SoluPrep Antiseptic Swab

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Chlorhexidine gluconate 2%{relative};  ; Isopropyl alcohol 70%{vol};  ;  

Available from:

3M New Zealand Ltd

INN (International Name):

Chlorhexidine gluconate 2% w/v

Pharmaceutical form:

Antiseptic solution

Composition:

Active: Chlorhexidine gluconate 2%{relative}   Isopropyl alcohol 70%{vol}     Excipient: Purified water

Prescription type:

General sale

Manufactured by:

Medichem SA

Therapeutic indications:

Antiseptic for preparation of the patient's skin prior to invasive procedure on dry skin sites only. Helps reduce bacteria that potentially can cause skin infection. Efficacy on moist sites such as groin has not been demonstrated.

Product summary:

Package - Contents - Shelf Life: Sachet, aluminium foil, containing large swab impregnated with 5.2 mL solution - 30 dose units - 36 months from date of manufacture stored at or below 25°C. Do not refrigerate - Sachet, aluminium foil, containing small swab impregnated with 1.6 mL solution - 50 dose units - 36 months from date of manufacture stored at or below 25°C. Do not refrigerate

Authorization date:

2013-06-17

Summary of Product characteristics

NEW ZEALAND DATA SHEET
New Zealand Data Sheet SoluPrep v1 25Oct19
Page 1 of 8
1 PRODUCT NAME
SoluPrep® Antiseptic Sponge (clear)
SoluPrep® Antiseptic Sponge (tinted)
SoluPrep® Antiseptic Wipe (clear)
SoluPrep® Antiseptic Swab (clear)
SoluPrep® Antiseptic Swab (tinted)
SoluPrep® Antiseptic Solution (clear)
SoluPrep® Antiseptic Solution (tinted)
Not all products may be marketed.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SoluPrep® Antiseptic Sponge (clear) contains Chlorhexidine gluconate
2%w/v and Isopropyl alcohol
70%w/v
SoluPrep® Antiseptic Sponge (tinted) contains Chlorhexidine gluconate
2%w/v and Isopropyl alcohol
70%w/v
SoluPrep® Antiseptic Wipe (clear) contains Chlorhexidine gluconate
2%w/v and Isopropyl alcohol
70%w/v
SoluPrep® Antiseptic Swab (clear) contains Chlorhexidine gluconate
2%w/v and Isopropyl alcohol
70%w/v
SoluPrep® Antiseptic Swab (tinted) contains Chlorhexidine gluconate
2%w/v and Isopropyl alcohol
70%w/v
SoluPrep® Antiseptic Solution (clear) contains Chlorhexidine
gluconate 2%w/v and Isopropyl alcohol
70%w/v
SoluPrep® Antiseptic Solution (tinted) contains Chlorhexidine
gluconate 2%w/v and Isopropyl alcohol
70%w/v
Not all products may be marketed.
For full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Solution (clear, tinted red);
Sponges (clear, tinted red);
Swabs (clear, tinted red);
Wipes (clear);
Cutaneous solution
Not all solutions may be marketed.
NEW ZEALAND DATA SHEET
New Zealand Data Sheet SoluPrep v1 25Oct19
Page 2 of 8
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Antiseptic for preparation of the patient’s skin prior to invasive
procedure on dry skin sites only.
Helps reduce bacteria that potentially can cause skin infection.
4.2
Dose and method of administration
For cutaneous use.
Not recommended for use on infants less than 2 months of age.
The choice of application, (sponge, wipe, swab or solution), will
depend on the procedure being
undertaken, the coverage area required and the clinician’s
preference.
PRODUCT
CODE
APPLICATION TYPE
COVERAGE AR