Ioverskan (Solution) Instructions for Use

Marketing Authorization Holder

Pharmasintez-Tyumen, LLC (Russia)

ATC Code

V08AB07 (Ioversol)

Active Substance

Iodine (Ph.Eur. European Pharmacopoeia)

Dosage Forms

	Ioverskan	Solution for intravenous and intra-arterial administration 240 mg iodine/1 ml: fl. 10 ml, 20 ml, 30 ml, 50 ml, 75 ml, 100 ml, 125 ml, 150 ml, 200 ml or 500 ml 1, 5 or 10 pcs.
		Solution for intravenous and intra-arterial administration 300 mg iodine/1 ml: fl. 10 ml, 20 ml, 30 ml, 50 ml, 75 ml, 100 ml, 125 ml, 150 ml, 200 ml or 500 ml 1, 5 or 10 pcs.
		Solution for intravenous and intra-arterial administration 320 mg iodine/1 ml: fl. 10 ml, 20 ml, 30 ml, 50 ml, 75 ml, 100 ml, 125 ml, 150 ml, 200 ml or 500 ml 1, 5 or 10 pcs.
		Solution for intravenous and intra-arterial administration 350 mg iodine/1 ml: fl. 10 ml, 20 ml, 30 ml, 50 ml, 75 ml, 100 ml, 125 ml, 150 ml, 200 ml or 500 ml 1, 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intra-arterial administration transparent, colorless or light yellow, or light yellow with a brownish tint.

Excipients : trometamol hydrochloride – 4.1 mg, trometamol – 0.48 mg, sodium calcium edetate – 0.2 mg, hydrochloric acid solution 1M – to pH value 6.0-7.4, water for injections – to 1 ml.

Osmolality: from 465 to 575 mOsm/kg.
Viscosity: from 4.0 to 5.3 mPa*s.

10 ml – glass bottles (1) – cardboard packs.
10 ml – glass bottles (5) – cardboard packs.
10 ml – glass bottles (10) – cardboard packs.
20 ml – glass bottles (1) – cardboard packs.
20 ml – glass bottles (5) – cardboard packs.
20 ml – glass bottles (10) – cardboard packs.
30 ml – glass bottles (1) – cardboard packs.
30 ml – glass bottles (5) – cardboard packs.
30 ml – glass bottles (10) – cardboard packs.
50 ml – glass bottles (1) – cardboard packs.
50 ml – glass bottles (5) – cardboard packs.
50 ml – glass bottles(10) – cardboard packs.
75 ml – glass bottles (1) – cardboard packs.
75 ml – glass bottles (5) – cardboard packs.
75 ml – glass bottles (10) – cardboard packs.
100 ml – glass bottles (1) – cardboard packs.
100 ml – glass bottles (5) – cardboard packs.
100 ml – glass bottles (10) – cardboard packs.
125 ml – glass bottles (1) – cardboard packs.
125 ml – glass bottles (5) – cardboard packs.
125 ml – glass bottles (10) – cardboard packs.
150 ml – glass bottles (1) – cardboard packs.
150 ml – glass bottles (5) – cardboard packs.
150 ml – glass bottles (10) – cardboard packs.
200 ml – glass bottles (1) – cardboard packs.
200 ml – glass bottles (5) – cardboard packs.
200 ml – glass bottles (10) – cardboard packs.
500 ml – glass bottles (1) – cardboard packs.
500 ml – glass bottles (5) – cardboard packs.
500 ml – glass bottles (10) – cardboard packs.

Solution for intravenous and intra-arterial administration transparent, colorless or light yellow, or light yellow with a brownish tint.

Excipients : trometamol hydrochloride – 4.1 mg, trometamol – 0.48 mg, sodium calcium edetate – 0.2 mg, hydrochloric acid solution 1M – to pH value 6.0-7.4, water for injections – to 1 ml.

Osmolality from 580 to 705 mOsm/kg.
Viscosity from 6.0 to 8.6 mPa*s.

