益目寧眼用懸浮液

Maa: Taiwan

Kieli: kiina

Lähde: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

Aktiivinen ainesosa:

FLUOROMETHOLONE;;TETRAHYDROZOLINE HCL

Saatavilla:

台灣諾華股份有限公司 台北市中正區仁愛路二段99號11、12、13樓 (01516589)

ATC-koodi:

S01GA52

Lääkemuoto:

點眼懸液劑

Koostumus:

TETRAHYDROZOLINE HCL (5232000310) MG; FLUOROMETHOLONE (8406001200) MG

Kpl paketissa:

瓶裝

luokka:

製　劑

Prescription tyyppi:

須由醫師處方使用

Valmistaja:

NOVARTIS PHARMA. AG LICHTSTRASSE 35 CH-4056 BASLE SWITZERLAND CH

Terapeuttinen alue:

tetryzoline, combinations

Käyttöaiheet:

眼瞼炎、結膜炎

Tuoteyhteenveto:

註銷日期: 2013/07/26; 註銷理由: 自請註銷; 有效日期: 2013/08/08; 英文品名: EFEMOLINE EYE DROPS

Valtuutuksen tilan:

已註銷

Valtuutus päivämäärä:

1992-01-27

Pakkausseloste

EFEMOLINE

Other Ophthalmics
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Eye drop, suspension
ACTIVE SUBSTANCES
Fluorometholone 1mg/ ml, tetryzoline hydrochloride 0.25mg/ ml eye
drops.
Certain dosage strengths and dosage forms may not be available in all
countries.
ACTIVE MOIETIES
Fluorometholone
Tetryzoline
EXCIPIENTS
Benzalkonium chloride, Aluminium hydroxide gel, Boric acid, Borax,
Sodium chloride, Disodium edetate, hypromellose and water for
injection.
Pharmaceutical formulations may vary between countries.
INDICATIONS

Acute,
non-infectious
allergic
conjunctivitis
and
keratitis
(especially when accompanied by severe swelling and intense
injection).

Non-infectious inflammation of the anterior segment of the eye
(including anterior uveitis, episcleritis and scleritis).

Post-operative
conditions
following
surgery
for
strabismus,
cataract
or
glaucoma;
in
combination
with
antimicrobial
therapy.
DOSAGE AND ADMINISTRATION
One drop of Efemoline solution 2–3 times daily. In adults, the
dosage can
be increased for the first 24-48 hours as directed by the physician.
SPECIAL POPULATIONS
PEDIATRIC POPULATION
Safety and efficacy have not been established in the pediatric age
group.
GERIATRIC POPULATION
No information is available to suggest dosage adjustment in patients
above
65 years of age.
RENAL IMPAIRMENT/HEPATIC IMPAIRMENT
No studies have been performed in renally/hepatically impaired
patients.
METHOD OF ADMINISTRATION
Instill 1 drop of Efemoline solution into the lower conjunctival sac
of the
affected eye(s), looking upwards and gently pulling the lower eyelid
downwards.
The contents remain sterile until the original closure is broken. To
avoid
contamination do not touch any surface with the tip of the container.
The
tip of the container should also not come into contact with the eye as
this
may cause injury to the eye.
CONTRAINDICATIONS

Hypersensitivity to Fluorometholone, Tetryzoline, or any other
component of the formulation.

Infectious conjunctivitis or keratitis.

Corneal lesions