MINIMS CHLORAMPHENICOL 0.5 % EYE DROPS, SOLUTION

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

CHLORAMPHENICOL

Предлага се от:

Bausch & Lomb UK Limited

АТС код:

S01AA01

INN (Международно Name):

CHLORAMPHENICOL

дозиране:

0.5 Per Cent

Лекарствена форма:

Eye Drops Solution

Вид предписание :

Product subject to prescription which may not be renewed (A)

Терапевтична област:

chloramphenicol

Статус Оторизация:

Marketed

Дата Оторизация:

1977-04-01

Листовка

MINIMS
® CHLORAMPHENICOL 0.5%
EYE DROPS, SOLUTION
CHLORAMPHENICOL
IN THIS LEAFLET:
1. What Minims
®
Chloramphenicol eye drops are and what they are used for
2. Before you use your eye drops
3. How to use your eye drops
4. Possible side effects
5. How to store your eye drops
6. Further information
1. WHAT MINIMS
® CHLORAMPHENICOL EYE DROPS ARE AND WHAT ARE THEY USED FOR
Minims
®
Chloramphenicol contains an antibiotic. It is used to treat infections
of your eyes.
Sometimes parts of the outer surface of the eye, such as the cornea
(the transparent membrane covering the surface of the eye) or the
conjunctiva (the lining of the inside of the eyelids and part of the
eye), may become infected with bacteria. These eye drops can be used
to treat this infection and are effective against many different types
of bacteria.
If the eye infection is very severe, your doctor may give you
antibiotic tablets as well as this antibiotic eye drops. This medicine
is
indicated for children, adults and the elderly.
2. BEFORE YOU USE YOUR EYE DROPS
DO NOT USE THESE DROPS IF
•
you are allergic to the active substance (chloramphenicol) or any of
the ingredients (refer to the end of this leaflet).
TAKE SPECIAL CARE
If you use these eye drops over a long period of time they could
possibly become less effective or produce allergic reactions.
In order to prevent this, make sure that you stop using this medicine
as soon as your doctor tells you to.
DO YOU USE ANY OF THESE MEDICINES?
Chymotrypsin (solution used during cataract surgery) may not work
properly when used at the same time as Minims
®
Chloramphenicol.
If you are pregnant, may be pregnant, or are breastfeeding tell your
doctor or eye specialist, he/she may decide to use these drops or to
prescribe you an alternative.
CONTACT LENSES
Your doctor will ask you to remove your contact lenses prior to the
administration of the drops.
Do not wear your contact lenses throughout the entire treatment
course.
DRIVING AND USING MACHINES
As with all eye drops, your vision may be blurred after

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minims Chloramphenicol 0.5% Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Chloramphenicol 0.5% w/v.
_For a full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Clear, colourless, sterile single use eye drops solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Chloramphenicol is indicated for the topical treatment of infections
due to micro-organisms sensitive to the anti-
infective. Chloramphenicol is indicated in adults and children.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults (including the Elderly)
One to two drops applied topically to each affected eye up to six
times daily or more frequently if required. (Severe
infections may require one to two drops every fifteen to twenty
minutes initially, reducing the frequency of instillation
gradually as the infection is controlled).
Paediatric population
As for adults however dosage adjustment may be necessary in newborn
infants because of reduced systemic
elimination due to immature metabolism and the risk of dose-related
adverse effects. The maximum duration of
treatment is 10 - 14 days.
4.3 CONTRAINDICATIONS
Use in patients with a history of hypersensitivity or toxicity to
chloramphenicol or any other component of the
preparation.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In severe infections topical use of chloramphenicol should be
supplemented with appropriate systemic treatment.
Aplastic anaemia has, very rarely, followed topical use of
chloramphenicol eye drops and, whilst this hazard is an
uncommon one, it should be borne in mind when the benefits of the use
of chloramphenicol are assessed.
Prolonged use should be avoided as it may increase the likelihood of
sensitisation and the emergence of resistant
organisms.
Chloramphenicol should be reserved for use only in infections for
which it is specifically indicated.
Contact lenses should be removed during the period of treatment.
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