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Alpha1-Proteinase Inhibitor (Human) (Prolastin-C Liquid)

Trade Name : Prolastin-C Liquid

GRIFOLS USA, LLC

INJECTION, SOLUTION, PLASMA DERIVATIVE

Strength 1000 mg/20mL

.ALPHA.1-PROTEINASE INHIBITOR HUMAN Human alpha-1 Proteinase Inhibitor [EPC],Trypsin Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Alpha1-Proteinase Inhibitor (Human) (Prolastin-C Liquid) which is also known as Prolastin-C Liquid and Manufactured by GRIFOLS USA, LLC. It is available in strength of 1000 mg/20mL per ml. Read more

Alpha1-Proteinase Inhibitor (Human) (Prolastin-C Liquid) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • PROLASTIN-C LIQUID is an Alpha-Proteinase Inhibitor (Human) (Alpha-PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of Alpha-PI (alpha-antitrypsin deficiency).
  • Limitations of Use
  • PROLASTIN-C LIQUID is an Alpha-Proteinase Inhibitor (Human) (Alpha-PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of Alpha-PI (alpha-antitrypsin deficiency). ()n
  • Limitations of Use:
  • The effect of augmentation therapy with any Alpha-PI, including PROLASTIN-C LIQUID, on pulmonary exacerbations and on the progression of emphysema in Alpha-PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials.
  • Clinical data demonstrating the long-term effects of chronic augmentation or maintenance therapy with PROLASTIN-C LIQUID are not available.
  • PROLASTIN-C LIQUID is not indicated as therapy for lung disease in patients in whom severe Alpha-PI deficiency has not been established.
  • For intravenous use only.
  • For intravenous use only
  • 2
  • Dose: 60 mg/kg body weight intravenously once per week. ()
  • Dose ranging studies using efficacy endpoints have not been performed with any Alpha-PI product, including PROLASTIN-C LIQUID. (n )
  • Administration: 0.08 mL/kg/min as determined by patient response and comfort. ()
  • PROLASTIN-C LIQUID is supplied in a 1,000 mg (approximate) single-use vial containing 20 mL of solution for injection. The actual amount of functionally active Alpha-PI in milligrams is printed on the vial label and carton.
  • For injection: approximately 1,000 mg in a single-use vial containing 20 mL of solution for injection. ()
  • PROLASTIN-C LIQUID is contraindicated in:
  • Immunoglobulin A (IgA) deficient patients with antibodies against IgA. ()
  • History of anaphylaxis or other severe systemic reaction to Alpha-PI. ()
  • No data
  • Severe hypersensitivity and anaphylactic reactions may occur in IgA deficient patients with antibodies against IgA. Discontinue administration of the product and initiate appropriate emergency treatment if hypersensitivity reactions occur. ()
  • Because PROLASTIN-C LIQUID is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.()
  • The most serious adverse reaction observed during clinical trials with PROLASTIN-C was an abdominal and extremity rash in one subject. The most common adverse reactions observed at a rate of > 5% in subjects receiving PROLASTIN-C LIQUID were diarrhea and fatigue, each of which occurred at a rate of 6% (two subjects each).
  • The most common adverse reactions during PROLASTIN-C LIQUID clinical trials in > 5% of subjects were diarrhea and fatigue, each of which occurred in 2 subjects (6%). ()n n n n
  • No data
  • PROLASTIN-C LIQUID is a sterile, concentrate of Alpha-PI for intravenous infusion. The solution is clear, colorless or pale yellow or pale green. Each vial of PROLASTIN-C LIQUID contains approximately 1,000 mg of functionally active Alpha-PI as determined by capacity to neutralize porcine pancreatic elastase. The specific activity of PROLASTIN-C LIQUID is u2265 0.7 mg functional Alpha-PI per mg of total protein. PROLASTIN-C LIQUID has a purity of u2265 90% Alpha-PI (Alpha-PI protein/total protein). PROLASTIN-C LIQUID has a pH of 6.6u20137.4, a sodium phosphate content of 0.013u20130.025 M, and is stabilized with 0.20-0.30 M of alanine. The total sodium concentration is u2264 100 mEq/L. PROLASTIN-C LIQUID contains no preservative.
  • PROLASTIN-C LIQUID is produced from pooled human plasma through modifications of the PROLASTIN process using purification by polyethylene glycol (PEG) precipitation, anion exchange chromatography, and cation exchange chromatography. All Source Plasma used in the manufacture of PROLASTIN-C LIQUID is non-reactive (negative) by FDA-licensed serological test methods for hepatitis B surface antigen (HBsAg) and antibodies to hepatitis C virus (HCV) and human immunodeficiency virus types 1 and 2 and negative by FDA-licensed Nucleic Acid Technologies (NAT) for HCV and human immunodeficiency virus type 1 (HIV-1). In addition, all Source Plasma is negative for hepatitis B virus (HBV) by either an FDA-licensed or investigational NAT assay. The goal of the investigational HBV NAT test is to detect low levels of viral nucleic acid; however, the significance of a negative result for the investigational HBV NAT test has not been established. By in-process NAT, all Source Plasma is negative for hepatitis A virus (HAV). As a final plasma safety step, all plasma manufacturing pools are tested by serological test methods and NAT.
