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CARTICEL
Overview
What is CARTICEL?
Autologous cultured chondrocytes, the Carticel product, are derived from expansion of chondrocytes harvested from the patient's normal, femoral articular cartilage. Biopsies from a lesser-weight bearing area are the source of chondrocytes, which are isolated, expanded through cell culture, and implanted into articular cartilage defects beneath an autologous periosteal flap. Prior to final packaging, cell viability is assessed to be at least 80%.
Each single use container of autologous cultured chondrocytes has approximately 12 million cells aseptically processed and suspended in 0.4 mL of sterile, buffered Dulbecco's Modified Eagles Medium (DMEM). Both the biopsy transport media and the cell culture media contain gentamicin. Residual quantities of gentamicin up to 5 µg/mL may be present in the Carticel product.
What does CARTICEL look like?
What are the available doses of CARTICEL?
Each Carticel vial of autologous cultured chondrocytes contains approximately 12 million cells per vial. ()
What should I talk to my health care provider before I take CARTICEL?
Use in children or patients over age 65 has not been assessed. ()
How should I use CARTICEL?
Carticel is indicated for the repair of symptomatic cartilage defects of the femoral condyle (medial, lateral or trochlea), caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure (e.g., debridement, microfracture, drilling/abrasion arthroplasty, or osteochondral allograft/autograft).
Carticel should be used only in conjunction with debridement, placement of a periosteal flap and rehabilitation. The independent contributions of the autologous cultured chondrocytes and other components of the therapy to outcome are unknown.
Carticel is not indicated for the treatment of cartilage damage associated with generalized osteoarthritis.
Carticel is not recommended for patients with total meniscectomy unless surgically reconstructed prior to or concurrent with Carticel implantation.
For Autologous Implantation Only
What interacts with CARTICEL?
Sorry No Records found
What are the warnings of CARTICEL?
Sorry No Records found
What are the precautions of CARTICEL?
Sorry No Records found
What are the side effects of CARTICEL?
Sorry No records found
What should I look out for while using CARTICEL?
Carticel should not be used in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides or materials of bovine origin.
Gentamicin is added to both the cartilage biopsy transport media and in the culture media used during the processing of Carticel. Residual quantities of gentamicin up to 5 µg/mL are present in the Carticel product.
Fetal bovine serum is a component in the culture medium used to propagate the autologous chondrocytes. Trace quantities of bovine-derived proteins may be present in the Carticel product.
What might happen if I take too much CARTICEL?
Sorry No Records found
How should I store and handle CARTICEL?
The Carticel transport box should be held at room temperature and remain closed until the time of implantation to ensure proper storage conditions for the cells.Do Not Refrigerate, Freeze, or Incubate the Carticel Shipping Container or its Contents.Do Not Sterilize.If the Vial is Damaged or Sterility has been Compromised, Do Not Use.The Carticel transport box should be held at room temperature and remain closed until the time of implantation to ensure proper storage conditions for the cells.Do Not Refrigerate, Freeze, or Incubate the Carticel Shipping Container or its Contents.Do Not Sterilize.If the Vial is Damaged or Sterility has been Compromised, Do Not Use.The Carticel transport box should be held at room temperature and remain closed until the time of implantation to ensure proper storage conditions for the cells.Do Not Refrigerate, Freeze, or Incubate the Carticel Shipping Container or its Contents.Do Not Sterilize.If the Vial is Damaged or Sterility has been Compromised, Do Not Use.The Carticel transport box should be held at room temperature and remain closed until the time of implantation to ensure proper storage conditions for the cells.Do Not Refrigerate, Freeze, or