NDC 0268-6513 Botrytis Cinerea
Injection, Solution Intradermal
Product Information
What is NDC 0268-6513?
The NDC code 0268-6513 is assigned by the FDA to the product Botrytis Cinerea which is a non-standardized allergenic label product labeled by Alk-abello, Inc.. The product's dosage form is injection, solution and is administered via intradermal form. The product is distributed in a single package with assigned NDC code 0268-6513-05 5 ml in 1 vial, multi-dose . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Botrytis Cinerea?
These products are for diagnostic use only. Diagnostic allergenic extracts are indicated for use in skin testing to establish the clinical relevance of specific allergens to which the patient has been exposed. By measuring skin test response the physician may assess the degree of sensitivity that patients have to the allergens. For extracts standardized in AU and BAU, see individual directions for use. Allergenic extracts for diagnostic use only of coffee, mosquito, cottonseed, and flaxseed have not been shown by adequate data to be safe and effective for therapeutic use.
Product Details
What are Botrytis Cinerea Active Ingredients?
Botrytis Cinerea Active Ingredients UNII Codes
- HOUSE DUST (UNII: EYO007VX98)
- HOUSE DUST (UNII: EYO007VX98) (Active Moiety)
- ALMOND (UNII: 3Z252A2K9G)
- ALMOND (UNII: 3Z252A2K9G) (Active Moiety)
- APPLE (UNII: B423VGH5S9)
- APPLE (UNII: B423VGH5S9) (Active Moiety)
- APRICOT (UNII: 269CJD5GZ9)
- APRICOT (UNII: 269CJD5GZ9) (Active Moiety)
- ASPARAGUS (UNII: Z1EJP3037Z)
- ASPARAGUS (UNII: Z1EJP3037Z) (Active Moiety)
- AVOCADO (UNII: SDS87L369F)
- AVOCADO (UNII: SDS87L369F) (Active Moiety)
- BANANA (UNII: 4AJZ4765R9)
- BANANA (UNII: 4AJZ4765R9) (Active Moiety)
- BARLEY (UNII: 5PWM7YLI7R)
- BARLEY (UNII: 5PWM7YLI7R) (Active Moiety)
- BEAN (UNII: 8WB9PV3YW5)
- BEAN (UNII: 8WB9PV3YW5) (Active Moiety)
- STRING BEAN (UNII: N9D69B2Q7Y)
- STRING BEAN (UNII: N9D69B2Q7Y) (Active Moiety)
- BEEF (UNII: 4PIB2155QP)
- BEEF (UNII: 4PIB2155QP) (Active Moiety)
- BRAZIL NUT (UNII: XKR79OET1K)
- BRAZIL NUT (UNII: XKR79OET1K) (Active Moiety)
- BROCCOLI (UNII: UOI4FT57BZ)
- BROCCOLI (UNII: UOI4FT57BZ) (Active Moiety)
- BUCKWHEAT (UNII: N0Y68724R3)
- BUCKWHEAT (UNII: N0Y68724R3) (Active Moiety)
- CABBAGE (UNII: GW0W1Y9I97)
- CABBAGE (UNII: GW0W1Y9I97) (Active Moiety)
- CANTALOUPE (UNII: 8QF5D5H6UH)
- CANTALOUPE (UNII: 8QF5D5H6UH) (Active Moiety)
- CARROT (UNII: L56Z1JK48B)
- CARROT (UNII: L56Z1JK48B) (Active Moiety)
- CASEIN (UNII: 48268V50D5)
- CASEIN (UNII: 48268V50D5) (Active Moiety)
- CELERY (UNII: 44IDY6DTKX)
- CELERY (UNII: 44IDY6DTKX) (Active Moiety)
- CHERRY (UNII: BUC5I9595W)
- CHERRY (UNII: BUC5I9595W) (Active Moiety)
- CHICKEN (UNII: 0X8Q245Y7B)
- CHICKEN (UNII: 0X8Q245Y7B) (Active Moiety)
- CINNAMON (UNII: 5S29HWU6QB)
- CINNAMON (UNII: 5S29HWU6QB) (Active Moiety)
- QUAHOG, UNSPECIFIED (UNII: 226LY0AFR9)
- QUAHOG, UNSPECIFIED (UNII: 226LY0AFR9) (Active Moiety)
- COCOA (UNII: D9108TZ9KG)
- COCOA (UNII: D9108TZ9KG) (Active Moiety)
- COCONUT (UNII: 3RT3536DHY)
