PREDNISOLONE

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

PREDNISOLONE

Предлага се от:

Chemidex Pharma Limited

АТС код:

D07AA03

INN (Международно Name):

PREDNISOLONE

дозиране:

20 Milligram

Лекарствена форма:

Rectal Foam

Вид предписание :

Product subject to prescription which may not be renewed (A)

Терапевтична област:

prednisolone

Статус Оторизация:

Marketed

Дата Оторизация:

1989-11-28

Листовка

IR8-1/L/1
1.
Shake before use.
2.
When using for the first time remove
and discard the small plastic safety
tag from under the button.
3.
Carefully push an applicator nozzle
onto the side arm of the canister.
Line up semi-circular cut-out on cap
with nozzle.
4.
The easiest way to use Prednisolone 20mg
Rectal Foam is to stand with one foot raised
on a chair and gently insert the nozzle
tip into your rectum. It may help if you
smear the nozzle with lubricating jelly
before insertion. 5.
Important: Holding the canister
with the dose button pointing down,
press the button on the canister
firmly and release. Only press the
button once otherwise you will
exceed the recommended dose.
Note: the canister will only work
when held with the dose button
pointing down.
Foam is expelled when the button is
released.
Dispose of the used nozzle in the
plastic bag provided - the nozzles
will not flush down toilets.
canister nozzle
applicator nozzle
foam
canister
safety tag
semi-circular
cut-out
dose button
This medicine has been designed for your maximum comfort and ease of
use. Read these instructions carefully before using Prednisolone
20 mg Rectal Foam for the first time. This medicine is for
application in the rectum only.
If you find it difficult to use Prednisolone 20 mg Rectal Foam in a
standing position an alternative is to administer while lying on your
side
with both legs bent up.
DISPOSAL
The used nozzles should be disposed of in the plastic bag provided.
IF YOU FORGET TO USE PREDNISOLONE 20 MG RECTAL FOAM
Do not worry if you miss a dose of Prednisolone 20 mg Rectal Foam.
Administer it as soon as you remember and then use your next dose at
the usual time. Do not use more than 2 doses in one day.
IF YOU USE MORE PREDNISOLONE 20 MG RECTAL FOAM THAN YOU SHOULD
Overdosage by this route is unlikely, but if someone else takes your
medicine or it is used incorrectly take the canister to your doctor
and
ask for advice.
If you have any further questions on the use of this medicine, ask
your doctor.
4. POSSIBLE SIDE EFFECTS
Lik

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prednisolone 20 mg Rectal Foam
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose contains 31.4 mg of the active ingredient
prednisolone metasulphobenzoate sodium, equivalent to
prednisolone 20.0 mg
Excipients with known effect: Cetostearyl alcohol 4.4 mg and Sorbic
Acid 1.74 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Rectal Foam
A white to pale cream coloured, metered-dose rectal foam.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of proctitis and ulcerative colitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND ELDERLY PATIENTS:
One metered dose rectally once or twice daily for 2 weeks, extending
treatment for a further 2 weeks when a good
response is obtained. Use should be discontinued at the discretion of
the physician once the disease is stable and under
control.
PAEDIATRIC POPULATION:
Not recommended.
Shake canister before use. When using for the first time remove and
discard the small plastic safety tag from under the
button. An applicator nozzle is then pushed on to the side arm of the
canister. The semi-circular cut-out on the cap is
lined up with the nozzle. The easiest way to administer Prednisolone
20 mg Rectal Foam is to stand with one foot
raised on a chair and gently insert the nozzle tip into the rectum.
Smearing the nozzle with lubricating jelly may help insertion. Holding
the canister with the dose button pointing down,
press the button on the canister firmly and release. Only press the
button once so as not to exceed the recommended
dose.
Method of administration:
For rectal administration only.
Posology
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_