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- Isoconazole nitrate
The treatment of vaginal mycoses with GYNO-TRAVOGEN is a local therapy, which does not require effective plasma levels of isoconazole. By insertion of the ovule into the vagina, a drug depot is established. The ovule melts at body temperature and forms a viscid, oily mass, which panels the vaginal wall. A part of the drug is dissolved in the vaginal secretion and penetrates into the vaginal epithelium. In the secretion and in the epithelium, a concentration of the antimycotic distinctly above the in vitro determined minimum inhibitory and minimum biocidal concentration is maintained for several days.
Fungal infections of the vagina including mixed infections with gram-positive bacteria.
Hypersensitivity to drug compositions.
For treatment of the external genital region or for simultaneous prophylactic treatment of the partner it is recommended to use an appropriate anti-fungal cream.
During treatment and in the following week vaginal douching should be avoided. To avoid renewed infection, personal linen (face cloth, towels, underwear - preferably of cotton) should be changed daily and boiled.
Preclinical Safety DataThe results from repeated dose toxicity studies did not indicate that particular health risks could be associated with the therapeutic use of
In a series of special reproduction toxicity studies, isoconazole exerted no adverse effects on any phase of the reproductive cycle. In particular, there was no evidence of a teratogenic potential.
According to the results from local tolerance studies on the skin and mucous membranes, no remarkable local irritation has to be expected under therapeutic conditions. In view of the results obtained at the rabbit eye, conjunctival irritation has to be expected after inadvertent contamination of the eye.
Pregnancy and Lactation
Use in Pregnancy
The experience with the use of isoconazole-containing preparations during pregnancy does not indicate a teratogenic risk in humans.
Use in Lactation
Because of the only slight absorption (less than 5 % of the dose administered) and the short duration of the therapy, damage to the baby from isoconazole nitrate transferred with the breast milk can be ruled out.
The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
Local concomitant symptoms such as smarting and itching occur occasionally.
The side effects listed above may not include all of the side effects reported by the drug's manufacturer.
Tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine.
Since GYNO-TRAVOGEN does not contain rubber-softening substances - an incompatibility with latex condoms is not to be expected.
DO NOT SHARE THIS MEDICINE with others. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS PRODUCT, as well as syringes and needles, if needed during treatment, out of the reach of children. Do not reuse needles, syringes, or other materials.
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