Minims prednisolone sodium phosphate 0.5% eye drops 0.5ml unit dose

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Prednisolone sodium phosphate

可用日期:

Bausch & Lomb UK Ltd

ATC代码:

S01BA04

INN（国际名称）:

Prednisolone sodium phosphate

剂量:

5mg/1ml

药物剂型:

Eye drops

给药途径:

Ocular

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 11040100; GTIN: 5027519002306

资料单张

Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.
ULOTKA PIL
Nazwa produktu
Product Name
MINIMS PREDNISOLONE
SODIUM PHOSPHATE 0.5 %
W/V DRP 20 SDU
Kolor nadruku Colours
Black
Kraj
Country (ISO)
UNITED KINGDOM (UK),
IRELAND (IE)
Nr wykrojnika
Spec No
5338
Opracowane przez
Designed by
Kod Wytwórcy
Manufacturer code
77002
Nr korekty
Proof No
2
Data
Date
09.05.2017
Kod farmaceutyczny
Pharmacode
-
Kod wersji
Valeant version code
P1UKIE05
Inny kod
Other code
77002 (DATA MATRIX)
Rozmiar czcionki
Font size
MINIMUM 8 PT
Wymiar ulotki
PIL size
160 X 240 MM
Krój czcionki
Font used
Frutiger Neue LT W1G
Condensed
FRUTIGER NEUE LT W1G
CONDENSED BOLD
Gramatura papieru
Paper weight
60 G/M
2
Komentarze Comments (Reason for the change)
IMPLEMENTATION OF PRAC - RESUBMISSION
PMR_ICN-17-0514-A
PACKING SITE: LABORATOIRE CHAUVIN, AUBENAS, FRANCE
Akceptacja Techniczna Technical Approval
Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval
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 cortic

产品特点

OBJECT 1
MINIMS PREDNISOLONE SODIUM PHOSPHATE 0.5%
W/V, EYE DROPS SOLUTION
Summary of Product Characteristics Updated 14-Jun-2017 | Bausch & Lomb
U.K Limited
1. Name of the medicinal product
Minims Prednisolone Sodium Phosphate
2. Qualitative and quantitative composition
Clear, colourless, sterile eye drops containing Prednisolone Sodium
Phosphate Ph. Eur. 0.5% w/v.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Sterile single-use eye drop.
4. Clinical particulars
4.1 Therapeutic indications
Non-infected inflammatory conditions of the eye.
4.2 Posology and method of administration
Posology
_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 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.
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
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
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.).
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 ca