Antithrombin Iii (Human) (Thrombate Iii)

Trade Name : THROMBATE III

GRIFOLS USA, LLC

KIT, PLASMA DERIVATIVE

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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 Antithrombin Iii (Human) (Thrombate Iii) which is also known as THROMBATE III and Manufactured by GRIFOLS USA, LLC. It is available in strength of per ml. Read more

Antithrombin Iii (Human) (Thrombate Iii) 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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No data

THROMBATE III is a human antithrombin (AT) indicated in patients with hereditary antithrombinu00a0deficiency for:
THROMBATE III is a human antithrombin (AT) indicated in patients with hereditary antithrombin deficiency for:

Treatment and prevention of thromboembolism
Prevention of peri-operative and peri-partum thromboembolism ()

For intravenous use after reconstitution only
For intravenous use after reconstitution only
Adapt the rate of administration to the response of the patient; typically the full dose is given over 10 to 20 minutes.u00a0 ()

Individualize dose to achieve AT level of 80% to 120% of normal human plasma ()

No data

THROMBATE III is a sterile lyophilized powder for reconstitution in single use vials. u00a0Each vial of THROMBATE III contains the labeled amount of antithrombin in units per vial, typically 500 units. When reconstituted with 10 mL of Sterile Water for Injection, USP, the final concentration is approximately 50 units per mL.
The potency is determined with a standard calibrated in International Units against a World Health Organization (WHO) antithrombin reference preparation.
For injection: approximately 500 units, lyophilized powder in single-use vial for reconstitution.u00a0()

None.
None. ()

No data

Hypersensitivity reactions, including anaphylaxis, are possible.u00a0 Should symptoms occur, discontinue THROMBATE III infusion and begin appropriate treatment. ()
Because THROMBATE III 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 (CJD) disease agent. ()
Perform coagulation tests to avoid excessive or insufficient anticoagulation and monitor for bleeding or thrombosis. Measure functional plasma AT levels with amidolytic or clotting assays; do not use immunoassays. ()

In clinical studies, the most common adverse reactions (u2265 5% of subjects) were dizziness, chest discomfort, nausea, dysgeusia, and pain (cramps).
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of one drug cannot be directly compared to rates in other clinical trials of another drug and may not reflect the rates observed in clinical practice.
Two clinical trials were conducted in 33 subjects with congenital AT deficiency. The first was a prospective, open-label, dose-escalation, dose-ranging, and pharmacokinetic study in 11 asymptomatic subjects. Eight subjects received a single dose, escalated sequentially, followed by weekly dose ranging from 25 to 125 unit/kg. Five subjects (including 2 from the first part of the study) received weekly THROMBATE III for periods of up to 23 weeks in doses ranging from 125 to 225 unit/kg. The second trial was a phase III, prospective, open-label study conducted in 24 subjects for additional kinetics (n=3), the prevention of thrombosis (n=13) during high risk conditions (pregnancy, surgery), or the treatment of thrombosis (n=10). Loading doses targeted an AT plasma level of 120% and ranged from 33 to 150 unit/kg. Maintenance doses targeted a plasma AT range of 70% to 120%, which were 23 to 75 unit/kg.
Adverse reactions reported during the 2 clinical trials are listed in . Nine subjects (27%) experienced 29 adverse reactions which occurred during 17 of 389 infusions. There were no serious adverse reactions reported. The severity of adverse reactions was reported as mild or moderate, except for wound secretion and hematoma, which was severe.
During clinical investigation of THROMBATE III, there were no reports of virus transmission. None of 12 subjects monitored for a median of 8 months (range 2u201319 months) after receiving THROMBATE III became antibody positive to human immunodeficiency virus (HIV-1). None of 14 subjects monitored for u2265 3 months demonstrated any evidence of hepatitis.
The most common adverse reactions (u2265 5% of subjects) in clinical studies were dizziness, chest discomfort, nausea, dysgeusia, and pain (cramps). ()n n
To report SUSPECTED ADVERSE REACTIONS, contact Grifols Therapeuticsu00a0LLC at 1-800-520-2807u00a0or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The anticoagulant effect of heparin is enhanced by concurrent treatment with THROMBATE III in patients with hereditary AT deficiency. Thus, in order to avoid bleeding, the dosage of heparin (or low molecular weight heparin) may need to be reduced during treatment with THROMBATE III.
The effect of drugs that use antithrombin to exert their anticoagulation may be altered when THROMBATE III is added or withdrawn.u00a0 Regularly perform coagulation tests suitable for the anticoagulant used (e.g., aPTT and anti-Factor Xa activity) and at close intervals to avoid excessive or insufficient anticoagulation. Adjust dosage of anticoagulant as necessary. Additionally, monitor the patients for the occurrence of bleeding or thrombosis.
The anticoagulant effect of heparin is enhanced by concurrent treatment with THROMBATE III. To avoid bleeding, reduce the dosage of heparin. ()

Pregnancy: suspend heparin administration and continue THROMBATE III administration during labor and delivery. ()