- COCONUT (UNII: 3RT3536DHY) (Active Moiety)
- COD, UNSPECIFIED (UNII: 8D6Q5LNG3D)
- COD, UNSPECIFIED (UNII: 8D6Q5LNG3D) (Active Moiety)
- COFFEE BEAN (UNII: JFH385Y744)
- COFFEE BEAN (UNII: JFH385Y744) (Active Moiety)
- CRAB LEG, UNSPECIFIED (UNII: S1VF61QLO9)
- CRAB LEG, UNSPECIFIED (UNII: S1VF61QLO9) (Active Moiety)
- CUCUMBER (UNII: YY7C30VXJT)
- CUCUMBER (UNII: YY7C30VXJT) (Active Moiety)
- EGG WHITE (UNII: 3E0I92Z2GR)
- EGG WHITE (UNII: 3E0I92Z2GR) (Active Moiety)
- EGG (UNII: 291P45F896)
- EGG (UNII: 291P45F896) (Active Moiety)
- EGG YOLK (UNII: 4IPS17B70T)
- EGG YOLK (UNII: 4IPS17B70T) (Active Moiety)
- FLOUNDER, UNSPECIFIED (UNII: T197LO581X)
- FLOUNDER, UNSPECIFIED (UNII: T197LO581X) (Active Moiety)
- GARLIC (UNII: V1V998DC17)
- GARLIC (UNII: V1V998DC17) (Active Moiety)
- GRAPE (UNII: 6X543N684K)
- GRAPE (UNII: 6X543N684K) (Active Moiety)
- GRAPEFRUIT (UNII: O82C39RR8C)
- GRAPEFRUIT (UNII: O82C39RR8C) (Active Moiety)
- KARAYA GUM (UNII: 73W9IQY50Q)
- KARAYA GUM (UNII: 73W9IQY50Q) (Active Moiety)
- HONEYDEW MELON (UNII: RN8P45F92A)
- HONEYDEW MELON (UNII: RN8P45F92A) (Active Moiety)
- LAMB (UNII: FOF26T73HA)
- LAMB (UNII: FOF26T73HA) (Active Moiety)
- LEMON (UNII: 24RS0A988O)
- LEMON (UNII: 24RS0A988O) (Active Moiety)
- LETTUCE (UNII: 5PO6NN3RRJ)
- LETTUCE (UNII: 5PO6NN3RRJ) (Active Moiety)
- LIMA BEAN (UNII: 112YH1ZMX2)
- LIMA BEAN (UNII: 112YH1ZMX2) (Active Moiety)
- LOBSTER, UNSPECIFIED (UNII: ZQ6LG2C39M)
- LOBSTER, UNSPECIFIED (UNII: ZQ6LG2C39M) (Active Moiety)
- GOAT MILK (UNII: XE5K5I4RP7)
- GOAT MILK (UNII: XE5K5I4RP7) (Active Moiety)
- COW MILK (UNII: 917J3173FT)
- COW MILK (UNII: 917J3173FT) (Active Moiety)
- CULTIVATED MUSHROOM (UNII: 54C8E6W6JY)
- CULTIVATED MUSHROOM (UNII: 54C8E6W6JY) (Active Moiety)
- MUSTARD SEED (UNII: 58RXI817UT)
- MUSTARD SEED (UNII: 58RXI817UT) (Active Moiety)
- OAT (UNII: Z6J799EAJK)
- OAT (UNII: Z6J799EAJK) (Active Moiety)
- BLACK OLIVE (UNII: 2M6QWV94OC)
- BLACK OLIVE (UNII: 2M6QWV94OC) (Active Moiety)
- ONION (UNII: 492225Q21H)
- ONION (UNII: 492225Q21H) (Active Moiety)
- ORANGE (UNII: 5EVU04N5QU)
- ORANGE (UNII: 5EVU04N5QU) (Active Moiety)
- OYSTER, UNSPECIFIED (UNII: S614XWR17V)
- OYSTER, UNSPECIFIED (UNII: S614XWR17V) (Active Moiety)
- PEA (UNII: W4X7H8GYFM)
- PEA (UNII: W4X7H8GYFM) (Active Moiety)
- PEACH (UNII: 3OKE88I3QG)
- PEACH (UNII: 3OKE88I3QG) (Active Moiety)
- PEANUT (UNII: QE1QX6B99R)
- PEANUT (UNII: QE1QX6B99R) (Active Moiety)
- PEAR (UNII: 2ZN8DWC0YF)
- PEAR (UNII: 2ZN8DWC0YF) (Active Moiety)
- PECAN (UNII: F14P91GB5F)
- PECAN (UNII: F14P91GB5F) (Active Moiety)
- GREEN BELL PEPPER (UNII: 4J4DOU3HEK)
- GREEN BELL PEPPER (UNII: 4J4DOU3HEK) (Active Moiety)
- BLACK PEPPER (UNII: KM66971LVF)
- BLACK PEPPER (UNII: KM66971LVF) (Active Moiety)
- PINEAPPLE (UNII: 2A88ZO081O)
- PINEAPPLE (UNII: 2A88ZO081O) (Active Moiety)
- PISTACHIO (UNII: 6815CPT6ZJ)
- PISTACHIO (UNII: 6815CPT6ZJ) (Active Moiety)
- PLUM (UNII: 67M3EQ6BE1)
- PLUM (UNII: 67M3EQ6BE1) (Active Moiety)
- PORK (UNII: O138UB266J)
- PORK (UNII: O138UB266J) (Active Moiety)
- POTATO (UNII: CFE1S8DYWD)
