HYDREX SURGICAL SCRUB 4.0% W/V CUTANEOUS SOLUTION

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

CHLORHEXIDINE GLUCONATE

Prieinama:

Ecolab Limited

ATC kodas:

D08AC02

INN (Tarptautinis Pavadinimas):

CHLORHEXIDINE GLUCONATE

Dozė:

4 %w/v

Vaisto forma:

Cutaneous Solution

Recepto tipas:

Product not subject to medical prescription

Gydymo sritis:

chlorhexidine

Autorizacija statusas:

Marketed

Leidimo data:

1995-10-16

Pakuotės lapelis

SURGICAL SCRUB
Hydrex
®
SURGICAL SCRUB
4.0% W/V CUTANEOUS
SOLUTION CHLORHEXIDINE
GLUCONATE SKIN CLEANSER
500 ML
3030500
3030500F/ 01JUN15 / IE
A cutaneous (relating to the skin)
solution also containing Ponceau
4R (E124), Dialkylamine Oxide,
Glycerol, Industrial Methylated
Spirit, Hydroxyethyl Cellulose,
Purifi ed Water and Perfume
(Hibetone).
For use as an antiseptic hand
wash, a pre-operative hand
scrub and a pre-operative skin
preparation prior to surgery.
FOR EXTERNAL USE ONLY
Licence holder, manufacturer
and assembler: ECOLAB LTD.
Lotherton Way, Garforth, Leeds
LS25 2JY (GB) · tel: [phone]
PA 1110/4/1
Batch No, Expiry and Manufacture
Date to be overprinted on the label
SURGICAL SCRUB
HOW TO USE
MEDICAL AND
NURSING STAFF:
Antiseptic hand wash
– wet the hands and
forearms, apply 5ml of
Hydrex Surgical Scrub
and wash for 1 minute.
Rinse thoroughly and dry.
Pre-operative surgical
scrub – wet the hands
and forearms, apply 5ml
of Hydrex Surgical Scrub
and wash for 1 minute,
cleaning the fi ngernails
with a brush. Rinse and
repeat the procedure
using a further 5ml of
Hydrex Surgical Scrub
and wash for 2 minutes.
Rinse thoroughly and dry.
PATIENTS: Pre-operative
skin preparation – wash
the whole body with
25ml of Hydrex Surgical
Scrub on at least two
occasions, usually the
day before and on the day
of the operation. Rinse
thoroughly and dry.
DO NOT use in body
openings (eg nose, ears).
SURGICAL SCRUB
AVOID contact with
eyes, ears, brain and
meninges (skin covering
the brain and spinal
cord).
Use with care in
newborn babies and
infants, especially
those born prematurely.
Hydrex Surgical Scrub
may cause chemical
burns.
ACTIONS TO BE TAKEN
IF SWALLOWED – If you
accidentally swallow
Hydrex Surgical
Scrub you should go
to the accident and
emergency department
of your nearest hospital.
POSSIBLE SIDE EFF ECTS
– Chlorhexidine can
very rarely cause
hypersensitivity,
including anaphylactic
shock (throat or lip
swelling, low blood
pressure), and
allergic reactions (e.g.
dermatitis, itching,
redness, e

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hydrex Surgical Scrub 4.0% w/v Cutaneous Solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine gluconate 4% w/v (equivalent to 40mg/ml)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous Solution.
Red-coloured antiseptic solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use as an antiseptic hand wash, a pre-operative hand scrub and a
pre-operative skin preparation to surgery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ANTISEPTIC HAND WASH - wet the hands and forearms, apply 5 ml of skin
cleanser and wash for one minute.
Rinse
thoroughly and dry.
PRE-OPERATIVE SURGICAL SCRUB - wet hands and forearms, apply 5 ml of
skin cleanser and wash for one minute,
cleaning the finger nails with a brush. Rinse and repeat the procedure
using a further 5 ml of skin cleanser and wash for
2 minutes.
Rinse thoroughly and dry.
PRE-OPERATIVE SKIN PREPARATION - the patient should wash his whole
body with 25 ml of the cleanser on at least two
occasions, usually the day before and on the day of the operation.
4.3 CONTRAINDICATIONS
Avoid contact with eyes, middle ear, brain and meninges.
Known hypersensitivity to the product or any of its components,
especially in those with a history of possible
chlorhexidine-related allergic reactions (see sections 4.4 and 4.8).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only.
Keep out of the reach and sight of children.
Do not use in body cavities.
Hydrex Surgical Scrub contains chlorhexidine. Chlorhexidine is known
to induce hypersensitivity, including
generalised allergic reactions and anaphylactic shock. The prevalence
of chlorhexidine hypersensitivity is not known,
but available literature suggests this is likely to be very rare.
Hydrex Surgical Scrub should not be administered to
anyone with a potential history of an allergic reaction to a
chlorhexidine-containing compound (see sections 4.3 and
4.8).
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