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Description
The instruction for use
medicine for experts
FARMATEKS
A trade name
of FARMATEKS
the International Unlicensed Name (IUN)
Benzalkoniya chloride
the Dosage form
Cream vaginal
Structure
of 100 g of cream is contained:
Active agent:
Benzalkoniya chloride of 50% aqueous solution, 2.4 g
that there correspond a benzalkoniya to chloride 1.2 g
excipients: citric acid, makrogol 300 and 1500 and ethylene glycol stearate (Тефоз® 63), lavender essence, q.s.p purified water. 100 g.
The description
White cream with a lavender smell.
Pharmacotherapeutic group
Contraceptive means for topical administration.
The code of automatic telephone exchange
G02BB
Pharmacological
Benzalkoniya properties chloride is at the same time spermitsidy and an antiseptic agent. Active ingredient destroys membranes of spermatozoa. Destruction of spermatozoa happens in two stages: in the beginning destruction of a flagellum, then a rupture of a head that causes impossibility of fertilization.
Pharmatex’s use considerably reduces risk of emergence of pregnancy, however does not eliminate it completely.
Clinical performance is defined by the corrected Perlya index which makes less than 1 in case drug is correctly used.
In vitro drug is effective concerning many activators causing diseases, sexually transmitted, especially a gonokokka, chlamydias, a herpes virus type 2, a human immunodeficiency virus, a vaginal trichomonad, golden staphylococcus.
Drug has no effect on mycoplasmas and poorly acts on Gardnerella vaginalis, Candida albicans, Haemophilus ducrey and Treponema pallidum.
In vivo components of drug show some activity in prevention of some diseases, sexually transmitted, however proofs to it are not available.
Drug does not influence saprophytic vaginal microflora, including Doderlyayn’s stick.
Benzalkoniya’s pharmacokinetics chloride is not soaked up by a mucous membrane of a vagina. It is absorbed only on a surface of walls of a vagina and then removed with normal physiological discharges or is eliminated with simple washing with water.
Indications
Local contraception for any woman of reproductive age who does not have to it contraindications and also in cases:
– existence of temporary or absolute contraindications to use of oral contraceptives or an intrauterine spiral (Naval Forces),
– during the period after the delivery and during feeding by a breast,
– after termination of pregnancy,
– during the period preceding a menopause
– in need of incidental protection from pregnancy,
– at constant use of oral contraceptives in case of the admission or delay in reception of a tablet.
As additional local contraception when using a vaginal diaphragm or intrauterine spiral (especially if in the same time some drugs, such as non-steroidal anti-inflammatory drugs are taken).
Contraindications
– impossibility of the correct use of Pharmatex for persons with disturbances of mentality or the persons which are not allowing any interventions on genitals which interfere with use of a contraceptive,
– to any person not capable to understand or agree with this type of contraception,
– hypersensitivity to drug components,
– a colpitis,
– an ulceration and irritation of a mucous membrane of a vagina and uterus.
To Enter a route of administration and doses into a vagina.
To install the portioning device on the end of a tube. To fill it completely (to a ring-shaped tag or against the stop the piston) so that air bubbles were not formed. To disconnect it from a tube. Before sexual intercourse to enter cream deeply into a vagina by means of the portioning device, slowly pressing the piston. To take the portioning device. It is easier to make introduction lying. protective action begins immediately and at least 10 hours proceed. It is obligatory to enter a new portion of cream before each repeated sexual intercourse.
Single dose: one portion of cream is counted on one sexual intercourse. The frequency rate of use is limited to individual tolerance of active ingredient and frequency of sexual intercourses.
use of a pharmatex together with a vaginal diaphragm or Naval Forces is possible.
Side effect
allergic reactions to drug components (burning, itching), contact dermatitis.
In case of their emergence to stop Pharmatex’s use.
Overdose
Signs of a peredoziroka are not described.
Interaction with other medicines
is not recommended simultaneous use with the medicines used vaginalno. Any medicine entered into a vagina can inactivate local spermicidal action of Pharmatex.
Special indications
of Pharmatex collapses soap. It is not necessary to do irrigations of a vagina before sexual contact because soap, even its traces, destroys active ingredient.
The efficiency of contraception is connected only with strict observance of rules of its use.
· To apply systematically before each sexual intercourse.
· It is obligatory to enter a new dose of cream before each repeated sexual intercourse.
· To enter the portioning device with portion of cream so that it as it is possible more deeply got into a vagina, it is preferable in a prone position.
· Use of soap for a toilet of genitals in 2 hours prior to sexual intercourse and within 2 hours after sexual intercourse since soap, even in residual quantities, destroys Pharmateksa active ingredient is forbidden.
· Right after sexual intercourse only the external toilet of genitals only clear water or by means of the foaming means of Pharmatex which is not containing soap which part the benzalkoniya chloride is is possible. Before doing vaginal irrigation, it is necessary to wait within 2 hours after sexual intercourse.
· With Pharmatex, entered into a vagina, it is impossible to take baths, to swim in the sea, the pool and reservoirs because of danger of decrease in the subsequent contraceptive action.
· As Pharmatex the benzalkoniya contains chloride, it is necessary to interrupt its use at what emergence – or diseases of a vagina or their aggravation.
· In case there is a need of treatment of diseases of a vagina and/or prescribing of any other medicine vaginalno, it is necessary to wait for the end of treatment before renewing (to begin) contraception by means of Pharmatex.
Use during pregnancy and feeding by a breast
of Any harmful effects connected with use of drug during pregnancy was revealed not: examination of teratogenic properties of the final product yielded negative takes as well as examination of teratogenic properties of the most active ingredient. Besides, researches showed that the benzalkoniya chloride does not get into blood.
Feeding by a breast – as was proved lack of penetration of active ingredient into blood and maternal milk, use of this spermitsid during feeding by a breast does not constitute any danger.
A release form
On 72 g of drug are packed into the aluminum tuba covered with protective epoxyphenolic varnish from bushona from polyethylene. To a tube together with the instruction for use and the portioning device in a cardboard pack.
To Store storage conditions at a temperature not above 25 °C. To store in the place not available to children.
Expiration date
3 years. Not to apply after the expiration date specified on packing.
Prescription status
Without prescription of the doctor.
The Innotek Internasional Laboratory producer, Innotera Shuzi, France,
Rue Rene Chantereau L ‘ Isle Vert, 41150 CHOUZY-SUR-CISSE, France is made.
Additional information
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