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2020 PRODUCT CATALOG 2 Call Sales Support at 800-325-7354 Page 04 Introduction TABLE 06 PRE-PEN® (Benzylpenicilloyl Polylysine Injection USP)

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2020 PRODUCT CATALOG 2 Call Sales Support at 800-325-7354 Page 04 Introduction TABLE 06 PRE-PEN® (Benzylpenicilloyl Polylysine Injection USP) 2020 PRODUCT CATALOG 2 Call Sales Support at 800-325-7354 page 04 Introduction TABLE 06 PRE-PEN® (benzylpenicilloyl polylysine injection USP) 07 Center-Al® (allergenic extract, alum precipitated) OF 08 Sublingual Immunotherapy Tablets 09 ODACTRA® CONTENTS 10 GRASTEK® 11 RAGWITEK® 12 Allergen Extracts 13 Pollen Extracts 16 Pollen Mixes 17 Molds 17 Smuts 18 Insects 18 Epidermals 19 Foods/Ingestants 21 Standardized Extracts 22 Pollen 22 Pollen Mixes 22 Epidermals 22 Mites 23 Ancillary Products 24 Normal Saline with Phenol (NSP) 24 Albumin Saline with Phenol (HSA) 24 50% Glycerin 25 Sterile Empty Vials (SEV) 26 Amber Sterile Empty Vials (SEV) 27 Non-Sterile Dropper Vials, Dropper Tips, Pumps 28 Colored Caps for Vials 28 Miscellaneous (labels, information sheets, etc.) 29 Allergy Diagnostics 29 Diagnostic Controls 29 Skin Testing Systems 30 Syringes 30 Mixing Syringes 30 Safety Syringes 30 Standard Syringes 31 Trays 32 Package Inserts 57 Fax Order Form 58 Ordering Information You are encouraged to report patient reactions to skin testing and/or immunotherapy to ALK. Our contact information is toll-free 1-855-216-6497 or email [email protected] ALK is a global allergy solutions company, with a wide range of allergy treatments, products and services that meet the unique needs of allergy sufferers, their families and healthcare professionals. ALK is committed to helping as many people with allergy as possible, which means providing your practice with quality supplies and services to help your business thrive and provide your patients with educational materials to support immunotherapy awareness and improve compliance. From our extensive selection of allergy extracts, skin testing devices, unique products, and patient resources, we are committed to helping you improve the lives of more allergic patients. UNIQUE* PRODUCTS PRE-PEN® (benzylpenicilloyl polylysine injection USP) Penicillin Allergy Testing FDA approved for the assessment of sensitization to penicillin (benzylpenicillin or penicillin G) in patients suspected to have a clinical penicillin hypersensitivity. Center-Al® (allergenic extracts, alum precipitated) Center-Al is the only alum precipitated extract offered in the United States. Histatrol® (histamine phosphate) Positive Skin Test Control. ODACTRA® (House Dust Mite [Dermatophagoides farinae and Dermatophagoides pteronyssinus] Allergen Extract Tablet for Sublingual Use 12 SQ-HDM) The first and only FDA-approved sublingual tablet for house dust mite–induced allergic rhinitis, with or without conjunctivitis. GRASTEK® (Timothy Grass Pollen Allergen Extract Tablet for Sublingual Use 2800 BAU) The first FDA-approved sublingual tablet indicated for allergic rhinitis with or without conjunctivitis due to timothy grass or cross-reactive grass pollen. RAGWITEK® (Short Ragweed Pollen Allergen Extract Tablet for Sublingual Use 12 Amb a 1-U) The first and only FDA-approved sublingual tablet to treat ragweed pollen allergies. * At the time of this publication, these products are only available through ALK 4 Call Sales Support at 800-325-7354 You are encouraged to report patient reactions to skin testing and/or immunotherapy to ALK. 5 Our contact information is toll-free 1-855-216-6497 or email [email protected] PRE-PEN® (benzylpenicilloyl polylysine injection USP) PRE-PEN® is FDA approved for the assessment of sensitization to penicillin (benzylpenicillin or penicillin G) in patients suspected to have a clinical penicillin hypersensitivity. PRE-PEN® (benzylpenicilloyl polylysine injection USP) is manufactured by AllerQuest, LLC, and distributed exclusively by ALK. PRE-PEN® (benzylpenicilloyl polylysine injection USP) is a clear, colorless, sterile solution supplied in 0.25 mL sealed glass ampules. Each ampule is sufficient to evaluate one patient by skin prick (percutaneous) test and duplicate intradermal (intracutaneous) tests. PRE-PEN® (benzylpenicilloyl polylysine injection USP) Item# NDC # Description Vial Size Concentration PRPE 49471-001-05 PRE-PEN® (benzylpenicilloyl polylysine injection USP) 5 x 0.25 mL 6.0 x 10-5 M PRE-PEN® is sold in boxes of 5 ampules; each ampule is intended for single patient use only. Diagnostic Supplies Item# Description Qty Diagnostic DILU15 Aqueous Negative Control 5 mL Multi-Dose Intradermal Testing NSP100 Normal Saline with Phenol (NSP) 100ml 1 20 mm x 52 mm vial Skin Prick Testing HIST14 Histatrol® (histamine phosphate), 1.0 mg/mL 5 mL Dropper Skin Prick Testing DT2D Duotip-Test® II Devices Box of 400 Skin Prick Testing 1058155 Duotip-Test® II , 5 device pack 50 packs Skin Prick Testing 1059360 Penicillin Skin Testing Supply Kit Box of 5 Each kit contains: • Duotip-Test® II devices (5 pack) • Pre-printed syringe labels • Testing preparation instruction card • Alcohol swabs & ruler Note: Penicillin G is also required for penicillin allergy skin testing and is available from your pharmacy or healthcare wholesaler. The recommended strength for skin testing per the Drug Allergy Practice Parameters is 10,000 units/mL.