BETADINE 10GARZE IMPREGN 10X10

BETADINE

active ingredients

Betadine 10% Skin solution, alcohol: 100 ml contain: Active ingredient: Iodopovidone (to 10% iodine) g 10. Betadine 1% Collutory: 100 ml contain: Active ingredient: Iodopovidone (to 10% iodine) g 1.0. Excipient with known effects: ethanol Betadine 10% Gel: 100 g gel or gel contain: Active ingredient: Iodopovidone (to 10% iodine) g 10. Betadine 10% Garze impregnated 1 gauze tablet of 1 dm2 from 3 g contains: Active ingredient: Iodopovidone (to 10% iodine) g 0.25. For the full list of excipients, see paragraph 6.1.

Excellent

Betadine 10% Skin solution, alcohol: Isopropyl alcohol, citric acid, bibasic phosphate sodium, purified water. Betadine 10% Gel: Polyethyleneglycol 400, Polyethyleneglycol 4000, Polyethyleneglycol 6000, Purified Water. Betadine 1% Collutory: Ethanol, Glycerol, Eucalyptusol, Menthol, Sodium Saccarine, Monohydrate Citric Acid, Bihydrate Bibasic Phosphate Sodium, Potassium iodated Purified Water,. Betadine 10% Garze impregnated: Polyethyleneglycol 400, Polyethyleneglycol 4000, Polyethyleneglycol 6000, Purified Water.

Therapeutic indications

Betadine 10% Skin solution, alcohol: Disinfection and cleansing of the skin (small surface wounds, decubited sores with limited interest to the epidermis). The medicine can be used for disinfecting the skin before surgery. Betadine 1% Collutory: Disinfection of the oral mucosa. Betadine 10% Gel: Disinfection of the skin (small surface wounds, decubited sores with limited interest to the epidermis). Betadine 10% Garze impregnated: Disinfection of the skin (small surface wounds, decubited sores with limited interest to the epidermis).

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. • Hyperthyroidism • Do not use in children under 6 months. • Collutory should not be used in children under 6 years of age.

Population

Betadine 10% Skin solution, alcohol: Apply the alcohol solution of Betadine not diluted once or twice on the entire skin area to be disinfected. Distribute the product with a sterile gauze. Let dry completely. Betadine 1% Collutory: Dilute to your own taste, only when necessary, keeping in mind that the effectiveness is maintained at dilution of 1 part of Betadine for 2 parts of water, and make gargles, 2-3 times a day. DON'T OVERDO IT. Betadine 10% Gel: Apply 2 times a day according to need directly on the affected area (small size) a light layer of gel. Betadine 10% Garze impregnated: Apply 1 gauze, 1-3 times a day. DON'T OVERDO IT.

Conservation

Betadine 1% Collutory: Store at a temperature not exceeding 25°C. Betadine 10% Skin Solution, Alcohol: Store at a temperature not exceeding 25°C Betadine 10% Gel and Betadine 10% Garze impregnated: Store at temperature not exceeding 30°C

Warnings

Only for external use. The product should not be applied on severely loose skin and on extended surfaces. Do not use for prolonged treatments: use of species if prolonged can give rise to awareness phenomena. In this case, the treatment must be stopped and a clinical evaluation must be carried out. Particular caution should be used in patients with pre-existing kidney failure that need regular Betadine applications on skin lesa (see paragraph 5.2). Patients with goiter, thyroid nodules or other acute and non-acute thyroid pathologies are at risk of developing thyroid hyperfunction (hyperthyroidism) as a result of administration of large amounts of iodine. In this population of patients, the solution of iodopovidone should not be used for a prolonged period of time and extensive body surfaces. Even after the end of the treatment it is necessary to seek the early symptoms of possible hyperthyroidism and to monitor the thyroid function. Do not use at least 10 days before making a scintigraphy or after scintigraphy with radioactive iodine or in treatment with radioactive iodine of thyroid carcinoma. The pediatric population is more likely to develop hypothyroidism as a result of high doses of iodine. Due to the permeability of the skin and their high sensitivity to iodine, the use of ioodopovidone must be reduced to the minimum indispensable in children. A control of the thyroid function of the child may be necessary (for example, T4 and TSH levels). Any oral ingestion of hypopovidone by the child must be avoided. In pediatric age use only under strict control and in cases of actual need. Ingestion or accidental inhalation of some disinfectants may have serious, sometimes fatal consequences. Avoid contact with eyes. Betadine 10% cutaneous solution, alcohol: The alcohol solution is highly flammable: must dry completely before any device is applied (especially high-frequency surgical devices). In pre-operative preparation, avoid accumulation under the patient, as chemical burns of the skin may occur. Prolonged exposure to moisture conditions related to the solution can cause irritation or, rarely, severe skin reactions. In case of skin irritation, contact dermatitis or hypersensitivity, stop use. Do not heat before the application. Betadine 1% collutory: It is necessary to pay attention in case of oropharyngeal use to avoid inhalation of Betadine 1% collutory through the respiratory tract since it can cause complications such as pneumonia. This can occur especially in in intubated patients. Long-term use of hypopovidone for gargarism must be avoided in pregnant women, nursing mothers and people with a high risk of developing thyroid dysfunctions due to excessive intake of iodine (see paragraphs 4.6 and 5.2). Important information about some excipients Betadine 1% Collutory contains less than 1 mmol (23 mg) of sodium for 20 ml of collutory, i.e. essentially ‘without sodium’. Betadine 1% Collutory contains 681.88 mg of alcohol (ethanol) in 20 ml of collutory. The quantity in 20 ml of this medicine is equivalent to less than 18 ml of beer or 8 of wine. The small amount of alcohol in this medicine will not produce significant effects.