THROMBATE III Antithrombin III (Human), is a sterile, non-pyrogenic concentrate of human antithrombinu00a0(AT) in lyophilized powder form for reconstitution for intravenous injection. When reconstituted with Sterile Water for Injection, USP, THROMBATE III has a pH of 6.0 to 7.5 and contains 110 mEq/L to 210 mEq/L sodium, 110 mEq/L to 210 mEq/L chloride, 0.075 M to 0.125 M alanine, and not more than 0.1 unit of heparin per 1 unit of AT. THROMBATE III contains no preservative.
THROMBATE III is prepared from pooled units of human plasma from normal donors. The capacity of the THROMBATE III manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model using a wide range of viruses with diverse physicochemical properties. There are two dedicated virus inactivation/removal steps included in the THROMBATE III manufacturing process: a heat treatment step at 60u00b0C u00b1 0.5u00b0C for not less than 10 hours for virus inactivation and a nanofiltration step for effective removal of viruses as small as 18 nm.
The THROMBATE III manufacturing process was also 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. An individual production step in the THROMBATE III manufacturing process has been shown to decrease TSE infectivity of that experimental model agent. The TSE reduction step is the Effluent I to Effluent II + III fractionation step (6.0 log). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.

No data

In a prospective, open-label clinical trial, 21 subjects were administered THROMBATE III for 16 prophylaxis events (n=13 subjects) and 10 for treatment of thrombosis (n=10 subjects) with 2 subjects receiving THROMBATE III for both prophylaxis and treatment of thrombosis. None of the 13 subjects with hereditary AT deficiency and histories of thromboembolism treated prophylactically on 16 separate occasions with THROMBATE III for high thrombotic risk situations (11 surgical procedures, 5 pregnancies and/or deliveries) developed a thrombotic complication. Heparin was administered in 3 of the 11 surgical procedures. Two of the pregnant subjects received LMW heparin prophylactically during the first trimester, but which was unable to maintain anti-coagulation with increasing dosages. They experienced a thrombosis, which subsequently resolved with the addition of THROMBATE III, and were therefore administered THROMBATE III and LMW heparin prophylaxis weekly during the second and third trimesters, and during labor and delivery. These two subjects did not experience a new thrombosis.
Ten subjects with hereditary AT deficiency were treated with THROMBATE III as well as heparin (n=9) for major thrombotic or thromboembolic complications, including 4 subjects with thrombosis during the first trimester of pregnancy. u00a0Nine subjects recovered with no additional thromboses or extension of existing thrombosis. The tenth subject died due to complications from the original pulmonary embolism with infarction which preceded treatment with THROMBATE III.

No data

THROMBATE III is supplied in a kit containing one single use vial of THROMBATE III lyophilized powder for reconstitution, one vial of Sterile Water for Injection, USP, one sterile double-ended transfer needle, and one sterile filter needle. The total activity of AT in International Units is stated on the label of the THROMBATE III vial.
u00a0Components of the packaging do not contain natural rubber latex.

Hypersensitivity Reactions
Inform patients that allergic-type hypersensitivity reactions are possible and instruct them to inform their physicians about any past or present known hypersensitivity to human plasma proteins prior to treatment with THROMBATE III. Inform patients of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis and to notify their health care provider immediately if these events develop. n
Transmission of Infectious Disease
Inform patients that THROMBATE III is made from human plasma and may carry a risk of transmitting infectious agents that can cause disease (e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent). Inform patients that this risk has been reduced by screening plasma donors for prior exposure to certain infectious agents, by testing the donated plasma for markers of certain current infections, and by inactivating and/or removing pathogens during manufacturing. n
Manufactured by:n GRIFOLSn n n- Grifols Therapeutics LLCn

NDC n- Antithrombin III (Human)n n- THROMBATE IIIn n n- Heat-Treatedn Nanofilteredn n- Lyophilizedu00a0n- Powdern n- For Intravenous Administration Onlyn n- Grifols Therapeuticsu00a0LLC n n- No PreservativeSterile u2014 Nonpyrogenicn n- Store at temperatures not to exceed 25u00b0C (77u00b0F). Do not freeze.n Dosage and Administration: Read package insert.n n- Rx
NDC n- Antithrombin III (Human)n n- THROMBATE IIIn n- Heat-Treatedn n n- Nanofilteredn n- Lyophilizedu00a0n- Powdern n n- For Intravenous Administration Onlyn Grifolsn n n- No PreservativeSterileu2014Nonpyrogenicn THIS PRODUCT IS PREPARED FROM LARGE POOLS OF HUMAN PLASMA WHICH MAY CONTAIN INFECTIOUS AGENTS. SEE PACKAGE INSERT WARNINGS.n- Dosage and Administration: Read enclosed package insert.n n- Store at temperatures not to exceed 25u00b0C (77u00b0F). Do not freeze.n n n- Not Returnable for Credit or Exchangen n- Rxn- Grifols Therapeuticsu00a0LLC n n- Open other endn
NDC 13533-200-10n n n n n n n n n Single-Dose Container, Nonpyrogenicn Do not use unless clear. n No antimicrobial agent or other substance has been added. n Do not use for intravascular injection without making approximately isotonic by addition of suitable solute. n Discard unused portion.n Mfd by: , Parets del Vallu00e8s, Barcelona, 08150 SpainMfd for: , Research Triangle Park, NC, 27709 USAn 3051810n Lot / Exp.

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Antithrombin Iii (Human) (Thrombate Iii)

Trade Name : THROMBATE III

KIT, PLASMA DERIVATIVE

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Antithrombin Iii (Human) (Thrombate Iii)

Trade Name : THROMBATE III

KIT, PLASMA DERIVATIVE

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

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NZ Drugs

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