Incubate the Carticel Shipping Container or its Contents.Do Not Sterilize.If the Vial is Damaged or Sterility has been Compromised, Do Not Use.PredniSONE Tablets USP1 mg, round, white, scored tablets (Identified 54 092)NDC 0615-6516-39: Blistercards of 30 tablets.2.5 mg, round, white, scored tablets (Identified 54 339)NDC 0615-2513-39: Blistercards of 30 tablets.5 mg, round, white, scored tablets (Identified 54 612)10 mg, round, white, scored tablets (Identified 54 899)20 mg, round, white, scored tablets (Identified 54 760)NDC 0615-1542-39: Blistercards of 30 tablets.50 mg, round, white, scored tablets (Identified 54 343)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PROTECT FROM MOISTURE.PredniSONE Oral Solution USP, 5 mg per 5 mLClear, colorless solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mLClear, colorless, slightly viscous solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.PredniSONE Tablets USP1 mg, round, white, scored tablets (Identified 54 092)NDC 0615-6516-39: Blistercards of 30 tablets.2.5 mg, round, white, scored tablets (Identified 54 339)NDC 0615-2513-39: Blistercards of 30 tablets.5 mg, round, white, scored tablets (Identified 54 612)10 mg, round, white, scored tablets (Identified 54 899)20 mg, round, white, scored tablets (Identified 54 760)NDC 0615-1542-39: Blistercards of 30 tablets.50 mg, round, white, scored tablets (Identified 54 343)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PROTECT FROM MOISTURE.PredniSONE Oral Solution USP, 5 mg per 5 mLClear, colorless solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mLClear, colorless, slightly viscous solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.PredniSONE Tablets USP1 mg, round, white, scored tablets (Identified 54 092)NDC 0615-6516-39: Blistercards of 30 tablets.2.5 mg, round, white, scored tablets (Identified 54 339)NDC 0615-2513-39: Blistercards of 30 tablets.5 mg, round, white, scored tablets (Identified 54 612)10 mg, round, white, scored tablets (Identified 54 899)20 mg, round, white, scored tablets (Identified 54 760)NDC 0615-1542-39: Blistercards of 30 tablets.50 mg, round, white, scored tablets (Identified 54 343)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PROTECT FROM MOISTURE.PredniSONE Oral Solution USP, 5 mg per 5 mLClear, colorless solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mLClear, colorless, slightly viscous solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.PredniSONE Tablets USP1 mg, round, white, scored tablets (Identified 54 092)NDC 0615-6516-39: Blistercards of 30 tablets.2.5 mg, round, white, scored tablets (Identified 54 339)NDC 0615-2513-39: Blistercards of 30 tablets.5 mg, round, white, scored tablets (Identified 54 612)10 mg, round, white, scored tablets (Identified 54 899)20 mg, round, white, scored tablets (Identified 54 760)NDC 0615-1542-39: Blistercards of 30 tablets.50 mg, round, white, scored tablets (Identified 54 343)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PROTECT FROM MOISTURE.PredniSONE Oral Solution USP, 5 mg per 5 mLClear, colorless solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mLClear, colorless, slightly viscous solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.PredniSONE Tablets USP1 mg, round, white, scored tablets (Identified 54 092)NDC 0615-6516-39: Blistercards of 30 tablets.2.5 mg, round, white, scored tablets (Identified 54 339)NDC 0615-2513-39: Blistercards of 30 tablets.5 mg, round, white, scored tablets (Identified 54 612)10 mg, round, white, scored tablets (Identified 54 899)20 mg, round, white, scored tablets (Identified 54 760)NDC 0615-1542-39: Blistercards of 30 tablets.50 mg, round, white, scored tablets (Identified 54 343)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PROTECT FROM MOISTURE.PredniSONE Oral Solution USP, 5 mg per 5 mLClear, colorless solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mLClear, colorless, slightly viscous solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.PredniSONE Tablets USP1 mg, round, white, scored tablets (Identified 54 092)NDC 0615-6516-39: Blistercards of 30 tablets.2.5 mg, round, white, scored tablets (Identified 54 339)NDC 0615-2513-39: