Centruroides (Scorpion) Immune F(Ab)2 (Equine) (Anascorp)

Trade Name : ANASCORP

Rare Disease Therapeutics, Inc

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, PLASMA DERIVATIVE

Strength 3.8 mg/mL

CENTRUROIDES FAB2 ANTIVENIN (EQUINE) Antivenin [EPC],Passively Acquired Immunity [PE],Venom Neutralization [MoA],Antivenins [CS]

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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 Centruroides (Scorpion) Immune F(Ab)2 (Equine) (Anascorp) which is also known as ANASCORP and Manufactured by Rare Disease Therapeutics, Inc. It is available in strength of 3.8 mg/mL per ml. Read more

Centruroides (Scorpion) Immune F(Ab)2 (Equine) (Anascorp) 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

ANASCORPu00ae [centruroides (scorpion) immune F(ab') (equine) injection] is an equine-derived antivenom indicated for treatment ofntttttttpatients with clinical signs of scorpion envenomation.

ANASCORP is an antivenin indicated for the treatment of clinical signs of scorpion envenomation. ()

For Intravenous use only.
ntttttttInitiate treatment with ANASCORP as soon as possible after scorpion sting in patients who develop clinically important signs of scorpion envenomation,ntttttttincluding but not limited to loss of muscle control, roving or abnormal eye movements, slurred speech, respiratory distress, excessive salivation, frothing at the mouth and vomiting.()nttttttt
Initial Dose: 3 vials
Additional Dosing
Intravenous use only.

Initiate treatment with ANASCORP as soon as possible after scorpion sting in patients who develop clinically important signs of scorpion envenomation,nttttttttincluding but not limited to loss of muscle control, roving or abnormal eye movements, slurred speech, respiratory distress, excessive salivation, frothing at the mouth, vomiting.()
Close patient monitoring is necessary.()

Each vial of ANASCORP contains a sterile, lyophilized preparation containing not more than 19 milligrams total protein and not less than 150 LD (mouse) neutralizing units.

Each vial contains a sterile, lyophilized preparation containing not more than 19 milligrams total protein and not less than 150 LD (mouse) neutralizing units.()

None.
None ()

No data

Severe hypersensitivity reactions, including anaphylaxis, are possible with ANASCORP. Prepare for monitoring and managementnttttttttof allergic reactions, particularly in patients with a history of hypersensitivity to equine (horse) proteins or patients who haventtttttttreceived previous therapy with antivenoms containing scorpion or equine proteins.()
Delayed allergic reactions (serum sickness) may occur following treatment with ANASCORP. Patient monitoring with follow-up visit isnttttttttrecommended.()
ANASCORP is made from equine plasma and may contain infectious agents, e.g. viruses.()
Localized reactions and generalized myalgias have been reported with the use of cresol as an injectable excipient.()

The most common adverse reactions observed in u2265 2% of patients in the clinical studies for ANASCORP were: vomiting, pyrexia, rash,ntttttttttnausea and pruritus.()n n n

No drug interaction studies have been conducted with ANASCORP.

Pregnancy: No human or animal data. Use only if clearly needed.()

ANASCORP [centruroides (scorpion) immune F(ab') (equine) injection] is a sterile nonpyrogenic, lyophilized, polyvalent preparation of equine immune globulin F(ab') fragments,nttttmanufactured from plasma of horses immunized with with venom of , , , and . The product is obtained by pepsin digestion of horse plasma to remove the F portion of immune globulin, followed by fractionation and purification steps.nttttThe F(ab') content is not less than 85%, F(ab) content is not more than 7%, and the product contains less than 5% intact immunoglobulin. nttttEach vial of ANASCORP contains 45-80 milligrams of sodium chloride, 4.3 - 38.3 milligrams of sucrose, and 6.6-94.9 milligrams of glycine as stabilizers. Trace amounts of pepsin, cresol (< 0.058 mg/vial), borates (< 1 mg/vial) and Sulfates (< 1.7 mg/vial) may be present from the manufacturing process. nttttEach vial contains no more than 19 milligrams of protein and will neutralize at least 150 LD of Centruroides scorpion venom in a mouse neutralization assay.n nttttThe manufacturing procedures that contribute to the reduction of risk of viral transmission include pepsin digestion, ammonium sulfate precipitation/heat treatment nttttand nanofiltration.