Interactions

Avoid the contemporary use of other antiseptics and detergents. The polyvinylpyrrolidone-idine complex is effective and stable 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 of its effectiveness. The concomitant use of preparations with enzyme components for the treatment of wounds causes a weakening of the effects of both substances. Hyodopovidone should not be used simultaneously with products containing mercury salts or compounds of benzonium, carbonates, tannic acid, alkali, hydrogen peroxide, taurolidine and silver. The use of products containing iodopovidone in conjunction with other antiseptics containing octedine in the same locations or in adjacent locations can cause a momentary dark coloring of the affected areas. The oxidative effect of the preparations based on hypopovidone can cause false positive results of some laboratory diagnostic tests (e.g. tests with toluidine or gum of sheath for the determination of hemoglobin or glucose in feces or urine). Avoid regular use in patients with lithium The absorption of iodine from the solution of iodopovidone can reduce thyroid captation of iodine. This can interfere with different examinations (thyroid science, iodine binding protein determination, diagnostic with radioactive iodine) and can make a planned treatment of thyroid with iodine impossible (radioactive iodine therapy). After the end of the treatment, before performing a new scintigraphy it is necessary to spend an appropriate period of time.

Effects

Undesirable effects are classified according to their frequency: Very common (≥ 1/10) Common (> 1/100 to Immune disorders Rare Hypersensitivity Very rare Anaphylactic reaction Endocrine diseases Very rare Hyperthyroidism * (sometimes with symptoms such as tachycardia or agitation) I don't know hypothyroidism Disorders of metabolism and nutrition Notable Electrolytic Balance**, Metabolic Acids** Respiratory, chest and mediastinic pathologies Not known Polmonite (only in case of use of Betadine 1% collutory) Pathologies of skin and subcutaneous tissue Rare Contact Dermatitis (with symptoms such as erythema, microvescicles and itching) Very rare Angio Not known Dermatitis exfoliative, Cute dry ^^ (only in case of use of Betadine 10% skin solution, alcohol) Kidney and urinary disorders Not known Acute Renal Insufficiency**, Abnormal Blood Osmolarity** Traumatism, poisoning and procedure complications Do not note Chemistry burn ****, Thermal burn ^ (only in case of use of Betadine 10% cutaneous solution, alcohol) *In patients with history of thyroid pathologies (see paragraph Warnings and special precautions of use) following high iodine caption, for example after long-term use of hypopovidone solution for the treatment of wounds and burns on extended skin areas. **It may occur as a result of the high amount of hypopovidone (e.g. in the treatment of burns) ***Ipothyroidism as a result of prolonged or extended use of hypopovidone **** Following the "accumulation" behind the patient during preoperative preparation *****Complications due to inhalation - see paragraph 4.4 ^^ Due to the high flammability, the iodopovidone alcohol solution must dry completely before using devices (especially high-frequency surgical devices) ^^^ It can occur after repeated applications due to the high alcohol content in the solution; the risk is greater for the genital area (e.g. for scrotum) Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

In case of overdose, intentional or accidental (highly unlikely for pharmaceutical forms such as garze) hypothyroidism or hyperthyroidism can be manifested. Systemic absorption of iodine after repeated applications of the product on extended wounds or severe burns can produce a number of symptoms such as: metallic flavor, increased salivation, burning or pungent pain in the mouth and throat, irritation or swelling in the eyes, fever, skin rash, diarrhea and gastrointestinal disorders, hypotension, tachycardia, metabolic acidosis, hypernatriemia, kidney function failure, pulmonary edema and shock. In case of accidental ingestion of high quantities of product establish a symptomatic and support treatment with particular attention to the electrolytic balance and renal and thyroid function.

During pregnancy and breastfeeding, the solution of iodopovidone should only be used if strictly necessary and at the minimum possible dose, due to the ability of iodine to cross the placenta and to be secreted in breast milk and for the high sensitivity of the fetus and the newborn to iodine. Iodine also concentrates more in breast milk than whey, therefore it can cause transient hypothyroidism with increase of TSH (the thyroid stimulating hormone) in the fetus or in the newborn.

Source: Farmadati