Savlon antiseptic liquid

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Cetrimide; Chlorhexidine gluconate

Tersedia dari:

Novartis Consumer Health UK Ltd

Kode ATC:

D08AC52

INN (Nama Internasional):

Cetrimide; Chlorhexidine gluconate

Dosis:

30mg/1ml ; 3mg/1ml

Bentuk farmasi:

Cutaneous liquid

Rute administrasi :

Cutaneous

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 13110200; GTIN: 0000050931156 5010518674506

Selebaran informasi

SAVLON ANTISEPTIC LIQUID - PL 44673/0115 –LABEL/LEAFLET
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
BOTTLE
1.
NAME OF THE MEDICINAL PRODUCT
Savlon Antiseptic Liquid
Cetrimide 3.0% w/v
Chlorhexidine Gluconate 0.3% w/v
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
ACTIVE INGREDIENTS:
Cetrimide 3.0% w/v and Chlorhexidine Gluconate 0.3% w/v
3.
LIST OF EXCIPIENTS
ALSO CONTAINS:
Isopropyl alcohol, terpineol, liquid deodoriser, benzyl benzoate,
d-gluconolactone, sodium
hydroxide and purified water.
4.
PHARMACEUTICAL FORM AND CONTENTS
Liquid
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
DIRECTIONS FOR USE:
FOR FIRST AID TREATMENT
– Apply the diluted liquid carefully to the affected area. Add 2
capfuls (30ml)
of the liquid to ½ litre of warm water.
FOR PERSONAL HYGIENE AND MIDWIFERY
– Add 2 capfuls (30ml) of the liquid to ½ litre of warm water.
FOR BATHING
– For full benefit do not mix with soap or detergents. Add 5 capfuls
(75ml) to bath water.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF
THE SIGHT AND REACH OF CHILDREN
DO NOT USE UNDILUTED ON THE SKIN
.
CAUTION:
Avoid contact with the eyes and ears. Treat any accidental splashes to
the eyes by washing open
eyes with water for at least ten minutes and seek medical advice. If
accidentally swallowed wash out the
mouth and drink plenty of water or milk. Consult your doctor and show
this container.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
Do not use after the expiry date given.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
SIDE EFFECTS
: In rare cases, skin irritation may occur; stop using and seek
medical advice. If symptoms
persist, or any unwanted effects occur, seek medical advice.
Use with care in newborn babies, especially those born prematurely.
Savlon Antiseptic Liquid may cause
chemical skin burns.
8.
EXPIRY DATE
EXP
9.
SPECIAL STORAGE CONDITIONS
Do not store above 25°C.
10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
11.
NAME AND ADDRESS OF THE MARKETING AU

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Savlon Antiseptic Liquid
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients: Cetrimide 3.0% w/v
Chlorhexidine Gluconate 0.3% w/v
3
PHARMACEUTICAL FORM
Liquid
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
A general antiseptic for external first-aid use.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults, children and elderly:
Savlon Antiseptic Liquid is for external use only and must be diluted
with
water as follows:
-
First aid for cuts, grazes, minor burns and bites
2 capfuls (30ml) to a ½ litre of
warm water
-
Personal hygiene and midwifery
2 capfuls (30ml) to a ½ litre of
warm water
-
Bathing
5 capfuls (75ml) to the bathwater
4.3
CONTRAINDICATIONS
None known.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Keep all medicines out of the reach of children.
Keep out of the eyes and ears.
Treat accidental splashes by washing open eyes with water for at least
ten minutes,
seek medical advice.
The use of chlorhexidine solutions, both alcohol based and aqueous,
for skin
antisepsis prior to invasive procedures has been associated with
chemical burns in
neonates. Based on available case reports and the published
literature, this risk
appears to be higher in preterm infants, especially those born before
32 weeks of
gestation and within the first 2 weeks of life.
Remove any soaked materials, drapes or gowns before proceeding with
the
intervention. Do not use excessive quantities and do not allow the
solution to pool in
skin folds or under the patient or drip on sheets or other material in
direct contact with
the patient. Where occlusive dressings are to be applied to areas
previously exposed
to Savlon Antiseptic Liquid, care must be taken to ensure no excess
product is present
prior to application of the dressing.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.6
FERTILITY, PREGNANCY AND LACTATION
No known restriction.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
The ability to drive or use machi