Blistercards of 30 tablets.5 mg, round, white, scored tablets (Identified 54 612)10 mg, round, white, scored tablets (Identified 54 899)20 mg, round, white, scored tablets (Identified 54 760)NDC 0615-1542-39: Blistercards of 30 tablets.50 mg, round, white, scored tablets (Identified 54 343)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PROTECT FROM MOISTURE.PredniSONE Oral Solution USP, 5 mg per 5 mLClear, colorless solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mLClear, colorless, slightly viscous solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.PredniSONE Tablets USP1 mg, round, white, scored tablets (Identified 54 092)NDC 0615-6516-39: Blistercards of 30 tablets.2.5 mg, round, white, scored tablets (Identified 54 339)NDC 0615-2513-39: Blistercards of 30 tablets.5 mg, round, white, scored tablets (Identified 54 612)10 mg, round, white, scored tablets (Identified 54 899)20 mg, round, white, scored tablets (Identified 54 760)NDC 0615-1542-39: Blistercards of 30 tablets.50 mg, round, white, scored tablets (Identified 54 343)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PROTECT FROM MOISTURE.PredniSONE Oral Solution USP, 5 mg per 5 mLClear, colorless solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mLClear, colorless, slightly viscous solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.PredniSONE Tablets USP1 mg, round, white, scored tablets (Identified 54 092)NDC 0615-6516-39: Blistercards of 30 tablets.2.5 mg, round, white, scored tablets (Identified 54 339)NDC 0615-2513-39: Blistercards of 30 tablets.5 mg, round, white, scored tablets (Identified 54 612)10 mg, round, white, scored tablets (Identified 54 899)20 mg, round, white, scored tablets (Identified 54 760)NDC 0615-1542-39: Blistercards of 30 tablets.50 mg, round, white, scored tablets (Identified 54 343)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PROTECT FROM MOISTURE.PredniSONE Oral Solution USP, 5 mg per 5 mLClear, colorless solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mLClear, colorless, slightly viscous solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.PredniSONE Tablets USP1 mg, round, white, scored tablets (Identified 54 092)NDC 0615-6516-39: Blistercards of 30 tablets.2.5 mg, round, white, scored tablets (Identified 54 339)NDC 0615-2513-39: Blistercards of 30 tablets.5 mg, round, white, scored tablets (Identified 54 612)10 mg, round, white, scored tablets (Identified 54 899)20 mg, round, white, scored tablets (Identified 54 760)NDC 0615-1542-39: Blistercards of 30 tablets.50 mg, round, white, scored tablets (Identified 54 343)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PROTECT FROM MOISTURE.PredniSONE Oral Solution USP, 5 mg per 5 mLClear, colorless solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mLClear, colorless, slightly viscous solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.PredniSONE Tablets USP1 mg, round, white, scored tablets (Identified 54 092)NDC 0615-6516-39: Blistercards of 30 tablets.2.5 mg, round, white, scored tablets (Identified 54 339)NDC 0615-2513-39: Blistercards of 30 tablets.5 mg, round, white, scored tablets (Identified 54 612)10 mg, round, white, scored tablets (Identified 54 899)20 mg, round, white, scored tablets (Identified 54 760)NDC 0615-1542-39: Blistercards of 30 tablets.50 mg, round, white, scored tablets (Identified 54 343)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PROTECT FROM MOISTURE.PredniSONE Oral Solution USP, 5 mg per 5 mLClear, colorless solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mLClear, colorless, slightly viscous solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.PredniSONE Tablets USP1 mg, round, white, scored tablets (Identified 54 092)NDC 0615-6516-39: Blistercards of 30 tablets.2.5 mg, round, white, scored tablets (Identified 54 339)NDC 0615-2513-39: Blistercards of 30 tablets.5 mg, round, white, scored tablets (Identified 54 612)10 mg, round, white, scored tablets (Identified 54 899)20 mg, round, white, scored tablets (Identified 54 760)NDC 0615-1542-39: Blistercards of 30 tablets.50 mg, round, white, scored tablets (Identified 54 343)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PROTECT