Disinfection of the skin before injection, blood collection, needle biopsy, transfusion. Disinfection of the skin and mucous membranes before surgery. Aseptic supply of wounds. Treatment of bacterial and fungal infections. Total and partial disinfection of the patient before surgery (antiseptic bath).
Composition:
1 ml of solution contains 100 mg iodinated povidone.
Action:
A disinfectant containing a complex of Iodine with povidone. This combination ensures a constant release of active iodine (extended release) and reduces irritating properties on the skin, mucous membranes and wounds. Free iodine reacts with the groups -SH and -OH of amino acids that are part of the enzymes and structural proteins of microorganisms, resulting in their destruction and inactivation. The drug works on: Gram-positive, Gram-negative bacteria,Gardenella vag., Treponema pallium, mycolpases, chlamydia, fungi (e.g.Candida), viruses (inclherpes andHIV), protozoa (e.g.Trichomonas) and spores. The povidone and iodine complex is effective at pH 2-7. There is no resistance to the preparation, even in case of chronic use. It is possible to absorb Iodine, which depends on on the method and time of use, the amount of preparation used and the extent of the wound. Due to the molecular weight of povidone (35,000-5,000), retention may occur. The excretion of both iodine and povidone takes place via the kidneys.
Contraindications:
Hypersensitivity to iodine or other components of the preparation, hyperthyroidism or other overt thyroid disease, dermatitis herpetiformis (Duhring's disease), renal failure, before and after treatment with radioactive iodine or radioiodine test.
Precautions:
Due to the fact that the subsequent development of hyperthyroidism can not be definitely ruled out in patients with latent thyroid disorders (especially in the elderly), long-term use (longer than 14 days) of the preparation or its use on large areas of the skin (over 10%) body surface area) is allowed only after careful consideration of benefits and risks. These patients require observation for early signs of hyperthyroidism and if thyroid function is needed, even after discontinuation of treatment (up to 3 months). When preparing for surgery, avoid collecting the product under the patient. In cases of skin irritation, contact dermatitis or hypersensitivity, the preparation should be discontinued. Patients with thyroid will, thyroid nodules or other non-acute thyroid diseases are at risk of developing hyperthyroidism after administration of large amounts of iodine. In this patient population, the product should not be used over a long period of time and on large areas of the skin, unless there are strict indications. Even after treatment, the early symptoms of hyperthyroidism should be monitored and the thyroid function monitored if necessary. In neonates and infants up to 6 months of age, the preparation can only be used for confirmed diagnosis and strict indications for use; thyroid function should be monitored. Newborns and infants are at risk of developing hypothyroidism after administration of large amounts of iodine. In neonates and infants, due to the significant penetration of the drug through the skin and increased sensitivity to iodine, the use should be limited to an absolute minimum. Special care should be taken when using the product in patients with pre-existing renal failure. Avoid contact with eyes. If the preparation gets into the eyes, spread the eyelids and rinse eyes with a lot of running water for 10-15 minutes. The patient should be examined by an ophthalmologist.
Pregnancy and lactation:
The use of the drug after the second month of pregnancy and breastfeeding is allowed only in the case of accurate diagnosis and absolute indications for the use of the preparation (mother and baby should be monitored for thyroid function). Treatment should be limited to a short period of time. Iodine passes through the placenta and into breast milk. Iodine has higher concentrations in breast milk than in serum.Iodized povidone may induce transient hypothyroidism with increased TSH levels in the fetus or newborn. It is essential to protect the infant against ingestion.
Side effects:
Rare: hypersensitivity, contact dermatitis (with symptoms such as erythema, slight blisters and pruritus). Very rare: anaphylactic reaction, hyperthyroidism sometimes with symptoms such as tachycardia or restlessness (in patients with a history of thyroid gland disease after clear iodine uptake, eg after prolonged use of the preparation for wounds and burns on large areas of the skin), angioneurotic edema. Frequency unknown: hypothyroidism (after prolonged or intensive use), chemical skin burn (due to the solution under the patient during preparation for surgery), renal dysfunction and after the uptake of large amounts of iodine povidone (eg in the course of treatment of burns) - electrolyte disturbances, metabolic acidosis, acute renal failure, abnormal blood osmolarity.
Dosage:
Topically, in undiluted form or as a 10% or 1% aqueous solution, depending on the application site. In skin disinfection prior to injection, blood collection, needle biopsy, transfusion or infusion, the solution is applied to the intact skin for 1-2 min. Use a 10% solution to supply wounds, disinfect mucous membranes and treat bacterial and fungal infections. For aseptic bath the 1% solution is applied evenly on the patient's body and rinsed with water after 2 min. The solution of the preparation is diluted just before its application. In neonates and infants up to 6 months of age, the preparation can only be used for confirmed diagnosis and strict indications for use; thyroid function should be monitored.