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RX ITEM-Atryn 1750 Unit Vial by ASD Healthcare

NDC No.42976-0121-02 UPC/GTIN No.3-42976-12102-1 MPN 42561 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical TherapisASD Specialty Healthcare-Special OrderOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

RX ITEM-Atryn 1750 Unit Vial by ASD Healthcare

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NDC No.42976-0121-02 UPC/GTIN No.3-42976-12102-1 MPN 42561 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No.Rx327433 Atryn 1750 Unit Vial by ASD Healthcare Item No.3327433 NDC No.42976012102 UPC No.342976121021 Other Name Atryn Therapeutic Code 201204 Therapeutic Class Direct Thrombin Inhibitors Ite

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ATRYN- antithrombin alfa injection, powder, lyophilized, for solution
Lundbeck Inc.
DESCRIPTION
ATryn for Injection is nanofiltered, sterile, terminally heat treated, lyophilized dosage form. Antithrombin (Recombinant), active ingredient of ATryn, is recombinant human antithrombin. It is 432 amino acid glycoprotein with molecular weight of approximately 57,215 Daltons. The molecular formula is: C2191 H3457 N583 O656 S18 Antithrombin (Recombinant) is produced by recombinant DNA technology using genetically engineered goats into which the DNA coding sequence for human antithrombin has been introduced along with mammary gland specific DNA sequence, which directs the expression of the antithrombin into the milk. The goats in which antithrombin (Recombinant) is produced are USDA certified scrapie-free, and controlled for specific pathogens.
The amino acid sequence of Antithrombin (Recombinant) is identical to that of human plasma-derived antithrombin. Antithrombin (Recombinant) and plasma-derived antithrombin both contain six cysteine residues forming three disulphide bridges and 3-4 N-linked carbohydrate moieties. The glycosylation profile of Antithrombin (Recombinant) is different from plasma-derived antithrombin, which results in an increased heparin affinity. When assayed in the presence of excess of heparin the potency of the recombinant product is not different from that of plasma-derived product.
Mechanism of Action
Antithrombin (AT) plays central role in the regulation of hemostasis. AT is the principal inhibitor of thrombin and Factor Xa5 the serine proteases that play pivotal roles in blood coagulation. AT neutralizes the activity of thrombin and Factor Xa by forming complex which is rapidly removed from the circulation. The ability of antithrombin to inhibit thrombin and Factor Xa can be enhanced by greater than 300 to 1000 fold when AT is bound to heparin.

INDICATIONS AND USAGE
ATryn? is recombinant antithrombin indicated for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients1.
It is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients.
2 DOSAGE AND ADMINISTRATION
For Intravenous Use Only after Reconstitution
2.1 Preparation for Administration
Bring vials to room temperature no more than hours prior to reconstitution.
Reconstitute with 10 mL Sterile Water for Injection [(WFI) not supplied with ATryn] immediately prior to use. Do not shake.
Do not use solution containing visible particulates or if it is discolored or cloudy.
Draw solution from one or more vials into sterile disposable syringe for intravenous administration or add solution to an infusion bag containing 0.9% sterile sodium chloride for injection (e.g., dilute solution to obtain concentration of 100 IU/mL).
Administer using an infusion set with 0.22 micron pore-size, in-line filter.
Administer contents of infusion syringes or diluted solution within to 12 hours of preparation when stored at room temperature (68-77?F (20-25?C)).
Discard unused product in accordance with local requirements.
2.2 Recommended Dose and Schedule
The dosage of ATryn is to be individualized based on the patient?s pre-treatment functional AT activity level (expressed in percent of normal) and body weight (expressed in kilograms) and using therapeutic drug monitoring (Table 1).
The goal of treatment is to restore and maintain functional antithrombin (AT) activity levels between 80% 120% of normal (0.8 1.2 IU/mL).
Treatment should be initiated prior to delivery or approximately 24 hours prior to surgery to ensure that the plasma antithrombin level is in the target range at that time.
Different dosing formulae are used for the treatment of surgical and pregnant patients. Pregnant women who need surgical procedure other than Cesarean section should be treated according to the dosing formulae for pregnant patients.
Administer loading dose as 15-minute intravenous infusion, immediately followed by continuous infusion of the maintenance dose.
AT activity monitoring and dose adjustments should be made according to Table 2.
Continue treatment until adequate follow-on anticoagulation is established
DOSAGE FORMS AND STRENGTHS
ATryn is sterile lyophilized formulation. Each vial of ATryn contains the potency stated on the label, which is approximately 1750 IU.
4 CONTRAINDICATIONS
ATryn is contraindicated in patients with known hypersensitivity to goat and goat milk proteins.
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
Allergic-type hypersensitivity reactions are possible. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. If these symptoms occur during administration, treatment must be discontinued immediately and emergency treatment should be administered.
DRUG INTERACTIONS
The anticoagulant effect of heparin and low molecular weight heparin (LMWH) is enhanced by antithrombin. The half-life of antithrombin may be altered by concomitant treatment with these anticoagulants due to an altered antithrombin turnover. Thus, concurrent administration of antithrombin with heparin, low molecular weight heparin, or other anticoagulants that use antithrombin to exert their anticoagulant effect must be monitored clinically and biologically. To avoid excessive anticoagulation, regular coagulation tests (aPTT, and where appropriate, anti-Factor Xa activity) are to be performed at close intervals, with adjustment in dosage of the anticoagulant as necessary.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category C
HOW SUPPLIED/STORAGE AND HANDLING
Dosage Form
NDC 67386-521-51
Approximately 1750 IU/vial in sterile white to off-white lyophilized powder for reconstitution. Each carton contains one single dose vial of ATryn.
The actual potency of ATryn is stated on the vial label and carton.
Storage and Handling
Store ATryn refrigerated at between 2-8?C (36-46?F).
Do not use product beyond the expiration date printed on the package. Discard unused portions.


NDC No.42976-0121-02 UPC/GTIN No.3-42976-12102-1 MPN 42561 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapis
Atryn 1750 Unit Vial by ASD Healthcare
NDC No.42976-0121-02 UPC/GTIN No.3-42976-12102-1 MPN 42561 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapis

ASD Specialty Healthcare-Special Order
AmericanPharmaWholesale.com
ASD Specialty Healthcare-Special Order

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
ANTITHROMBIN III, HUMAN R
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
AmericanPharmaWholesale.com
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.