URO-VAKSOM
(URO-VAXOM®)
the Trade name
Ouro-Vaksy (Uro-Vaxom®)
the International unlicensed name
Is not present
the Dosage form
of the Capsule of 6 mg
Structure
One capsule contains
active substance – the standardized OM-89 of the lyophilisate of 60.0 mg corresponding to the lyophilized bacterial lysate of 18 Esherichia coli of 6.0 mg
excipients: anhydrous propyl gallate, sodium glyutamat anhydrous, Mannitolum, starch prezhelatinizirovanny, magnesium stearate,
structure of a cover: gland (III) oxide red (E 172), gland (III) oxide yellow (E 172), the titan dioxide (E 171), the water purified, gelatin,
the body: gland (III) oxide yellow (E 172), the titan dioxide (E 171), the water purified, gelatin.
The description
of the Capsule, size No. 3, with a lid of orange color and the body of yellow color. Contents of capsules – powder of light-beige color.
Pharmacotherapeutic group
Other immunostimulators
the Code of automatic telephone exchange L03AX
the Pharmacological
Pharmacokinetics In view of properties of specificity of drug, data on pharmacokinetics at people it is not provided.
However, researches on animal (rats) revealed that at oral reception the absorption of 50% of fraction with a molecular weight not less than 30 kg is observed.
Peak concentration in plasma are reached in 4 hours after reception, and plasma elimination half-life averages 33 hours.
Pharmacodynamics
Immunostimuliruyushchy drug of bacterial origin. Stimulates T lymphocytes, induces formation of endogenous interferon, increases level secretory immunoglobulins A in urine. In vitro stimulates metabolic and functional activity of macrophages, promotes release of various lymphokines (interleukin 2, interleukin 6, tumor necrosis factor).
Ouro-Vaksy has effect on macrophages, on immunocompetent cells in peyerovy plaques and on V-lymphocytes. Clinical trials showed what Ouro-Vaksy reduces the frequency of a recurrence of infections of an uric path, in particular cystitis.
Indications
- treatment of infectious diseases of an urinary system, irrespective of the activator nature (in combination with antibiotics or antiseptic agents)
- prevention of exacerbations of chronic diseases of an urinary system
the Route of administration and doses
to Adults and children are more senior than 6 years.
Prevention and treatment of infections: on 1 capsule a day, in the morning on an empty stomach within 3 months.
For treatment of acute infections: on 1 capsule daily in the morning on an empty stomach as addition to traditional antibacterial therapy before total disappearance of symptoms, but not less than 10 days. the doctor, proceeding from the state of health of the patient has to determine duration of treatment or purpose of a repeated course of therapy.
Side effects
Frequent (from 1 to 10%)
- a headache
- nausea, diarrhea, an abdominal distension
Infrequent (from 0.1 to 1%)
- an abdominal pain
fever
allergic reactions (skin rash, an itching, an easy dieback)
Rare (from 0.01 to 0.1%)
- baldness
Extremely rare (less than 0.01%)
- hypostasis of an oral cavity and peripheral hypostasis
At emergence of skin reactions, fervescence or hypostasis, drug treatment it is necessary to stop immediately since such manifestations can be symptoms of allergic reactions.
Contraindications
- hypersensitivity to one of drug components
- pregnancy and the period of a lactation
- children's age up to 6 years
Medicinal interactions
of Immunodepressanta reduce effect of drug. Reception Ouro-Vaksy in two weeks prior to and within two weeks after vaccination is not recommended.
It is possible to characterize the special instructions Hypostasis of an Oral Cavity and peripheral hypostasis as the swelling of soft tissues caused by accumulation of an intercellular lymph.
The intercellular lymph consists of extracellular liquid, and except for plasma, is present at limfa, cerebrospinal fluid, eyes, synovial fluid, serous liquid and secretion of digestive tract. At the adult man with the body weight of 70 kg 12 liters of an intercellular lymph (that makes 30% of the general content of water in an organism) contain, and it is necessary that development of clinical hypostasis requires increase in body weight by 15% (2 liters of liquid).
The feature of influence of medicine on ability to run the vehicle or dangerous mechanisms
does not influence.
Overdose
of Data on cases of overdose are absent.
A form of release and packing
On 10 capsules in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 3 or 9 blister strip packagings together with the instruction for medical use place in a pack from cardboard.
To Store storage conditions at a temperature of 15 - 25 0C.
To store out of children's reach!
Not to use a period of storage of 5 years after the expiration of the storage specified on packing!