- POTATO (UNII: CFE1S8DYWD) (Active Moiety)
- BROWN RICE (UNII: 659G217HPG)
- BROWN RICE (UNII: 659G217HPG) (Active Moiety)
- RYE (UNII: 0R4AQI398X)
- RYE (UNII: 0R4AQI398X) (Active Moiety)
- SALMON, UNSPECIFIED (UNII: 6122W2M0GB)
- SALMON, UNSPECIFIED (UNII: 6122W2M0GB) (Active Moiety)
- SESAME SEED (UNII: 7Y1255HVXR)
- SESAME SEED (UNII: 7Y1255HVXR) (Active Moiety)
- SHRIMP, UNSPECIFIED (UNII: 1891LE191T)
- SHRIMP, UNSPECIFIED (UNII: 1891LE191T) (Active Moiety)
- SOYBEAN (UNII: L7HT8F1ZOD)
- SOYBEAN (UNII: L7HT8F1ZOD) (Active Moiety)
- SPINACH (UNII: 6WO75C6WVB)
- SPINACH (UNII: 6WO75C6WVB) (Active Moiety)
- SQUASH (UNII: 9961HBA483)
- SQUASH (UNII: 9961HBA483) (Active Moiety)
- STRAWBERRY (UNII: 4J2TY8Y81V)
- STRAWBERRY (UNII: 4J2TY8Y81V) (Active Moiety)
- CORN (UNII: 0N8672707O)
- CORN (UNII: 0N8672707O) (Active Moiety)
- TOMATO (UNII: Z4KHF2C175)
- TOMATO (UNII: Z4KHF2C175) (Active Moiety)
- TUNA, UNSPECIFIED (UNII: V2T3IHT3E2)
- TUNA, UNSPECIFIED (UNII: V2T3IHT3E2) (Active Moiety)
- TURKEY (UNII: 8E9NT44R8I)
- TURKEY (UNII: 8E9NT44R8I) (Active Moiety)
- VANILLA (UNII: Q74T35078H)
- VANILLA (UNII: Q74T35078H) (Active Moiety)
- ENGLISH WALNUT (UNII: 1V3SHR7QB7)
- ENGLISH WALNUT (UNII: 1V3SHR7QB7) (Active Moiety)
- WATERMELON (UNII: 231473QB6R)
- WATERMELON (UNII: 231473QB6R) (Active Moiety)
- WHEAT (UNII: 4J2I0SN84Y)
- WHEAT (UNII: 4J2I0SN84Y) (Active Moiety)
- BOS TAURUS SKIN (UNII: 7J12CD6O9L)
- BOS TAURUS SKIN (UNII: 7J12CD6O9L) (Active Moiety)
- COTTON FIBER (UNII: 70LDW53ROO)
- COTTON FIBER (UNII: 70LDW53ROO) (Active Moiety)
- COTTON SEED (UNII: DI0ZRJ0MXN)
- COTTON SEED (UNII: DI0ZRJ0MXN) (Active Moiety)
- CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T)
- CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (Active Moiety)
- CAVIA PORCELLUS SKIN (UNII: GM3H4U6QS8)
- CAVIA PORCELLUS SKIN (UNII: GM3H4U6QS8) (Active Moiety)
- EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4)
- EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4) (Active Moiety)
- CEIBA PENTANDRA FIBER (UNII: 758Z9H9WV9)
- CEIBA PENTANDRA FIBER (UNII: 758Z9H9WV9) (Active Moiety)
- MUS MUSCULUS SKIN (UNII: 390AN9GB09)
- MUS MUSCULUS SKIN (UNII: 390AN9GB09) (Active Moiety)
- IRIS X GERMANICA ROOT (UNII: 8N6VTJ9IWV)
- IRIS X GERMANICA ROOT (UNII: 8N6VTJ9IWV) (Active Moiety)
- TANACETUM CINERARIIFOLIUM FLOWER (UNII: CGF76TP7X6)
- TANACETUM CINERARIIFOLIUM FLOWER (UNII: CGF76TP7X6) (Active Moiety)
- RABBIT (UNII: O5V0F26RUW)
- RABBIT (UNII: O5V0F26RUW) (Active Moiety)
- SOLENOPSIS INVICTA (UNII: 5O7CR4P444)
- SOLENOPSIS INVICTA (UNII: 5O7CR4P444) (Active Moiety)
- PERIPLANETA AMERICANA (UNII: 2RQ1L9N089)
- PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (Active Moiety)
- BLATTELLA GERMANICA (UNII: G9O67I0A8Q)
- BLATTELLA GERMANICA (UNII: G9O67I0A8Q) (Active Moiety)
- SAROCLADIUM STRICTUM (UNII: 3F36V0451W)
- SAROCLADIUM STRICTUM (UNII: 3F36V0451W) (Active Moiety)
- ALTERNARIA ALTERNATA (UNII: 52B29REC7H)
- ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (Active Moiety)
- ASPERGILLUS FUMIGATUS (UNII: X88DF51T48)
- ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (Active Moiety)
- ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6)
- ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (Active Moiety)
- AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK)
- AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (Active Moiety)
- BOTRYTIS CINEREA (UNII: TBW53313S7)
- BOTRYTIS CINEREA (UNII: TBW53313S7) (Active Moiety)
- CANDIDA ALBICANS (UNII: 4D7G21HDBC)
- CANDIDA ALBICANS (UNII: 4D7G21HDBC) (Active Moiety)
- CHAETOMIUM GLOBOSUM (UNII: 5016WB8B8A)
- CHAETOMIUM GLOBOSUM (UNII: 5016WB8B8A) (Active Moiety)
- CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO)
- CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (Active Moiety)
- CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R)
- CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (Active Moiety)
- COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W)
- COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (Active Moiety)
- EPICOCCUM NIGRUM (UNII: 87U156LEN7)
- EPICOCCUM NIGRUM (UNII: 87U156LEN7) (Active Moiety)
- FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ)
- FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (Active Moiety)
- HELMINTHOSPORIUM SOLANI (UNII: U6Z259H815)
- HELMINTHOSPORIUM SOLANI (UNII: U6Z259H815) (Active Moiety)
- MUCOR PLUMBEUS (UNII: D7401PWY6E)
- MUCOR PLUMBEUS (UNII: D7401PWY6E) (Active Moiety)
- NEUROSPORA INTERMEDIA (UNII: 2072U60DUI)
- NEUROSPORA INTERMEDIA (UNII: 2072U60DUI) (Active Moiety)
- KHUSKIA ORYZAE (UNII: VK8C112WTS)
- KHUSKIA ORYZAE (UNII: VK8C112WTS) (Active Moiety)
- PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M)
- PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M) (Active Moiety)
- RHIZOPUS ARRHIZUS (UNII: 8476849N1Y)
- RHIZOPUS ARRHIZUS (UNII: 8476849N1Y) (Active Moiety)
- RHODOTORULA RUBRA (UNII: 15W81V867R)
- RHODOTORULA RUBRA (UNII: 15W81V867R) (Active Moiety)
- USTILAGO MAYDIS (UNII: 4K7Z7K7SWG)
- USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (Active Moiety)
- USTILAGO TRITICI (UNII: BV82OL2IZ8)
- USTILAGO TRITICI (UNII: BV82OL2IZ8) (Active Moiety)
- STEMPHYLIUM SOLANI (UNII: 1IEK4UDP5M)
- STEMPHYLIUM SOLANI (UNII: 1IEK4UDP5M) (Active Moiety)
- TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV)
- TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (Active Moiety)
- PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG)
- PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (Active Moiety)
- ACACIA (UNII: 5C5403N26O)
- ACACIA (UNII: 5C5403N26O) (Active Moiety)
- ALNUS INCANA SUBSP. RUGOSA POLLEN (UNII: 605T96G8Y5)
- ALNUS INCANA SUBSP. RUGOSA POLLEN (UNII: 605T96G8Y5) (Active Moiety)
- MEDICAGO SATIVA POLLEN (UNII: G515RAI9FY)
- MEDICAGO SATIVA POLLEN (UNII: G515RAI9FY) (Active Moiety)
- FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q)
- FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (Active Moiety)
- PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK)
- PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (Active Moiety)
- MORELLA CERIFERA POLLEN (UNII: LC8MEV9S89)