** See the Syringe section on page 30 for a syringe product list. Availability may vary. INDICATION PRE-PEN is indicated for the assessment of sensitization to penicillin (benzylpenicillin or penicillin G) in patients suspected to have clinical penicillin hypersensitivity. A negative skin test to PRE-PEN is associated with an incidence of immediate allergic reactions of less than 5% after the administration of therapeutic penicillin, whereas the incidence may be more than 50% in a history-positive patient with a positive skin test to PRE-PEN. These allergic reactions are predominantly dermatologic. Whether a negative skin test to PRE-PEN predicts a lower risk of anaphylaxis is not established. Similarly, when deciding the risk of proposed penicillin treatment, there are not enough data at present to permit relative weighing in individual cases of a history of clinical penicillin hypersensitivity as compared to positive skin tests to PRE-PEN and/or minor penicillin determinants. IMPORTANT SAFETY INFORMATION The risk of sensitization to repeated skin testing with PRE-PEN is not established. Rarely, a systemic allergic reaction including anaphylaxis (see below) may follow a skin test with PRE-PEN. To decrease the risk of a systemic allergic reaction, puncture skin testing should be performed first. Intradermal skin testing should be performed only if the puncture test is entirely negative. PRE-PEN is contraindicated in those patients who have exhibited either a systemic or marked local reaction to its previous administration. Patients known to be extremely hypersensitive to penicillin should not be skin tested. No reagent, test, or combination of tests will completely assure that a reaction to penicillin therapy will not occur. The value of the PRE-PEN skin test alone as a means of assessing the risk of administering therapeutic penicillin (when penicillin is the preferred drug of choice) in the following situations is not established: • Adult patients who give no history of clinical penicillin hypersensitivity. • Pediatric patients. In addition, the clinical value of PRE-PEN where exposure to penicillin is suspected as a cause of a current drug reaction or in patients who are undergoing routine allergy evaluation is not known. Likewise, the clinical value of PRE-PEN skin tests alone in determining the risk of administering semisynthetic penicillins (phenoxymethyl penicillin, ampicillin, carbenicillin, dicloxacillin, methicillin, nafcillin, oxacillin, amoxicillin), cephalosporinderived antibiotics, and penem antibiotics is not known. In addition to the results of the PRE-PEN skin test, the decision to administer or not administer penicillin should take into account individual patient factors. Healthcare professionals should keep in mind the following: • A serious allergic reaction to therapeutic penicillin may occur in a patient with a negative skin test to PRE-PEN. • It is possible for a patient to have an anaphylactic reaction to therapeutic penicillin in the presence of a negative PRE-PEN skin test and a negative history of clinical penicillin hypersensitivity. • If penicillin is the drug of choice for a life-threatening infection, successful desensitization with therapeutic penicillin may be possible irrespective of a positive skin test and/or a positive history of clinical penicillin hypersensitivity. Occasionally, patients may develop an intense local inflammatory response at the skin test site. Rarely, patients will develop a systemic allergic reaction, manifested by generalized erythema, pruritus, angioedema, urticaria, dyspnea, hypotension, and anaphylaxis. The usual methods of treating a skin test antigen-induced reaction —the applications of a venous occlusion tourniquet proximal to the skin test site and administration of epinephrine are recommended. The patient should be kept under observation for several hours. Pregnancy Category C: Animal reproduction studies have not been conducted with PRE-PEN. It is not known whether PRE-PEN can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. The hazards of skin testing in such patients should be weighed against the hazard of penicillin therapy without skin testing. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information on page 39, for additional Important Safety Information. **Solensky et al., Drug Allergy: An Updated Practice Parameter. The Annals of Allergy, Asthma
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