Neofordex
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
17-05-2023
Produktets egenskaber
(SPC)
17-05-2023
Offentlige vurderingsrapport
(PAR)
01-04-2016
Aktiv bestanddel:
dexamethasone
Tilgængelig fra:
THERAVIA
ATC-kode:
H02AB02
INN (International Name):
dexamethasone
Terapeutisk gruppe:
Corticosteroids for systemic use
Terapeutisk område:
Multiple Myeloma
Terapeutiske indikationer:
Treatment of multiple myeloma.
Produkt oversigt:
Revision: 11
Autorisation status:
Authorised
Autorisation dato:
2016-03-16
Indlægsseddel
23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NEOFORDEX 40 MG TABLET
dexamethasone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Neofordex is and what it is used for
2.
What you need to know before you take Neofordex
3.
How to take Neofordex
4.
Possible side effects
5.
How to store Neofordex
6.
Contents of the pack and other information
1.
WHAT NEOFORDEX IS AND WHAT IT IS USED FOR
Neofordex is a medicine that contains the active substance
dexamethasone. Dexamethasone is a type of
hormone called a glucocorticoid, sometimes called a corticoid or
corticosteroid, with various actions
including effects on white blood cells, which form part of the immune
system (the body’s natural defences).
Dexamethasone is similar to glucocorticoids which are naturally
produced in the body.
Neofordex is used to treat adult patients with multiple myeloma, a
cancer of the blood affecting the white
blood cells that produce antibodies. Neofordex will be given in
combination with other medicines for
multiple myeloma. They act together by killing cancerous white blood
cells.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEOFORDEX
_ _
DO NOT TAKE NEOFORDEX
−
if you are allergic to dexamethasone or any of the other ingredients
of this medicine (listed in section 6);
−
if you have a viral infection, especially viral hepatitis, herpes,
chickenpox or shingles;
−
if you have an untreated psychiatric illness.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist, nurse, before taking Neofordex
esp
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Neofordex 40 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains dexamethasone acetate equivalent to 40 mg
dexamethasone.
Excipient with known effect
Each tablet contains 98.1 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White, oblong (11 mm × 5.5 mm) tablet, with “40 mg” engraved on
one side..
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Neofordex is indicated in adults for the treatment of symptomatic
multiple myeloma in combination with
other medicinal products.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment must be initiated and monitored under the supervision of
physicians experienced in the
management of multiple myeloma.
Posology
The dose and administration frequency varies with the therapeutic
protocol and the associated treatment(s).
Neofordex administration should follow instructions for dexamethasone
administration when described in
the Summary of Product Characteristics of the associated treatment(s).
If this is not the case, local or
international treatment protocols and guidelines should be followed.
Prescribing physicians should carefully
evaluate which dose of dexamethasone to use, taking into account the
condition and disease status of the
patient.
The usual posology of dexamethasone is 40 mg once per day of
administration.
At the end of dexamethasone treatment, the dose should be tapered in a
stepwise fashion until a complete
stop.
_Missed dose_
The tablet should be taken immediately if the dose was missed for less
than 12 hours.
The next tablet should be taken at the usual time, if the dose was
missed for more than 12 hours.
In case of a missed dose, a double dose must not be taken.
Special population
_Elderly _
3
In elderly and/or frail patients, where the dose needs to be reduced,
it can be decided to prescribe another
product containing a lower dose of dexamethasone, according to the
appropriate treatment regimen.
_ _
_ _
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