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Staphylococcal bacteriophage liquid 4’s 20 ml liq. for oral administration, for local and external application in (vial)

$59.20

61cf64634af6

Description

The instruction for medical use

of LIQUID BACTERIOPHAGE STAPHYLOCOCCAL medicine

A trade name

the Staphylococcal bacteriophage liquid

the International unlicensed name

Is not present

the Dosage form

Sterile liquid in bottles on 20 ml for intake, topical and external use.

The structure

of 1 ml of drug contains

active agent – mix of sterile filtrates of fagolizat of bacteria Staphylococcus aureus a caption of a phage not less than 1х106,

excipient – 5% sterile solution of Chinosolum – 0.01% of the volume of a liquid phage.

The description

Transparent liquid of yellow color of various intensity with specific taste.

Pharmacotherapeutic group

Other antibacterial drugs.

The code of automatic telephone exchange J 01 X

Pharmacological

Bacteriophage properties staphylococcal – immunobiological drug, a phage. Drug represents the fagolizat filtrate active concerning staphylococcal bacteria of the most widespread fagotip, including staphylococcus golden. Irrespective of a method of administration, drug gets into blood and a lymph and gets to the inflammation center. The main part of drug is removed by kidneys, rendering the sanifying effect on urinary tract, and the rest – through digestive tract.

The bacteriophage is a specific virus of a bacterium which is adsorbed on a cell membrane of a homological bacterium, gets into a cell and lyses it.

In structure the Staphylococcal Bacteriophage liquid only the virulent phages of bacteria having ability to lyse Staphylococcus aureus allocated in purulent infections that provides high activity and efficiency of drug enter selection.

Indications

Drug is used for treatment and prevention of bacterial pyoinflammatory diseases of the caused Staphylococcus aureus in all age and high risk

the Treatment groups

– surgical infections: a purulent wound, a burn, abscess, phlegmon, a furuncle, an anthrax, a hydradenitis, a felon, a paraproctitis, mastitis, a bursitis, osteomyelitis

– urogenital infections: an urethritis, cystitis, pyelonephritis, a colpitis, an endometritis, a salpingo-oophoritis

– gastroenterological diseases: a coloenteritis, cholecystitis, the syndrome of the angry intestines (SAI) (dysbacteriosis)

– bacterial infections of upper and lower airways: inflammations of bosoms of a nose, a middle ear, a tonsillitis, pharyngitis, laryngitis, tracheitis, bronchitis, pneumonia, pleurisy

Prevention

– processing of fresh wounds,

– purulent complications at surgical manipulations and operations

– bacterial complications in acute respiratory viral diseases

– sepsis and a coloenteritis at newborns of children at pre-natal infection

– bacterial pollution and intrahospital infections in the medical

institutions Route of administration and doses

Drug is used in combination with other antibacterial agents and also as monotherapy – at intolerance the patient of antibiotic treatment and at an antibiotikoustoychivost of strains of an infestant. Before use of drug it is reasonable to define sensitivity of an infestant to a bacteriophage staphylococcal. Drug in an initial stage of a disease is especially effective and at use directly in the defeat center.

Taking into account localization of the center of an infection, drug the Staphylococcal Bacteriophage liquid can be used:

locally – in the form of irrigations, washings, rinsings, injections, burying, appliques, tampons, turundas,

by introduction in cavities (belly, pleural, joint, a bladder) through a capillary drainage, a catheter,

by intake (per os),

way of introduction to a rectum (per rectum) by means of an enema.

For treatment it is purulent-vospolitelnykh diseases with local defeats the Staphylococcal Bacteriophage liquid it is appointed at the same time as locally, so for intake (per os). Duration of a course of treatment drug from 5 to 10 days.

Doses of drug are defined by the nature of the center of an infection and make:

up to 200 ml (taking into account the sizes of an affected area) – for irrigations, lotions, tampons,

up to 100 ml – for introduction in cavities (pleural, joint, other limited cavities), enter through a capillary drainage, then tightly sew up a cavity or leave a capillary drainage through which within several days repeatedly enter a bacteriophage. In purulent pleurisy, a bursitis or arthritises the bacteriophage is entered into a cavity (after removal of pus) in quantity to 200 ml and more, every other day, by only 3-4 times.

10-20 ml – for injections in a wound in osteomyelitis (after the corresponding surgical treatment).

In abscesses the drug is administered in a center cavity after removal of pus from it by means of a puncture, at the same time the amount of the administered drug has to be slightly less than the volume of the seized pus, pus can be removed by opening of abscess with the subsequent introduction to a cavity of the tampon which is plentifully moistened with a bacteriophage. In the next days the drug in the infected cavity by means of a drainage is administered. The procedure is carried out once a day, within 3-5 days.

5-10 – ml for irrigations or plugging of cavities of a vagina and a uterus in pyoinflammatory gynecologic diseases, tampon once a day (tampons leave on 2 h),

10 ml – for irrigations or plugging in a colpitis, tampon 2 times a day (tampons leave on 2 h),

2-10 ml – for irrigations, rinsings, washings, burying, wetting of turundas in pyoinflammatory diseases of an ear, throat, nose, the procedure is carried out by 1-3 times a day (the turunda is left on 1 h). Aged up to 11 years of a tonsil it is reasonable to children to process by means of the syringe (or pears) and to dig in drug in a nose – for processing of a back surface of a throat, children of advanced age can rinse a pharynx and dig in a small amount (2 ml) of drug in a nose.

