SoluPrep Antiseptic Wipe

Ülke: Yeni Zelanda

Dil: İngilizce

Kaynak: Medsafe (Medicines Safety Authority)

Aktif bileşen:

Chlorhexidine gluconate 2%{relative} (2.35% overage);  ; Isopropyl alcohol 70%{vol};  ;  

Mevcut itibaren:

3M New Zealand Ltd

INN (International Adı):

Chlorhexidine gluconate 2% w/v (2.35% overage)

Farmasötik formu:

Antiseptic solution

Kompozisyon:

Active: Chlorhexidine gluconate 2%{relative} (2.35% overage)   Isopropyl alcohol 70%{vol}     Excipient: Purified water

Reçete türü:

General sale

Tarafından üretildi:

Medichem SA

Terapötik endikasyonlar:

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.

Ürün özeti:

Package - Contents - Shelf Life: Sachet, aluminium foil, containing large wipe and 1.5 mL solution - 100 dose units - 36 months from date of manufacture stored at or below 25°C. Do not refrigerate - Sachet, aluminium foil, containing small wipe and 0.65 mL solution - 200 dose units - 36 months from date of manufacture stored at or below 25°C. Do not refrigerate - Sachet, aluminium foil, containing large wipe and 1.6 mL solution - 1000 dose units - 36 months from date of manufacture stored at or below 25°C. Do not refrigerate

Yetkilendirme tarihi:

2013-06-17

Ürün özellikleri

NEW ZEALAND DATA SHEET
New Zealand Data Sheet SoluPrep v2 29Apr2024
Page 1 of 9
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 v2 29Apr2024
Page 2 of 9
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
COVERAG