Dexamethasone phosphate Teva 4 mg/ml solution for injection

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Dexamethasone sodium phosphate

Διαθέσιμο από:

Teva B.V.

Φαρμακολογική κατηγορία (ATC):

H02AB02

INN (Διεθνής Όνομα):

Dexamethasone sodium phosphate

Φαρμακοτεχνική μορφή:

Solution for injection

Θεραπευτική περιοχή:

dexamethasone

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

2022-01-28

Φύλλο οδηγιών χρήσης

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DEXAMETHASONE PHOSPHATE TEVA 4 MG/ML SOLUTION FOR INJECTION
dexamethasone phosphate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Dexamethasone phosphate Teva is and what it is used for
2.
What you need to know before you use Dexamethasone phosphate Teva
3.
How to use Dexamethasone phosphate Teva
4.
Possible side effects
5.
How to store Dexamethasone phosphate Teva
6.
Contents of the pack and other information
1.
WHAT DEXAMETHASONE PHOSPHATE TEVA IS AND WHAT IT IS USED FOR
DEXAMETHASONE IS A SYNTHETIC GLUCOCORTICOID
(adrenocortical hormone) with an effect on
metabolism, electrolyte balance and tissue functions.
DEXAMETHASONE PHOSPHATE TEVA IS USED FOR
Diseases that require treatment with glucocorticoids. These include,
depending on the type and
severity:
SYSTEMIC USE
•
Swelling of the brain caused by brain tumours, neurosurgery, brain
abscess, bacterial
inflammation of the lining of the brain.
•
Shock after a serious injury, for preventative treatment for acute
respiratory distress
syndrome and due to a severe allergic reaction (anaphylactic shock).
•
Severe acute asthma attack and a specific form of lung inflammation
(interstitial aspiration
pneumonia).
•
Initial treatment of extensive, severe, acute skin diseases, including
erythroderma,
pemphigus vulgaris, acute eczema.
•
Treatment of rheumatic systemic diseases (rheumatic diseases that can
affect internal
organs), such as systemic lupus erythematosus.
•
Some blood vessel inflam

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
03 October 2022
CRN00CXWZ
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dexamethasone phosphate Teva 4 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for injection contains 4.37 mg dexamethasone
sodium phosphate equivalent to 4 mg dexamethasone
phosphate or 3.3 mg dexamethasone.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SYSTEMIC USE
Neurology
Cerebral oedema (only with confirmed cerebral symptoms based on CT
scan) caused by cerebral tumour, neurosurgical
procedures, brain abscess, bacterial meningitis
Emergency treatment
Post-traumatic shock/prevention of post-traumatic acute respiratory
distress syndrome
Anaphylactic shock (following primary epinephrine injection)
Lung and respiratory diseases
Severe acute asthma attack, interstitial aspiration pneumonia
Dermatology
Parenteral initial treatment of extensive, severe, acute skin
diseases, including erythroderma, pemphigus vulgaris, acute eczema
Autoimmune diseases/Rheumatology
Parenteral initial treatment of autoimmune diseases, including
systemic Lupus erythematodes, especially visceral forms
Active phases of systemic vasculitis, including polyarteritis nodosa
(duration of treatment should be limited to 2 weeks in the
case of simultaneous positive hepatitis B serology)
Severe progressive form of active rheumatoid arthritis, e.g. rapidly
destructive forms and/or with extra-articular manifestations
Juvenile idiopathic arthritis with severe systemic variant (Still's
syndrome) or iridocyclitis unable to be influenced locally
Rheumatic fever with carditis
Infectiology
Severe infectious diseases with toxic states (e.g. tuberculosis,
typhoid, brucellosis; only with concomitant anti-infective therapy)
Oncology
Palliative therapy of malignant tumours
Prevention and treatment of post-operative or cytostatic agent-induced
vomiting within the scope of antiem