Chlorhexidine gluconate 0.5% solution

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Chlorhexidine gluconate

Boleh didapati daripada:

Ennogen Healthcare Ltd

Kod ATC:

B05CA02

INN (Nama Antarabangsa):

Chlorhexidine gluconate

Dos:

5mg/1ml

Borang farmaseutikal:

Cutaneous solution

Laluan pentadbiran:

Cutaneous

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 13110200

Risalah maklumat

Prevase
™
PREVASE
For pre-operative skin disinfection prior to minor surgical
procedures.
CHLORHEXIDINE GLUCONATE 0.5% W/V IN 70% V/V DEB CUTANEOUS SOLUTION
PL 04509/0062
Text revised March 2018

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Prevase Chlorhexidine Gluconate 0.5% w/v in 70% v/v DEB Cutaneous
Solution.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Gluconate Solution 20% BP (Ph Eur) 2.5% v/v
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Cutaneous Solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For pre-operative skin disinfection prior to minor surgical
procedures.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This product is applied topically.
4.3
CONTRAINDICATIONS
Do not use in patients with a known hypersensitivity to the product or
any of
its components, especially in those with a history of possible
chlorhexidine-
related allergic reactions (see sections 4.4 and 4.8).
Do not use in contact with eyes, brain, meninges, middle ear or
external ear
with a perforated tympanic membrane.
Do not inject.
When use is to be followed by diathermy do not allow pooling of the
fluid to
occur and ensure that the skin and surrounding drapes are dry. Do not
use in
body cavities.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Prevase contains chlorhexidine. Chlorhexidine is known to induce
hypersensitivity, including generalised allergic reactions and
anaphylactic
shock. The prevalence of chlorhexidine hypersensitivity is not known,
but
available literature suggests this is likely to be very rare. Prevase
should not
be administered to anyone with a potential history of an allergic
reaction to a
chlorhexidine-containing compound (see section 4.3 and 4.8).
Accidental ingestion:- chlorhexidine is poorly absorbed orally. Treat
with
gastric lavage using milk, egg white, gelatine or mild soap. Employ
supportive measures as appropriate.
Accidental intravenous infusion – blood transfusion may be necessary
to
counteract haemolysis.
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
literatur