Genoptic

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Gentamicin sulfate 0.3%{relative} (10% overage added)

Disponible des:

AbbVie Limited

Designació comuna internacional (DCI):

Gentamicin sulfate 0.3% w/w (10% overage added)

Dosis:

0.3% w/w

formulario farmacéutico:

Eye drops, solution

Composición:

Active: Gentamicin sulfate 0.3%{relative} (10% overage added) Excipient: Benzalkonium chloride Dibasic sodium phosphate heptahydrate Disodium edetate dihydrate Hydrochloric acid Polyvinyl alcohol Sodium chloride Sodium hydroxide Water for injection

Unidades en paquete:

Bottle, dropper, with HIPS cap, 5 mL

clase:

Prescription

tipo de receta:

Prescription

Fabricat per:

Lek Pharmaceuticals d.d.

indicaciones terapéuticas:

The product is indicated in the topical treatment of infections of the external eye and its adnexa caused by susceptible bacteria. Such infections include conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis and dacryocystitis.

Resumen del producto:

Package - Contents - Shelf Life: Bottle, dropper, with HIPS cap - 5 mL - 24 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C

Data d'autorització:

1984-12-13

Informació per a l'usuari

GENOPTIC
®
Gentamicin Sulfate Eye Drops- CMI Version 3.0 14 July 2023
Page 1 of 3
GENOPTIC
®
EYE DROPS
_ _
[gentamicin sulfate]
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
GENOPTIC
®
eye drops, (including
how to use the 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 using GENOPTIC
®
eye drops against the benefits
they expect it will have for you.
If you have any concerns about
using/taking this medicine, ask
your doctor or pharmacist.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read
it again.
WHAT
GENOPTIC
®
EYE
DROPS ARE USED FOR
GENOPTIC
®
eye drops are used
for the treatment of infections of
the eye caused by bacteria. These
include conjunctivitis (an infection
of the transparent skin that covers
the inner surface of the eyelid and
the surface of the eye which
causes the eye to produce
discharge, to be itchy and to form
crusty eyelids); infection of the
cornea (the front layer of the
eyeball); corneal ulcers; infection
of the edges of the eyelids
including hair follicles and glands;
infection of the oil producing gland
that covers the inner surface of the
eyelid and infection of the tear
sac.
_Mechanism of action: _
The active ingredient in
GENOPTIC
®
eye drops,
gentamicin sulfate, belongs to a
chemical group called the
aminoglycosides which have an
antibiotic activity against a wide
range of bacteria.
Your doctor may have prescribed
GENOPTIC
®
eye drops for another
reason. Ask your doctor if you
have any questions about why
GENOPTIC
®
eye drops have been
prescribed for you.
BEFORE YOU TAKE
GENOPTIC
®
EYE DROPS
_ _
_WHEN YOU MUST NOT USE IT _
Do not use GENOPTIC
®
eye
drops if:
1.
you have an allergy to
GENOPTIC
®
eye drops or
any of the ingredients listed at
the end of this leaflet.
Check with your doctor if:
•
you are pregnant or have
the intention of becoming
pregna

Fitxa tècnica

GENOPTIC
®
gentamicin sulfate Datasheet Version 4.0 7 July 2023
NEW ZEALAND DATA SHEET
GENOPTIC
® EYE DROPS
1.PRODUCT NAME
GENOPTIC
®
0.3% w/w eye drops
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Gentamicin sulfate equivalent to 3 mg gentamicin (0.3% w/w)
For a full list of excipients, see section 6.1 List of excipients
3. PHARMACEUTICAL FORM
Gentamicin sulfate is a white to buff hygroscopic powder which is
freely soluble in water,
ethylene glycol and formamide. It is practically insoluble in alcohol,
acetone, chloroform and
ether. Gentamicin sulfate is a mixture of the sulfates of gentamicin
C1, gentamicin C1A and
gentamicin C2. When dry, gentamicin sulfate contains not less than 590
units of gentamicin
per mg. GENOPTIC
®
eye drops are a sterile, aqueous solution buffered to approximately pH
7.0 for use in the eye.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
GENOPTIC
®
eye drops are indicated in the topical treatment of infections of the
external eye
and its adnexa caused by susceptible bacteria. Such infections include
conjunctivitis,
keratitis, keratoconjunctivitis, corneal ulcers, blepharitis,
blepharoconjunctivitis, acute
meibomianitis and dacryocystitis.
4.2 DOSAGE AND ADMINISTRATION
Instil one or two drops of GENOPTIC
®
eye drops into the affected eye(s) every four hours.
In severe infections, dosage may be increased to a maximum of 2 drops
once every hour.
In order to minimise systemic absorption of GENOPTIC
®
eye drops, apply pressure to the
tear duct immediately following administration of the drug.
_Paediatric population: _
Safety and effectiveness of GENOPTIC
®
eye drops in paediatric patients have not been
established
_Elderly population: _
Safety and effectiveness of GENOPTIC
®
eye drops in elderly patients have not been
established.
GENOPTIC
®
gentamicin sulfate Datasheet Version 4.0 7 July 2023
4.3 CONTRAINDICATIONS
Hypersensitivity to gentamicin sulfate or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
GENOPTIC
®
eye drops are not