Celluvisc 1.0% w/v Eye drops, solution, unit dose

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Carmellose sodium

Sẵn có từ:

Imbat Limited

Mã ATC:

S01XA; S01XA20

INN (Tên quốc tế):

Carmellose sodium

Liều dùng:

1 percent weight/volume

Dạng dược phẩm:

Eye drops, solution

Loại thuốc theo toa:

Product not subject to medical prescription

Khu trị liệu:

Other ophthalmologicals; artificial tears and other indifferent preparations

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2009-08-28

Tờ rơi thông tin

Page 1 of 2
CELLUVISC
® 1.0% W/V EYE DROPS, SOLUTION, UNIT DOSE
(carmellose sodium)
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. Always use this
medicine exactly as described in this
leaflet or as your pharmacist or nurse has told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor, or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.

You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET:
1.
WHAT CELLUVISC IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CELLUVISC
3.
HOW TO USE CELLUVISC
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE CELLUVISC
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT CELLUVISC IS AND WHAT IT IS USED FOR
CELLUVISC is a tear substitute and contains the lubricant called
carmellose sodium. It is used for the
treatment of the symptoms of dry eye (such as soreness, burning,
irritation or dryness).
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CELLUVISC
DO NOT USE CELLUVISC:

If you are allergic (hypersensitive) to carmellose sodium or any of
the other ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS

If you wear contact lenses, these should be removed before using
CELLUVISC. The lenses can be
put back again 15 minutes after you have applied your drops.
OTHER MEDICINES AND CELLUVISC
Please tell your doctor or pharmacist if you are using, have recently
used or might use any other
medicines, including medicines obtained without a prescription.
If you are using other eye drops, leave at least 15 minutes before
putting in CELLUVISC.
PREGNANCY AND BREAST-FEEDING
CELLUVISC can be used during preg

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Celluvisc 1.0% w/v Eye drops, solution, unit dose
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml contains 10mg carmellose sodium
One drop ( approx 0.05ml) contains 0.5mg of carmellose sodium
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
_Product imported from France and the UK_:
A clear, colourless to slightly yellow viscous solution
4 CLINICAL PARTICULARS
As per PA0148/059/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0148/059/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Sodium Chloride
Sodium Lactate
Potassium Chloride
Calcium Chloride
Purified Water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on each,
single dose container and outer carton of the
product as marketed in the country of origin.
The eye drop solution should be used immediately after opening. Any
unused solution should be discarded.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25
°
C
6.5 NATURE AND CONTENTS OF CONTAINER
Clear, single-dose containers formed with a twist-off tab in an over
labelled outer container.
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Each unit is filled with 0.4ml of solution.
Pack sizes: 60 single-dose containers
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A US