- MORELLA CERIFERA POLLEN (UNII: LC8MEV9S89) (Active Moiety)
- FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4)
- FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4) (Active Moiety)
- BETULA LENTA POLLEN (UNII: JQ5HI5004M)
- BETULA LENTA POLLEN (UNII: JQ5HI5004M) (Active Moiety)
- BETULA NIGRA POLLEN (UNII: 93963RFO1P)
- BETULA NIGRA POLLEN (UNII: 93963RFO1P) (Active Moiety)
- ACER NEGUNDO POLLEN (UNII: P6K070AR8V)
- ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (Active Moiety)
- AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH)
- AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH) (Active Moiety)
- JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y)
- JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (Active Moiety)
- JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G)
- JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (Active Moiety)
- XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI)
- XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (Active Moiety)
- POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP)
- POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (Active Moiety)
- CUPRESSUS ARIZONICA POLLEN (UNII: 232DMH0XVF)
- CUPRESSUS ARIZONICA POLLEN (UNII: 232DMH0XVF) (Active Moiety)
- TAXODIUM DISTICHUM POLLEN (UNII: O12H03B41R)
- TAXODIUM DISTICHUM POLLEN (UNII: O12H03B41R) (Active Moiety)
- RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW)
- RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (Active Moiety)
- RUMEX CRISPUS POLLEN (UNII: V825XJG64G)
- RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (Active Moiety)
- ULMUS AMERICANA POLLEN (UNII: 89BAT511BD)
- ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (Active Moiety)
- SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5)
- SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5) (Active Moiety)
- CELTIS OCCIDENTALIS POLLEN (UNII: 68R9X9Y96X)
- CELTIS OCCIDENTALIS POLLEN (UNII: 68R9X9Y96X) (Active Moiety)
- CARYA OVATA POLLEN (UNII: 54UN9R2798)
- CARYA OVATA POLLEN (UNII: 54UN9R2798) (Active Moiety)
- SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP)
- SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (Active Moiety)
- JUNIPERUS CALIFORNICA POLLEN (UNII: 0H1V4V5V9L)
- JUNIPERUS CALIFORNICA POLLEN (UNII: 0H1V4V5V9L) (Active Moiety)
- BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5)
- BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (Active Moiety)
- CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN)
- CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (Active Moiety)
- ACER RUBRUM POLLEN (UNII: 700NK45C76)
- ACER RUBRUM POLLEN (UNII: 700NK45C76) (Active Moiety)
- ACER SACCHARUM POLLEN (UNII: V38QUQ7861)
- ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (Active Moiety)
- CYCLACHAENA XANTHIFOLIA POLLEN (UNII: V80TPZ0T6J)
- CYCLACHAENA XANTHIFOLIA POLLEN (UNII: V80TPZ0T6J) (Active Moiety)
- IVA ANNUA POLLEN (UNII: Y2U5S5PF22)
- IVA ANNUA POLLEN (UNII: Y2U5S5PF22) (Active Moiety)
- PROSOPIS JULIFLORA POLLEN (UNII: 6EIJ3D04MR)
