Hydrex Surgical Scrub 4.0% w/v Cutaneous Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

Chlorhexidine gluconate

Available from:

Ecolab Deutschland GmbH

ATC code:

D08AC; D08AC02

INN (International Name):

Chlorhexidine gluconate

Dosage:

4 percent weight/volume

Pharmaceutical form:

Cutaneous solution

Therapeutic area:

Biguanides and amidines; chlorhexidine

Authorization status:

Marketed

Authorization date:

1995-10-16

Patient Information leaflet

                                1
HYDREX SURGICAL SCRUB 4.0% W/V CUTANEOUS SOLUTION
CHLORHEXIDINE GLUCONATE SKIN CLEANSER

A cutaneous (relating to the skin) solution also containing Ponceau 4R
(E124), Dialkylamine
Oxide, Glycerol, Industrial Methylated Spirit, Hydroxyethyl Cellulose,
Purified 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
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 fingernails 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 (e.g. nose and ears).
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 EFFECTS
- Chlorhexidine can very rarely cause hypersensitivity, including
anaphylactic shock (throat or lip swelling, low blood pressure), and
allergic reactions (e.g.
dermatitis, itching, redness, eczema, rash, hives, skin irritation,
blisters). Chemical burns in
neonates and infants. If any of these reactions occur, stop using the
product and seek medical
attention immediately.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor
                                
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Summary of Product characteristics

                                Health Products Regulatory Authority
21 May 2019
CRN0091ZM
Page 1 of 4
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 hypersensitivityto 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.
                                
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