10 ml – glass bottles (1) – cardboard packs.
10 ml – glass bottles (5) – cardboard packs.
10 ml – glass bottles (10) – cardboard packs.
20 ml – glass bottles (1) – cardboard packs.
20 ml – glass bottles (5) – cardboard packs.
20 ml – glass bottles (10) – cardboard packs.
30 ml – glass bottles (1) – cardboard packs.
30 ml – glass bottles (5) – cardboard packs.
30 ml – glass bottles (10) – cardboard packs.
50 ml – glass bottles (1) – cardboard packs.
50 ml – glass bottles (5) – cardboard packs.
50 ml – glass bottles(10) – cardboard packs.
75 ml – glass bottles (1) – cardboard packs.
75 ml – glass bottles (5) – cardboard packs.
75 ml – glass bottles (10) – cardboard packs.
100 ml – glass bottles (1) – cardboard packs.
100 ml – glass bottles (5) – cardboard packs.
100 ml – glass bottles (10) – cardboard packs.
125 ml – glass bottles (1) – cardboard packs.
125 ml – glass bottles (5) – cardboard packs.
125 ml – glass bottles (10) – cardboard packs.
150 ml – glass bottles (1) – cardboard packs.
150 ml – glass bottles (5) – cardboard packs.
150 ml – glass bottles (10) – cardboard packs.
200 ml – glass bottles (1) – cardboard packs.
200 ml – glass bottles (5) – cardboard packs.
200 ml – glass bottles (10) – cardboard packs.
500 ml – glass bottles (1) – cardboard packs.
500 ml – glass bottles (5) – cardboard packs.
500 ml – glass bottles (10) – cardboard packs.

Solution for intravenous and intra-arterial administration transparent, colorless or light yellow, or light yellow with a brownish tint.

Excipients : trometamol hydrochloride – 4.1 mg, trometamol – 0.48 mg, sodium calcium edetate – 0.2 mg, hydrochloric acid solution 1M – to pH value 6.0-7.4, water for injections – to 1 ml.
Osmolality from 615 to 745 mOsm/kg.
Viscosity from 7.0 to 10.5 mPa*s.

10 ml – glass bottles (1) – cardboard packs.
10 ml – glass bottles (5) – cardboard packs.
10 ml – glass bottles (10) – cardboard packs.
20 ml – glass bottles (1) – cardboard packs.
20 ml – glass bottles (5) – cardboard packs.
20 ml – glass bottles (10) – cardboard packs.
30 ml – glass bottles (1) – cardboard packs.
30 ml – glass bottles (5) – cardboard packs.
30 ml – glass bottles (10) – cardboard packs.
50 ml – glass bottles (1) – cardboard packs.
50 ml – glass bottles (5) – cardboard packs.
50 ml – glass bottles(10) – cardboard packs.
75 ml – glass bottles (1) – cardboard packs.
75 ml – glass bottles (5) – cardboard packs.
75 ml – glass bottles (10) – cardboard packs.
100 ml – glass bottles (1) – cardboard packs.
100 ml – glass bottles (5) – cardboard packs.
100 ml – glass bottles (10) – cardboard packs.
125 ml – glass bottles (1) – cardboard packs.
125 ml – glass bottles (5) – cardboard packs.
125 ml – glass bottles (10) – cardboard packs.
150 ml – glass bottles (1) – cardboard packs.
150 ml – glass bottles (5) – cardboard packs.
150 ml – glass bottles (10) – cardboard packs.
200 ml – glass bottles (1) – cardboard packs.
200 ml – glass bottles (5) – cardboard packs.
200 ml – glass bottles (10) – cardboard packs.
500 ml – glass bottles (1) – cardboard packs.
500 ml – glass bottles (5) – cardboard packs.
500 ml – glass bottles (10) – cardboard packs.

Solution for intravenous and intra-arterial administration transparent, colorless or light yellow, or light yellow with a brownish tint.

Excipients : trometamol hydrochloride – 4.1 mg, trometamol – 0.48 mg, sodium calcium edetate – 0.2 mg, hydrochloric acid solution 1M – to pH value 6.0-7.4, water for injections – to 1 ml.

Osmolality:from 670 to 810 mOsm/kg.
Viscosity: from 10.0 to 14.6 mPa*s.

