CELESTONE CHRONODOSE betamethasone 5.7 mg/1 mL (as acetate and sodium phosphate) injection ampoule

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

betamethasone acetate, Quantity: 3 mg/mL (Equivalent: betamethasone, Qty 5.7 mg/mL); betamethasone sodium phosphate, Quantity: 3.9 mg/mL

Disponible depuis:

ORGANON PHARMA PTY LTD

forme pharmaceutique:

Injection, suspension

Composition:

Excipient Ingredients: disodium edetate; monobasic sodium phosphate; water for injections; dibasic sodium phosphate; benzalkonium chloride

Mode d'administration:

Intracavitary, Intramuscular, Intraarticular, Intracutaneous, Intralesional

Unités en paquet:

1 mL x 5, 1 mL x 2 (sample)

classe:

Medicine Registered

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

Celestone Chronodose is indicated in the treatment of both severe and moderate conditions in acute and chronic self-limiting diseases responsive to systemic corticosteroid therapy and is especially useful in patients for whom treatment with oral corticosteroid medication is not feasible. Representative conditions: Rheumatic Disorders: rheumatoid arthritis, acute and subacute bursitis, epicondylitis, acute non-specific tenosynovitis, myositis, fibrositis, tendonitis, psoriatic arthritis. Collagen Diseases: systemic lupus erythematosus, scleroderma, dermatomyositis. Allergic States: status asthmaticus, chronic bronchial asthma, seasonal or perennial allergic rhinitis, severe allergic bronchitis, contact dermatitis, atopic dermatitis, hypersensitivity reactions to drug and insect bites. Dermatologic Conditions: localised, hypertrophic infiltrated lesions of lichen planus, psoriatic plaques, granuloma annulare and lichen simplex chronicus(neurodermatitis). keloids, discoid lupus erythematosus, necrobiosis lipoidi

Descriptif du produit:

Visual Identification: Clear colourless liquid containing easily suspendable white particles with no visible agglomerates; free from foreign matter; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Statut de autorisation:

Registered

Date de l'autorisation:

1991-10-08

Notice patient

CELESTONE
®
CHRONODOSE
®
_INJECTION_
_Betamethasone sodium phosphate/betamethasone acetate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about Celestone
Chronodose. 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 Celestone
Chronodose against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE
OR IN A SAFE PLACE.
You may want to read it again.
WHAT CELESTONE
CHRONODOSE IS USED
FOR
Celestone Chronodose contains
betamethasone as the active
ingredient. Betamethasone is a
glucocorticoid and belongs to a
group of medicines called
corticosteroids.
Celestone Chronodose is used to treat
symptoms associated with
inflammatory processes and/or
allergic reactions, which may
include:
•
swelling
•
redness
•
itching.
It may be used as part of the
treatment for a number of different
diseases such as severe allergies, skin
problems, asthma or arthritis.
Although Celestone Chronodose may
relieve the symptoms of these
diseases, it will not cure them.
Celestone Chronodose can also be
used to prevent respiratory distress
syndrome in premature infants.
Your doctor may have prescribed
Celestone Chronodose for another
reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CELESTONE
CHRONODOSE HAS BEEN PRESCRIBED
FOR YOU.
BEFORE YOU START
CELESTONE
CHRONODOSE
_WHEN YOU MUST NOT RECEIVE_
_IT:_
CELESTONE CHRONODOSE SHOULD NOT
BE USED IF:
1.
YOU HAVE AN ALLERGY TO:
•
Celestone Chronodose, or
betamethasone
•
any of the ingredients listed at the
end of this leaflet
•
any other cortisone-like
medicines.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath, wheezing,
difficulty breathing or a tight
feeling in your chest
•
swelling of the face, lips, tongue
or other parts o

Résumé des caractéristiques du produit

AUSTRALIAN PRODUCT INFORMATION
CELESTONE
® CHRONODOSE
® INJECTION
1
NAME OF THE MEDICINE
Betamethasone acetate and Betamethasone sodium phosphate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Celestone Chronodose Injection is a sterile aqueous suspension
containing the combination of
betamethasone
sodium
phosphate
and
betamethasone
acetate.
Each
mL
of
Celestone
Chronodose Injection contains betamethasone 5.7 mg, as betamethasone
sodium phosphate 3.9
mg (in solution) and betamethasone acetate 3 mg (in suspension) in an
aqueous vehicle.
EXCIPIENTS WITH KNOWN EFFECT:
Celestone Chronodose contains benzalkonium chloride.
For the full list of
excipients, see Section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
Suspension for injection.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Celestone Chronodose is indicated in the treatment of both severe and
moderate conditions, in
acute and chronic self-limiting diseases responsive to systemic
corticosteroid therapy, especially
in patients for whom treatment with oral corticosteroid medication is
not feasible.
REPRESENTATIVE CONDITIONS:
RHEUMATIC DISORDERS
Rheumatoid arthritis, acute and subacute bursitis, epicondylitis,
acute non-specific tenosynovitis,
myositis, fibrositis, tendinitis, psoriatic arthritis.
COLLAGEN DISEASES
Systemic lupus erythematosus, scleroderma, dermatomyositis.
ALLERGIC STATES
Status asthmaticus, chronic bronchial asthma, seasonal or perennial
allergic rhinitis, severe
allergic bronchitis, contact dermatitis, atopic dermatitis,
hypersensitivity reactions to drug and
insect bites.
DERMATOLOGICAL CONDITIONS
Localised, hypertrophic, infiltrated lesions of lichen planus,
psoriatic plaques, granuloma annulare
and lichen simplex chronicus (neurodermatitis), keloids, discoid lupus
erythematosus, necrobiosis
lipoidica diabeticorum, alopecia areata.
ANTEPARTUM USE IN THE PREVENTION OF RESPIRATORY DISTRESS SYNDROME IN
PREMATURE INFANTS
When it is deemed necessary to induce labour prior to the
thirty-second week of gestation or when
premature birth before the