Celestone Chronodose

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Betamethasone acetate 3 mg/mL; Betamethasone sodium phosphate 3.9 mg/mL;  

Disponible depuis:

Organon (New Zealand) Limited

DCI (Dénomination commune internationale):

Betamethasone acetate 3 mg/mL

forme pharmaceutique:

Solution for injection

Composition:

Active: Betamethasone acetate 3 mg/mL Betamethasone sodium phosphate 3.9 mg/mL   Excipient: Benzalkonium chloride Dibasic sodium phosphate Disodium edetate dihydrate Monobasic sodium phosphate monohydrate Water for injection

Unités en paquet:

Ampoule, 5 x 1ml, 5 mL

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

MSD International GmbH (Singapore Branch)

Descriptif du produit:

Package - Contents - Shelf Life: Ampoule, 5 x 1ml - 5 mL - 18 months from date of manufacture stored at or below 25°C protect from light

Date de l'autorisation:

1969-12-31

Notice patient

CELESTONE CHRONODOSE
1
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, to

Résumé des caractéristiques du produit

NEW ZEALAND DATA SHEET
Page 1 of 9
S-CCDS-MK1459-SOi-MK5166A-SUi-082017a
1. PRODUCT NAME
CELESTONE
®
CHRONODOSE
®
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Celestone
Chronodose
Injection
is
a
sterile
aqueous
suspension
containing
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.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Suspension for injection
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Celestone Chronodose Injection is recommended in the therapy of both
severe and moderate diseases, in
acute and chronic self-limiting diseases responsive to systemic
corticosteroid therapy, especially useful in
patients for whom treatment with oral corticosteroid medication is not
feasible. Corticosteroid hormone
therapy is an adjunct to, and not a replacement for, conventional
therapy.
REPRESENTATIVE CONDITIONS:
_Rheumatic disorders_.
Rheumatoid arthritis, acute and subacute bursitis, epicondylitis,
acute nonspecific 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 drugs 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
thirty-second
week