Uro-Vaxom capsules

দেশ: আর্মেনিয়া

ভাষা: ইংরেজি

সূত্র: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

সক্রিয় উপাদান:

lyophilized bacterial lysates of Escherichia coli

থেকে পাওয়া:

OM Pharma SA

এটিসি কোড:

առկա չէ (L03AX)

INN (আন্তর্জাতিক নাম):

lyophilized bacterial lysates of Escherichia coli

ডোজ:

6mg

ফার্মাসিউটিকাল ফর্ম:

capsules

প্যাকেজ ইউনিট:

(30/3x10/) in blister

প্রেসক্রিপশন টাইপ:

Prescription

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2016-06-23

পণ্য বৈশিষ্ট্য

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