  • To evaluate further the virus safety profile of PROLASTIN-C LIQUID, studies have been conducted to validate the capacity of the manufacturing process to reduce the infectious titer of a wide range of viruses with diverse physicochemical properties. These studies evaluated the inactivation/removal of clinically relevant viruses, including human immunodeficiency virus type 1 (HIV-1) and hepatitis A virus (HAV), as well as the following model viruses: bovine viral diarrhea virus (BVDV), a surrogate for hepatitis C virus; pseudorabies virus (PRV), a surrogate for large enveloped DNA viruses (e.g., herpes viruses); vesicular stomatitis virus (VSV), a model for enveloped viruses; reovirus type 3 (Reo3), a non-specific model for non-enveloped viruses; and porcine parvovirus (PPV), a model for human parvovirus B19.
  • The PROLASTIN-C LIQUID manufacturing process has several steps (Cold Ethanol Fractionation, PEG Precipitation, and Depth Filtration) that are important for purifying Alpha-PI as well as removing potential virus contaminants. Two additional steps, Solvent/Detergent Treatment and 15 nm Virus Removal Nanofiltration, are included in the process as dedicated pathogen reduction steps. The Solvent/Detergent Treatment step effectively inactivates enveloped viruses (such as HIV-1, VSV, HBV, and HCV). The 15 nm Virus Removal Nanofiltration step has been implemented to reduce the risk of transmission of enveloped and non-enveloped viruses as small as 18 nm. u00a0presents the virus reduction capacity of each process step and the accumulated virus reduction for the process as determined in viral validation studies in which virus was deliberately added to a process model in order to study virus reduction. In addition, the Solvent/Detergent Treatment step inactivates u2265 5.4 log of West Nile virus, a clinically relevant enveloped virus.
  • Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents. Studies of the PROLASTIN-C LIQUID manufacturing process demonstrate that a minimum of 6 log reduction of TSE infectivity is achieved. These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.
  • No data
  • No data
  • The clinical efficacy of PROLASTIN-C LIQUID in influencing the course of pulmonary emphysema or pulmonary exacerbations has not been demonstrated in adequately powered, randomized, controlled clinical trials.
  • A total of 23 subjects with the PiZZ variant and documented emphysema were studied in a single-arm, open label clinical trial with PROLASTIN, the predecessor product. Nineteen of the subjects received PROLASTIN, 60 mg/kg, once weekly for up to 26 weeks (average 24 weeks). Blood levels of Alpha-PI were maintained above 11 u00b5M. Bronchoalveolar lavage studies demonstrated statistically significant increased levels of Alpha-PI and functional ANEC in the epithelial lining fluid of the lower respiratory tract of the lung, as compared to levels prior to dosing.
  • In addition to the PROLASTIN-C LIQUID/PROLASTIN-C crossover trial described above, in which 31 subjects received PROLASTIN-C, PROLASTIN-C has been studied in 62 individual subjects in 2 separate clinical trials. The first study was a crossover pharmacokinetic study. The second PROLASTIN-C clinical trial was a multi-center, open-label single arm safety study conducted to evaluate the safety and tolerability of PROLASTIN-C. In this study, 38 subjects were treated with weekly intravenous infusions of 60 mg/kg body weight of PROLASTIN-C for 20 weeks. Half the subjects were nau00efve to previous Alpha-PI augmentation prior to study entry and the other half were receiving augmentation with PROLASTIN prior to entering the study. A diagnosis of severe Alpha-PI deficiency was confirmed by the demonstration of the PiZZ genotype in 32 of 38 (84.2%) subjects, and 6 of 38 (15.8%) subjects presented with other alleles known to result in severe Alpha-PI deficiency. These groups were distributed evenly between the nau00efve and non-nau00efve cohorts.
  • No data
  • No data
  • No data
  • No data
  • NDC 13533-705-01n n n n n n n n n n n n n n n n n n The patient and physician should discuss the risks and benefits of this product.n Dosage and administration: Read enclosed package insert.Store refrigerated at 2 to 8u00b0C (36 to 46u00b0F)u00a0with no more than 1 month at room temperatures (up to 25u00b0C; 77u00b0F) after which the product must be used or immediately discarded. Do not use after the expiration date.Do not freeze.n n n One vial of Prolastin-C Liquidn No preservativen For intravenous administration onlyn Sterile-nonpyrogenicn THIS PRODUCT IS PREPARED FROM LARGE POOLS OF HUMAN PLASMA WHICH MAY CONTAIN INFECTIOUS AGENTS. SEE PACKAGE INSERT WARNINGS.n Single dose vialDo not use if turbid.Discard unused portion.Do not store after entry into vial.n Administer within 3 hours after preparation.n The product is a sterile solution containing 0.013-0.025M sodium phosphate and is stabilized with 0.20-0.30M alanine.n If the shrink band is absent or shows any sign of tampering, do not use the product and notify Grifols Therapeuticsu00a0LLC immediately.n The components of the packaging do not contain natural rubber latex.n n n Research Triangle Park, NC27709 USAn U.S. License No. 1871n Carton: 3048558n LOT XXXXXXXXXX EXP DDMMMYYYYMG A1-PIu00a0 XXXX SN XXXXXXXXXXXXXXXXn GTIN 00313533705015n
  • NDCn- Alpha-Proteinase Inhibitor (Human)n- PROLASTIN C LIQUIDn n- Arrayn- Solvent detergent treatedNanofilteredn- GRIFOLSn n- 20 mLn- Rx onlyn- Grifols Therapeutics LLC

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