PREDMIX prednisolone (as sodium phosphate) 5mg/1mL liquid bottle

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

prednisolone sodium phosphate, Quantity: 6.72 mg/mL (Equivalent: prednisolone, Qty 5 mg/mL)

Disponible depuis:

Aspen Pharmacare Australia Pty Ltd

forme pharmaceutique:

Oral Liquid, solution

Composition:

Excipient Ingredients: propylene glycol; dibasic sodium phosphate dodecahydrate; monobasic sodium phosphate; disodium edetate; methyl hydroxybenzoate; propyl hydroxybenzoate; purified water

Mode d'administration:

Oral

Unités en paquet:

30mL

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

Whenever corticosteroid therapy is indicated.

Descriptif du produit:

Visual Identification: Clear, colourless, liquid free from haze and substantially free from particulate matter; Container Type: Bottle; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Statut de autorisation:

Registered

Date de l'autorisation:

1999-01-19

Notice patient

PREDMIX ORAL LIQUID – Consumer Medicine Information
Page 1 of 5
PREDMIX ORAL LIQUID
_prednisolone sodium phosphate _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PredMix Oral
Liquid. It does not contain all the
information that is known about
PredMix Oral Liquid.
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 taking PredMix Oral
Liquid 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 PREDMIX ORAL
LIQUID IS USED FOR
PredMix Oral Liquid contains
prednisolone sodium phosphate
which is changed to prednisolone
after it enters the body.
Prednisolone belongs to a group of
medicines called corticosteroids. It is
a synthetic version of a naturally
occurring body hormone called
cortisol.
It works by entering inflammatory
cells and blocking the inflammatory
reaction. This medicine is only able
to prevent or reduce symptoms of
your condition, it does not cure it.
PredMix Oral Liquid is used in the
treatment of many different
conditions. Some of these conditions
include: severe allergies, severe or
chronic asthma, skin problems,
arthritis, inflammatory diseases of
the bowel, cancer and "auto-immune"
diseases.
PredMix Oral Liquid is also used to
prevent or reduce the symptoms of
inflammation (such as swelling,
redness, pain, tenderness or itching)
in any part of the body. These
symptoms can occur in response to
injury or can be caused by many
different conditions.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY PREDMIX ORAL
LIQUID HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
This medicine is only available with
a doctor's prescription.
There is no evidence that it is
addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PREDMIX ORAL LIQUID
IF YO

Résumé des caractéristiques du produit

Predmix – Product Information
Page 1
of 10
AUSTRALIAN PRODUCT INFORMATION
PREDMIX
(PREDNISOLONE SODIUM PHOSPHATE)
ORAL LIQUID
1
NAME OF THE MEDICINE
Prednisolone sodium phosphate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Predmix contains the active ingredient prednisolone sodium phosphate
7.06 mg/1 mL
equivalent to prednisolone 5 mg/1 mL.
It contains excipients with known effect, methyl hydroxybenzoate and
propyl hydroxybenzoate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Predmix is a clear, colourless liquid free from haze and substantially
free from particulate matter.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Whenever corticosteroid therapy is indicated.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Dosage should be individualised according to severity of condition and
response of patient.
_ _
CHILDREN:
Asthma: 1 mg/kg once daily
Croup: 1 mg/kg/dose every 8-12 hours for 48 hours
Physiological replacement: 4-5 mg/m
2
/day (Preferable to use shorter acting steroid to avoid growth
suppression)
Infantile spasms, intractable epilepsy: 2 mg/kg/day
Nephrotic syndrome: 2 mg/kg/day (max 80 mg/day) until protein free
urine for 5 days. Increase to 4
mg/kg/day (max 120 mg/day) if no response within 28 days.
Autoimmune liver disease, Crohn's disease, Ulcerative colitis: 2
mg/kg/day for initial control, reducing
over 2 months to a maintenance dose of 5 mg/day or less (or cease).
_ _
ADULTS:
10-40 mg daily (up to 100 mg can be used in divided doses) reducing
gradually when control is achieved
to the lowest possible dose (5-20 mg).
Predmix – Product Information
Page 2
of 10
4.3
C
ONTRAINDICATIONS
Patients with active or doubtfully quiescent tuberculosis should not
be given Predmix Oral Liquid except
as an adjunct to treatment with tuberculostatic drugs.
Systemic fungal infections and known hypersensitivity to prednisolone
or any of the excipients_. _
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
SCLERODERMA RENAL CRISIS:
Caution is required in patients with systemic scl