No data

The efficacy of ANASCORP was assessed in a prospective double-blind randomized placebo-controlled study, four open-label studies and one retrospectiventtttttttstudy in various treatment settings in the United States and Mexico, where scorpion envenomation is common. A total of 1534 patientsnttttttttranging from less than one month to 90 years old were treated. The majority of patients (78%, 1204/1534) were pediatric, rangingnttttttttfrom less than one month to 18.7 years of age. Male (52.3%) and female patients (47.7%) were equally represented. Treatmentnttttttttsuccess was determined by resolution of clinically important signs of scorpion envenomation within four hours of starting infusion.nttttttttThe randomized placebo study enrolled 15 subjects, eight to the ANASCORP treated group and seven to the placebo. The symptomnttttttttresolution success rate was 100% for the ANASCORP treated and 14.3% for the placebo group.n nttttttttA retrospective hospital chart review provided historical data from envenomated patients (N=97) who did not receive antivenom but were treated with sedatives and supportive ntttttttt care for symptoms of envenomation. These data were used as a historical control for expected outcomes in the absence of antivenom treatment. The historical controls werenttttttttpediatric patients admitted to two pediatric intensive care units between 1990 and 2003 for the treatment of scorpion envenomationnttttttttwith supportive care only. The proportion of patients that required intensive carenttttttttsupport four hours after intensive care unit admission, and the overall duration of the intensive care support requirement were calculated.n nttttttttOverall, 95-100% of patients were relieved of systemic signs associated with scorpion envenomation in less than four hours afternttttttttinitiating ANASCORP treatment. In the historical control database, only 3.1% of patients experienced relief of symptoms within 4 hours of hospitalnttttttttadmission.n nttttttttIn 1396/1534 patients the mean time from start of ANASCORP infusion to resolution of clinical signs and symptoms of envenomationnttttttttwas 1.42 hours (0.2 to 20.5 hours). Pediatric patients generally experienced a slightly faster time to resolution (1.28 u00b1 0.8 hours)nttttttttcompared with that of adult patients (1.91 u00b11.4 hours). The time to resolution of symptoms was not affected by use of sedativesntttttttt(474 patients who received sedatives resolved in 1.49 u00b1 1.1 hours and 922 patients who did not receive sedatives resolved in 1.38 u00b1ntttttttt0.9 hours).nttttt

1. Krifi MN, Savin S, Debray M, Bon C, Ayeb ME, Choumet V. Pharmacokinetic studies of scorpion venom before and after antivenom immunotherapy. ntttt, 2005; 45: 187u2013198.
2. Boyer LV, Theodorou AA, Berg RA, Mallie J. Antivenom for Critically Ill Children with Neurotoxicity from Scorpion Stings. 2009;360:2090-8.
3. Vasquez H, Chavez-Haro A, Garcia-Ubbelohde W, et al., Pharmacokinetics of a F(abu2019) scorpion antivenin in healthy human volunteers, Toxicon,ntttt 2005;46: 797-805.

ANASCORP is supplied as a sterile lyophilized preparation in a single-use vial. When reconstituted, each vial contains not more than 3.8 milligrams per milliliter of protein, and not less than 150 mouse LD neutralizing units.
Each carton NDC 66621-0150-2 contains 1 vial of ANASCORP NDC 66621-0150-1.

Serious Allergic Reactionsn- Array
Manufactured by:
Laboratorios Silanes, S.A. de C.V.
Toluca, Estado de Mexico, Mexico
Manufactured for:
Rare Disease Therapeutics, Inc.
2550 Meridian Blvd., Suite 150
Franklin, TN 37067
www.raretx.com
U.S. License No. 1860
RDT Part No: ANS-PI-006
Silanes Part No. 360891-4
Arrayn- PACKAGE LABEL

Anascorp Carton label
Anascorp Vial label
Serialization Example of Anascorp Carton label

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Centruroides (Scorpion) Immune F(Ab)2 (Equine) (Anascorp)

Trade Name : ANASCORP

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, 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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Centruroides (Scorpion) Immune F(Ab)2 (Equine) (Anascorp)

Trade Name : ANASCORP

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, 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

Canadian DIN

Swiss Drugs

NZ Drugs

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