MINIMS PREDNISOLONE SODIUM PHOSPHATE 0.5% 5mg/mL eye drops ampoule

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

prednisolone sodium phosphate, Quantity: 5 mg/mL

Saadav alates:

Bausch & Lomb Australia Pty Ltd

Ravimvorm:

Eye Drops, solution

Koostis:

Excipient Ingredients: sodium hydroxide; sodium chloride; monobasic sodium phosphate; disodium edetate; purified water

Manustamisviis:

Ophthalmic

Ühikuid pakis:

20 x 0.5mL ampoules

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

Non-infected inflammatory conditions of the eye.

Toote kokkuvõte:

Visual Identification: Clear colourless solution; Container Type: Tube; Container Material: PP; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Volitamisolek:

Registered

Loa andmise kuupäev:

1991-10-30

Infovoldik

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
involved.
DO NOT USE THIS

Toote omadused

Minims Prednisolone PI-A20180905v5
Page 1 of 6_ _
AUSTRALIAN PRODUCT INFORMATION – MINIMS
®
PREDNISOLONE
EYE DROPS
1
NAME OF THE MEDICINE
Prednisolone Sodium Phosphate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Minims Prednisolone Eye Drops contain prednisolone sodium phosphate
0.5% w/v as well
as disodium edetate, monobasic sodium phosphate, sodium chloride,
sodium hydroxide
and purified water. No preservatives are contained in the formulation.
3
PHARMACEUTICAL FORM
Minims Prednisolone Eye Drops are clear, colourless sterile eye drops.
Each unit
contains approximately 0.5mL solution in a container that has a twist
and pull cap.
Each unit should be discarded after a single use. The solution has a
neutral pH.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Minims Prednisolone Eye Drops are indicated for non-infected
inflammatory conditions
of the eye.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Adults and the elderly
One drop applied topically to the eye as required.
Children
At the discretion of the physician.
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
passage of the drops via the naso-lacrimal duct to the wide absorptive
area of the nasal
and pharyngeal mucosa.).
Each Minims Prednisolone Eye Drops unit should be discarded after a
single use.
4.3
C
ONTRAINDICATIONS
Minims Prednisolone Eye Drops are contraindicated in the following
patient groups /
conditions:
•
Patients with hypersensitivity to any of the components of the
preparation.
•
Presence of viral, fungal, tuberculous or other bacterial infection.
•
In children, long-term, continuous topical corticosteroid therapy
should be
avoided due to possible adrenal suppression.
•
Glaucoma.
Minims Prednisolone PI-A20180905v5
Page 2 of 6_ _
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
Minims Prednisolone Eye Drops are for topical ophthalmic use only. The
solution
should not be injected.
Care should be taken to ensure that the eye