Minims Prednisolone Sodium Phosphate 0.5% w/v Eye Drops, Solution

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Prednisolone sodium phosphate

可用日期:

Bausch + Lomb Ireland Limited

ATC代码:

S01BA; S01BA04

INN（国际名称）:

Prednisolone sodium phosphate

药物剂型:

Eye drops, solution

治疗领域:

Corticosteroids, plain; prednisolone

授权状态:

Marketed

授权日期:

1982-02-18

资料单张

BAUSCH & LOMB
MINIMS® PREDNISOLONE SODIUM PHOSPHATE 0.5%W/V
EYE DROPS, SOLUTION
PREDNISOLONE SODIUM PHOSPHATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even
if their signs of illness are the
same as yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects
not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
1. What Minims® Prednisolone Sodium Phosphate eye drops are and what
they are used for
2. What you need to know 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. Contents of the pack and other information
1. WHAT MINIMS® PREDNISOLONE SODIUM PHOSPHATE EYE DROPS ARE AND WHAT
ARE THEY USED FOR
Minims® Prednisolone Sodium Phosphate contains a corticosteroid.
It is used to treat inflamed eyes (red and painful) for which the
inflammation is not caused by an
infection. The part of the eye affected
will vary depending on the cause of the inflammation.
Your doctor may sometimes prescribe other drugs at the same time to
make sure that the
inflammation is treated effectively.
This medicine is indicated for children, adults and the elderly.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE YOUR EYE DROPS
DO NOT USE THESE DROPS IF:
• you are allergic to the active substance (prednisolone) or any of
the other ingredients of this
medicine (listed in section 6).
• you have high pressure inside the eye or you are at risk of
developing glaucoma. Your doctor will
have checked for this.
• you have an eye infection.
• it is intended for long term continuous therapy in children (at
the discretion of the physician).
WARNING AND PRECAUTIONS
Contact your doctor if you experience blurred vision or

产品特点

Health Products Regulatory Authority
03 June 2022
CRN00CTY6
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minims Prednisolone Sodium Phosphate 0.5% w/v Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Prednisolone sodium phosphate 0.5 % w/v.
Excipients with known effect
Sodium dihydrogen phosphate dihydrate
(0.07 mg phosphates in each drop equivalent to 1.83mg/ml)
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
Clear, colourless, aqueous, single-use eye drops, solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Non-infected inflammatory conditions of the eye.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults and the elderly_
One or two drops applied topically to the eye as required.
_Paediatric population_
At the discretion of the physician.
4.3 CONTRAINDICATIONS
Use of this medicine is contraindicated in patients with a known
hypersensitivity to the active ingredient.
Use is also contraindicated in viral, fungal, tuberculosis and other
bacterial infections.
Prolonged application to the eye of preparations containing
corticosteroids has caused increased intra-ocular 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.
Topical corticosteroids should not be used for longer than one week,
except under ophthalmic supervision with regular checks
of intra-ocular pressure.
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 drops via
the naso-lacrimal duct to the wide absorptive area of the
nasal and pharyngeal mucosa. It is especially advisable in children).
Health Products Regulatory Authority
03 June 2022
CRN00