CORTIVAL 1/2 betamethasone 0.5mg/g (as valerate) ointment tube

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

betamethasone valerate, Quantity: 0.61 mg/g (Equivalent: betamethasone, Qty 0.5 mg/g)

Доступно од:

Aspen Pharmacare Australia Pty Ltd

INN (Међународно име):

Betamethasone valerate

Фармацеутски облик:

Ointment

Састав:

Excipient Ingredients: liquid paraffin; white soft paraffin

Пут администрације:

Topical

Јединице у пакету:

30g, 15g

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

INDICATIONS AS AT 23 APRIL 2004 : Eczema including : atopic infantile, stasis and discoid eczemas. Besnier's (flexural) prurigo. Otitis externa. Neurodermatoses including lichen simplex, lichen planus. Seborrheic dermatitis, contact sensitivity reactions and allergies.

Резиме производа:

Visual Identification: A smooth greyish-white translucent mass. Free from undispersed particles and visible foreign contamination.; Container Type: Tube; Container Material: Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Статус ауторизације:

Registered

Датум одобрења:

2003-01-09

Информативни летак

CORTIVAL cream and ointment - Consumer Medicine Information
Page 1 of 4
CORTIVAL
CREAM AND OINTMENT
_betamethasone valerate _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CORTIVAL. It does
not contain all the available
information about this medicine.
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 CORTIVAL against the
benefits this medicine is expected to
have for you.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY CONCERNS ABOUT USING
THIS MEDICINE.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT IS CORTIVAL
USED FOR
CORTIVAL contains the active
ingredient betamethasone valerate (a
type of cortisone) and belongs to the
group of medicines called
corticosteroids.
CORTIVAL is available as a cream
and an ointment.
It is a topical corticosteroid, which is
applied to the body surface (skin).
It is used to help relieve the redness,
swelling, itching and discomfort of
various skin problems such as:
•
eczema
•
other types of dermatitis.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
CORTIVAL HAS BEEN PRESCRIBED
FOR YOU.
Your doctor knows which skin
conditions CORTIVAL is helpful for.
The cream and ointment are only
available with a doctor's prescription.
BEFORE YOU USE IT
_ _
_WHEN YOU MUST NOT USE IT _
DO NOT USE CORTIVAL IF YOU HAVE
EVER HAD AN ALLERGIC REACTION TO:
•
betamethasone valerate or any
other corticosteroid
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction to CORTIVAL may include
red, itchy skin rashes or a lumpy rash
(“hives”).
It may also include some or all of the
following: wheezing, swelling of the
lips/mouth, difficulty in breathing, hay
fever or fainting.
DO NOT USE THIS MEDICINE IF YOU ARE
PREGNANT OR INTEND TO BECOME
PREGNANT OR BREAST FEED.
Your doctor will discuss the risks and
benefits of using CORTIVAL during
pregnancy

Карактеристике производа

1
AUSTRALIAN PRODUCT INFORMATION
CORTIVAL (BETAMETHASONE VALERATE)
CREAM AND OINTMENT
1
NAME OF THE MEDICINE
Betamethasone valerate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CORTIVAL 1/2 cream and ointment contain 0.5 mg/g of betamethasone,
present as
0.61 mg/g of betamethasone 17
α
-valerate.
CORTIVAL 1/5 cream contains 0.2 mg/g of betamethasone, present as 0.24
mg/g of
betamethasone 17
α
-valerate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
CORTIVAL cream: A soft white cream with an odour faintly of
chlorocresol. Free from visible
contamination.
CORTIVAL ointment: A smooth greyish-white translucent mass. Free from
undispersed
particles and visible foreign contamination.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Eczema including: atopic infantile, stasis and discoid eczemas.
Besnier's (flexural) prurigo.
Otitis externa. Neurodermatoses including lichen simplex, lichen
planus. Seborrheic
dermatitis, contact sensitivity reactions and allergies.
4.2
D
OSE AND METHOD OF ADMINISTRATION
A small quantity should be applied to the affected area once or twice
daily until improvement
occurs. If necessary, cover the area with a dry dressing.
CORTIVAL 1/5 may be applied up to four times daily.
Different presentations of topical corticosteroids may demonstrate
variable activity as
measured by skin blanching tests, and treatment should be monitored
for efficacy and safety
in individual patients.
4.3
C
ONTRAINDICATIONS
•
Hypersensitivity to the preparations
•
Rosacea and acne vulgaris
•
Perioral dermatitis, perianal and genital pruritus
2
•
Viral infections of the skin (e.g. herpes simplex, chickenpox)
•
Gravitational ulcers
•
Tuberculosis of the skin.
The use of CORTIVAL skin preparations is not indicated in the
treatment of primarily infected
skin lesions caused by infections with fungi or bacteria or dermatoses
in children under one
year of age, including dermatitis and napkin eruptions.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
Long-term continuou