Dexamethason solution for i/m and i/v injection

Երկիր: Հայաստան

Լեզու: անգլերեն

Աղբյուրը: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ակտիվ բաղադրիչ:

dexamethasone (dexamethasone sodium phosphate)

Հասանելի է:

Arpimed LLC

ATC կոդը:

H02AB02

INN (Միջազգային անվանումը):

dexamethasone (dexamethasone sodium phosphate)

Դոզան:

4mg/ml

Դեղագործական ձեւ:

solution for i/m and i/v injection

Միավորները փաթեթում:

(10/2x5/) ampoules 2ml in blister

Ռեկվիզորի տեսակը:

Prescription

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

2019-05-27

Ապրանքի հատկությունները

SUMMARY OF PRODUCT CHARACTERISTICS
DEXAMETHASONE
8 MG / 2 ML SOLUTION FOR INJECTION
1.1 BRAND NAME – Dexamethasone
1.2 INTERNATIONAL NON-PROPERTY NAME - Dexamethasone
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL Dexamethasone, solution contains:
ACTIVE INGREDIENT: Dexamethasone sodium phosphate – 4, 37 mg
(equivalent to 4 mg
dexamethasone phosphate).
_For a full list of excipients, see section 6.1 _
3. PHARMACEUTICAL FORM
Solution for injection or infusion.
Clear, colourless solution, having pH ranging from 7.0 to 8.5.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dexamethasone can be used for all forms of general and local
glucocorticoid injection therapy
and all acute conditions in which intravenous glucocorticoids may be
life-saving.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE
N.B. FOR THIS SECTION OF DOCUMENT ALL DOSES ARE EXPRESSED AS MG
DEXAMETHASONE
In general, glucocorticoid dosage depends on the severity of the
condition and response of the
patient. Under certain circumstances, for instance in stress, extra
dosage adjustments may be
necessary. If no favourable response is noted within a couple of days,
glucocorticoid therapy
should be discontinued.
_Adults and Elderly_
Once the disease is under control the dosage should be reduced or
tapered off to the lowest
suitable level under continuous monitoring and observation of the
patient (See Section 4.4).
For acute life-threatening situations (e.g. anaphylaxis, acute severe
asthma) substantially higher
dosages may be needed. Cerebral oedema (adults): initial dose 8-16 mg
iv followed by 5 mg iv
or im every 6 hours, until a satisfactory result has been obtained. In
brain surgery these dosages
may be necessary until several days after the operation. Thereafter,
the dosage has to be tapered
off gradually. Increase of intracranial pressure associated with brain
tumours can be counteracted
by continuous treatment.
For local treatment, the following dosages can be recommended:
• intra-articulary:
1.6-3 mg large joints
0.6-0.8 mg small joints