Description
Release form
Vaginal solution.
Packaging
140 ml of the preparation in a bottle of pink polyethylene, with a lid with a white cannula with a check valve and a guide nozzle, with a translucent lid to protect and seal the cannula.
Five vials, together with instructions for use, are placed in a cardboard box.
Pharmacological action of
Pharmacotherapeutic group: non-steroidal anti-inflammatory drug Code ATC: G 2 ¡ ¡
Pharmacological properties of
Pharmacodynamics:
benzidamine is a non-steroidal anti-inflammatory drug that belongs to the indazole group. It has anti-inflammatory and local anesthetic effects, has antibacterial, antifungal and antiseptic effects.
The mechanism of action of the drug is associated with stabilization of cell membranes and inhibition of prostaglandin synthesis.
Benzidamine has an antibacterial and specific antimicrobial effect due to the rapid penetration of microorganisms through the membranes, followed by damage to cellular structures, metabolic processes and cell lysosomes.
Has antifungal activity against Candida alblcans.
Causes structural modifications of the cell wall of fungi and their metabolic chains, thus inhibiting their reproduction, which was the basis for the use of benzidamine in inflammatory processes, including infectious etiology.
Pharmacokinetics:
when applied topically,
is well absorbed through the mucous membranes and penetrates into the inflamed tissue. 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)
non-specific vulvovaginitis and cervicovaginitis of any etiology, including
bacterial vaginosis
, which developed secondarily during chemotherapy and radiotherapy, the prevention of postoperative infectious complications in operative gynecology.
Contraindications
Hypersensitivity to any of the components of the drug.
Use during pregnancy and lactation
There are no contraindications to the local use of the drug Tantum ® Rosa during pregnancy and lactation (breast-feeding).
Special instructions
Long-term use of the drug may cause increased sensitivity. When using the drug for long periods, a doctor’s consultation is necessary.
Influence on the ability to drive vehicles and control mechanisms: the use of the drug does not affect the ability to drive vehicles, engage in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
Composition of
100 ml of the solution contains:
active substance:
benzydamine hydrochloride O, 1 g
excipients:
benzalkonium chloride
disodium edetate
ethanol 96%
l srpl srpl oil polrd.
Dosage and administration
Vaginal solution O, 1%: solution in a vial, which is a disposable syringe, ready to 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 fluid should remain in the vagina for several minutes. For a single douching, use the entire volume of the bottle 140 ml.
– in the postpartum period as a therapeutic and prophylactic agent to accelerate the process of rehabilitation and prevention of postpartum infectious complications: vaginal irrigation 1 time per day for
3-5 days.
– for bacterial vaginosis: vaginal irrigation 1 – 2 times a day for 7-1O days
– for nonspecific vulvovaginitis and cervicovaginitis of any etiology, including those secondary to chemotherapy and radiation therapy: 2 times a day for at least 1O days
– with specific vulvovaginitis, as part of complex therapy: 2 times a day for 3-5 days
– prevention of postoperative complications in surgical gynecology: 1 time per day for 3-5 days.
Side effects
In rare cases, allergic reactions, dry mucous membranes of the oral cavity are possible.
Drug Interactions
No clinically significant interaction of the drug Tantum ® Rose with other drugs.
Storage conditions
At a temperature not exceeding 25 ° C, in a dark place.
Keep out of the reach and sight of children!
Shelf life
4 years.
Deystvuyushtee substance
benzydamine
Dosage form
topical solution
Asiende Kimike Riunite Angelini Francesco A.K.P.A., Italy
