ENCLOR EAR DROPS 5% WV

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CHLORAMPHENICOL

Boleh didapati daripada:

IDAMAN PHARMA MANUFACTURING SDN BHD

INN (Nama Antarabangsa):

CHLORAMPHENICOL

Unit dalam pakej:

5 ml

Dikeluarkan oleh:

IDAMAN PHARMA MANUFACTURING SDN BHD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ENCLOR EAR DROPS 5% W/V
Chloramphenicol (5% w/v)
1
WHAT IS IN THIS LEAFLET
1.
What Enclor Ear Drops 5% w/v is
used for
2.
How Enclor Ear Drops 5% w/v
works
3.
Before you use Enclor Ear Drops
5% w/v
4.
How to use Enclor Ear Drops 5%
w/v
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Enclor
Ear Drops 5% w/v
8.
Product Description
9.
Product Registration Holder &
Manufacturer
10.
Date of revision
WHAT ENCLOR EAR DROPS 5% W/V
IS
USED FOR
Enclor Ear Drops 5% w/v is used in the
treatment of a wide range of bacterial
infections of the outer ear.
HOW ENCLOR EAR DROPS 5% W/V
WORKS
Enclor Ear Drop 5% w/v belongs to a
group of medicines known as
antibiotics. It works by stopping the
growth of bacteria causing your
infection.
BEFORE YOU USE ENCLOR EAR DROPS 5%
W/V
_-When you must not use it _
You must not take this medicine and
should talk to your doctor or
pharmacist if:
•
You are allergic to Chloramphenicol
or any of the ingredients in this
medicine.
_Pregnancy and breast-feeding _
Do not use if you are pregnant,
thinking of becoming pregnant, or
breast feeding. Ask your doctor or
pharmacist before taking this medicine.
_ _
_-Before you start use it _
Tell your doctor or pharmacist if you
have other medical problems.
_-Taking other medicines _
Please inform your doctor or
pharmacist if you are taking any or
have recently taken any other medicine
even those not prescribed which you
obtained from a pharmacy,
supermarket or any other source.
The effects of some medicines may be
affected if other medicines are used at
the same time.
HOW TO USE ENCLOR EAR DROPS 5%
W/V
Always use the medicine exactly as
your doctor or pharmacist has told you.
Read the direction labels carefully. If
you do not understand the instructions
on the label, ask your doctor or
pharmacist to explain the instructions
to you.
_ _
_-How much to use _
Two to three drops are instilled into the
ear three times daily.
_-When to use it _
Follow the direction label carefully and
as instruc

Ciri produk

IDAMAN PHARMA MANUFACTURING
ENCLOR EAR DROPS 5% W/V
DESCRIPTION
Clear, mobile liquid, free from visible impurities. Colour: Colourless
or with slight yellow tinge.
ACTIVE SUBSTANCE
Each ml contains Chloramphenicol 50mg
PHARMACODYNAMICS
Chloramphenicol is a broad-spectrum antibiotic which has shown to
have therapeutic activity against a wide range of gram-negative and
gram-positive bacteria. Staphylococci and many other bacteria are
known to develop a minimal resistance to chloramphenicol. In
severe
infection
the
topical
use
chloramphenicol
should
be
supplemented with appropriate systemic therapy.
PHARMACOKINETICS
This preparation is a topical preparation meant for local therapeutic
effect.
INDICATIONS
Enclor ear drops are indicated in the treatment of bacterial otitis
extern by _Escherichia coli_, _Haemophilus Influenzae,_
_staphylococci_,
_Morax-Axenfeld diplobacillus, Proteus morgani_ and _ Pseudomonas _
_pyocyanea._
RECOMMENDED DOSAGE
Two or three
drops are instilled
into the
ear
three times
daily.
Treatment should be continued for a period as decided by the
physician.
ROUTE OF ADMINISTRATION
Topical
CONTRAINDICATIONS
This
medicine
is
contraindicated
in
patients
with
a
history
of
hypersensitive reaction to chloramphenicol or any constituents of
the otic drops.
WARNINGS & PRECAUTIONS
Prolonged use in some cases may result in overgrowth of non-
susceptible organisms including fungi. Should superinfection occur,
the
drug
should
be
discontinued
and/or
appropriate
therapy
instituted.
THIS PRODUCT MAY CAUSE BLOOD DYSCRASIAS.
INTERACTIONS WITH OTHER MEDICAMENTS
Not applicable.
PREGNANCY AND LACTATION
Chloramphenicol crosses the placenta but no problems have been
reported with the use of ear drops. As with all drugs in pregnancy
and during breast feeding, care should be taken in assessing the
risk-benefits.
SIDE EFFECTS/ ADVERSE REACTIONS
May occasionally cause bone marrow hypoplasia, blood dyscrasia
or hypersensitivity reactions.
SYMPTOMS AND TREATMENT FOR OVERDOSAGE
Overdose is unlikely to occur with this preparatio