Universal reference book for medicines
Name of the preparation: TANTUM ® ROSE (TANTUM ROSE)

Active substance: benzydamine

Type: NSAIDs for topical application in gynecology

Manufacturer: Aziende Chimiche Riunite Angelini Francesco ACRAF (Italy)
Composition, form of production and packaging
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Powder for preparation of vaginal solution in the form of homogeneous granules of white color, without lumps and foreign particles.
1 sachet

benzidamine hydrochloride 500 mg

[PRING] trimethylcetylammonium-p-toluene sulfonate, povidone, sodium chloride.

9.44 g - sachets of paper and polypropylene (10) - packs of cardboard.

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Vaginal solution 0.1% is colorless, transparent, with a characteristic smell of roses.
1 ml

benzidamine hydrochloride 1 mg

[PRING] trimethylcetylammonium-p-toluene sulfonate, ethanol 96%, polysorbate 20, rose oil, purified water.

140 ml - polyethylene bottles with lid with cannula and guide nozzle (5) - cardboard boxes.

INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

NSAIDs for topical application, belongs to the group of indazoles.
Benzydamine has antibacterial, anti-inflammatory, antiexudative and analgesic action, as well as histoprotective activity.
The mechanism of action of the drug is associated with the stabilization of cell membranes and the inhibition of the synthesis of prostaglandins.

Benzydamine has an antibacterial effect due to the rapid penetration of microorganisms through the membranes, followed by damage to cellular structures, metabolic disorders and cell lysis.

Has an antifungal effect against Candida albicans.
It causes structural modifications of the cell wall of fungi and metabolic chains of mycetes and thus prevents their reproduction.
PHARMACOKINETICS

When applied locally, the drug is well absorbed through the mucous membranes and penetrates into inflamed tissues.

Benzimidine is excreted mainly by the kidneys and through the intestine in the form of metabolites or conjugation products.

Benzidamine in topical dosage forms does not have a systemic effect and does not penetrate breast milk.

INDICATIONS

- bacterial vaginosis;

- specific vulvovaginitis (as part of complex therapy);

- nonspecific vulvovaginitis and cervicovaginitis of any etiology, including those that developed secondary against chemotherapy and radiotherapy;

- prevention of pre- and postoperative complications in operative gynecology;

- as a hygienic means in the postpartum period.

DOSING MODE

The drug is used intravaginally.

Powder for the preparation of a vaginal solution: the contents of 1 packet of powder are dissolved in 500 ml of water before use.

Vaginal solution 0.1%: for the 1 syringing use the entire volume of the vial (140 ml).
Before administration, the solution should be slightly heated in a water bath.The procedure should be carried out lying down, the liquid should remain in the vagina for several minutes.
In bacterial vaginosis, vaginal irrigation is performed 1-2 times / day for 7-10 days.

With nonspecific vulvovaginitis and cervicovaginitis of any etiology, including those secondary to chemotherapy and radiotherapy, with specific vulvovaginitis (as part of complex therapy), the drug is used 2 times / day for 10 days.

For the prevention of pre- and postoperative complications in operative gynecology and as a hygienic means in the postpartum period, the drug is applied 1 time / day for 3-5 days.

SIDE EFFECT

When used according to indications and in recommended doses, no side effects are observed.

CONTRAINDICATIONS

- children's age till 12 years;

- Hypersensitivity to the components of the drug.

PREGNANCY AND LACTATION

Contraindications to the local use of the drug Tantum rose during pregnancy and lactation (breastfeeding) are absent.

APPLICATION FOR CHILDREN

Protyovpokazanie: children under 12 years.

SPECIAL INSTRUCTIONS

Do not use the drug for a long time.
this can cause the development of hypersensitivity reactions. If there is no therapeutic effect during the recommended course of treatment, the patient should consult a doctor.
Impact on the ability to drive vehicles and manage mechanisms

The use of the drug does not affect the ability to drive vehicles and other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

OVERDOSE

At present, cases of an overdose of the drug Tantum rose have not been reported.

DRUG INTERACTION

There is no clinically significant interaction of the drug with other drugs.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored out of the reach of children, protected from light at a temperature of no higher than 25 ° C.
Shelf life - 5 years.
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