Savlon Antiseptic Cream Cetrimide 0.5% w/w Chlorhexidine Digluconate 0.1% w/w

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Cetrimide; Chlorhexidine gluconate

متاح من:

Clonmel Healthcare Ltd

ATC رمز:

D08AJ; D08AJ04

INN (الاسم الدولي):

Cetrimide; Chlorhexidine gluconate

جرعة:

0.5/0.1 percent weight/weight

الشكل الصيدلاني:

Cream

المجال العلاجي:

Quaternary ammonium compounds; cetrimide

الوضع إذن:

Marketed

تاريخ الترخيص:

1991-06-26

خصائص المنتج

Health Products Regulatory Authority
04 November 2019
CRN0098VW
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Savlon Antiseptic Cream Cetrimide 0.5% w/w Chlorhexidine Digluconate
0.1% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients:
Cetrimide 0.50% w/w
Chlorhexidine digluconate 0.10% w/w
Excipients:
Cetostearyl alcohol 10.00% w/w
Methyl parahydroxybenzoate (E218) 0.01% w/w
Propyl parahydroxybenzoate (E216) 0.01% w/w
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cream.
Smooth, white, homogenous cream with an antiseptic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For prevention and management of superficial infections in skin tissue
including wounds and minor burns.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use.
Apply the cream over the affected area after cleansing.
4.3 CONTRAINDICATIONS
Hypersensitivity to chlorhexidine digluconate, cetrimide or to any of
the excipient listed in section 6.1
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only.
Avoid contact with the eyes, ears, mouth or other mucosa.
If accidentally splashed into the eye, the open eye should be
irrigated for at least 10 minutes.
If symptoms persist or condition worsens, discontinue use and consult
a physician.
The product is incompatible with anionic substances (e.g. soap).
Information concerning excipients
Savlon cream contains:
- Cetostearyl alcohol which may cause local skin reactions (e.g.
contact dermatitis)
- Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate
(E216) which may cause allergic reactions (possibly delayed).
Health Products Regulatory Authority
04 November 2019
CRN0098VW
Page 2 of 4
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
No interaction studies have been performed.
4.6 FERTILITY, PREGNANCY AND LACTATION
Pregnancy:
There are no adequate data from the use of chlorhexidine digluconate
and cetrimide in pregnant women. The potential risk for
humans is unknown but is most