1 g gel contains ganciclovir 1.5 mg
excipients: benzalkonium chloride, carbomer, sorbitol (e 420), sodium hydroxide, purified water.The
agents used in ophthalmology. Antiviral drug. Ganciclovir. ATC code D09 S01A.
treatment of acute superficial keratitis caused by herpes simplex virus.
Hypersensitivity to ganciclovir, acyclovir or any component of the drug.
the Drug is injected into the lower conjunctival SAC of the affected eye (s).
Apply 1 drop 5 times a day to complete re-epithelialization of the cornea, then 1 drop 3 times a day for 7 days. The duration of treatment usually does not exceed 21 days.
when using the product tube should be stored vertically, tip down on the stand, which is provided in the package. This ensures proper droplet formation.
Very often (> 1/10): a burning or tingling sensation passes quickly.
Frequently (> 1/l00, <1/10): superficial speckled keratitis.
allergic reactions, visual disturbances, eye irritation have been Reported.
there is not enough experience of safe gel application during pregnancy and lactation.
teratogenicity and effects on fertility were observed in animal studies with oral or intravenous administration of ganciclovir. In addition, ganciclovir has detected a potential genotoxicity of low safety profile.
Thus, the use of this drug in pregnancy and lactation is not recommended, except for the lack of alternative therapies. Women of reproductive age should use contraceptives.
due to a detected in the animal studies, genotoxicity, men who use Virgin, it is recommended to use a local contraception (condoms) during treatment and for three months after its completion.
the use of the medicine in children is not recommended, as no special studies have been conducted.The
this medicine is not intended to treat cytomegalovirus (CMV) infection in the retina.
the effectiveness of keratoconjunctivitis software caused by other types of viruses has not been established.
No special clinical studies involving patients with immunodeficiencies have not been conducted.
Benzalkonium chloride may cause eye irritation. Do not allow contact with soft contact lenses. Contact lenses should be removed before instillation and re-installed no sooner than 15 minutes after instillation. May discolor soft contact lenses.
the Ability to influence the reaction rate when driving or working with other machinery.
the Patient should refrain from driving or operating the vehicle in the event of any visual impairment during treatment.The
if any additional ophthalmic preparations are used, a break of at least 15 minutes is recommended between the use of the two drugs. Virginshould be applied last.
Although the number of ganciclovir, which reaches the systemic circulation after intraocular use, small, we cannot exclude the risk of interaction between drugs.
in the case of the systematic use of ganciclovir, the following interactions were observed.
the Binding of ganciclovir to plasma proteins is only about 1-2%, so interactions with drugs that involve displacement from the active center are unlikely.
in the case of joint use of drugs that inhibit the replication of cell populations, rapidly divide like bone marrow, spermatogonial cells, germ layers of the skin and gastrointestinal mucosa, a combined additive toxic effect is possible when administered with, before or after ganciclovir. Due to the possibility of additive toxicity in the use of drugs such as Dapsone, pentamidine, flucystosine, vincristine, vinblastine, adriamycin, amphotericin B, trimethoprim/sulfate combinations or other nucleoside analogues, concomitant use of ganciclovir drugs is possible only if the potential benefit exceeds the risks.
As zidovudine, and ganciclovir can cause neutropenia, concomitant use of these drugs during induction therapy with ganciclovir is not recommended. Studies show that maintenance doses of ganciclovir and zidovudine in the recommended doses lead to severe neutropenia in most patients.
in patients taking both ganciclovir and imipenem-cilastatin was observed the occurrence of generalized seizures.
it is Also possible that probenecid, as with other drugs that inhibit renal tubular secretion or resorption, may reduce renal clearance of ganciclovir and increase the period of its half-life from plasma.The
Ganciclovir, 9- [(1,3-dihydroxy-2-propoxy) methyl] guanine or DHPG, is a nucleoside that inhibitsin vitroreplication of human viruses of groupHerpes (Herpes simplextypes 1 and 2, cytomegalovirus) and adenoviruses of serotypes 1, 2 4, 6, 8, 10, 19, 22, 28.
in infected cells ganciclovir is converted into ganciclovir triphosphate, the active form of the active substance.
Phosphorylation occurs mainly in infected cells, with concentrations of ganciclovir triphosphate in uninfected cells 10 times lower.
the Antiviral activity of ganciclovir triphosphate is inhibition of viral DNA synthesis by two mechanisms: competitive inhibition of viral DNA polymerase and direct incorporation into viral DNA, inhibits elongation.
in humans, after using the drug 5 times a day for 11-15 days in the treatment of superficial herpetic keratitis plasma level, determined by a sensitive analytical method (limit of quantitative determination: 0.005 µg/ml), were very low: 0.013 µg/ml on average (0-0,037).
Ophthalmic pharmacokinetic studies on rabbits showed a fast and strong penetration of ganciclovir into the cornea and anterior segment of the eye, which created a concentration of higher than average effective dose (ED50) within a few hours.
a colorless gel.The
After the opening of the tube 4 weeks.
Store at a temperature not exceeding 25 ° C.
keep out of reach of children.The
5 g of the drug in a tube with a screw cap tip. 1 tube together with instructions for use and removable stand in a cardboard box.The
According to the recipe.The
prominent "farmer" -ZEA Farmaceutici S. p. A./Farmila - Thea Farmaceutici SpaThe
via Enrico Fermi, 50-2008 Settimo milanes (MI), Italy/
Via Enrico Fermi, 50-2008 Settimo Milanese (MI), Italy.
Virgan eye gel 1.5 mg tuba 5 g – used in ophthalmology for the treatment of superficial keratitis in acute form, the causative agent of which was the herpes virus. The main active ingredient is ganciclovir. The gel is injected into the conjunctival SAC drop by drop. The first days of the acute form of the disease should be eye drops 5 times a day. When the corneal epithelium begins to recover, it is enough to carry out the procedure three ti