Ghayr 500 mg (10 tablets)

The instruction
for medical use
of GAYRO medicine

the Trade name


of Gayro Mezhdunarodnoye the unlicensed


name Ornidazol Lekarstvennaya
the Tablet form film coated 500 mg

Structure
One tablet contains
active agent: ornidazol 500 mg,
excipients: microcrystalline cellulose, lactose, dioxide of colloidal silicone, povidone (K-30), sodium the lauryl sulfate, talc purified magnesium stearate, croscarmellose sodium
a film cover: a gipromelloz (GPMC E-15), polyethyleneglycol 400, talc purified, kviinolinovy yellow, diamond blue, the titan dioxide, polyethyleneglycol 6000

the Description
Biconvex, green color, oblong shape of a tablet, film coated with the line of a break on one party and a plain surface on another.

Pharmacotherapeutic group
Antimicrobial drugs for systemic action. Imidazole derivatives.
The code of automatic telephone exchange J01XD03




The pharmacological


Pharmacokinetics Later properties of intake ornidazol is quickly soaked up in digestive tract. On average, absorption is 95%. The maximum concentration in blood plasma are reached within 3 hours.
Linking with blood proteins makes about 13%. Active agent gets into cerebrospinal fluid, into breast milk, passes through a blood-brain barrier (GEB) and a placenta. Concentration of drug in blood plasma varies in limits 6-36¼ú/l. Ornidazol is metabolized in a liver by hydroxylation, oxidation and a glyukuronirovaniye with education 2 hydroxymethyl and alpha hydroksmetil metabolites. Both metabolites are less active concerning Trichomonas vaginalis and anaerobic bacteria, than not changed ornidazol.
Elimination half-life makes about 13 hours. After single dose of 85% of a dose it is removed through kidneys during the first five days, mainly, in the form of metabolites.

Gayro's pharmacodynamics – antiprotozoan, bactericidal and antimicrobial drug, derivative 5 nitroimidazoles. The mechanism of action consists in biochemical restoration 5 nitrogroups of an ornidazol intracellular transport proteins of anaerobic microorganisms and protozoa. The restored 5 nitrogroup of an ornidazol interacts with DNA of microorganisms and inhibits synthesis of their nucleic acids that leads to death of bacteria.
Gardnella vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia spp. and also strict anaerobes of Bacteroides spp., (including Bacteroides fragilis, Bacteroides distanosis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus) is active concerning Trichomonas vaginalis, Fusobacterium spp., Veillonela spp., Prevotella (P.bivia, P.buccae, P.disiens).

Indications
- trichomoniasis at women and men: a mecotic vulvovaginitis, an urethritis, a bartholinitis, a cervicitis, prostatitis, an adnexitis, etc.
- an amebiasis: amoebic dysentery, an abenteric amebiasis (including amoebic abscess of a liver)
- a giardiasis
- the infections caused by anaerobic bacteria: a septicaemia, meningitis, peritonitis, abscesses in ophthalmology
- postoperative infections in coloproctology, gynecology, surgery, maxillofacial surgery: an endometritis, septic abortion, suppurative processes after extraction of teeth, etc.
- the peptic ulcer of a stomach and duodenum associated by H.Pylori
- a bacterial vaginosis
- prevention of a mephitic gangrene after surgical and gynecologic interventions
- treatment of a demodicosis in dermatology and ophthalmology.


The route of administration and doses
of the Tablet accept inside after a meal.
At treatment of trichomoniasis at adults two schemes of combination therapy





the Course of treatment

1

scheme 2 the scheme


Single dose

of 1.5 g are applied (the 3rd tab.) in

1 g (the 2nd tab.) inside +
1 vaginal tablet (Gayro) before going to bed


5 days

of 500 mg (1 tab.) in the morning
and 500 mg (1 tab.) in the evening in

500 mg (1 tab.) in the morning
and 500 mg (1 tab.) in the evening in +1 vaginal a tab. (Gayro) before going to bed

to Children a dose is established at the rate of 25 mg/kg of body weight/day.
In amebiozny dysentery to adults and children with body weight over 35 kg are appointed inside on 1.5 g (the 3rd tab.) 1 time/days in the evening, adult with body weight more than 60 kg - 2 g/days (the 2nd tab. in the morning and the 2nd tab. in the evening).
To children with body weight less than 35 kg drug appoint 1 times/days at the rate of 40 mg/kg of body weight. A course of treatment - 3 days.
At other forms of an amebiasis to adults and children higher than 35 kg are appointed inside on 500 mg of 2 times/days (1 tab. in the morning and 1 tab. in the evening).
Course of treatment of 5-10 days.
In a giardiasis to adults and children with body weight over 35 kg are appointed inside on 1.5 g (the 3rd tab.) 1 time/days in the evening within 1-2 days, or on 500 mg of 2 times/days (1 tab. in the morning and 1 tab. in the evening) within 5-10 days. To children with body weight less than 35 kg drug appoint 1 times/days at the rate of 40 mg/kg of body weight at reception within 1-2 days.
For treatment of an infection, caused by anaerobic bacteria, the adult appoint 500 mg of 2 times/days (1 tab. in the morning and 1 tab. in the evening) within 5-10 days. The daily dose for children is established at the rate of 25 mg/kg of body weight. For prevention appoint 500 mg before operation and on 500 mg of 2 times/days after operation within 1-5 days.

Side effects
- a headache, dizziness
- consciousness disturbance, a tremor of hands, a lack of coordination of movements
- spasms, the touch or mixed peripheral neuropathy
- nausea, vomiting, diarrhea
- a leukopenia (at long-term treatment)

Contraindications
- hypersensitivity to an ornidazol and other derivatives of a nitroimidazole
- pregnancy (I trimester), the lactation period
- diseases of the central nervous system.

Medicinal interactions
At combined use of Gayro with other derivatives
5 nitroimidazoles can be observed a peripheral neuropathy, a depression and epileptoformny spasms.
Gayro does not inhibit an aldegiddegidrogenaza and therefore does not interact with alcohol.
Simultaneous use with inductors of microsomal enzymes (barbiturates, benzodiazepines, rifampitsina, etc.) reduces a half-life period of an ornidazol in serum. Inhibitors of microsomal enzymes (Cimetidinum, macroleads, etc.) increase a half-life period of an ornidazol.
Gayro strengthens action of anticoagulative means that demands correction of their dose.
Gayro's combination with neurotoxic and
gematotoksichny drugs is not recommended.

Special instructions
In trichomoniasis it is necessary to carry out simultaneous treatment of the sexual partner in order to avoid repeated infection.
Use in pediatrics.
This dosage form is not used at children up to 6 years.
Pregnancy and a lactation
Use of drug at pregnancy (III trimester of pregnancy) and in the period of a lactation (breastfeeding) is possible only after assessment advantage/risk.
Influence of medicine on ability to run vehicles
does not influence.

Overdose
Symptoms: epileptiform spasms, depression, peripheral neuritis.
Treatment: symptomatic (in spasms diazepam).

A form of release and packing
of the Tablet on 500 mg No. 1х10 in the blister packing it is enclosed together with the instruction for medical use in cardboard packing
the Cardboard packing No. 10 is enclosed together with the instruction for medical use in cardboard packing No. 10х1х10.


To Store storage conditions in the dry, protected from light place at a temperature below +30 °C.
To store out of children's reach!



Not to apply an expiration date of 36 months after the expiration date specified on packing.

Prescription status
According to the prescription


of Proizvoditel Panatseya Biotek Ltd
Malpur, Buddy, Tejsil Nalagarj
Rayon Solana (H.P.) –
173205 India