ANAVIP: Package Insert and Label Information (Page 3 of 3)

17 PATIENT COUNSELING INFORMATION

  • Advise patients to contact their physician immediately if they experience unusual bruising or bleeding (e.g., nosebleeds, excessive bleeding after brushing teeth, the appearance of blood in stools or urine, excessive menstrual bleeding, petechiae, excessive bruising or persistent oozing from superficial injuries) after hospital discharge.5
  • Serious Allergic Reactions
    o Advise patients to contact their physician immediately if they experience any signs and symptoms of delayed allergic reactions or serum sickness (e.g., rash, fever, myalgias, arthralgia, pruritus, urticaria) after hospital discharge [see Hypersensitivity (5.1)].4

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. ANV-PI-007

Silanes Part number: 360893-6

PACKAGE LABEL

Anavip Carton label

Anavip Carton Label
(click image for full-size original)

Serialization Example of Anavip Carton label

Anavip Carton Label
(click image for full-size original)

Anavip Vial label

Anavip Vial Label
(click image for full-size original)
ANAVIP crotalidae immune f(ab)2(equine) injection, powder, lyophilized, for solution
Product Information
Product Type Item Code (Source) NDC:66621-0790
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIT VIPER (CROTALINAE) IMMUNE GLOBULIN ANTIVENIN (EQUINE) (PIT VIPER (CROTALINAE) IMMUNE GLOBULIN ANTIVENIN (EQUINE)) PIT VIPER (CROTALINAE) IMMUNE GLOBULIN ANTIVENIN (EQUINE) 12 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66621-0790-2 1 VIAL in 1 CARTON contains a VIAL (66621-0790-1)
1 NDC:66621-0790-1 10 mL in 1 VIAL This package is contained within the CARTON (66621-0790-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125488 05/06/2015
Labeler — Rare Disease Therapeutics, Inc (966133100)
Registrant — Rare Disease Therapeutics, Inc (966133100)
Establishment
Name Address ID/FEI Operations
Laboratorios Silanes S.A. de C.V. 588387584 manufacture (66621-0790)

Revised: 04/2021 Rare Disease Therapeutics, Inc

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