Zeqmelit 6 mg Munsönderfallande film

Kraj: Szwecja

Język: szwedzki

Źródło: Läkemedelsverket (Medical Products Agency)

Składnik aktywny:

dexametason

Dostępny od:

AcuCort AB

Kod ATC:

H02AB02

INN (International Nazwa):

dexamethasone

Dawkowanie:

6 mg

Forma farmaceutyczna:

Munsönderfallande film

Skład:

glycerol Hjälpämne; dexametason 6 mg Aktiv substans

Typ recepty:

Receptbelagt

Podsumowanie produktu:

Förpacknings: Dospåse, 3 x 1 film; Dospåse, 2 x 1 film; Dospåse, 5 x 1 film

Status autoryzacji:

Godkänd

Data autoryzacji:

2020-10-06

Ulotka dla pacjenta

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZEQMELIT 4 MG ORODISPERSIBLE FILM
ZEQMELIT 6 MG ORODISPERSIBLE FILM
ZEQMELIT 8 MG ORODISPERSIBLE FILM
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 [product name] is and what it is used for
2.
What you need to know before you take [product name]
3.
How to take [product name]
4.
Possible side effects
5.
How to store [product name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[product name] contains the active substance dexamethasone, which
belongs to a group of medicinal
products called corticosteroids (cortisones). Corticosteroids reduce
inflammation and symptoms of
allergic reactions and suppress the immune system.
[product name] is used in the treatment of:
-
Swelling of the brain causedby brain tumours, neurosurgery or
abscesses
-
Acute severe asthma
-
Severe acute skin diseases
-
Autoimmune diseases
-
Rheumatoid arthritis
-
Prevention and treatment of nausea and vomiting due to treatment with
anti-cancer drugs
-
Croup
-
Allergic reactions, including acute allergic reactions
-
Treatment of coronavirus disease 2019 (COVID-19) in adult and
adolescent patients (aged 12
years and older with body weight of at least 40 kg) with difficulty
breathing and need of
oxygen therapy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [PRODUCT NAME]
DO NOT TAKE [PRODUCT NAME]
-
if you are allergic to dexamethasone or any of the other ingredients
of this medicine (listed in
section 6).
WARNINGS AND PRECAUTION

Charakterystyka produktu

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zeqmelit 4 mg orodispersible film
Zeqmelit 6 mg orodispersible film
Zeqmelit 8 mg orodispersible film
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[product name] 4 mg orodispersible film
Each orodispersible film contains 4 mg of dexamethasone.
[product name] 6 mg orodispersible film
Each orodispersible film contains 6 mg of dexamethasone.
[product name] 8 mg orodispersible film
Each orodispersible film contains 8 mg of dexamethasone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible film
[product name] 4 mg orodispersible film
White to pale yellow, translucent, rectangular film, 20 mm x 17 mm in
dimensions.
[product name] 6 mg orodispersible film
White to pale yellow, translucent, rectangular film, 20 mm x 25 mm in
dimensions.
[product name] 8 mg orodispersible film
White to pale yellow, translucent, rectangular film, 20 mm x 33 mm in
dimensions.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Processes that require anti-inflammatory and immunosuppressant
treatment among others:
•
Treatment of cerebral oedema secondary to brain tumours, neurosurgery,
brain abscesses
•
Treatment of acute severe asthma
•
Initial treatment of severe acute dermatological diseases
•
Initial treatment of autoimmune diseases
•
Treatment of active rheumatoid arthritis
•
Prophylaxis and treatment of nausea and vomiting induced by cytostatic
agents within the
scope of anti-emetic regimens
•
Croup
•
Allergic reactions, including acute allergic reactions
•
Treatment of coronavirus disease 2019 (COVID-19) in adult and
adolescent patients (aged 12
years and older with body weight at least 40 kg) who require
supplemental oxygen therapy.
2
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose required depends on the severity of the disease and the
patient’s individual response. In
general, higher doses are administered initially. The dose tends to be
higher during acute severe
conditions than during chronic d