VIDENE ANTISEPTIC

Videne Antiseptic Solution is intended for topical application either undiluted or diluted. 200ml pack size is for single use only. Used as a disinfectant or an antiseptic for the skin or mucosa, eg, prior to surgery, biopsies, injections, punctures, blood-taking and bladder catheterisations Videne Antiseptic Solution should be applied undiluted.

For the disinfection of skin areas with a sparse distribution of sebaceous glands the exposure time is at least one minute, in skin areas with a dense distribution of sebaceous glands at least 10 minutes. The skin should be kept moist for the entire duration of the exposure time with the undiluted preparation.

For the antiseptic treatment of superficial wounds Videne Antiseptic Solution is applied undiluted to the areas to be treated. In antiseptic topical therapy of burn wounds, Videne Antiseptic Solution is generally applied undiluted to the areas to be treated.

For antiseptic irrigation, washes and baths Videne Antiseptic Solution can be diluted. The following dilutions are recommended as standard ratios: – Irrigation within the scope of wound treatment (eg, decubitus, varicose ulcer and gangrene) and perioperative infection prophylaxis 1:2 to 1:20 – Antiseptic washes 1:2 to 1:25 – Antiseptic partial baths approx.

1:25, antiseptic full baths approx. 1:100 Normal tap water is suitable for dilution. Where conditions approximating isotonicity are desired, physiological saline or Ringer’s solution can be used. For application to the eye solutions buffered with phosphate buffer solutions are recommended.

Dilutions must always be freshly prepared and used immediately. Sufficient Videne Antiseptic Solution must be applied to wet the area to be treated completely. The antiseptic film that forms as it dries can be easily rinsed off with water.

Due to the possibility of skin irritations, when used for preoperative disinfection of the skin avoid pooling of the product under the patient. In repeated use, the frequency and duration of application depends on the indication for use.

System Organ Class 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 (cannot be estimated from the data available) Immune System Disorders Hyper- sensitivity Anaphylactic reactions Metabolic and Nutrition Disorders Hyper- thyroidism Metabolic Acidosis Electrolyte disturbance Skin and Subcutaneous Tissue Disorders Dependent rubor Skin irritation Pruritus Vesicles Renal and Urinary Disorders Renal Insufficiency Investigations Serum osmolarity disturbance Immune System Disorders: Rare: Hypersensitivity reactions of the skin.

Very Rare:

Anaphylactic reactions Metabolic and Nutrition Disorders: Very Rare: An appreciable uptake of iodine can occur with long-term application of Videne Antiseptic Solution to extensive skin, wound or burn areas. Very rarely, in predisposed patients, iodine-induced hyperthyroidism can occur.

, in the treatment of burns), the occurrence of (additional) electrolyte and serum osmolarity disturbances as well as severe metabolic acidosis has been described.

Skin and Subcutaneous Tissue Disorders:

Rare: Delayed contact allergy reactions, which can express themselves in the form of pruritus, rubor, vesicles. Irritations of the skin after preoperative disinfection have been reported. , in the treatment of burns) renal insufficiency has been described.

, in the treatment of burns) serum osmolarity disturbances have been described. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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4 Special warnings and special precautions for use Care must be taken when applying Videne to the oral cavity to avoid the risk of aspiration with consequent pneumonia and other possible respiratory complications. The product must not be swallowed.

Regular or prolonged use should be avoided in patients with thyroid disorders or those receiving lithium therapy. e. with autonomous adenomas and/or functional automony (especially in elderly patients) as subsequent iodine-induced hyperthyroidism cannot be completely ruled out.

In these cases, the doctor should be vigilant for early symptoms of possible hyperthyroidism for up to 3 months after therapy has been discontinued and, where necessary, thyroid function monitored; – to an extremely limited extent in neonates and nursing infants up to the age of 6 months as the risk of hypothyroidism cannot be completely ruled out.

After applying Videne Antiseptic Solution thyroid function should be checked. In the case of hypothyroidism, early treatment with thyroid hormones must be carried out until thyroid function becomes normal. Accidental oral intake by the nursing infant must be avoided.

Videne Antiseptic Solution must not be used: – in hyperthyroidism or other manifest thyroid diseases; – in herpetiform dermatitis (Duhring's disease); – before and after a radioiodine application (until the end of the treatment); – in known cases of hypersensitivity to iodinated povidone or any of the ingredients of the medication.