1
i-Medical Ophthalmic International Heidelberg GmbH Markircher Straße 7 • 68229 Mannheim • Germany • www.imedical.de i-Visc VISCOELASTIC SOLUTION FOR INTRAOCULAR USE based on SODIUM HYALURONATE Specification Sodium hyaluronate Molecular weight [mio. Daltons] Viscosity* [mPas] Osmolality [mOsm/kg] Storage pH Volume [ml] Shelf life [months] * after steam sterilization 1.0 % 1.1 - 1.5 approx. 20 000 270 - 400 2° - 25° C 6.8 - 7.4 1.0 42 1.4 % 1.1 - 2.0 approx. 30 000 270 - 400 2° - 25° C 6.8 - 7.4 1.0 42 1.6 % 1.2 - 2.0 approx. 60 000 270 - 400 2° - 25° C 6.8 - 7.4 1.0 42 1.8 % 1.2 - 2.0 approx. 100 000 270 - 400 2° - 25° C 6.8 - 7.4 1.0 42 3.0 % 1.0 - 1.8 approx. 300 000 270 - 400 2° - 25° C 6.8 - 7.4 1.0 42 Composition [1ml] Sodium hyaluronate Sodium chloride Disodium hydrogenphosphate 2 H2O Sodium dihydrogenphosphate 2 H2O Water for injection 10.000 mg 8.500 mg 0.563 mg 0.045 mg q.s. 14.000 mg 8.500 mg 0.563 mg 0.045 mg q.s. 16.000 mg 8.500 mg 0.563 mg 0.045 mg q.s. 18.000 mg 8.500 mg 0.563 mg 0.045 mg q.s. 30.000 mg 6.500 mg 0.563 mg 0.045 mg q.s. i-Visc 1.0 i-Visc 1.0 i-Visc 1.4 i-Visc 1.4 i-Visc 1.6 i-Visc 1.6 i-Visc 1.8 i-Visc 1.8 i-Visc 3.0 i-Visc 3.0 • Free of conservation substances • Isotonic solution • Good maintenance of the anterior chamber and the capsular bag • No preservatives • Steam sterilized • No inflammable or immunogene reaction • Easy to inject • Easy to remove • CE certified 0481

i-Visc · i-Visc VISCOELASTIC SOLUTION FOR INTRAOCULAR USE based on SODIUM HYALURONATE Specification Sodium hyaluronate Molecular weight [mio. Daltons] Viscosity* [mPas] Osmolality

  • Upload
    others

  • View
    34

  • Download
    1

Embed Size (px)

Citation preview

Page 1: i-Visc · i-Visc VISCOELASTIC SOLUTION FOR INTRAOCULAR USE based on SODIUM HYALURONATE Specification Sodium hyaluronate Molecular weight [mio. Daltons] Viscosity* [mPas] Osmolality

i-Medical Ophthalmic International Heidelberg GmbHMarkircher Straße 7 • 68229 Mannheim • Germany • www.imedical.de

i-ViscVISCOELASTIC SOLUTION FOR INTRAOCULAR USE based on SODIUM HYALURONATE

Specification

Sodium hyaluronate

Molecular weight [mio. Daltons]

Viscosity* [mPas]

Osmolality [mOsm/kg]

Storage

pH

Volume [ml]

Shelf life [months]

* after steam sterilization

1.0 %

1.1 - 1.5

approx. 20 000

270 - 400

2° - 25° C

6.8 - 7.4

1.0

42

1.4 %

1.1 - 2.0

approx. 30 000

270 - 400

2° - 25° C

6.8 - 7.4

1.0

42

1.6 %

1.2 - 2.0

approx. 60 000

270 - 400

2° - 25° C

6.8 - 7.4

1.0

42

1.8 %

1.2 - 2.0

approx. 100 000

270 - 400

2° - 25° C

6.8 - 7.4

1.0

42

3.0 %

1.0 - 1.8

approx. 300 000

270 - 400

2° - 25° C

6.8 - 7.4

1.0

42

Composition [1ml]

Sodium hyaluronate

Sodium chloride

Disodium hydrogenphosphate 2 H2O

Sodium dihydrogenphosphate 2 H2O

Water for injection

10.000 mg

8.500 mg

0.563 mg

0.045 mg

q.s.

14.000 mg

8.500 mg

0.563 mg

0.045 mg

q.s.

16.000 mg

8.500 mg

0.563 mg

0.045 mg

q.s.

18.000 mg

8.500 mg

0.563 mg

0.045 mg

q.s.

30.000 mg

6.500 mg

0.563 mg

0.045 mg

q.s.

i-Visc 1.0

i-Visc 1.0 i-Visc 1.4

i-Visc 1.4 i-Visc 1.6

i-Visc 1.6

i-Visc 1.8

i-Visc 1.8

i-Visc 3.0

i-Visc 3.0

• Free of conservation substances• Isotonic solution• Good maintenance of the anterior chamber and the capsular bag • No preservatives• Steam sterilized• No in�ammable or immunogene reaction• Easy to inject• Easy to remove• CE certi�ed

0481