Sumamed

Land: Armenía

Tungumál: enska

Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Virkt innihaldsefni:

azithromycin (azithromycin dihydrate)

Fáanlegur frá:

Pliva Hrvatska d.o.o.

INN (Alþjóðlegt nafn):

azithromycin (azithromycin dihydrate)

Skammtar:

500mg

Lyfjaform:

powder lyophilized for solution for infusion

Gerð lyfseðils:

Prescription

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF MEDICINAL PRODUCT
SUMAMED
® INJECTIONS
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 mg azithromycin as citrate.
3. PHARMACEUTICAL FORM
Powder for solution for infusion.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sumamed injections are indicated for the treatment of patients with
infections caused by susceptible
microorganisms in specific conditions listed below:
_COMMUNITY-ACQUIRED _
_PNEUMONIA_
due
to
_Chlamydia _
_pneumoniae_,
_Haemophilus _
_influenzae_,
_Legionella _
_pneumophila_, _ Moraxella catarrhalis_, _ Mycoplasma pneumoniae_, _
Staphylococcus aureus_, or _ Streptococcus _
_pneumoniae_ in patients who require initial intravenous therapy.
_PELVIC INFLAMMATORY DISEASE_ due to _Chlamydia trachomatis, Neisseria
gonorrhoeae_, or _Mycoplasma hominis_
in patients who require initial intravenous therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_COMMUNITY-ACQUIRED PNEUMONIA:_ 500 mg as a single daily dose by the
intravenous route for at least two
days. Intravenous therapy should be followed by azithromycin by the
oral route at a single daily dose of 500
mg, to complete a 7- to 10-day course of therapy. The timing of the
switch to oral therapy should be done at
the discretion of the physician and in accordance with clinical
response.
_PELVIC INFLAMMATORY DISEASE: _500 mg as a single daily dose by the
intravenous route for one or two days.
Intravenous therapy should be followed by azithromycin by the oral
route at a single daily dose of 250 mg, to
complete a 7-day course of therapy.
The timing of the switch to oral therapy should be done at the
discretion of the physician and in accordance
with clinical response. It is recommended that a 500 mg dose of
azithromycin diluted as described below
should be infused over a period of not less than 60 minutes.
Sumamed injections should not be given as a bolus or an intramuscular
injection!
_Preparation of the solution for infusion _(see 6.6. Instructions for
use/handling).
4.3 CONTRAINDICATIONS