FROM MOISTURE.PredniSONE Oral Solution USP, 5 mg per 5 mLClear, colorless solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mLClear, colorless, slightly viscous solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.PredniSONE Tablets USP1 mg, round, white, scored tablets (Identified 54 092)NDC 0615-6516-39: Blistercards of 30 tablets.2.5 mg, round, white, scored tablets (Identified 54 339)NDC 0615-2513-39: Blistercards of 30 tablets.5 mg, round, white, scored tablets (Identified 54 612)10 mg, round, white, scored tablets (Identified 54 899)20 mg, round, white, scored tablets (Identified 54 760)NDC 0615-1542-39: Blistercards of 30 tablets.50 mg, round, white, scored tablets (Identified 54 343)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PROTECT FROM MOISTURE.PredniSONE Oral Solution USP, 5 mg per 5 mLClear, colorless solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mLClear, colorless, slightly viscous solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.PredniSONE Tablets USP1 mg, round, white, scored tablets (Identified 54 092)NDC 0615-6516-39: Blistercards of 30 tablets.2.5 mg, round, white, scored tablets (Identified 54 339)NDC 0615-2513-39: Blistercards of 30 tablets.5 mg, round, white, scored tablets (Identified 54 612)10 mg, round, white, scored tablets (Identified 54 899)20 mg, round, white, scored tablets (Identified 54 760)NDC 0615-1542-39: Blistercards of 30 tablets.50 mg, round, white, scored tablets (Identified 54 343)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PROTECT FROM MOISTURE.PredniSONE Oral Solution USP, 5 mg per 5 mLClear, colorless solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mLClear, colorless, slightly viscous solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.PredniSONE Tablets USP1 mg, round, white, scored tablets (Identified 54 092)NDC 0615-6516-39: Blistercards of 30 tablets.2.5 mg, round, white, scored tablets (Identified 54 339)NDC 0615-2513-39: Blistercards of 30 tablets.5 mg, round, white, scored tablets (Identified 54 612)10 mg, round, white, scored tablets (Identified 54 899)20 mg, round, white, scored tablets (Identified 54 760)NDC 0615-1542-39: Blistercards of 30 tablets.50 mg, round, white, scored tablets (Identified 54 343)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PROTECT FROM MOISTURE.PredniSONE Oral Solution USP, 5 mg per 5 mLClear, colorless solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mLClear, colorless, slightly viscous solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.PredniSONE Tablets USP1 mg, round, white, scored tablets (Identified 54 092)NDC 0615-6516-39: Blistercards of 30 tablets.2.5 mg, round, white, scored tablets (Identified 54 339)NDC 0615-2513-39: Blistercards of 30 tablets.5 mg, round, white, scored tablets (Identified 54 612)10 mg, round, white, scored tablets (Identified 54 899)20 mg, round, white, scored tablets (Identified 54 760)NDC 0615-1542-39: Blistercards of 30 tablets.50 mg, round, white, scored tablets (Identified 54 343)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PROTECT FROM MOISTURE.PredniSONE Oral Solution USP, 5 mg per 5 mLClear, colorless solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mLClear, colorless, slightly viscous solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.PredniSONE Tablets USP1 mg, round, white, scored tablets (Identified 54 092)NDC 0615-6516-39: Blistercards of 30 tablets.2.5 mg, round, white, scored tablets (Identified 54 339)NDC 0615-2513-39: Blistercards of 30 tablets.5 mg, round, white, scored tablets (Identified 54 612)10 mg, round, white, scored tablets (Identified 54 899)20 mg, round, white, scored tablets (Identified 54 760)NDC 0615-1542-39: Blistercards of 30 tablets.50 mg, round, white, scored tablets (Identified 54 343)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PROTECT FROM MOISTURE.PredniSONE Oral Solution USP, 5 mg per 5 mLClear, colorless solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mLClear, colorless, slightly viscous solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.PredniSONE Tablets USP1 mg, round, white, scored tablets (Identified 54 092)NDC 