Uro-Vaxom capsules

Χώρα: Αρμενία

Γλώσσα: Αγγλικά

Πηγή: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Δραστική ουσία:

lyophilized bacterial lysates of Escherichia coli

Διαθέσιμο από:

OM Pharma SA

Φαρμακολογική κατηγορία (ATC):

առկա չէ (L03AX)

INN (Διεθνής Όνομα):

lyophilized bacterial lysates of Escherichia coli

Δοσολογία:

6mg

Φαρμακοτεχνική μορφή:

capsules

Μονάδες σε πακέτο:

(30/3x10/) in blister

Τρόπος διάθεσης:

Prescription

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2016-06-23

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE MEDICINAL PRODUCT
URO-VAXOM
®
, capsules 6 mg
COMPOSITION
a)
Active
substance:
OM-89
lyophilizate
–
60
mg
equivalent
to
lyophilized
bacterial lysates of Escherichia coli – 6.0 mg.
b)
Excipients:
starch
(pregelatinised),
magnesium
stearate,
propyl
gallate
(E 310), monosodium glutamate, mannitol.
Composition of the capsule shell: gelatine, yellow iron oxide (E 172),
red iron
oxide (E 172), titanium dioxide (E 171).
PHARMACEUTICAL FORM AND QUANTITY OF THE ACTIVE SUBSTANCE PER
UNIT
Capsule contains 6 mg capsule of lyophilised bacterial lysates of
Escherichia coli
INDICATIONS/POSSIBILITIES FOR USE
Immunotherapy. Prevention of recurrent lower urinary tract infections.
Adjuvant treatment of acute urinary tract infections.
POSOLOGY/METHOD OF ADMINISTRATION
_Preventive and/or supplementary treatment:_ 1 capsule per day,
preferably taken in
the morning on an empty stomach, for 3 consecutive months.
_Recurrent urinary infections in the acute phase:_ 1 capsule per day,
preferably taken
in the morning on an empty stomach, as an adjuvant to conventional
antibiotic
therapy, until symptoms disappear, but for at least 10 consecutive
days.
_Specific posology recommendations: _
_Use in children and adolescents:_ The safety and efficacy of
Uro-Vaxom have not
been studied in children under 4 years old.
_Elderly patients:_ There is no need to adjust the dose according to
the patient’s age.
_Patients with hepatic and/or renal impairment:_ There are no specific
data on the
safety and efficacy of Uro-Vaxom in patients with impaired hepatic or
renal function.
Therefore no dose recommendation can be made.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in the
section “composition”.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Uro-Vaxom can cause hypersensitivity reactions, such as skin
reactions, fever or the
development of an oedema. If any of these occur, the treatment must be
interrupted
as they may be allergic reactions.
Immunosuppressan