Diprosone OV

Země: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktivní složka:

Betamethasone dipropionate 0.064 mg/g Equivalent to 0.5 mg Betamethasone dipropionate;  

Dostupné s:

Organon (New Zealand) Limited

INN (Mezinárodní Name):

Betamethasone dipropionate 0.064 mg/g (Equivalent to 0.5 mg Betamethasone dipropionate)

Dávkování:

0.05% w/w

Léková forma:

Topical ointment

Složení:

Active: Betamethasone dipropionate 0.064 mg/g Equivalent to 0.5 mg Betamethasone dipropionate   Excipient: Propylene glycol Propylene glycol monostearate White beeswax White soft paraffin

Jednotky v balení:

Tube, HDPE cap, 30 g

Třída:

Prescription

Druh předpisu:

Prescription

Výrobce:

Crystal Pharma SA

Přehled produktů:

Package - Contents - Shelf Life: Tube, HDPE cap - 30 g - 24 months from date of manufacture stored at or below 25°C

Datum autorizace:

1981-07-28

Informace pro uživatele

DIPROSONE OV
1
DIPROSONE OV
_(OPTIMISED VEHICLE) _
_Betamethasone dipropionate 0.05% _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Diprosone OV
Cream and Ointment.
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 Diprosone OV
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT DIPROSONE OV IS
USED FOR
Diprosone OV contains the active
ingredient betamethasone
dipropionate.
Betamethasone dipropionate is a very
strong corticosteroid used to decrease
inflammation, redness, itchiness and
discomfort of some skin conditions.
Diprosone OV Cream and Ointment
are used to treat persistent or severe:
•
dermatitis
•
eczema (an often itchy skin
condition with redness, swelling,
oozing of fluid, crusting which
may lead to scaling)
•
acute or chronic psoriasis (a
stubborn skin disorder with
raised, rough, reddened areas
covered with dry, fine silvery
scales)
Your doctor may have prescribed
Diprosone OV for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DIPROSONE OV
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU USE
DIPROSONE OV
_WHEN YOU MUST NOT USE IT _
DO NOT USE DIPROSONE OV IF YOU
HAVE HAD AN ALLERGIC REACTION TO:
•
other medicines containing
betamethasone dipropionate
•
any other corticosteroid(s)
•
any of the ingredients listed at the
end of this leaflet.
Some symptoms of an allergic
reaction include wheezing, skin rash
and hives.
DO NOT USE DIPROSONE OV IF YOU
HAVE:
•
a viral infection (such as cold
sores, shingles or chicken pox)
•
a fungal infection (such as
thrush, ringworm or tinea)
•
tuberculosis of the skin
•
acne rosacea
•
inflammation around the mou

Charakteristika produktu

1
S-CCDS-MK1460-DPL-MTL-082017
DATA SHEET
1.
DIPROSONE OV
DIPROSONE OV (0.05% w/w) cream
DIPROSONE OV (0.05% w/w) ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Betamethasone dipropionate equivalent to betamethasone 0.5 mg/g (0.05%
w/w).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
DIPROSONE OV Cream is a white cream in an optimised vehicle.
DIPROSONE OV Ointment is a white ointment in an optimised vehicle.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DIPROSONE OV Cream and Ointment are indicated for the relief of the
inflammatory and
pruritic manifestations of resistant or severe
corticosteroid-responsive dermatoses. These
include atopic eczema, nummular eczema, contact dermatitis,
neurodermatitis, anogenital
and senile pruritus, lichen planus and psoriasis. DIPROSONE OV
Ointment is also indicated
for the maintenance of remission in chronic psoriasis.
4.2
DOSE AND METHOD OF ADMINISTRATION
DIPROSONE OV Cream and Ointment: Apply a thin film once or twice daily
to cover
completely the affected area.
Patients with chronic psoriasis who have achieved at least a marked
improvement in their
psoriatic lesion(s) (i.e., approximately
≥
80% improvement) with DIPROSONE OV may be
maintained in remission with a pulse dosing regimen consisting of
three consecutive
applications of up to 3.5 g each of DIPROSONE OV Ointment, twelve
hours apart (e.g.,
morning, evening, following morning) to the previously affected areas
once each week. For
this purpose, DIPROSONE OV Ointment should be applied to the lesion
sites previously
affected and treated.
Patients
on
this
pulse
dose
regimen
who
relapse
should
be
reverted
back
to
the
conventional dosing regimen.
4.3
CONTRAINDICATIONS
Hypersensitivity to betamethasone dipropionate, other corticosteroids
or any components in
DIPROSONE OV. Like other topical corticosteroids, DIPROSONE OV is
contraindicated in
viral infections of the skin, such as vaccinia, varicella and Herpes
simplex, also tuberculosis,
acne
rosacea,
fungal
skin
infections
(moniliasis)