Minims Prednisolone Sodium Phosphate 5 mg/ml eye drops, solution in single dose-container

দেশ: মাল্টা

ভাষা: ইংরেজি

সূত্র: Medicines Authority

থেকে পাওয়া:

Health-Med sp. z o.o. sp.j. ul. Wawelska 8/5 04-222 Warszawa, Poland

এটিসি কোড:

S01BA04

INN (আন্তর্জাতিক নাম):

PREDNISOLONE 5 mg/ml

ফার্মাসিউটিকাল ফর্ম:

EYE DROPS, SOLUTION

রচনা:

PREDNISOLONE 5 mg/ml

প্রেসক্রিপশন টাইপ:

POM

থেরাপিউটিক এলাকা:

OPHTHALMOLOGICALS

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

2023-09-26

তথ্য লিফলেট

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MINIMS PREDNISOLONE SODIUM PHOSPHATE, 0.5% W/V EYE DROPS, SOLUTION,
5 MG/ML EYE DROPS SOLUTION IN SINGLE DOSE-CONTAINER
PREDNISOLONE SODIUM PHOSPHATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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
is and what it is used for
2.
What you need to know before you
MINIMS PREDNISOLONE SODIUM PHOSPHATE
3.
How to take
MINIMS PREDNISOLONE SODIUM PHOSPHATE
4.
Possible side effects
5.
How to store
MINIMS PREDNISOLONE SODIUM PHOSPHATE
6.
Contents of the pack and other information.
1.
WHAT MINIMS PREDNISOLONE SODIUM PHOSPHATE IS AND WHAT IT IS USED FOR
MINIMS PREDNISOLONE SODIUM PHOSPHATE
contains prednisolone sodium phosphate which belongs to
a group of medicines called corticosteroids. It is used to treat
ocular inflammation (red and painful in
eyes) 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.
This medicine is indicated for adults.
MINIMS PREDNISOLONE SODIUM PHOSPHATE
is not suitable for treating of eye infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MINIMS PREDNISOLONE SODIUM
PHOSPHATE
_ _
DO NOT TAKE THE MINIMS PREDNISOLONE SODIUM PHOSPHATE
-
If you are allergic to prednisolone or any of the other ingredients of
this medicine (listed in section
6).
-
If you have eye infection caused by viruses, fungi or bacteria.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist if you experience blurred vision or
visual disturbanc

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minims Prednisolone Sodium Phosphate 5 mg/ml eye drops, solution in
single dose-container
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of eye drops solution contains 5 mg of Prednisolone Sodium
Phosphate Ph. Eur.
Each single dose unit contains 0.5 ml eye drops solution of 2.5 mg
prednisolone sodium phosphate.
Each drop contains 0.185 mg prednisolone sodium phosphate.
Excipient(s) with known effect:
Each ml of eye drops solution contains 3 mg of Sodium dihydrogen
phosphate dihydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution in single-dose container
Clear, colourless, sterile .eye drops, solution.
pH: 7.5-8.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Non-infected, inflammatory conditions of the eye in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and the elderly _
One drop should be administered into the conjunctival sac of the
affected eye four times up to eight
times daily, adjusted or tapered based on the severity of the
condition and the patients’ response.
Typically, one drop should be administered 4 times daily for 1 to 3
weeks, followed by one drop twice
daily. In more severe cases, beginning with one drop 8 times daily for
the first week may be
considered.
The use of anti-inflammatory steroidal drugs should be continued for
the minimal required period
needed to control the information and ophthalmological assessment
should be made after 1 week or if
the symptoms get worse.
_ _
_Paediatric population _
The safety and efficacy of Minims Prednisolone Sodium Phosphate in
children has not been
established.
Method of administration
For ocular use only.
This product is sterile when packaged. Patients should be advised not
to allow the dropper tip to touch
any surface, as this may contaminate the solution.
Systemic absorption may be reduced by compressing the lacrimal sac at
the medial canthus for 1-2
minutes during and following the instillation of the drops. Th