MedPath

Treatment Set TS335657

ALLERGENIC EXTRACTSINDIVIDUAL TREATMENT VIAL

Approved
Approval ID

d32eec3b-6976-474c-a5a2-af67b6965284

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 26, 2010

Manufacturers
FDA

Antigen Laboratories, Inc.

DUNS: 030705628

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Treatment Set TS335657

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49288-0780
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Treatment Set TS335657
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateApril 26, 2010
FDA Product Classification

INGREDIENTS (30)

FRAXINUS AMERICANA POLLENActive
Quantity: 0.002 g in 1 mL
Code: G684LX721Q
Classification: ACTIB
IVA ANNUA VAR. ANNUA POLLENActive
Quantity: 0.002 g in 1 mL
Code: Y2U5S5PF22
Classification: ACTIB
SPORISORIUM CRUENTUMActive
Quantity: 0.00004 g in 1 mL
Code: GQM6LVU5V8
Classification: ACTIB
CANIS LUPUS FAMILIARIS HAIRActive
Quantity: 0.00008 g in 1 mL
Code: 05S7L91ZTR
Classification: ACTIB
DERMATOPHAGOIDES FARINAEActive
Quantity: 400 [AU] in 1 mL
Code: PR9U2YPF3Q
Classification: ACTIB
DERMATOPHAGOIDES PTERONYSSINUSActive
Quantity: 16 [AU] in 1 mL
Code: 57L1Z5378K
Classification: ACTIB
PERIPLANETA AMERICANAActive
Quantity: 0.00008 g in 1 mL
Code: 2RQ1L9N089
Classification: ACTIB
JUNIPERUS VIRGINIANA POLLENActive
Quantity: 0.00008 g in 1 mL
Code: PY0JA16R2G
Classification: ACTIB
CYNODON DACTYLON POLLENActive
Quantity: 400 [BAU] in 1 mL
Code: 175F461W10
Classification: ACTIB
CARYA ALBA POLLENActive
Quantity: 0.0002 g in 1 mL
Code: G2A764T54B
Classification: ACTIB
ACER NEGUNDO POLLENActive
Quantity: 0.00008 g in 1 mL
Code: P6K070AR8V
Classification: ACTIB
BETULA NIGRA POLLENActive
Quantity: 0.002 g in 1 mL
Code: 93963RFO1P
Classification: ACTIB
POPULUS DELTOIDES POLLENActive
Quantity: 0.00008 g in 1 mL
Code: 476DVV63WP
Classification: ACTIB
CARYA ILLINOINENSIS POLLENActive
Quantity: 0.0002 g in 1 mL
Code: PYO4JR720Y
Classification: ACTIB
QUERCUS ALBA POLLENActive
Quantity: 0.002 g in 1 mL
Code: Z4Y9ZSV4KK
Classification: ACTIB
USTILAGO NUDA HORDEIActive
Quantity: 0.00002 g in 1 mL
Code: 9Y53ZS6I82
Classification: ACTIB
USTILAGO MAYDISActive
Quantity: 0.00002 g in 1 mL
Code: 4K7Z7K7SWG
Classification: ACTIB
USTILAGO AVENAEActive
Quantity: 0.00002 g in 1 mL
Code: YIH315U1TU
Classification: ACTIB
USTILAGO TRITICIActive
Quantity: 0.00002 g in 1 mL
Code: BV82OL2IZ8
Classification: ACTIB
PLEOSPORA HERBARUMActive
Quantity: 0.00008 g in 1 mL
Code: 0N3Z1P4B2W
Classification: ACTIB
SORGHUM HALEPENSE POLLENActive
Quantity: 0.00008 g in 1 mL
Code: 577VA5B4HP
Classification: ACTIB
RUMEX ACETOSELLA POLLENActive
Quantity: 0.00008 g in 1 mL
Code: N52MIQ81ZW
Classification: ACTIB
USTILAGO CYNODONTISActive
Quantity: 0.00004 g in 1 mL
Code: 0V3J4YEX2W
Classification: ACTIB
KOCHIA SCOPARIA POLLENActive
Quantity: 0.00008 g in 1 mL
Code: 07A108ZKW5
Classification: ACTIB
AMARANTHUS RETROFLEXUS POLLENActive
Quantity: 0.00008 g in 1 mL
Code: 73B14PX5FW
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT

Treatment Set TS335683

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49288-0781
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Treatment Set TS335683
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateApril 26, 2010
FDA Product Classification

INGREDIENTS (7)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
PHLEUM PRATENSE POLLENActive
Quantity: 20000 [BAU] in 1 mL
Code: 65M88RW2EG
Classification: ACTIB
CYNODON DACTYLON POLLENActive
Quantity: 2000 [BAU] in 1 mL
Code: 175F461W10
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT

Drug Labeling Information

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 4/26/2010

ADVERSE REACTIONS

Systemic reactions may range from mild exaggeration of the patient’s allergic symptoms to anaphylactic reactions. Very sensitive patients may show a rapid response. In some instances a severe systemic reaction with blood pressure fall and/or shock may occur. Quantitation of patient's sensitivity combined with careful early observation is essential for safe skin testing and treatment.

Other reactions include, but are not necessarily limited to urticaria, itching, edema of the extremities, respiratory wheezing or asthma, dyspnea, cyanosis, tachycardia, lacrimation, marked perspiration, flushing of the face, neck or upper chest, mild persistent clearing of the throat, hacking cough, or persistent sneezing.

1) Local Reactions

Small amounts of erythema and swelling at the site of injection are common, the extent varying with the patient. Such reactions should not be considered significant unless they persist for at least 24 hours or exceed 50 mm. in diameter.

Larger local reactions are not only uncomfortable, but also indicate the possibility of a systemic reaction if dosage is increased. In such cases the dosage should be reduced to the last level not causing the reaction and maintained at this level for two or three treatments before cautiously increasing again.

Large, persistent local reactions or minor exacerbations of the patient’s allergic symptoms may be treated by local cold applications and/or the use of oral antihistamines, but they should be considered a warning of possible severe systemic reactions and the need for temporarily reduced dosages.

A mild burning immediately after the injection is to be expected; this usually leaves in 10 to 20 seconds. Prolonged pain, or pain radiating up the arm, is usually the result of intramuscular injection, making this injection route undesirable. Subcutaneous injection is the recommended route.

2) Systemic Reactions

With careful attention to dosage and administration, such reactions occur infrequentIy, but it must be remembered that allergenic extracts are highly potent to sensitive individuals and OVERDOSE could result in anaphylactic symptoms. Therefore, it is imperative that physicians administering allergenic extracts understand and be prepared for the treatment of severe reactions.

Adverse reaction frequency data for allergenic extract administration is not available. Inherent difficulties in establishing such data are the wide variations in clinical allergy types, patient sensitivity, treatment schedules used by allergists, potency of extracts from various sources, etc.

It cannot be overemphasized that, under certain unpredictable combinations of circumstances, anaphylactic shock is always a possibility. Other possible systemic reaction symptoms are, in varying degrees of severity, fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis, and urticaria.17,18

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