYE
DROPS ARE USED FOR
CEQUA is used to treat a condition
known as 'keratoconjunctivitis sicca'
which is also known as 'dry eye'.
When you have this condition, your
tear glands do not produce enough
tears and your eyes can become dry,
red and irritated.
Your doctor will give you CEQUA if
you have this condition and treatment
with tear substitute medicines alone
have not worked.
CEQUA belongs to a group of
medicines called
immunosuppressants. It works by
reducing inflammation and
increasing tear production so that
your eyes are better lubricated.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
CEQUA is not addictive.
CEQUA is available only with a
doctor's prescription.
CEQUA is not expected to affect
your ability to drive a car or operate
machinery.
There is not enough information to
recommend the use of this medicine
for children under the age of 18
years.
BEFORE YOU USE
CEQUA EYE DROPS
_WHEN YOU MUST NOT USE IT _
DO NOT USE CEQUA IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
ciclosporin
•
any of the ingredients listed at the
end of this leaflet.
Some

Características técnicas

1
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 – CEQUA
TM (CICLOSPORIN) EYE
DROPS
1
NAME OF THE MEDICINE
Ciclosporin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CEQUA contains ciclosporin 900 microgram/mL as the active ingredient.
It has an osmolality of
160 to 190 mOsmol/kg and a pH of 6.5-7.2.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Eye drops.
CEQUA is a sterile, clear, colourless solution, practically free from
visible particulates.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
CEQUA is indicated to increase tear production in patients with
moderate to severe
keratoconjunctivitis sicca (dry eye) where prior use of artificial
tears has not been sufficient.
4.2
D
OSE AND METHOD OF ADMINISTRATION
For topical ophthalmic use.
Each CEQUA ampoule is for single use in one patient only.
Instil one drop of CEQUA twice daily (approximately 12 hours apart)
into the affected eye(s).
Response to treatment should be reassessed at least every 6 months.
CEQUA can be used concomitantly with artificial tears, allowing a
15-minute interval between
products. Discard the ampoule immediately after using in both eyes.
4.3
C
ONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1 List of
excipients.
Active or suspected ocular or peri-ocular infection (see Section 4.4
Special warnings and
precautions for use).
Ocular or peri-ocular malignancies or premalignant conditions.
2
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
POTENTIAL FOR EYE INJURY AND CONTAMINATION
To avoid the potential for eye injury and contamination, advise
patients not to touch the
ampoule tip to the eye or other surfaces.
USE WITH CONTACT LENSES
CEQUA should not be administered while wearing contact lenses. If
contact lenses are