0615-6516-39: Blistercards of 30 tablets.2.5 mg, round, white, scored tablets (Identified 54 339)NDC 0615-2513-39: Blistercards of 30 tablets.5 mg, round, white, scored tablets (Identified 54 612)10 mg, round, white, scored tablets (Identified 54 899)20 mg, round, white, scored tablets (Identified 54 760)NDC 0615-1542-39: Blistercards of 30 tablets.50 mg, round, white, scored tablets (Identified 54 343)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PROTECT FROM MOISTURE.PredniSONE Oral Solution USP, 5 mg per 5 mLClear, colorless solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mLClear, colorless, slightly viscous solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.PredniSONE Tablets USP1 mg, round, white, scored tablets (Identified 54 092)NDC 0615-6516-39: Blistercards of 30 tablets.2.5 mg, round, white, scored tablets (Identified 54 339)NDC 0615-2513-39: Blistercards of 30 tablets.5 mg, round, white, scored tablets (Identified 54 612)10 mg, round, white, scored tablets (Identified 54 899)20 mg, round, white, scored tablets (Identified 54 760)NDC 0615-1542-39: Blistercards of 30 tablets.50 mg, round, white, scored tablets (Identified 54 343)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PROTECT FROM MOISTURE.PredniSONE Oral Solution USP, 5 mg per 5 mLClear, colorless solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mLClear, colorless, slightly viscous solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.PredniSONE Tablets USP1 mg, round, white, scored tablets (Identified 54 092)NDC 0615-6516-39: Blistercards of 30 tablets.2.5 mg, round, white, scored tablets (Identified 54 339)NDC 0615-2513-39: Blistercards of 30 tablets.5 mg, round, white, scored tablets (Identified 54 612)10 mg, round, white, scored tablets (Identified 54 899)20 mg, round, white, scored tablets (Identified 54 760)NDC 0615-1542-39: Blistercards of 30 tablets.50 mg, round, white, scored tablets (Identified 54 343)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PROTECT FROM MOISTURE.PredniSONE Oral Solution USP, 5 mg per 5 mLClear, colorless solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mLClear, colorless, slightly viscous solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.PredniSONE Tablets USP1 mg, round, white, scored tablets (Identified 54 092)NDC 0615-6516-39: Blistercards of 30 tablets.2.5 mg, round, white, scored tablets (Identified 54 339)NDC 0615-2513-39: Blistercards of 30 tablets.5 mg, round, white, scored tablets (Identified 54 612)10 mg, round, white, scored tablets (Identified 54 899)20 mg, round, white, scored tablets (Identified 54 760)NDC 0615-1542-39: Blistercards of 30 tablets.50 mg, round, white, scored tablets (Identified 54 343)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PROTECT FROM MOISTURE.PredniSONE Oral Solution USP, 5 mg per 5 mLClear, colorless solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mLClear, colorless, slightly viscous solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.PredniSONE Tablets USP1 mg, round, white, scored tablets (Identified 54 092)NDC 0615-6516-39: Blistercards of 30 tablets.2.5 mg, round, white, scored tablets (Identified 54 339)NDC 0615-2513-39: Blistercards of 30 tablets.5 mg, round, white, scored tablets (Identified 54 612)10 mg, round, white, scored tablets (Identified 54 899)20 mg, round, white, scored tablets (Identified 54 760)NDC 0615-1542-39: Blistercards of 30 tablets.50 mg, round, white, scored tablets (Identified 54 343)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PROTECT FROM MOISTURE.PredniSONE Oral Solution USP, 5 mg per 5 mLClear, colorless solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mLClear, colorless, slightly viscous solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.PredniSONE Tablets USP1 mg, round, white, scored tablets (Identified 54 092)NDC 0615-6516-39: Blistercards of 30 tablets.2.5 mg, round, white, scored tablets (Identified 54 339)NDC 0615-2513-39: Blistercards of 30 tablets.5 mg, round, white, scored tablets (Identified 54 612)10 mg, round, white, scored tablets (Identified 54 899)20 mg, round, white, scored tablets (Identified 54 760)NDC 0615-1542-39: Blistercards