RESTASIS

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

CICLOSPORIN

Tilgjengelig fra:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

ATC-kode:

L04AA01

Legemiddelform:

OPHTHALMIC EMULSION

Sammensetning:

CICLOSPORIN 0.05 %

Administreringsrute:

OCULAR

Resept typen:

Required

Produsert av:

ALLERGAN INC., USA

Terapeutisk gruppe:

CYCLOSPORIN

Terapeutisk område:

CYCLOSPORIN

Indikasjoner:

To increase tear production in patients whose tear production is presumed to be supressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.

Autorisasjon dato:

2022-02-28

Informasjon til brukeren

RES APL JUN 23 CL
RES APL JUN 23 CL
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with a doctor's prescription only
RESTASIS
TM
Ophthalmic emulsion
ACTIVE INGREDIENT AND ITS QUANTITY:
ciclosporin 0.05% w/v
For the list of inactive ingredients and allergens in this medicine -
see section 6
'Additional Information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This
leaflet contains concise information about this medicine. If you have
any further
questions, consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness/for you. Do
not pass it on to
others.
It may harm them, even if it seems to you that their illness/medical
condition is
similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Restasis ophthalmic emulsion is intended to increase tear production
in patients
with reduced ability to produce tears due to eye inflammation
associated with dry
eye syndrome. No increase in tear production was observed in patients
taking local
anti-inflammatory medicines or using tear duct plugs.
THERAPEUTIC GROUP: Medicines with a localized immune effect.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient ciclosporin or
to any of
the other ingredients that this medicine contains (see section 6
'Additional
Information').
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
Possible eye injury and contamination of the emulsion:
To prevent possible injury to your eye and contamination of the
emulsion, make
sure the vial tip does not touch your eye or other surfaces.
Use with contact lenses:
Do not use Restasis while you are wearing contact lenses. Usually,
wearing contact
lenses is not recommended for patients with reduced tear production.
If you wear
contact lenses, remove them before using this medicine. You may
reinsert your
lenses 15 minutes after applying the medicine to your eye.
CHILDREN AND ADOLESCENTS
This medicine has not been studied in childr

Preparatomtale

RES API JUN 23 CL
Page 1 of 4
1 NAME OF THE MEDICINAL PRODUCT
RESTASIS
™
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ciclosporin 0.05% w/v
3 PHARMACEUTICAL FORM
Ophthalmic Emulsion 4
INDICATIONS AND USAGE
RESTASIS ophthalmic emulsion is indicated to increase tear production
in patients whose tear production is
presumed to be suppressed due to ocular inflammation associated with
keratoconjunctivitis sicca. Increased tear
production was not seen in patients currently taking topical
anti-inflammatory drugs or using punctal plugs.
5
DOSAGE AND ADMINISTRATION
Invert the unit dose vial a few times to obtain a uniform, white,
opaque emulsion before using. Instill one drop of
RESTASIS ophthalmic emulsion twice a day in each eye approximately 12
hours apart. RESTASIS can be used
concomitantly with lubricant eye drops, allowing a 15-minute interval
between products. Discard vial immediately
after use.
6
CONTRAINDICATIONS
RESTASIS is contraindicated in patients with known or suspected
hypersensitivity to the active substance or to any of
the excipients listed in section 10.
7
WARNINGS AND PRECAUTIONS
7.1
POTENTIAL FOR EYE INJURY AND CONTAMINATION
Be careful not to touch the vial tip to your eye or other surfaces to
avoid potential for eye injury and contamination.
7.2
USE WITH CONTACT LENSES
RESTASIS should not be administered while wearing contact lenses.
Patients with decreased tear production typically
should not wear contact lenses. If contact lenses are worn, they
should be removed prior to the administration of the
emulsion. Lenses may be reinserted 15 minutes following administration
of RESTASIS ophthalmic emulsion.
8
ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in the
labeling:
•
Potential for Eye Injury and Contamination [_see Warnings and
Precautions (7.1)_]
8.1 CLINICAL TRIALS EXPERIENCE
Because clinical trials are conducted under widely varying conditions,
adverse reaction rates observed in the
clinical trials of a drug cannot be directly compared to rates in the
clinical