Tantum® Rose (Tantum® Rosa)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceBenzidamineBenzidamine
Dosage form: & nbspPowder for the preparation of vaginal solution.
Composition:
For one sachet powder for the preparation of a solution of the vaginal 500 mg:
Active component - benzidamine hydrochloride - 0.500 g;
Auxiliary components: trimethylcetylammonium-p-toluenesulfonate, sodium chloride, povidone.
Description:

Homogeneous granules of white color without lumps and foreign particles.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug.
ATX: & nbsp

A.01.A.D.02   Benzidamine

G.02.C.C.03   Benzidamine

Pharmacodynamics:

Benzydamine is a non-steroidal anti-inflammatory drug, belongs to the group of indazoles. Has an anti-inflammatory and local anesthetic effect ;; has antibacterial, antifungal and antiseptic action. 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 and specific antimicrobial effect due to the rapid penetration of microorganisms through membranes, followed by damage to cellular structures, metabolic disturbances and cell lysosomes.

Has antifungal effect against Candida albicans. It causes structural modifications of the cell wall of fungi and their metabolic chains, thus hampering their reproduction, which was the basis for the use of benzidamine in inflammatory processes, including infectious etiology.

Pharmacokinetics:

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

Excretion of the drug occurs mainly by the kidneys and through the intestine in the form of metabolites or conjugation products.

Indications:

  • in the postpartum period as a therapeutic and prophylactic means for the prevention of postpartum infectious complications, specific vulvovaginitis (in complex therapy);
  • nonspecific vulvovaginitis and cervicovaginitis of any etiology, including those developed secondary to chemotherapy and radiotherapy; bacterial vaginosis;
  • prevention of postoperative infectious complications in operative gynecology;

Contraindications:

Hypersensitivity to any of the components of the drug.

Pregnancy and lactation:

There are no contraindications to the local use of the drug Tantum® Rose during pregnancy and lactation (breastfeeding).

Dosing and Administration:

Intravaginal.

Powder for the preparation of a solution of vaginal 500 mg - the contents of 1 packet are dissolved in 500 ml of boiled water. 140 ml of the resulting solution is used for a single syringe. The prepared solution can be stored for up to 5 days at room temperature. At repeated application, the solution needs to be warmed up to body temperature.

The douching procedure should be performed while lying, the liquid should remain in the vagina for several minutes.

  • in the postpartum period as a therapeutic and prophylactic means for accelerating the process of rehabilitation and prevention of postpartum infectious complications: vaginal irrigation once a day for 3-5 days,
  • with bacterial vaginosis: vaginal irrigation 1 - 2 times a day for 7-10 days;
  • with nonspecific vulvovaginitis and cervicovaginitis of any etiology, including those secondary to chemotherapy and radiotherapy: 2 times a day for at least 10 days;
  • with specific vulvovaginitis, as part of complex therapy: 2 times a day for 3-5 days;
  • prevention of pre- and postoperative complications in operative gynecology: 1 time per day for 3-5 days.

Side effects:

In rare cases, allergic reactions are possible, dryness of the oral mucosa.

Overdose:At present, no cases of an overdose of Tantum® Rose have been reported.
Interaction:

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

Special instructions:

Long-term use of the drug may lead to increased sensitivity. When using the drug for long periods, it is necessary to consult a doctor.

Effect on the ability to drive transp. cf. and fur:

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

Form release / dosage:

Powder for the preparation of vaginal solution.

Packaging:Powder for the preparation of a solution of vaginal 500 mg:

9.44 grams of powder in a sachets of polypropylene paper sealed by a thermal method;

- 10 sachets along with instructions for use are placed in a cardboard box.

Storage conditions:

List B.

At a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life:

5 years ,

Do not use after the expiration date indicated.

Terms of leave from pharmacies:Without recipe
Registration number:П N014275 / 02
Date of registration:25.05.2009
The owner of the registration certificate:Aziande Kimike Riounite Angelini Francesco AKR.A.A. SpAAziande Kimike Riounite Angelini Francesco AKR.A.A. SpA Italy
Manufacturer: & nbsp
Information update date: & nbsp20.08.2010
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