Packaging
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DOTAREM® Vials1 |
DOTAREM Prefilled Syringes1 |
DOTAREM Pharmacy Bulk Package Vials1 |
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|---|---|---|---|
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Unit of Sale |
10 mL, 15 mL or 20 mL available in glass vials |
10mL, 15 mL, or 20 mL solution available in prefilled syringes |
Pharmacy Bulk Package is supplied in 100 mL |
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Unit/Carton |
Vials are packaged in a box of 10. |
Syringes, including plunger rod, are packaged in a box of 10. |
Pharmacy Bulk Package is individually packaged in a box of 6. |
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Wholesale Minimum Order |
1 box of 10 Vials |
1 box of 10 Prefilled Syringes |
1 box of 6 Vials |
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Storage |
Store at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see United States Pharmacopeia (USP), Controlled Room Temperature (CRT)]. |
Store at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see United StatesPharmacopeia (USP), Controlled Room Temperature (CRT)]. Prefilled syringes must not be frozen. Frozen syringes should be discarded. |
Store at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP, Controlled Room Temperature (CRT)]. |
Dotarem (gadoterate meglumine) Injection, 0.5 mmol/mL
- 10 mL in glass vials in case of 10 (NDC 67684-2001-1)
- 15 mL in glass vials in case of 10 (NDC 67684-2001-2)
- 20 mL in glass vials case of 10 (NDC 67684-2001-3)
- 100 mL in glass vials in a case of 6 (NDC 67684-2001-4)
- 10 mL in pre-filled syringe in a case of 10 (NDC 67684-3001-1)
- 15 mL in pre-filled syringe in a case of 10 (NDC 67684-3001-2)
- 20 mL in pre-filled syringe in a case of 10 (NDC 67684-3001-3)
Pharmacy Bulk Package: NOT FOR DIRECT INFUSION
Physical Characteristics1-2
| Osmolality mOsm/kg H2O | Viscosity mPa*s at 20˚C | Viscosity mPa*s at 37˚C | Thermodynamic Stability Log Ktherm* | Thermodynamic Stability Log Kcond† at pH 7.4 | Kinetic Stability11 (Dissociation Half-life) T1/2 at pH 1.0 at 25˚C | |
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Dotarem® |
1350 | 3.4 | 2.4 | 25.6 | 19.3 | > 338 h |
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* Log Ktherm = absolute thermodynamic stability constant
† Log Kcond = conditional thermodynamic stability constant depending on pH
For more information about Dotarem, please see the Full Prescribing Information and Medication Guide (also available: Spanish Version Medication Guide); Dear Health Care Provider Letter-Gadolinium Retention Letter
References
- Dotarem [package insert]. Princeton, NJ: Guerbet LLC; April 2022.
- Port M., et al. Efficiency, thermodynamic and kinetic stability of marketed gadolinium chelates and their possible clinical consequences: a critical review. Biometals. 2008.21(4):469–490