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CEPROTIN
Overview
What is CEPROTIN?
CEPROTIN [Protein C Concentrate (Human)] is manufactured from human plasma purified by a combination of filtration and chromatographic procedures, including a column of immobilized mouse monoclonal antibodies on gel beads. See
The manufacturing process for CEPROTIN includes processing steps designed to reduce the risk of viral transmission. Screening against potentially infectious agents begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of CEPROTIN is collected only at FDA-approved blood establishments and is tested by FDA licensed serological tests for Hepatitis B Surface Antigen (HBsAg), and for antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2) and Hepatitis C Virus (HCV) in accordance with U.S. regulatory requirements. As an additional safety measure, plasma pools for manufacturing are tested for the presence of HIV-1 and HCV by FDA licensed Nucleic Acid Testing (NAT) and found negative.
To further improve the margin of safety, two dedicated, independent and effective virus inactivation steps (Polysorbate 80 [P80] treatment and vapor heating) have been integrated into the manufacturing process in addition to other purification steps such as immunoaffinity chromatography.
Comprehensive virus clearance studies have been performed for the following steps: P80 treatment alone or coupled with an ion exchange chromatography step (IEX I), immunoaffinity chromatography (IAX) and vapor heating. In each study, the validity of the downscaled process has been confirmed by measuring process and biochemical parameters and comparing these with data from the large-scale manufacturing process. Where applicable (i.e. for P80 treatment and for vapor heating), the robustness of virus clearance has also been investigated by adjusting critical process parameters to levels least favorable for virus inactivation (e.g. temperature and incubation time for vapor heating).
Virus clearance studies for CEPROTIN have demonstrated that the process provides for a robust overall virus clearance capacity. A summary of log virus reduction factors per virus and manufacturing step is presented in the .
CEPROTIN is supplied as a sterile, white or cream colored, lyophilized powder for IV injection. It has a pH between 6.7 and 7.3 and an osmolality not lower than 240 mosmol/kg. One International Unit (IU) of protein C corresponds to the amidolytically measured activity of protein C in 1 mL of normal plasma. The potency (IU) is determined using a chromogenic substrate method referenced against the World Health Organization (WHO) International Standard (86/622).
What does CEPROTIN look like?
What are the available doses of CEPROTIN?
Blue Bar: Approximately 500 IU/vial
Green Bar: Approximately 1000 IU/vial
Each single-dose vial contains the following excipients: 8 mg/mL human albumin, 4.4 mg/mL trisodium citrate dihydrate and 8.8 mg/mL sodium chloride when reconstituted with the appropriate amount of diluent.
What should I talk to my health care provider before I take CEPROTIN?
How should I use CEPROTIN?
CEPROTIN is indicated for patients with severe congenital Protein C deficiency for the prevention and treatment of venous thrombosis and purpura fulminans. CEPROTIN is indicated as a replacement therapy for pediatric and adult patients.
Treatment with CEPROTIN should be initiated under the supervision of a physician experienced in replacement therapy with coagulation factors/inhibitors where monitoring of protein C activity is feasible.
CEPROTIN is administered by intravenous injection after reconstitution of the powder for solution for injection with Sterile Water for Injection. Allergic type hypersensitivity reactions are possible. See
The dose, administration frequency and duration of treatment with CEPROTIN depends on the severity of the protein C deficiency, the patient's age, the clinical condition of the patient and the patient's plasma level of protein C. See
Table 1
An initial dose of 100-120 IU/kg for determination of recovery and half-life is recommended for acute episodes and short-term prophylaxis. Subsequently, the dose should be adjusted to maintain a target peak protein C activity of 100 %. After resolution of the acute episode, continue the patient on the same dose to maintain trough protein C activity level above 25% for the duration of treatment.
In patients receiving prophylactic administration of CEPROTIN, higher peak protein C activity levels may be warranted in situations of an increased risk of thrombosis (such as infection, trauma, or surgical intervention). Maintenance of trough protein C activity levels above 25% is recommended.
These dosing guidelines are also recommended for neonatal and pediatric patients. See and .
What interacts with CEPROTIN?
Sorry No Records found
What are the warnings of CEPROTIN?
Sorry No Records found
What are the precautions of CEPROTIN?
Sorry No Records found
What are the side effects of CEPROTIN?
Sorry No records found
What should I look out for while using CEPROTIN?
