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: & nbspRastvor vaginal.
Composition:
in 100 ml of the solution contains:
active substance: benzidamine hydrochloride 0.1 g;
Excipients: benzalkonium chloride 0.020 g; disodium edetate 0.050 g; ethanol 96% 0.077 g; polysorbate 20 0.0045 g; roses oil 0.0046 g; water purified to 100 ml.
Description:

Colorless transparent liquid with a characteristic smell of roses.

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

A.01.A.D.02   Benzidamine

G.02.C.C.03   Benzidamine

Pharmacodynamics:

Benzimidine is non-steroidal anti-inflammatory drug, belongs to the group of indazoles. Has anti-inflammatory and local anesthetic effect, has antibacterial, antifungal and antiseptic effect.

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 topical application of the drug is good 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 agent 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.

Vaginal solution 0.1%: the solution in the vial, which is a disposable syringe, is ready for use.

The contents of the vial must be heated in a water bath to body temperature. The procedure should be carried out lying down, the liquid should remain in the vagina for several minutes.For a single syringing use the entire volume of the bottle 140 ml.

- 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 to 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 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:
The solution is vaginal 0.1%.
Packaging:For 140 ml of the preparation in a bottle of low density polyethylene of pink color, with a lid with a can of low-density white polyethylene with a return valve made of ethylene-vinyl acetate copolymer and a guide packing made of low-density polyethylene with a translucent lid for protecting and sealing the cannula.
Five vials with instructions for use in a cardboard box.
Storage conditions:
In the dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children!
Shelf life:

4 years.

Do not use after the expiration date indicated.

Terms of leave from pharmacies:Without recipe
Registration number:П N014275 / 01-2002
Date of registration:26.05.2009
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: & nbsp16.05.2012
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