Minims Prednisolone Sodium Phosphate

Riik: Uus-Meremaa

keel: inglise

Allikas: Medsafe (Medicines Safety Authority)

Toimeaine:

Prednisolone sodium phosphate 0.5%{relative} (3.6% overage );  

Saadav alates:

Bausch & Lomb (NZ) Ltd

INN (Rahvusvaheline Nimetus):

Prednisolone sodium phosphate 0.5% w/v (3.6% overage )

Annus:

0.5% w/v

Ravimvorm:

Eye drops, solution

Koostis:

Active: Prednisolone sodium phosphate 0.5%{relative} (3.6% overage )   Excipient: Disodium edetate dihydrate Monobasic sodium phosphate dihydrate Purified water Sodium chloride Sodium hydroxide

Ühikuid pakis:

Single use dropper, 0.5ml, 20 dose units

Klass:

Prescription

Retsepti tüüp:

Prescription

Valmistatud:

Sanofi Chimie

Toote kokkuvõte:

Package - Contents - Shelf Life: Single use dropper, 0.5ml - 20 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Loa andmise kuupäev:

1982-03-18

Infovoldik

MINIMS
®
PREDNISOLONE EYE DROPS
1
MINIMS
® PREDNISOLONE
EYE DROPS
_Prednisolone Sodium Phosphate Eye Drops _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Minims
Prednisolone 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 benefits and
risks. Your doctor has weighed the
risks of you using Minims
Prednisolone Eye Drops 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 MINIMS
PREDNISOLONE EYE
DROPS IS USED FOR
Minims Prednisolone Eye Drops
belongs to a class of medicines called
corticosteroids. It is used to treat
inflammation of the eye(s) that is not
caused by an infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED TO YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU USE MINIMS
PREDNISOLONE EYE
DROPS
_WHEN YOU MUST NOT USE IT _
DO NOT USE MINIMS PREDNISOLONE
EYE DROPS IF YOU HAVE AN ALLERGY
TO:
*
Any medicine containing
Prednisolone or Prednisone
*
Any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
*
Shortness of breath
*
Wheezing or difficulty breathing
*
Swelling of the face, lips, tongue
or other parts of the body
*
Rash, itching or hives on the skin
DO NOT USE MINIMS PREDNISOLONE
EYE DROPS IF YOU HAVE AN EYE
INFECTION.
Your doctor will want to treat the eye
infection first.
DO NOT USE MINIMS PREDNISOLONE
EYE DROPS IF YOU HAVE GLAUCOMA
(HIGH PRESSURE IN THE EYE).
Your doctor will discuss with you
how to use this medicine and the
risks and benefits involved.
DO NOT USE THIS MEDICINE IN
CHILDREN FOR CONTINUOUS, LONG
PERIODS OF TIME.
Your doctor will discuss with you
how long to use this medicine in
children and the risks and benefits

Toote omadused

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
MINIMS PREDNISOLONE SODIUM PHOSPHATE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clear, colourless, sterile eye drops containing prednisolone sodium
phosphate BP
0.5% w/v.
3.
PHARMACEUTICAL FORM
Single-use, sterile eye drops.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non-infected inflammatory conditions of the eye.
4.2
DOSE AND METHOD OF ADMINISTRATION
Adults and the elderly:
One or two drops applied topically to the eye as required.
Children:
At the discretion of the physician.
4.3
CONTRAINDICATIONS
Use is contraindicated in viral, fungal, tuberculous and other
bacterial infections.
Prolonged application to the eye of preparations containing
corticosteroids has caused
increased intraocular pressure and therefore the drops should not be
used in patients
with glaucoma.
In children, long-term, continuous topical corticosteroid therapy
should be avoided due
to possible adrenal suppression.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Care should be taken to ensure that the eye is not infected before
Minims Prednisolone
is used.
Systemic absorption may be reduced by compressing the lacrimal sac at
the medial
canthus for a minute during and following the instillation of the
drops. (This blocks the
2
passage of the drops via the naso lacrimal duct to the wide absorptive
area of the nasal
and pharyngeal mucosa. It is especially advisable in children.)
Visual disturbance
Visual disturbance may be reported with systemic and topical
corticosteroid use. If a
patient presents with symptoms such as blurred vision or other visual
disturbances, the
patient should be considered for referral to an ophthalmologist for
evaluation of
possible causes which may include cataract, glaucoma or rare diseases
such as central
serous chorioretinopathy (CSCR) which have been reported after use of
systemic and
topical corticosteroids.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Corticosteroids are known to increase the effects of barbiturates,
sedative hypnotic