None.
What might happen if I take too much CEPROTIN?
No symptoms of overdose with CEPROTIN have been reported.
The maximum infusion rate administered in clinical studies were doses of up to 600 IU/kg body weight (BW)/day (150 IU/kg BW every 6 hours) of CEPROTIN. There have been no overdosages of CEPROTIN reported during clinical studies. In long-term prophylactic treatment of doses up to 291.7 IU/kg BW/day, no adverse events were reported.
How should I store and handle CEPROTIN?
CEPROTIN is available in single-dose vials that contain the following nominal product strengths:Actual potency is printed on the vial label. One package of CEPROTIN contains one glass vial of CEPROTIN powder, one glass vial of Sterile Water for Injection, USP, one transfer needle, one filter needle, one full prescribing physician insert and one patient package insert. CEPROTIN, packaged for sale, is stable for 3 years when stored refrigerated at 2°C – 8°C (36°F - 46°F). Do not freeze in order to prevent damage to the diluent vial. Store the vial in the original carton to protect it from light. The reconstituted solution should be used within 3 hours of reconstitution. Do not use beyond the expiration date on the CEPROTIN vial.CEPROTIN is available in single-dose vials that contain the following nominal product strengths:Actual potency is printed on the vial label. One package of CEPROTIN contains one glass vial of CEPROTIN powder, one glass vial of Sterile Water for Injection, USP, one transfer needle, one filter needle, one full prescribing physician insert and one patient package insert. CEPROTIN, packaged for sale, is stable for 3 years when stored refrigerated at 2°C – 8°C (36°F - 46°F). Do not freeze in order to prevent damage to the diluent vial. Store the vial in the original carton to protect it from light. The reconstituted solution should be used within 3 hours of reconstitution. Do not use beyond the expiration date on the CEPROTIN vial.CEPROTIN is available in single-dose vials that contain the following nominal product strengths:Actual potency is printed on the vial label. One package of CEPROTIN contains one glass vial of CEPROTIN powder, one glass vial of Sterile Water for Injection, USP, one transfer needle, one filter needle, one full prescribing physician insert and one patient package insert. CEPROTIN, packaged for sale, is stable for 3 years when stored refrigerated at 2°C – 8°C (36°F - 46°F). Do not freeze in order to prevent damage to the diluent vial. Store the vial in the original carton to protect it from light. The reconstituted solution should be used within 3 hours of reconstitution. Do not use beyond the expiration date on the CEPROTIN vial.CEPROTIN is available in single-dose vials that contain the following nominal product strengths:Actual potency is printed on the vial label. One package of CEPROTIN contains one glass vial of CEPROTIN powder, one glass vial of Sterile Water for Injection, USP, one transfer needle, one filter needle, one full prescribing physician insert and one patient package insert. CEPROTIN, packaged for sale, is stable for 3 years when stored refrigerated at 2°C – 8°C (36°F - 46°F). Do not freeze in order to prevent damage to the diluent vial. Store the vial in the original carton to protect it from light. The reconstituted solution should be used within 3 hours of reconstitution. Do not use beyond the expiration date on the CEPROTIN vial.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Protein C is the precursor of a vitamin K-dependent anticoagulant glycoprotein (serine protease) that is synthesized in the liver. See . It is converted by the thrombin/thrombomodulin-complex on the endothelial cell surface to activated Protein C (APC). APC is a serine protease with potent anticoagulant effects, especially in the presence of its cofactor protein S. APC exerts its effect by the inactivation of the activated forms of factors V and VIII, which leads to a decrease in thrombin formation. APC has also been shown to have profibrinolytic effects.
The Protein C pathway provides a natural mechanism for control of the coagulation system and prevention of excessive procoagulant responses to activating stimuli. A complete absence of protein C is not compatible with life. A severe deficiency of this anticoagulant protein causes a defect in the control mechanism and leads to unchecked coagulation activation, resulting in thrombin generation and intravascular clot formation with thrombosis.
Non-Clinical Toxicology
None.CEPROTIN may contain traces of mouse protein and/or heparin as a result of the manufacturing process. Allergic reactions to mouse protein and/or heparin cannot be ruled out. If symptoms of hypersensitivity/allergic reaction occur, discontinue the injection/infusion. In case of anaphylactic shock, the current medical standards for treatment are to be observed.
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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