NATACYN (NATAMYCIN 5%) OPHTHALMIC SUSPENSION

Valsts: Malaizija

Valoda: angļu

Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktīvā sastāvdaļa:

NATAMYCIN

Pieejams no:

LINK HEALTHCARE SDN. BHD.

SNN (starptautisko nepatentēto nosaukumu):

NATAMYCIN

Vienības iepakojumā:

15ml mL

Ražojis:

ALCON LABS INC

Lietošanas instrukcija

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
NATACYN OPHTHALMIC SUSPENSION
_ _
Natamycin (50mg/ml)
1
WHAT IS IN THIS LEAFLET
1.
What NATACYN is used for
2.
How NATACYN works
3.
Before you use NATACYN
4.
How to use NATACYN
5.
While you are using NATACYN
6.
Side effects of NATACYN
7.
Storage and Disposal of
NATACYN
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT NATACYN IS USED FOR
Natacyn is used to treat the fungal
infections of the eye.
HOW NATACYN WORKS
Natacyn contains natamycin which is
anti-fungal.
BEFORE YOU USE NATACYN
-
_When you must not use it _
Do not use Natacyn if you are allergic
to natamycin or any of the other
ingredients of this medicine.
_ _
_Pregnancy and breast-feeding _
If you are pregnant or breastfeeding,
you think you may be pregnant or are
planning to have baby, ask your
doctor or pharmacist for advice
before using this medicine.
_ _
-
_Before you start to use it _
Talk to your doctor or pharmacist
before using Natacyn.
If your symptoms do not improve, get
worse or suddenly return, please
consult your doctor.
•
If you notice any signs of drug
toxicity such as pain, itching,
swelling or redness of the eye
with Natacyn, discontinue use
and consult your doctor.
A preservative in Natacyn
(benzalkonium chloride) may cause
eye irritation and is also known to
discolor soft contact lenses. Avoid
contact with soft contact lenses.
Contact lenses wear is not
recommended during treatment of eye
infection.
-
_Taking other medicines _
Tell your doctor or pharmacist if you
are using, have recently used or might
use any other medicines.
Caution is required in the use of
corticosteroids because they can
adversely affect the efficacy of
antifungal.
HOW TO USE NATACYN
-
_How much to use _
The recommended initial dosage in
fungal keratitis is one drop of
Natacyn instilled in the conjunctival
sac at hourly or two-hourly intervals.
Always use this medicine exactly as
your doctor has told you.
_ _
-
_When to use it _
Use as directed by your doctor or
p

Produkta apraksts

1. NAME OF THE MEDICINAL PRODUCT
NAT ACYN ® OPTHALMIC SUSPENSION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients: 50 mg of natamyci n in one mL of suspension (5%).
Preservative: benzalkonium chloride
For the full list of excipients, see section 6.1.
3. PHARM ACEUTICAL FORM
Eye drops, suspension
White to yellow
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
NATACYN
® is indicated for the treatment of fungal blepharitis, conjunctivitis, and keratitis caused by
susceptible organisms including Fusarium solani keratitis. As in other forms of suppurative keratitis, initial
and sustained therapy of fungal keratitis should be determined by the clinical diagnosis, laboratory
diagnosis by smear and culture of corneal scrapings and drug response. W henever possible the in vitro
activity of natamycin against the responsible fungus should be determined.
4.2 Posology and Method of Administration
Posology
The preferred initial dosage in fungal keratitis is one drop of NATACYN
® (natamycin ophthalmic suspension,
USP) 5% instilled in the conjunctival sac at hourly or two- hourly intervals. The frequency of application can
usually be reduced to one drop 6 to 8 times daily after the first 3 to 4 days. Therapy should generally be
continued for 14 to 21 days or until there is resolution of active fungal keratitis. In many cases, it may be
helpful to reduce the dosage gradually at 4 to 7 days intervals to assure that the replicating organism has
been eliminated. Less frequent initial dosage (4 to 6 daily applications) may be sufficient in fungal blepharitis
and conjunctivitis.
Method of administration
• For ocular use.
• Shake well before using.
• To prevent contamination of the dropper tip and suspension, care must be taken not to touch the
eyelids, surrounding areas or other surfaces with the dropper tip of the bottle. Keep the bottle tightly
closed when not in use.
• If more than one topical ophthalmic medicinal product is being used, the medicines must be
administered at least 5 minutes apart. Eye oi