Dexatobrom drops eye (suspension)

País: Armênia

Língua: inglês

Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes ativos:

tobramycin, dexamethasone

Disponível em:

Rompharm Company SRL

Código ATC:

S01CA01

DCI (Denominação Comum Internacional):

tobramycin, dexamethasone

Dosagem:

3mg/ml+ 1mg/ml

Forma farmacêutica:

drops eye (suspension)

Unidades em pacote:

plastic vial 5ml

Tipo de prescrição:

Prescription

Status de autorização:

Registered

Data de autorização:

2022-12-06

Características técnicas

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE DRUG PRODUCT
Dexatobrom 1 mg + 3 mg/ml eye drops, suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre of suspension contains 1 mg dexamethasone and 3 mg
tobramycin.
Suspension pH: 5.0 - 6.0
Excipient with known effect: benzalkonium chloride 0.10 mg/ml
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, suspension
White or almost white suspension that may present a sediment which is
readily redispersible
by shaking.
4. CLINICAL DATA
4.1. THERAPEUTIC INDICATION
Prevention and treatment of inflammation and prevention of infection
associated with cataract
surgery in adults and children aged 2 years and older.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Topical use.
_Doses _
Use in adolescents and adults, including the elderly
One or two drops are instilled into the conjunctival sac (s) of the
affected eye (s) at intervals of
4-6 hours. In the first 24 to 48 hours of treatment, the dose may be
increased to one or two
drops given at 2-hour intervals. The frequency of administration
should be gradually reduced
as clinical signs improve. Treatment will not be stopped prematurely.
In severe conditions, one or two drops should be given at one-hour
intervals until the
inflammation is under control, and then the frequency of
administration should be gradually
reduced to one or two drops at 2-hour intervals for 3 days;
subsequently, one or two drops are
administered at 4-hour intervals for 5 to 8 days, and finally, if
deemed necessary, one or two
drops per day for 5 to 8 days.
After cataract surgery, the dose is one drop instilled 4 times a day,
starting the following day
after surgery, for up to 24 days. Treatment can be started one day
before surgery, by
administering a drop 4 times a day, continuing with a drop after
surgery and then with a drop 4
2
times a day for up to 23 days. If deemed necessary, the frequency of
administration may be
increased to one drop administered at 2-hour intervals during the
first two days of treat