Dexamethason Medochemie 4 mg/ml, oplossing voor injectie/infusie

Land: Nederland

Språk: nederlandsk

Kilde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktiv ingrediens:

DEXAMETHASONDINATRIUMFOSFAAT 4,37 mg/ml SAMENSTELLING overeenkomend met ; DEXAMETHASONFOSFAAT 4 mg/ml

INN (International Name):

DEXAMETHASONDINATRIUMFOSFAAT 4,37 mg/ml SAMENSTELLING overeenkomend met ; DEXAMETHASONFOSFAAT 4 mg/ml

Legemiddelform:

Oplossing voor injectie of infusie

Sammensetning:

CREATININE ; DINATRIUMEDETAAT 2-WATER ; NATRIUMHYDROXIDE (E 524) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507)

Administreringsrute:

Intraveneus gebruik, Intramusculair gebruik, Intra-articulair gebruik, Infiltratie

Autorisasjon dato:

1900-01-01

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DEXAMETHASON MEDOCHEMIE 4 MG/ML, OPLOSSING VOOR INJECTIE/INFUSIE
dexamethasone phosphate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Dexamethason Medochemie is and what it is used for
2.
What you need to know before you are given Dexamethason Medochemie
3.
How Dexamethason Medochemie is given
4.
Possible side effects
5.
How to store Dexamethason Medochemie
6.
Contents of the pack and other information
1.
WHAT DEXAMETHASON MEDOCHEMIE IS AND WHAT IT IS USED FOR
DEXAMETHASONE IS A SYNTHETIC GLUCOCORTICOID (adrenocortical hormone)
with an effect on
metabolism, electrolyte balance and tissue functions.
DEXAMETHASON MEDOCHEMIE IS USED IN
Diseases requiring treatment with glucocorticoids. Depending on the
type and severity, these include:
SYSTEMIC USE:
-
Swelling of the brain caused by brain tumours, brain surgery, brain
abscess, bacterial
inflammation of the lining of the brain.
-
States of shock after severe injuries, for prophylactic treatment of
shock lung.
-
Severe acute asthma attack.
-
Initial treatment of extensive acute severe skin diseases such as
erythroderma, pemphigus vulgaris,
acute eczema.
-
Treatment of systemic rheumatic diseases (rheumatic diseases that can
affect internal organs) such
as systemic lupus erythematosus.
-
Active rheumatic inflammation of joints (rheumatoid arthritis) with a
severe progressive course,
e.g. forms rapidly leading to joint destruction, and/or where tissue
outside the joints is affected.
-
Severe infectious diseases with poisoning-like conditions (e.g. in
tuberculosis, typhoid,
brucellosis); only in addition to appropriate anti-infectious therap

Preparatomtale

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dexamethason Medochemie 4 mg/ml, oplossing voor injectie/infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule of 1 ml contains 4 mg dexamethasone phosphate (as
dexamethasone sodium
phosphate).
Each ampoule of 2 ml contains 8 mg dexamethasone phosphate (as
dexamethasone sodium
phosphate).
Excipient with known effect: sodium.
Each ampoule of 1 ml contains 3.12 mg sodium.
Each ampoule of 2 ml contains 6.24 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion
Clear, colourless to slightly yellowish solution, pH 7.0 to 8.5.
Osmolality: 160 to 230 mOsm/Kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Systemic use
-
Cerebral oedema associated with cerebral tumour, neurosurgical
procedures, cerebral abscess,
bacterial meningitis
-
Polytraumatic shock/prophylaxis of post-traumatic shock-lung syndrome
-
Severe, acute asthma attack
-
Initial parenteral treatment of extensive, acute, severe skin diseases
like erythroderma, pemphigus
vulgaris, acute eczema
-
Initial parenteral treatment of autoimmune diseases like systemic
lupus erythematosus (especially
visceral forms)
-
Active rheumatoid arthritis with a severe, progressive course, e.g.
fast proceeding destructive
forms and/or with extra-articular manifestations
-
Severe infectious diseases with toxic conditions (e.g. tuberculosis,
typhoid, brucellosis) only with
simultaneous anti-infectious therapy
-
Palliative therapy of malignant tumours
-
Prophylaxis and treatment of post-operative or cytostatic-induced
vomiting as part of anti-emetic
regimens.
-
Dexamethason Medochemie is indicated in the 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.
Local application
-
_Intraarticular injection_: persistent inflammation of one or a few
joints after general management
of chronic inflammatory joint diseas