10 ml – glass bottles (1) – cardboard packs.
10 ml – glass bottles (5) – cardboard packs.
10 ml – glass bottles (10) – cardboard packs.
20 ml – glass bottles (1) – cardboard packs.
20 ml – glass bottles (5) – cardboard packs.
20 ml – glass bottles (10) – cardboard packs.
30 ml – glass bottles (1) – cardboard packs.
30 ml – glass bottles (5) – cardboard packs.
30 ml – glass bottles (10) – cardboard packs.
50 ml – glass bottles (1) – cardboard packs.
50 ml – glass bottles (5) – cardboard packs.
50 ml – glass bottles(10) – cardboard packs.
75 ml – glass bottles (1) – cardboard packs.
75 ml – glass bottles (5) – cardboard packs.
75 ml – glass bottles (10) – cardboard packs.
100 ml – glass bottles (1) – cardboard packs.
100 ml – glass bottles (5) – cardboard packs.
100 ml – glass bottles (10) – cardboard packs.
125 ml – glass bottles (1) – cardboard packs.
125 ml – glass bottles (5) – cardboard packs.
125 ml – glass bottles (10) – cardboard packs.
150 ml – glass bottles (1) – cardboard packs.
150 ml – glass bottles (5) – cardboard packs.
150 ml – glass bottles (10) – cardboard packs.
200 ml – glass bottles (1) – cardboard packs.
200 ml – glass bottles (5) – cardboard packs.
200 ml – glass bottles (10) – cardboard packs.
500 ml – glass bottles (1) – cardboard packs.
500 ml – glass bottles (5) – cardboard packs.
500 ml – glass bottles (10) – cardboard packs.

Clinical-Pharmacological Group

Radiocontrast non-ionic diagnostic agent for intravascular administration

Pharmacotherapeutic Group

Contrast agents; X-ray contrast agents containing iodine; water-soluble nephrotropic low-osmolar X-ray contrast agents

Pharmacological Action

Elemental Iodine has pronounced antimicrobial properties. Preparations of elemental iodine are characterized by a pronounced local irritant effect on tissues, and in high concentrations – a cauterizing effect. The local action is due to the ability of elemental iodine to precipitate tissue proteins. Preparations that release elemental Iodine have a much less pronounced irritant effect, and iodides have local irritant properties only in very high concentrations.

Pharmacokinetics

Upon contact with the skin or mucous membranes, 30% is converted into iodides, and the rest into active Iodine. Partially absorbed. The absorbed part penetrates into tissues and organs, selectively absorbed by the thyroid gland. It is excreted mainly by the kidneys, intestines, sweat and mammary glands.

Indications

For external use: infectious and inflammatory skin lesions, injuries, wounds, myalgia.

For topical use: chronic tonsillitis, atrophic rhinitis, purulent otitis, trophic and varicose ulcers, wounds, infected burns, fresh thermal and chemical burns of I-II degree.

ICD codes

Dosage Regimen

Used externally and topically.

For external use, iodine is used to treat damaged skin areas.

Topically used for washing lacunae and supratonsillar spaces, for irrigation of the nasopharynx, for instillation into the ear and washing; in surgical practice and for burns, gauze napkins applied to the affected surface are moistened as needed. Doses, method of application and duration of treatment are determined depending on the indications.

Adverse Reactions

Rarely skin irritation; with prolonged use on large surfaces – iodism (rhinitis, urticaria, angioedema, salivation, lacrimation, acne).

Contraindications

Hypersensitivity to iodine.

For external use: thyrotoxicosis, dermatitis herpetiformis.

Use in Pregnancy and Lactation

Used as indicated during pregnancy and breastfeeding.

Use in Hepatic Impairment

Used as indicated.

Use in Renal Impairment

Used as indicated.

Pediatric Use

Used as indicated.

Geriatric Use

Used as indicated.

Special Precautions

With prolonged use, phenomena of iodism are possible.

Drug Interactions

Pharmaceutically incompatible with essential oils, ammonia solutions, white precipitated mercury (forms an explosive mixture).

Alkaline or acidic environment, the presence of fat, pus, blood weaken the antiseptic activity.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.