Alpha-1-Proteinase Inhibitor Human (Zemaira)

Trade Name : Zemaira

CSL Behring LLC

KIT, PLASMA DERIVATIVE

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Alpha-1-Proteinase Inhibitor Human (Zemaira) which is also known as Zemaira and Manufactured by CSL Behring LLC. It is available in strength of per ml. Read more

Alpha-1-Proteinase Inhibitor Human (Zemaira) 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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About GNH

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ZEMAIRA is an alpha-proteinase inhibitor (A-PI) indicated for chronic augmentation and maintenance therapy in adults with A-PI deficiency and clinical evidence of emphysema.
ZEMAIRA increases antigenic and functional (anti-neutrophil elastase capacity [ANEC]) serum levels and lung epithelial lining fluid (ELF) levels of A-PI.
Clinical data demonstrating the long-term effects of chronic augmentation therapy of individuals with ZEMAIRA are not available.
The effect of augmentation therapy with ZEMAIRA or any A-PI product on pulmonary exacerbations and on the progression of emphysema in A-PI deficiency has not been demonstrated in randomized, controlled clinical studies.
ZEMAIRA is not indicated as therapy for lung disease patients in whom severe A-PI deficiency has not been established.

ZEMAIRA is an alpha-proteinase inhibitor (A-PI) indicated for chronic augmentation and maintenance therapy in adults with A-PI deficiency and clinical evidence of emphysema ().
The effect of augmentation therapy with ZEMAIRA or any A-PI product on pulmonary exacerbations and on the progression of emphysema in A-PI deficiency has not been demonstrated in randomized, controlled clinical studies ().
ZEMAIRA is not indicated as therapy for lung disease patients in whom severe A-PI deficiency has not been established ().

For intravenous use after reconstitution only.
The recommended dose of ZEMAIRA is 60 mg/kg body weight administered once weekly. Dose ranging studies using efficacy endpoints have not been performed with ZEMAIRA or any A-PI product.
For intravenous use after reconstitution only
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The recommended weekly dose of ZEMAIRA is 60 mg/kg body weight. Dose ranging studies using efficacy endpoints have not been performed with ZEMAIRA or any A-PI product ().
Administer through a suitable 5 micron infusion filter (not supplied) at room temperature within 3 hours after reconstitution ().
Do not mix with other medicinal products. Administer through a separate dedicated infusion line ().
Administer at a rate of approximately 0.08 mL/kg/min as determined by the response and comfort of the patient ().
Monitor closely the infusion rate and the patient's clinical state, including vital signs, throughout the infusion. Slow or stop the infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient ().

ZEMAIRA is supplied in a single-use vial containing approximately 1000 mg, 4000 mg, or 5000 mg of functionally active A-PI as a white to off-white lyophilized powder for reconstitution with 20 mL, 76 mL, or 95 mL of Sterile Water for Injection, USP. The amount of functional A-PI is printed on the vial label and carton.
ZEMAIRA is supplied in a single-use vial containing approximately 1000 mg, 4000 mg, or 5000 mg of functionally active A-PI as a white to off-white lyophilized powder for reconstitution with 20 mL, 76 mL, or 95 mL of Sterile Water for Injection, USP. The amount of functional A-PI is printed on the vial label and carton ().

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History of anaphylaxis or severe systemic reactions to ZEMAIRA or A-PI protein ().
Immunoglobulin A (IgA)-deficient patients with antibodies against IgA, due to the risk of severe hypersensitivity ().

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Observe any signs of hypersensitivity such as tachycardia, hypotension, confusion, syncope, oxygen consumption decrease, and pharyngeal edema when administering ZEMAIRA to patients with known hypersensitivity to an A-PI product ().
Patients with selective or severe IgA deficiency can develop antibodies to IgA and, therefore, have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. If anaphylactic or severe anaphylactoid reactions occur, discontinue the infusion immediately ().
Because ZEMAIRA is made from human blood, 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 ().

