Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
CYCLOSPORINE (UNII: 83HN0GTJ6D) (CYCLOSPORINE - UNII:83HN0GTJ6D)
Teva Pharmaceuticals USA, Inc.
CYCLOSPORINE
CYCLOSPORINE 100 mg in 1 mL
ORAL
PRESCRIPTION DRUG
Cyclosporine Oral Solution USP MODIFIED is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine Oral Solution USP MODIFIED has been used in combination with azathioprine and corticosteroids. Cyclosporine Oral Solution USP MODIFIED is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Cyclosporine Oral Solution USP MODIFIED can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. Cyclosporine Oral Solution USP MODIFIED is indicated for the treatment of adult, nonimmunocompromised patients with severe (i.e., extensive and/or disabling), recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy (e.g., PUVA, retinoids, or methotrexate) or in patients for whom other systemic therapies are contraindicated, or cannot be tolerated. While rebound rarely occurs
Cyclosporine Oral Solution USP MODIFIED is available as a yellowish to yellow-brown oily liquid containing 100 mg/mL cyclosporine, USP in a 50 mL bottle (NDC 0172-7313-20). Store and Dispense PHARMACIST: Store and dispense in the original container at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 20°C (68°F) the solution may gel; light flocculation or the formation of a light sediment may also occur. This solution, when mixed with juice, may appear cloudy. There is no impact on product performance or dosing using the syringe provided. Allow to warm to room temperature 25°C (77°F) to reverse these changes. All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA. Manufactured In Czech Republic By: TEVA CZECH INDUSTRIES s.r.o. Opava-Komarov, Czech Republic Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. F 4/2015
Abbreviated New Drug Application
CYCLOSPORINE- CYCLOSPORINE SOLUTION TEVA PHARMACEUTICALS USA, INC. ---------- CYCLOSPORINE ORAL SOLUTION USP MODIFIED 7313 RX ONLY PRESCRIBING INFORMATION WARNING ONLY PHYSICIANS EXPERIENCED IN MANAGEMENT OF SYSTEMIC IMMUNOSUPPRESSIVE THERAPY FOR THE INDICATED DISEASE SHOULD PRESCRIBE CYCLOSPORINE ORAL SOLUTION USP MODIFIED. AT DOSES USED IN SOLID ORGAN TRANSPLANTATION, ONLY PHYSICIANS EXPERIENCED IN IMMUNOSUPPRESSIVE THERAPY AND MANAGEMENT OF ORGAN TRANSPLANT RECIPIENTS SHOULD PRESCRIBE CYCLOSPORINE ORAL SOLUTION USP MODIFIED. PATIENTS RECEIVING THE DRUG SHOULD BE MANAGED IN FACILITIES EQUIPPED AND STAFFED WITH ADEQUATE LABORATORY AND SUPPORTIVE MEDICAL RESOURCES. THE PHYSICIAN RESPONSIBLE FOR MAINTENANCE THERAPY SHOULD HAVE COMPLETE INFORMATION REQUISITE FOR THE FOLLOW-UP OF THE PATIENT. CYCLOSPORINE ORAL SOLUTION USP MODIFIED, A SYSTEMIC IMMUNOSUPPRESSANT, MAY INCREASE THE SUSCEPTIBILITY TO INFECTION AND THE DEVELOPMENT OF NEOPLASIA. IN KIDNEY, LIVER, AND HEART TRANSPLANT PATIENTS CYCLOSPORINE ORAL SOLUTION USP MODIFIED MAY BE ADMINISTERED WITH OTHER IMMUNOSUPPRESSIVE AGENTS. INCREASED SUSCEPTIBILITY TO INFECTION AND THE POSSIBLE DEVELOPMENT OF LYMPHOMA AND OTHER NEOPLASMS MAY RESULT FROM THE INCREASE IN THE DEGREE OF IMMUNOSUPPRESSION IN TRANSPLANT PATIENTS. CYCLOSPORINE ORAL SOLUTION USP MODIFIED HAS INCREASED BIOAVAILABILITY IN COMPARISON TO SANDIMMUNE (CYCLOSPORINE ORAL SOLUTION USP). CYCLOSPORINE ORAL SOLUTION USP MODIFIED AND SANDIMMUNE (CYCLOSPORINE ORAL SOLUTION USP) ARE NOT BIOEQUIVALENT AND CANNOT BE USED INTERCHANGEABLY WITHOUT PHYSICIAN SUPERVISION. FOR A GIVEN TROUGH CONCENTRATION, CYCLOSPORINE EXPOSURE WILL BE GREATER WITH CYCLOSPORINE ORAL SOLUTION USP MODIFIED THAN WITH SANDIMMUNE (CYCLOSPORINE ORAL SOLUTION USP). IF A PATIENT WHO IS RECEIVING EXCEPTIONALLY HIGH DOSES OF SANDIMMUNE (CYCLOSPORINE ORAL SOLUTION USP) IS CONVERTED TO CYCLOSPORINE ORAL SOLUTION USP MODIFIED, PARTICULAR CAUTION SHOULD BE EXERCISED. CYCLOSPORINE BLOOD CONCENTRATIONS SHOULD BE MONITORED IN TRANSPLANT AND RHEUMATOID ART Perskaitykite visą dokumentą