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VIATRIS HEALTHCARE LIMITED

Betadine 10% concentrate 5 bottles 140ml + 5 vials 10ml + 5 cannulas Vaginal solution

Betadine 10% concentrate 5 bottles 140ml + 5 vials 10ml + 5 cannulas Vaginal solution

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Betadine 10% concentrate is a product specifically formulated for the disinfection of the vaginal mucosa . Each pack contains 5 bottles of 140 ml , 5 vials of 10 ml and 5 solvent cannulas , designed to prepare an effective vaginal solution. The main active ingredient is povidone-iodine , known for its antiseptic properties. This product is ideal for those looking for a reliable method to maintain intimate hygiene, thanks to its ability to effectively eliminate microorganisms. The combination of bottles and vials allows for simple and practical preparation of the solution, while the cannulas ensure targeted and safe application. Perfect for use in contexts that require rigorous hygiene, Betadine 10% concentrate is a valuable ally in the care of intimate health.

ACTIVE INGREDIENTS

Active ingredients contained in Betadine 10% concentrate 5 bottles 140ml + 5 vials 10ml + 5 solvent cannulas for vaginal solution - What is the active ingredient of Betadine 10% concentrate 5 bottles 140ml + 5 vials 10ml + 5 solvent cannulas for vaginal solution?

Composition of the vial - 100 ml contain: Active ingredient: Iodopovidone 10 g For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Betadine 10% concentrate 5 bottles 140ml + 5 vials 10ml + 5 solvent cannulas for vaginal solution - What does Betadine 10% concentrate 5 bottles 140ml + 5 vials 10ml + 5 solvent cannulas for vaginal solution contain?

In the vial: Purified water. In the bottle: dodecylglucoside, Intimate hygiene perfume A 402580, Purified water.

DIRECTIONS

Therapeutic indications Betadine 10% concentrate 5 bottles 140ml + 5 vials 10ml + 5 solvent cannulas for vaginal solution - Why is Betadine 10% concentrate 5 bottles 140ml + 5 vials 10ml + 5 solvent cannulas for vaginal solution used? What is it used for?

Vaginal mucosa disinfectant.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Betadine 10% concentrate 5 bottles 140ml + 5 vials 10ml + 5 solvent cannulas for vaginal solution - When should Betadine 10% concentrate 5 bottles 140ml + 5 vials 10ml + 5 solvent cannulas for vaginal solution not be used?

• Hypersensitivity to the active substance, to any of the excipients listed in paragraph 6.1. • Hyperthyroidism

DOSAGE

Quantity and method of taking Betadine 10% concentrate 5 bottles 140ml + 5 vials 10ml + 5 solvent cannulas for vaginal solution - How do you take Betadine 10% concentrate 5 bottles 140ml + 5 vials 10ml + 5 solvent cannulas for vaginal solution?

After pouring the contents of the vial into the bottle, insert the vaginal cannula and perform irrigation 1-2 times a day. After a suitable period of time without appreciable results, consult your doctor.

CONSERVATION

Storage Betadine 10% concentrate 5 bottles 140ml + 5 vials 10ml + 5 solvent cannulas for vaginal solution - How do you store Betadine 10% concentrate 5 bottles 140ml + 5 vials 10ml + 5 solvent cannulas for vaginal solution?

Store away from heat.

WARNINGS

Warnings Betadine 10% concentrate 5 bottles 140ml + 5 vials 10ml + 5 solvent cannulas for vaginal solution - About Betadine 10% concentrate 5 bottles 140ml + 5 vials 10ml + 5 solvent cannulas for vaginal solution it is important to know that:

Do not use for prolonged treatments. Particular caution should be used in patients with pre-existing renal insufficiency who require regular applications of Betadine on damaged skin. Use of the product, especially if prolonged, may give rise to sensitization phenomena. In this case, discontinue treatment and adopt appropriate therapeutic measures. Patients with goiter, thyroid nodules or other acute and non-acute thyroid diseases are at risk of developing thyroid hyperfunction (hyperthyroidism) following administration of large amounts of iodine. In this patient population, povidone-iodine solution should not be used for a prolonged period of time and on large body surfaces unless strictly indicated. Even after the end of treatment, early symptoms of possible hyperthyroidism should be sought and, if necessary, thyroid function should be monitored. Do not use at least 10 days before or after scintigraphy with radioactive iodine or in the treatment of thyroid carcinoma with radioactive iodine. The pediatric population is at increased risk of developing hypothyroidism following administration of high doses of iodine. Due to the permeability of the skin and their high sensitivity to iodine, the use of povidone-iodine should be reduced to the minimum necessary in children. Monitoring of the child's thyroid function (e.g. T4 and TSH levels) may be necessary. Any oral ingestion of povidone-iodine by the child should be avoided. In pediatric age, use only under strict supervision and in cases of real need. Accidental ingestion or inhalation of some disinfectants can have serious, sometimes fatal, consequences. Avoid contact with eyes.

INTERACTIONS

Interactions Betadine 10% concentrate 5 bottles 140ml + 5 vials 10ml + 5 solvent cannulas for vaginal solution - Which medicines or foods can modify the effect of Betadine 10% concentrate 5 bottles 140ml + 5 vials 10ml + 5 solvent cannulas for vaginal solution?

