DP Fusidic Acid Cream

Maa: Uusi-Seelanti

Kieli: englanti

Lähde: Medsafe (Medicines Safety Authority)

Aktiivinen ainesosa:

Fusidic acid 20.35 mg/g (as the 0.5 hydrate)

Saatavilla:

Douglas Pharmaceuticals Limited

INN (Kansainvälinen yleisnimi):

Fusidic acid 20.35 mg/g (as the 0.5 hydrate)

Annos:

20 mg/g

Lääkemuoto:

Topical cream

Koostumus:

Active: Fusidic acid 20.35 mg/g (as the 0.5 hydrate) Excipient: Butylated hydroxyanisole Cetyl alcohol Glycerol Hydrochloric acid Liquid paraffin Polysorbate 60 Potassium sorbate Purified water White soft paraffin

Prescription tyyppi:

Prescription

Valmistaja:

Ercros S A

Käyttöaiheet:

Indicated either alone or in combination with systemic therapy, in the treatment of primary and secondary skin infections caused by sensitive strains of Staphylococcus aureus, Streptococcus spp and Corynebacterium minutissimum. Primary skin infections that may be expected to respond to treatment with fusidic acid applied topically include: impetigo contagiosa, superficial folliculitis, sycosis barbae, paronychia and erythrasma; also such secondary skin infections as infected eczematoid dermatitis, infected contact dermatitis and infected cuts/abrasions.

Tuoteyhteenveto:

Package - Contents - Shelf Life: Tube, aluminium, with HDPE screw cap - 15 g - 24 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C - Tube, aluminium, with HDPE screw cap - 30 g - 24 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C

Valtuutus päivämäärä:

2013-07-04

Pakkausseloste

CONSUMER MEDICINE INFORMATION
1
DP FUSIDIC ACID CREAM
_Fusidic Acid _
20 mg/g cream
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START
USING DP FUSIDIC ACID CREAM
This leaflet answers some common questions
about DP Fusidic Acid Cream. It does not contain
all the available information. It does not take the
place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your
doctor has weighed the risks of you using DP
Fusidic Acid Cream against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS
MEDICINE, ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. YOU MAY
NEED TO READ IT AGAIN.
WHAT DP FUSIDIC ACID CREAM IS
USED FOR
The active ingredient of DP Fusidic Acid Cream is
fusidic acid.
DP Fusidic Acid Cream should be used on the skin
for the local treatment of infections caused by
bacteria that are sensitive to fusidic acid such as
impetigo (a weeping, crusty and swollen patch of
skin), infected cuts and abrasions, infected
contact dermatitis (inflammation of the skin),
infected eczema.
Fusidic Acid Cream belongs to a group of
medicines called antibiotics. It works by
preventing bacterial protein synthesis and
therefore killing the bacteria causing the
infection.
Your doctor may have prescribed DP Fusidic Acid
Cream for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT
WHY DP FUSIDIC ACID CREAM HAS BEEN PRESCRIBED
FOR YOU.
This medicine is available only with a doctor's
prescription.
BEFORE YOU USE DP FUSIDIC ACID
CREAM
_WHEN YOU MUST NOT USE IT _
DO NOT SUE DP FUSIDIC ACID CREAM IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing fusidic acid or a
class of medicines called antibiotics for
topical use
•
any of the ingredients listed at the end of
this leaflet
Some of the symptoms of an allergic reaction
may include:
•
difficulty in breathing or wheezing
•
shortness of breath
•
swelling of the face, tongue, lips, or other
parts of the body
•
hives on the skin, rash, or itching
DO NOT USE

Valmisteyhteenveto

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
DP Fusidic Acid Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of DP Fusidic Acid Cream contains fusidic acid 20.35 mg, as
hydrate, equivalent to
fusidic acid 20 mg.
EXCIPIENT(S) WITH KNOWN EFFECT
Butylhydroxyanisole, Cetyl alcohol and Potassium sorbate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Smooth and white cream.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Indicated either alone or in combination with systemic therapy, in the
treatment of primary and
secondary skin infections caused by sensitive strains of
_Staphylococcus aureus_, _Streptococcus _
_spp._ and _Corynebacterium minutissimum_.
Primary skin infections that may be expected to respond to treatment
with fusidic acid applied
topically include: impetigo contagiosa, superficial folliculitis,
sycosis barbae, paronychia and
erythrasma; also, such secondary skin infections as infected
eczematoid dermatitis, infected
contact dermatitis and infected cuts / abrasions.
4.2.
DOSE AND METHOD OF ADMINISTRATION
DOSE
_ADULTS AND CHILDREN _
Uncovered lesions – apply gently three or four times daily.
Covered lesions – less frequent applications may be adequate.
METHOD OF ADMINISTRATION
2 | P a g e
Cutaneous use.
4.3.
CONTRAINDICATIONS
•
Infection caused by non-susceptible organisms, in particular,
_Pseudomonas aeruginosa_.
•
DP Fusidic Acid Cream contraindicated in patients with
hypersensitivity to fusidic acid
and its salts or to any of the excipients listed in section 6.1
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Bacterial resistance has been reported to occur with the use of
fusidic acid applied topically. As
with all topical antibiotics, extended or recurrent application may
increase the risk of contact
sensitisation and the development of antibiotic resistance.
Extended or recurrent use may increase the risk of developing contact
sensitisation.
When DP Fusidic Acid Cream is used on the face, care should be taken
to avoid the eyes,
because fusidic