SoluPrep Antiseptic solution

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

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

Tersedia dari:

3M New Zealand Ltd

INN (Nama Internasional):

Chlorhexidine gluconate 2% w/v

Bentuk farmasi:

Antiseptic solution

Komposisi:

Active: Chlorhexidine gluconate 2%{relative}   Isopropyl alcohol 70%{vol}     Excipient: Acid red 33 Allura red AC Brilliant blue FCF Purified water

Jenis Resep:

General sale

Diproduksi oleh:

Medichem SA

Indikasi Terapi:

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.

Ringkasan produk:

Package - Contents - Shelf Life: Bottle, plastic, HDPE bottle with P/Triseal white security cap - 225 mL - 36 months from date of manufacture stored at or below 25°C. Do not refrigerate - Bottle, plastic, HDPE bottle with P/Triseal white security cap - 500 mL - 36 months from date of manufacture stored at or below 25°C. Do not refrigerate

Tanggal Otorisasi:

2013-06-17

Karakteristik produk

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