Dexamethasone Phosphate Krka 4 mg/ml solution for injection/infusion

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Dexamethasone sodium phosphate

から入手可能:

KRKA, d.d., Novo mesto

ATCコード:

H02AB; H02AB02

INN（国際名）:

Dexamethasone sodium phosphate

投薬量:

4/1 milligram(s)/millilitre

医薬品形態:

Solution for injection/infusion

治療領域:

Glucocorticoids; dexamethasone

認証ステータス:

Marketed

承認日:

2020-05-22

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE USER
DEXAMETHASONE PHOSPHATE KRKA 4 MG/ML SOLUTION FOR INJECTION/INFUSION
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 or
nurse.
-
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Dexamethasone Phosphate Krka is and what it is used for
2.
What you need to know before you use Dexamethasone Phosphate Krka
3.
How to use Dexamethasone Phosphate Krka
4.
Possible side effects
5.
How to store Dexamethasone Phosphate Krka
6.
Contents of the pack and other information
1.
WHAT DEXAMETHASONE PHOSPHATE KRKA 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 KRKA 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, neurosurgery, brain
abscess, bacterial
inflammation of the lining of the brain (e.g. in tuberculosis,
typhoid, brucellosis)
-
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
-
supportive treatment in malignant tumours
-
prevention and treatment of vomiting after surger

製品の特徴

Health Products Regulatory Authority
06 July 2022
CRN00D09C
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dexamethasone Phosphate Krka 4 mg/ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule of 1 ml contains 4 mg dexamethasone phosphate as 4.37 mg
dexamethasone sodium phosphate, which is
equivalent to 3.3 mg dexamethasone.
Each ampoule of 2 ml contains 8 mg dexamethasone phosphate as 8.74 mg
dexamethasone sodium phosphate, which is
equivalent to 6.6 mg dexamethasone.
Excipient(s) with known effect
Each ampoule of 1 ml contains approx. 3 mg sodium.
Each ampoule of 2 ml contains approx. 6 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion (injection/infusion)
The solution for injection/infusion is a clear, colourless to light
yellow solution, practically free from particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SYSTEMIC ADMINISTRATION:

cerebral oedema associated with cerebral tumour, neurosurgical
procedures, cerebral abscess, bacterial meningitis
(e.g. tuberculosis, typhoid, brucellosis)

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

palliative therapy of malignant tumours

prophylaxis and treatment of post-operative or cytostatic-induced
vomiting as part of anti-emetic regimens

Dexamethasone Phosphate Krka 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.
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