Tantum rose solution vag. 1mg / ml vial 140ml # 5

Release form, composition and packaging

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

100 ml

benzydamine hydrochloride 0.1 g

benzalkonium chloride, disodium edetate, ethanol 96%, polysorbate 20, rose oil, purified water.

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

pharmachologic effect

NSAIDs for topical use, belongs to the indazole group.

It has anti-inflammatory and local analgesic effects, antibacterial, antifungal and antiseptic effects.

The mechanism of action of the drug is associated with the stabilization of cell membranes and inhibition of prostaglandin synthesis.

Benzydamine has an antibacterial effect due to the rapid penetration of microorganisms through membranes with subsequent damage to cellular structures, disruption of metabolic processes and cell lysis.

Has antifungal action against Candida albicans.

It causes structural modifications of the cell wall of fungi and the metabolic chains of mycetes and, thus, prevents their reproduction.

Pharmacokinetics

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

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

Indications for use

- in the postpartum period as a therapeutic and prophylactic agent for the prevention of postpartum infectious complications

- specific vulvovaginitis (as part of complex therapy)

- nonspecific vulvovaginitis and cervicovaginitis of any etiology, including those secondary to chemotherapy and radiotherapy

- bacterial vaginosis

- prevention of postoperative infectious complications in operative gynecology.

Contraindications for use

- hypersensitivity to drug components.

Dosage regimen

The drug is used intravaginally.

Vaginal solution 0.1% in a vial, which is a disposable syringe, ready to use.

The contents of the bottle must be warmed up 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 douching, use the entire volume of a bottle of 140 ml.

In the postpartum period as a therapeutic and prophylactic agent to accelerate the rehabilitation process and prevent postpartum infectious complications: the drug is used 1 time / day for 3-5 days.

With bacterial vaginosis, vaginal irrigation is carried out 1-2 times / day for 7-10 days.

For nonspecific vulvovaginitis and cervicovaginitis of any etiology, including those secondary to chemotherapy and radiotherapy, the drug is used 2 times / day for at least 10 days.

For specific vulvovaginitis (as part of complex therapy), the drug is used 2 times / day for 3-5 days.

For the prevention of postoperative infectious complications in surgical gynecology, the drug is used 1 time / day for 3-5 days.

Overdose

At present, no cases of overdose of the drug TantumRosa have been reported.

Side effect

Rarely: possible allergic reactions, dryness of the oral mucosa.

Drug interactions

There is no clinically significant interaction of TantumRosa with other drugs.

Application during pregnancy and lactation

There are no contraindications to the local use of TantumRosa during pregnancy and lactation (breastfeeding).

special instructions

Long-term use of the drug can lead to hypersensitivity.

When using the drug for a long time, a doctor's consultation is necessary.

Impact on the ability to drive a car

Name ENG

TANTUM ROSA

Clinical and pharmacological group

NSAIDs for topical use in gynecology

ATX code

Benzydamine

Dosage

0.1% x 140ml

Structure

100 ml of solution contains: active substance: benzydamine hydrochloride O, 1 g

excipients: benzalkonium chloride

disodium edetate

ethanol 96%

polysorbate 20

rose oil

purified water.

Indications

In the postpartum period as a therapeutic and prophylactic agent for the prevention of postpartum infectious complications.

specific vulvovaginitis (in combination therapy)

nonspecific vulvovaginitis and cervicovaginitis of any etiology, including those secondary to chemotherapy and radiotherapy

bacterial vaginosis

prevention of postoperative infectious complications in operative gynecology.

INN / Active ingredient

Benzydamine

Contraindications

Hypersensitivity to drug components

Storage conditions and periods

In a dark place, at a temperature not exceeding 25 degrees.

Expiration date: 4 years

Specifications

Category

Thrush

Scope of the drug

Metabolism

Release form

Solution

Manufacturer country

Italy

Package quantity, pcs

5

Way of introduction

Vaginally

Vacation conditions

Without recipe

Brand name

Tantum

The amount of the dosage form in the primary package

140 ml

Primary packaging type

Bottle

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

NSAIDs

Anatomical and therapeutic characteristics

G02CC03 Benzydamine

Dosage form

Vaginal solution

Dosage (volume) of the substance in the preparation

140 ml

Expiration date in days

1460

The target audience

Adult

Package weight, g

150

Mode of application

:

Vaginal solution O, 1%: solution in a vial, which is a disposable syringe, ready for use.

The contents of the bottle must be warmed up 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 douching, use the entire volume of a bottle of 140 ml.

Information on technical characteristics, delivery set, country of manufacture