Sofradex

Šalis: Naujoji Zelandija

kalba: anglų

Šaltinis: Medsafe (Medicines Safety Authority)

Veiklioji medžiaga:

Dexamethasone sodium metasulfobenzoate 0.076%{relative} equivalent to 0.05% w/v dexamethasone; Framycetin sulfate 0.67%{relative} equivalent to 0.5% framycetin;  ; Gramicidin 0.005%{relative}

Prieinama:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Tarptautinis Pavadinimas):

Dexamethasone sodium metasulfobenzoate 0.076% w/v (=0.05% w/v dexamethasone)

Vaisto forma:

Ear/eye drops

Sudėtis:

Active: Dexamethasone sodium metasulfobenzoate 0.076%{relative} equivalent to 0.05% w/v dexamethasone Framycetin sulfate 0.67%{relative} equivalent to 0.5% framycetin   Gramicidin 0.005%{relative} Excipient: Citric acid monohydrate Hydrochloric acid Lithium chloride as Lithium chloride solution 50%w/v Methylated spirits Phenethyl alcohol Polysorbate 80 Purified water Sodium citrate dihydrate Sodium hydroxide

Vienetai pakuotėje:

Bottle, dropper, glass, 8 mL

Klasė:

Prescription

Recepto tipas:

Prescription

Pagaminta:

Sanofi Chimie

Terapinės indikacijos:

In the eye: For the short term treatment of steroid responsive conditions of the eye when prophylactic antibiotic treatment is also required, after excluding the presence of fungal or viral disease. In the ear: Otitis externa.

Produkto santrauka:

Package - Contents - Shelf Life: Bottle, dropper, glass - 8 mL - 24 months from date of manufacture stored at or below 25°C

Leidimo data:

1969-12-31

Pakuotės lapelis

Sofradex CMI NZ
1
SOFRADEX

_ _
_FRAMYCETIN SULFATE _
_(FRA-ME-SEE-TIN SUL-FATE)_
_, GRAMICIDIN _
_(GRAMMY-SIGH-DIN)_
_, _
_DEXAMETHASONE _
_(DEX-AR-METH-AR-SONE)_
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sofradex.
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 or pharmacist has weighed
the risks of you using Sofradex against
the benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT USING
THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT SOFRADEX IS USED
FOR
Sofradex is a medicine used to treat
infection or inflammation of the ear or
eye. Sofradex contains antibiotics
(framycetin sulfate and gramicidin) to
kill germs and a corticosteroid
(dexamethasone) to stop inflammation,
itching and weeping.
This medicine is available only with a
doctor’s prescription.
BEFORE YOU USE IT
_WHEN YOU MUST NOT USE IT _
DO NOT USE SOFRADEX IF YOU HAVE AN
ALLERGY TO SOFRADEX OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
DO NOT USE SOFRADEX IF YOU ARE
ALLERGIC TO FRAMYCETIN, GRAMICIDIN OR
DEXAMETHASONE.
DO NOT USE SOFRADEX IF YOU HAVE:
•
a hole in your eardrum
•
viral, fungal or tubercular (nodular)
lesions
•
chicken pox (varicella virus)
•
vaccinia – a type of virus
•
pus-containing conditions of the eye
or ear
•
high pressure in the eye (glaucoma)
•
herpes of the eye (eg dendritic
ulcer)
•
undiagnosed red eye or eyelid
swelling
DO NOT USE SOFRADEX IF YOU ARE
PREGNANT OR INTEND TO BECOME
PREGNANT.
Like most aminoglycosides, Sofradex
is not recommended for use during
pregnancy.
DO NOT USE SOFRADEX AFTER THE EXPIRY
DATE (EXP) PRINTED ON THE PACK.
If you use this medicine after the expiry
date has passed, it may not work as
well.
DO NOT USE SOFRADEX IF THE PACKAGING
IS TORN OR SHOWS SIGNS OF TAMPERING,
OR IF IT DOESN�

Prekės savybės

sof-ds-ccdsv2-dsv4-16aug22
Page 1 of 7
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Sofradex, Ear/Eye Drops
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of drops contains framycetin sulfate 5mg, gramicidin 0.05mg
and dexamethasone
0.5mg.
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Ear/Eye Drops
Sterile, clear, colourless drops
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
IN THE EYE:
For the short term treatment of steroid responsive conditions of the
eye when
prophylactic antibiotic treatment is also required, after excluding
the presence of fungal or
viral disease.
IN THE EAR:
Otitis externa.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
_ADULTS, ELDERLY AND CHILDREN _
IN THE EYE:
1 or 2 drops applied to each affected eye up to six times daily or
more frequently
if required.
IN THE EAR:
2 or 3 drops instilled into the ear three or four times daily.
(No dosage adjustment is necessary for the Elderly and Children).
sof-ds-ccdsv2-dsv4-16aug22
Page 2 of 7
ADMINISTRATION
Auricular and Ocular use.
4.3
CONTRAINDICATIONS

Hypersensitivity to the active substance (see Section 2) or to any of
the excipients
listed in Section 6.1

Acute purulent, untreated infections of the eye, which, like other
diseases caused by
micro-organisms, may be masked or enhanced by the presence of the
steroid

Tuberculosis and fungal diseases of the eye

Glaucoma

If herpetic keratitis (eg dendritic ulcer) is considered a possibility

Herpes simplex and other viral diseases of the cornea and conjunctiva,
use of topical
steroids in this condition can lead to extension of the ulcer and
marked visual
deterioration

Trachoma

Eardrum perforation because of the risk of ototoxicity

Viral and fungal infections of the ear

Acute purulent, untreated infections of the ear
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Although it is unlikely that infants will be treated with Sofradex for
prolonged periods, there
is a risk of adrenal suppression, even without occlusive dressings,
after prolonged tre