Serious adverse reactions reported following administration of ZEMAIRA in pre-licensure clinical trials included one event each in separate subjects of bronchitis and dyspnea, and one event each in a single subject of chest pain, cerebral ischemia and convulsion.
The most common adverse reactions (ARs) occurring in at least 5% of subjects receiving ZEMAIRA in all pre-licensure clinical trials were headache, sinusitis, upper respiratory infection, bronchitis, asthenia, cough increased, fever, injection site hemorrhage, rhinitis, sore throat, and vasodilation.
Serious adverse reactions identified during postmarketing use were hypersensitivity reactions .
In post-licensure trials, the exposure adjusted incidence rate (EAIR) of serious exacerbations of chronic obstructive pulmonary disease (COPD) among subjects was higher during the RAPID Extension trial as compared to the rate observed during the preceding RAPID trial .
To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring Pharmacovigilance at 1-866-915-6958 or FDA at 1-800-FDA-1088 or n

Serious adverse reactions reported following administration of ZEMAIRA in pre-licensure clinical trials included one event each in separate subjects of bronchitis and dyspnea, and one event each in a single subject of chest pain, cerebral ischemia and convulsion.
The most common adverse reactions occurring in at least 5% of subjects receiving ZEMAIRA in all pre-licensure clinical trials were headache, sinusitis, upper respiratory infection, bronchitis, asthenia, cough increased, fever, injection site hemorrhage, rhinitis, sore throat, and vasodilation ().

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ZEMAIRA is a sterile, white to off-white, lyophilized preparation of purified alpha-proteinase inhibitor (human) (A-PI), also known as alpha-antitrypsin, to be reconstituted and administered by the intravenous route. The specific activity of ZEMAIRA is u22650.7 mg of functional A-PI per milligram of total protein. The purity (total A-PI/total protein) is u226590% A-PI. Each vial contains approximately 1000 mg, 4000 mg or 5000 mg of functionally active A-PI. The measured amount per vial of functionally active A-PI as determined by its capacity to neutralize human neutrophil elastase (NE) is printed on the vial label and carton. Following reconstitution with 20 mL, 76 mL or 95 mL of Sterile Water for Injection, USP, the ZEMAIRA solution contains 73 to 89 mM sodium, 33 to 42 mM chloride, 15 to 20 mM phosphate, and 121 to 168 mM mannitol. Hydrochloric acid and/or sodium hydroxide may have been added to adjust the pH. ZEMAIRA contains no preservative.
All plasma used in the manufacture of ZEMAIRA is obtained from US donors and is tested using serological assays for HBsAg and antibodies to HIV-1/2 and HCV. The plasma is tested with Nucleic Acid Testing (NAT) for HBV, HCV, HIV-1, and HAV, and found to be nonreactive (negative). The plasma is also tested by NAT for B19V. Only plasma that passed the virus screening is used for production. The limit for B19V in the fractionation pool is u226410 International Units of B19V per mL.
ZEMAIRA is manufactured from large pools of human plasma by cold ethanol fractionation according to a modified Cohn process followed by additional purification steps. The manufacturing process includes two virus clearance steps: heat treatment at 60u00b0C for 10 hours in an aqueous solution with stabilizers; and nanofiltration. These virus clearance steps have been validated in a series of in vitro experiments for their capacity to inactivate/remove both enveloped and non-enveloped viruses. Table 5 shows the virus clearance capacity of the ZEMAIRA manufacturing process, expressed as mean log reduction factor.

