Hibiscrub 4.0% w/v Cutaneous Solution

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Chlorhexidine gluconate

Saadav alates:

Molnlycke Health Care AB

ATC kood:

D08AC; D08AC02

INN (Rahvusvaheline Nimetus):

Chlorhexidine gluconate

Annus:

4.0 percent weight/volume

Ravimvorm:

Cutaneous solution

Retsepti tüüp:

Product not subject to medical prescription

Terapeutiline ala:

Biguanides and amidines; chlorhexidine

Volitamisolek:

Marketed

Loa andmise kuupäev:

1980-05-30

Infovoldik

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HIBISCRUB® 4% W/V CUTANEOUS SOLUTION
Chlorhexidine gluconate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor, pharmacist or nurse
have 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Hibiscrub is and what it is used for
2.
What you need to know before you use Hibiscrub
3.
How to use Hibiscrub
4.
Possible side effects
5.
How to store Hibiscrub
6.
Contents of the pack and other information
1.
WHAT HIBISCRUB IS AND WHAT IT IS USED FOR
Hibiscrub belongs to a group of medicines called antiseptics. This
means that it helps to prevent
infections by killing germs on the skin.
Hibiscrub cutaneous solution contains the active ingredient
chlorhexidine gluconate 4% w/v
(40 mg/ml), which has antimicrobial properties.
Hibiscrub is used to disinfect the hands and skin prior to or after an
operation or clean procedure (pre-
and post-operative hand and skin disinfection / antisepsis).
Hibiscrub is also used to disinfect hands after handling infected
materials (antiseptic handwashing).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE HIBISCRUB
DO NOT USE HIBISCRUB
-
if you are allergic (hypersensitive) to chlorhexidine gluconate or any
of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Hibiscrub.
-
Avoid contact with the eyes, brain, meninges (the membranes
surrounding the brain and spinal
cord) and middle ear. If Hibiscrub comes into contact with the eyes,
wash out immediately and
thoroughly with water.
-
In patients with head or spinal injuries or a perforated ear drum (

Toote omadused

Health Products Regulatory Authority
12 November 2018
CRN008KHM
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hibiscrub 4.0% w/v Cutaneous Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Gluconate 40 mg/ml (4.0% w/v).
(incorporated as Chlorhexidine Digluconate Solution).
Excipient with known effect
Herbacol 015393 TD 0.5 mg/ml, fragrance with
3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, Amyl
cinnamal,
Amylcinnamyl alcohol, Anisyl alcohol, Benzyl alcohol, Benzyl benzoate,
Benzyl
cinnamate, Benzyl salicylate, Cinnamal, Citral, Citronellol, Coumarin,
d-Limonene,
Eugenol, Farnesol, Geraniol, Hexyl cinnamaldehyde,
Hydroxymethylpentyl-cyclohexenecarboxaldehyde, Isoeugenol, Lilial,
Linalool, Methyl
heptine carbonate, Oak moss and Tree moss.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous Solution
A clear or slightly opalescent red aqueous detergent antiseptic
solution with a
characteristic citrus odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
'Hibiscrub' is an antimicrobial preparation for pre-operative surgical
hand
disinfection, antiseptic hand washing on the ward, pre-operative skin
preparation for
patients undergoing elective surgery and post-operative skin
antisepsis for the
patient.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For external use only.
Pre-operative surgical hand disinfection
Health Products Regulatory Authority
12 November 2018
CRN008KHM
Page 2 of 7
Wet the hands and forearms, apply 5 ml of 'Hibiscrub' and wash for one
minute
cleaning the fingernails with a brush or scraper. Rinse, apply a
further 5 ml of
'Hibiscrub' and continue washing for a further two minutes. Rinse
thoroughly and dry.
Antiseptic hand wash on the ward
Wet the hands and forearms, apply 5 ml of 'Hibiscrub' and wash for one
minute.
Rinse thoroughly and dry.
Pre-operative skin preparation for patients undergoing elective
surgery
This involves two stages:
First phase(e.g. on ward): The patient may prepare himself by
undertaki