Avoid the simultaneous use of other antiseptics and detergents. The polyvinylpyrrolidone-iodine complex is effective at pH values ​​between 2.0 and 7.0. It is possible that the complex reacts with proteins or other unsaturated organic compounds, and that this determines a reduction in its efficacy. The concomitant use of preparations with enzymatic components for the treatment of wounds determines a weakening of the effects of both substances. Povidone-iodine should not be used simultaneously with products containing mercury salts or benzoin compounds, carbonates, tannic acid, alkalis, hydrogen peroxide, taurolidine and silver. The use of products containing povidone-iodine in conjunction with other antiseptics containing octedine in the same or adjacent sites may cause a temporary darkening of the affected areas. The oxidative effect of povidone-iodine preparations may cause false positive results in some laboratory diagnostic tests (e.g. toluidine or guaiac gum tests for haemoglobin or glucose in stool or urine). Avoid routine use in patients receiving concomitant lithium treatment. The absorption of iodine from povidone-iodine solution may reduce the thyroid uptake of iodine. This may interfere with various tests (thyroid scintigraphy, determination of iodine-binding proteins, radioiodine diagnostics) and may make planned iodine treatment of the thyroid impossible (radioiodine therapy). After the end of treatment, an adequate period of time must elapse before a new scintigraphy is performed.

SIDE EFFECTS

Like all medicines, Betadine 10% concentrate 5 bottles 140ml + 5 vials 10ml + 5 solvent cannulas for vaginal solution can cause side effects - What are the side effects of Betadine 10% concentrate 5 bottles 140ml + 5 vials 10ml + 5 solvent cannulas for vaginal solution?

Undesirable effects are classified according to their frequency: Very common (≥ 1/10) Common (> 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (frequency cannot be estimated from the available data) Immune system disorders Rare: Hypersensitivity Very rare: Anaphylactic reaction Endocrine disorders Very rare: Hyperthyroidism * (sometimes with symptoms such as tachycardia or agitation) Not known: Hypothyroidism *** Metabolism and nutrition disorders Not known: Electrolyte imbalance **, Metabolic acidosis ** Skin and subcutaneous tissue disorders Rare: Contact dermatitis (with symptoms such as erythema, microvesicles and pruritus) Very rare: Angioedema Renal and urinary disorders Not known: Acute renal failure **, Abnormal blood osmolarity ** *In patients with a history of thyroid disease (see section Warnings and special precautions for use) following high iodine uptake, for example after long-term use of povidone-iodine solution for the treatment of wounds and burns on large areas of skin. **May occur following uptake of high amounts of povidone-iodine (for example in the treatment of burns) ***Hypothyroidism following prolonged or extensive use of povidone-iodine Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

OVERDOSE

Overdose Betadine 10% concentrate 5 bottles 140ml + 5 vials 10ml + 5 solvent cannulas for vaginal solution - What are the risks of Betadine 10% concentrate 5 bottles 140ml + 5 vials 10ml + 5 solvent cannulas for vaginal solution in case of overdose?

In case of intentional or accidental overdose (highly unlikely for vaginal dosage forms), hypothyroidism or hyperthyroidism may occur. Systemic absorption of iodine after repeated applications of the product on large wounds or severe burns may produce a series of symptoms such as: metallic taste, increased salivation, burning or stinging pain in the mouth and throat, irritation or swelling of the eyes, fever, skin rash, diarrhea and gastrointestinal disorders, hypotension, tachycardia, metabolic acidosis, hypernatremia, renal failure, pulmonary edema and shock. In case of accidental ingestion of large quantities of product, institute symptomatic and supportive treatment with particular attention to electrolyte balance and renal and thyroid function.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Betadine 10% concentrate 5 bottles 140ml + 5 vials 10ml + 5 solvent cannulas for vaginal solution

During pregnancy and breastfeeding, povidone-iodine solution should be used only if strictly necessary and at the lowest possible dose, due to the ability of iodine to cross the placenta and be secreted into breast milk and the high sensitivity of the fetus and newborn to iodine. Furthermore, iodine is more concentrated in breast milk than in serum. The use of povidone-iodine may cause transient hypothyroidism with increased TSH (thyroid stimulating hormone) in the fetus or newborn.

DRIVING AND USE OF MACHINERY

Taking Betadine 10% concentrate 5 bottles 140ml + 5 vials 10ml + 5 solvent cannulas for vaginal solution before driving or using machines - Does Betadine 10% concentrate 5 bottles 140ml + 5 vials 10ml + 5 solvent cannulas for vaginal solution affect driving or using machines?

Betadine does not alter the ability to drive vehicles or use machines.

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This sheet contains information that is not intended to replace a diagnosis or medical advice, as only a doctor can write any prescription and give therapeutic indications. All contents must be understood and are of an exclusively informative nature and aimed exclusively at bringing to the attention of customers or potential customers in the pre-purchase phase of the products sold through this site. In case of pathologies, disorders or allergies it is always best to consult your doctor first.

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