Minims tetracaine hydrochloride 1% eye drops 0.5ml unit dose

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Tetracaine hydrochloride

から入手可能:

Bausch & Lomb UK Ltd

ATCコード:

S01HA03

INN（国際名）:

Tetracaine hydrochloride

投薬量:

10mg/1ml

医薬品形態:

Eye drops

投与経路:

Ocular

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 11070000; GTIN: 5027519000203

情報リーフレット

Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.
ULOTKA PIL
Nazwa produktu
Product Name
MINIMS TETRACAINE
HYDROCHLORIDE 0,5% AND
1% W/V DRP SOL
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
76863
Nr korekty
Proof No
6
Data
Date
09.04.2015
Kod farmaceutyczny
Pharmacode
-
Kod wersji
Valeant version code
P9UKIE01
Inny kod
Other code
76863 (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
- G/M
2
Komentarze Comments (Reason for the change)
MAH TRANSFER FROM CHAUVIN PHARMACEUTICALS LTD UK TO B+L UK LTD
PMR_ICN-14-0811-A
PACKING SITE: LABORATOIRE CHAUVIN, AUBENAS, FRANCE
Akceptacja Techniczna Technical Approval
Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval
MINIMS® TETRACAINE HYDROCHLORIDE 0.5% W/V
MINIMS® TETRACAINE HYDROCHLORIDE 1% W/V
EYE DROPS, SOLUTION
TETRACAINE HYDROCHLORIDE
IN THIS LEAFLET:
1.
What Minims® Tetracaine Hydrochloride eye drops are and what they are
used for
2.
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.
Further information
1.
WHAT MINIMS® TETRACAINE HYDROCHLORIDE EYE DROPS ARE AND WHAT ARE THEY
USED FOR
Minims® Tetracaine Hydrochloride contains a local anaesthetic. It is
used to numb the eye temporarily. Your doctor or eye specialist may
use it to examine or treat your eye without it being painful.
This medicine should be avoided in premature babies.
2.
BEFORE YOU USE YOUR EYE DROPS
DO NOT USE THESE DROPS IF
•
if you are allergic to the active substance (tetracaine) or any of the
other ingredients (refer to the end of this leaflet).
•
if you are allergic to other similar types of local anaesthetic.
•
if you are taking medicines used to treat bacterial infection or
diabetes called “sulphonamides”.

製品の特徴

OBJECT 1
MINIMS TETRACAINE HYDROCHLORIDE 1.0% W/V, EYE
DROPS SOLUTION
Summary of Product Characteristics Updated 29-Jul-2015 | Bausch & Lomb
U.K Limited
1. Name of the medicinal product
Minims Tetracaine Hydrochloride 1% w/v Eye Drops, Solution
2. Qualitative and quantitative composition
Single-use, clear, colourless, sterile eye drops tetracaine
hydrochloride Ph.Eur. 1% w/v solution.
3. Pharmaceutical form
Single-use, sterile eye drops.
4. Clinical particulars
4.1 Therapeutic indications
Ocular anaesthetic for topical instillation into the conjunctival sac.
4.2 Posology and method of administration
Adults and children
One drop or as required. Each Minims unit should be discarded after
use.
4.3 Contraindications
Not to be used in patients with a known hypersensitivity to the
product.
Tetracaine is hydrolysed in the body to p-amino-benzoic acid and
should not therefore be used in patients
being treated with sulphonamides.
In view of the immaturity of the enzyme system which metabolises the
ester type local anaesthetics in
premature babies, tetracaine should be avoided in these patients.
4.4 Special warnings and precautions for use
The anaesthetised eye should be protected from dust and bacterial
contamination.
The cornea may be damaged by prolonged application of anaesthetic eye
drops.
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. It is especially advisable in
children.)
4.5 Interaction with other medicinal products and other forms of
interaction
Tetracaine should not be used in patients being treated with
sulphonamides (see 4.3 above)
4.6 Pregnancy and lactation
Safety for use in pregnancy and lactation has not been established,
therefore, use only when considered
essential by the physician.
4.7 Effects on ability to drive and use machines
May cause transient blurring of vision on