In cystitis, pyelonephritises, uretrita the bacteriophage is entered into a bladder through a catheter (or through tsistosty) or into a renal pelvis through nefrosty and the drug is taken also inside. In case the cavity of a bladder or a renal pelvis are trained, the bacteriophage is entered by 2 times a day on 20-30 ml into a bladder and on 5-10 ml in a renal pelvis.

At treatment of stomatitises and a chronic periodontal disease, drug is used in the form of rinsings of an oral cavity 3-4 times a day in a dose of 10-20 ml and also are entered into the parodontalny pockets of a turunda impregnated Staphylococcal with a bacteriophage for 5-10 minutes.

At intestinal diseases, SRK (dysbacteriosis), the Staphylococcal Bacteriophage liquid is applied in and in the form of enemas. The drug is taken on an empty stomach, in 1 hour prior to food. In the form of enemas it is appointed once a day, in the evening, before going to bed, after bowel emptying.

The recommended drug dosages:

the age

inside

in an enema

Up to 6 months

of 5 ml x once a day

10 ml x once a day

X once a day

From 1 year to 3 years

5 ml x 3 times in day

of 20 ml x once a day

From 3 to 8 years

10 ml x 2-3 times in day

of 30 ml x once a day

Is higher than 8 years from 6 to 12 months of 5 ml x 2 times in day of 10 ml

20 ml x 2-3 times in day

of 40 ml x once a day

Prevention

the Dose and a course of prescription of medicine for preventive use is defined by a condition of patients.

The staphylococcal bacteriophage is applied to prevention in number of 50 ml for irrigation of postoperative wounds and processing of fresh wounds.

For the purpose of prevention of sepsis and a coloenteritis at newborn children at pre-natal infection or danger of developing of an intrahospital infection the staphylococcal bacteriophage is applied in the form of enemas by 2 times a day within 5-7 days.

The bacteriophage staphylococcal can be used with the preventive purpose in a type of irrigation of integuments and mucous membranes in burns, pyoinflammatory diseases, contaminated wounds, in a tonsillitis.

In case before topical administration of a staphylococcal bacteriophage chemical antiseptic agents, except Furacilin were used, it is necessary to wash a wound with normal saline solution of sodium of chloride or 2-3% soda solution (Natrii hydrocarbonas).

Side effects

Drugs of bacteriophages are non-toxic. The undesirable effects and reactions connected with use of the Stafilokokovy bacteriophage are noted.

Contraindications

– hypersensitivity to any component of drug

Medicinal interactions

Medicinal interactions of drugs of bacteriophages are not described.

Drugs of bacteriophages can be used with other medicines including with antibacterial drugs.

The special
instructions Begin Treatment a bacteriophage follows as soon as possible.

Before use drug needs to be shaken up. Muddy drug is not subject to use.

If before use of a bacteriophage for processing of a wound chemical antiseptic agents were used, a wound it is necessary to wash carefully sterile 0.9% with chloride sodium solution.

As drug contains nutrient medium in which bacteria from the environment can develop, during the opening of a bottle, selection and storage of drug the following rules have to be followed:

– a hand it is necessary to wash up carefully,

– before removing a cap from a bottle, it should be processed the solution containing alcohol

– the cap should be removed, without taking out a stopper,

– drug from the opened bottle should be selected the sterile syringe (by a stopper puncture),

– if when opening a bottle together with a cap the stopper was withdrawn, it is not necessary to put it on a table an internal surface, it is not necessary to leave a bottle open, it should be closed a stopper after drug selection,

– opened the bottle needs to be stored in the fridge. Use of contents of a bottle within 24 hours after opening is allowed, at storage in the corresponding conditions.

Use in pediatrics

Drugs of bacteriophages can be used during the period

Pregnancy and the period of a lactation

Drugs of bacteriophages it is possible to use during pregnancy and a lactation.

Features of influence of medicine on ability to run the vehicle and potentially dangerous mechanisms

Drugs of bacteriophages do not influence ability to drive the car and to perform the works demanding the increased concentration of attention and motor reaction.

Overdose

Symptoms of overdose of drugs of bacteriophages are unknown.

A form of release and packing

Bottles on 20 ml from medical glass, in a cardboard box 4 bottles of drug together with the instruction for medical use in the state and Russian languages.

Storage conditions and transportation:

To store at a temperature from 2os to 15os.

To store out of children’s reach!
It is not necessary to use drugs of bacteriophages at turbidity.

2 years

not to apply a period of storage after the expiry date specified on packing.

Prescription status

Without prescription

JSC Biokhimfarm Producer, Georgia

Address: L. Gotua St. 3, Tbilisi 0160, Georgia,

Ph. +995 32 2 244777 / 2 244778, fax: +995 32 2 380895,

Al mail: biochimpharm@geophage.ge, www.biochimpharm.ge

the Owner of the registration certificate

of JSC Biokhimfarm, Georgia

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)

the Representative in RK Almaty, Shagabutdinov St. 66, sq.

22 phone number + 7(777) 723 27 72

the e-mail address:

To develop mss001@mail.ru

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