Prescription status
According to the prescription
the Producer:
OM PHARMA, Switzerland
22, Rue du Bois-du-Lan, CH - 1217 Meyrin 2/Geneva, Switzerland
(URO-VAXOM®)
the Trade name
Ouro-Vaksy (Uro-Vaxom®)
the International unlicensed name
Is not present
the Dosage form
of the Capsule of 6 mg
Structure
One capsule contains
active substance – the standardized OM-89 of the lyophilisate of 60.0 mg corresponding to the lyophilized bacterial lysate of 18 Esherichia coli of 6.0 mg
excipients: anhydrous propyl gallate, sodium glyutamat anhydrous, Mannitolum, starch prezhelatinizirovanny, magnesium stearate,
structure of a cover: gland (III) oxide red (E 172), gland (III) oxide yellow (E 172), the titan dioxide (E 171), the water purified, gelatin,
the body: gland (III) oxide yellow (E 172), the titan dioxide (E 171), the water purified, gelatin.
The description
of the Capsule, size No. 3, with a lid of orange color and the body of yellow color. Contents of capsules – powder of light-beige color.
Pharmacotherapeutic group
Other immunostimulators
the Code of automatic telephone exchange L03AX
the Pharmacological
Pharmacokinetics In view of properties of specificity of drug, data on pharmacokinetics at people it is not provided.
However, researches on animal (rats) revealed that at oral reception the absorption of 50% of fraction with a molecular weight not less than 30 kg is observed.
Peak concentration in plasma are reached in 4 hours after reception, and plasma elimination half-life averages 33 hours.
Pharmacodynamics
Immunostimuliruyushchy drug of bacterial origin. Stimulates T lymphocytes, induces formation of endogenous interferon, increases level secretory immunoglobulins A in urine. In vitro stimulates metabolic and functional activity of macrophages, promotes release of various lymphokines (interleukin 2, interleukin 6, tumor necrosis factor).
Ouro-Vaksy has effect on macrophages, on immunocompetent cells in peyerovy plaques and on V-lymphocytes. Clinical trials showed what Ouro-Vaksy reduces the frequency of a recurrence of infections of an uric path, in particular cystitis.
Indications
- treatment of infectious diseases of an urinary system, irrespective of the activator nature (in combination with antibiotics or antiseptic agents)
- prevention of exacerbations of chronic diseases of an urinary system
the Route of administration and doses
to Adults and children are more senior than 6 years.
Prevention and treatment of infections: on 1 capsule a day, in the morning on an empty stomach within 3 months.
For treatment of acute infections: on 1 capsule daily in the morning on an empty stomach as addition to traditional antibacterial therapy before total disappearance of symptoms, but not less than 10 days. the doctor, proceeding from the state of health of the patient has to determine duration of treatment or purpose of a repeated course of therapy.
Side effects
Frequent (from 1 to 10%)
- a headache
- nausea, diarrhea, an abdominal distension
Infrequent (from 0.1 to 1%)
- an abdominal pain
fever
allergic reactions (skin rash, an itching, an easy dieback)
Rare (from 0.01 to 0.1%)
- baldness
Extremely rare (less than 0.01%)
- hypostasis of an oral cavity and peripheral hypostasis
At emergence of skin reactions, fervescence or hypostasis, drug treatment it is necessary to stop immediately since such manifestations can be symptoms of allergic reactions.
Contraindications
- hypersensitivity to one of drug components
- pregnancy and the period of a lactation
- children's age up to 6 years
Medicinal interactions
of Immunodepressanta reduce effect of drug. Reception Ouro-Vaksy in two weeks prior to and within two weeks after vaccination is not recommended.
It is possible to characterize the special instructions Hypostasis of an Oral Cavity and peripheral hypostasis as the swelling of soft tissues caused by accumulation of an intercellular lymph.
The intercellular lymph consists of extracellular liquid, and except for plasma, is present at limfa, cerebrospinal fluid, eyes, synovial fluid, serous liquid and secretion of digestive tract. At the adult man with the body weight of 70 kg 12 liters of an intercellular lymph (that makes 30% of the general content of water in an organism) contain, and it is necessary that development of clinical hypostasis requires increase in body weight by 15% (2 liters of liquid).
The feature of influence of medicine on ability to run the vehicle or dangerous mechanisms
does not influence.
Overdose
of Data on cases of overdose are absent.
A form of release and packing
On 10 capsules in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 3 or 9 blister strip packagings together with the instruction for medical use place in a pack from cardboard.
To Store storage conditions at a temperature of 15 - 25 0C.
To store out of children's reach!
Not to use a period of storage of 5 years after the expiration of the storage specified on packing!
Prescription status
According to the prescription
the Producer:
OM PHARMA, Switzerland
22, Rue du Bois-du-Lan, CH - 1217 Meyrin 2/Geneva, Switzerland
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