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Clinical trials were conducted pre-licensure with ZEMAIRA in 89 subjects (59 males and 30 females). The subjects ranged in age from 29 to 68 years (median age 49 years). Ninety-seven percent of the treated subjects had the PiZZ phenotype of A-PI deficiency, and 3% had the M phenotype. At screening, serum A-PI levels were between 3.2 and 10.1 u00b5M (mean of 5.6 u00b5M). The objectives of the clinical trials were to demonstrate that ZEMAIRA augments and maintains serum levels of A-PI above 11 u00b5M (80 mg/dL) and increases A-PI levels in ELF of the lower lung.
In a double-blind, controlled clinical trial to evaluate the safety and efficacy of ZEMAIRA, 44 subjects were randomized to receive 60 mg/kg of either ZEMAIRA or Prolastin once weekly for 10 weeks. After 10 weeks, subjects in both groups received ZEMAIRA for an additional 14 weeks. Subjects were followed for a total of 24 weeks to complete the safety evaluation . The mean trough serum A-PI levels at steady state (Weeks 7-11) in the ZEMAIRA-treated subjects were statistically equivalent to those in the Prolastin-treated subjects within a range of u00b13 u00b5M. Both groups were maintained above 11 u00b5M. The mean (range and standard deviation [SD]) of the steady state trough serum antigenic A-PI level for ZEMAIRA-treated subjects was 17.7 u00b5M (range 13.9 to 23.2, SD 2.5) and for Prolastin-treated subjects was 19.1 u00b5M (range 14.7 to 23.1, SD 2.2). The difference between the ZEMAIRA and the Prolastin groups was not considered clinically significant and may be related to the higher specific activity of ZEMAIRA.
In a subgroup of subjects enrolled in the trial (10 ZEMAIRA-treated subjects and 5 Prolastin-treated subjects), bronchoalveolar lavage was performed at baseline and at Week 11. Four A-PI related analytes in ELF were measured: antigenic A-PI, A-PI:NE complexes, free NE, and functional A-PI (ANEC). A blinded retrospective analysis, which revised the prospectively established acceptance criteria showed that within each treatment group, ELF levels of antigenic A-PI and A-PI:NE complexes increased from baseline to Week 11 (Table 7). Free elastase was immeasurably low in all samples. The post-treatment ANEC values in ELF were not significantly different between the ZEMAIRA-treated and Prolastin-treated subjects (mean 1725 nM vs. 1418 nM). No conclusions can be drawn about changes of ANEC values in ELF during the trial period as baseline values in the ZEMAIRA-treated subjects were unexpectedly high. No A-PI analytes showed any clinically significant differences between the ZEMAIRA and Prolastin treatment groups.
The clinical efficacy of ZEMAIRA or any A-PI product in influencing the course of pulmonary emphysema or pulmonary exacerbations has not been demonstrated in adequately powered, randomized, controlled clinical trials.

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Manufactured by:n n Kankakee, IL 60901 USAUS License No. 1767
US Patent No. 8,124,736US Patent No. 8,722,624
Prolastin is a registered trademark of Grifols Therapeutics Inc.
Mix2Vial is a registered trademark of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceuticals Services, Inc.

NDC 0053-7201-02
1000 mg Range
Alpha-Proteinase Inhibitor(Human)n n n
For Intravenous Administration OnlyRx only
This package contains one vial of Zemaira, one vial of Sterile Water for Injection, USP and one Mix2Vial filter transfer set for reconstitution.
Storage: Zemaira stored up to 25u00b0C (77u00b0F) is stable for the period indicated by the expiration dateon the label. Avoid freezing, which may damage the diluent vial.
Manufactured by:n n Kankakee, IL 60901 USAUS License No. 1767
CSL Behring

NDC 0053-7202-02One single dose vial with diluent
4000 mg Range
Alpha-Proteinase Inhibitor(Human)
Zemairan
For Intravenous Administration Only Rx only
This package contains one vial of Zemaira, one vial of Sterile Water for Injection, USP and one Mix2Vial filter transfer set for reconstitution.
Storage: Zemaira stored up to 25u00b0C (77u00b0F) is stable for the period indicated by the expiration date on the label.Avoid freezing, which may damage the diluent vial.
Manufactured by:CSL Behring LLCKankakee, IL 60901 USAUS License No. 1767
CSL Behring

NDC 0053-7203-02One single dose vial with diluent
5000 mg Range
Alpha-Proteinase Inhibitor(Human)
Zemairan
For Intravenous Administration Only Rx only
This package contains one vial of Zemaira, one vial of Sterile Water for Injection, USP and one Mix2Vial filtertransfer set for reconstitution.
Storage: Zemaira stored up to 25u00b0C (77u00b0F) is stable for the period indicated by the expiration date on the label.Avoid freezing, which may damage the diluent vial.
Manufactured by:CSL Behring LLCKankakee, IL 60901 USAUS License No. 1767
CSL Behring

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