of 30 tablets.50 mg, round, white, scored tablets (Identified 54 343)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PROTECT FROM MOISTURE.PredniSONE Oral Solution USP, 5 mg per 5 mLClear, colorless solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense in a tight container, as defined in the USP/NF.PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mLClear, colorless, slightly viscous solutionStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Hyaline cartilage forms the articular surface of the femoral condyle. Studies have shown that implantation of autologous chondrocytes into the articular defect can result in the development of hyaline-like cartilage []. Normal hyaline cartilage consists of chondrocytes (≤ 5% total volume) and extracellular matrix (≥ 95% total volume). The matrix contains a variety of macromolecules, including type II collagen and proteoglycan. The structure of the matrix allows the hyaline cartilage to absorb shock and withstand shearing and compression forces. Normal hyaline cartilage also has an extremely low coefficient of friction at the articular surface. Damage to articular cartilage from acute or repetitive trauma often results in pain and disability. However, because hyaline cartilage is avascular, spontaneous healing of large defects is not believed to occur in humans.
A variety of surgical procedures have been used in attempts to promote repair of articular cartilage, and a few studies have evaluated the histology resulting from these interventions. Generally, procedures such as marrow stimulation techniques (MST) have been shown to produce fibrocartilage or hybrid mixtures of fibrocartilage and hyaline cartilage. Published data show that autologous chondrocyte implantation (ACI) is more likely than MST to result in hyaline-like cartilage at the repair site. However, because of differences in study design, lesion size and concomitant patient conditions, these data are not sufficient to draw conclusions concerning the long-term correlation of histology and clinical outcomes.
Non-Clinical Toxicology
Carticel should not be used in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides or materials of bovine origin.Gentamicin is added to both the cartilage biopsy transport media and in the culture media used during the processing of Carticel. Residual quantities of gentamicin up to 5 µg/mL are present in the Carticel product.
Fetal bovine serum is a component in the culture medium used to propagate the autologous chondrocytes. Trace quantities of bovine-derived proteins may be present in the Carticel product.
Antidiabetics
Bupropion
Cholestyramine:
Cyclosporine:
Digitalis Glycosides
Estrogens, Including Oral Contraceptives:
Ketoconazole:
Phenytoin
Quetiapine
Skin Tests
Thalidomide:
Review of the data from the Study of the Treatment of Articular Repair (STAR) and the Registry Based Study (RBS) [] as well as the Carticel worldwide experience (adverse reactions solicited through the Cartilage Repair Registry (CRR) and spontaneous reports) as of November 21, 1997 showed that the occurrence of a subsequent surgical procedure, primarily arthroscopic, following Carticel implantation is common. In the STAR study, 49% of patients underwent a subsequent surgical procedure, irrespective of relationship to Carticel (6.2). Symptoms leading to arthroscopic intervention included catching, locking, clicking or pain. Patients who develop clinical signs of tissue hypertrophy, including catching or clicking, should be evaluated and arthroscopy may be indicated for treatment or further assessment.
Information on the safety of implanted autologous chondrocytes is derived from the Study of the Treatment of Articular Repair (STAR) [], the Cartilage Repair Registry, the Swedish Series, and post-marketing adverse event reporting.
The most common serious adverse events (> 5% of patients) derived from the STAR study include arthrofibrosis/joint adhesion, graft overgrowth, chondromalacia or chondrosis, cartilage injury, graft complication, meniscal lesion and graft delamination. Only serious adverse events were collected in this study.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).