- PROSOPIS JULIFLORA POLLEN (UNII: 6EIJ3D04MR) (Active Moiety)
- ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D)
- ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (Active Moiety)
- MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52)
- MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52) (Active Moiety)
- MORUS ALBA POLLEN (UNII: 3I9T68187H)
- MORUS ALBA POLLEN (UNII: 3I9T68187H) (Active Moiety)
- QUERCUS RUBRA POLLEN (UNII: SVW19ET93C)
- QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (Active Moiety)
- QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO)
- QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO) (Active Moiety)
- QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK)
- QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (Active Moiety)
- OLEA EUROPAEA POLLEN (UNII: 43R41XZ627)
- OLEA EUROPAEA POLLEN (UNII: 43R41XZ627) (Active Moiety)
- SYAGRUS ROMANZOFFIANA POLLEN (UNII: 84ZOM591BB)
- SYAGRUS ROMANZOFFIANA POLLEN (UNII: 84ZOM591BB) (Active Moiety)
- CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y)
- CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (Active Moiety)
- AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW)
- AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (Active Moiety)
- PINUS STROBUS POLLEN (UNII: TX1ER5UV3T)
- PINUS STROBUS POLLEN (UNII: TX1ER5UV3T) (Active Moiety)
- PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI)
- PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (Active Moiety)
- POPULUS ALBA POLLEN (UNII: VU8C8SB23P)
- POPULUS ALBA POLLEN (UNII: VU8C8SB23P) (Active Moiety)
- LIGUSTRUM VULGARE POLLEN (UNII: Y3FRX92Z0E)
- LIGUSTRUM VULGARE POLLEN (UNII: Y3FRX92Z0E) (Active Moiety)
- ELYMUS REPENS POLLEN (UNII: ON2T85TA2O)
- ELYMUS REPENS POLLEN (UNII: ON2T85TA2O) (Active Moiety)
- AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX)
- AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (Active Moiety)
- SALSOLA KALI POLLEN (UNII: 2MH135KC6G)
- SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (Active Moiety)
- ARTEMISIA TRIDENTATA POLLEN (UNII: YI19RB8YFD)
- ARTEMISIA TRIDENTATA POLLEN (UNII: YI19RB8YFD) (Active Moiety)
- LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS)
- LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (Active Moiety)
- PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK)
- PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (Active Moiety)
- JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR)
- JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (Active Moiety)
- AILANTHUS ALTISSIMA POLLEN (UNII: 2A64U81OQ3)
- AILANTHUS ALTISSIMA POLLEN (UNII: 2A64U81OQ3) (Active Moiety)
- POPULUS TREMULOIDES POLLEN (UNII: 928OC2TJDA)
- POPULUS TREMULOIDES POLLEN (UNII: 928OC2TJDA) (Active Moiety)
- POA ANNUA POLLEN (UNII: 7U437HHU5C)
- POA ANNUA POLLEN (UNII: 7U437HHU5C) (Active Moiety)
- BROMUS INERMIS POLLEN (UNII: 766QT72BK6)
- BROMUS INERMIS POLLEN (UNII: 766QT72BK6) (Active Moiety)
- ZEA MAYS POLLEN (UNII: 74PD8J616H)
- ZEA MAYS POLLEN (UNII: 74PD8J616H) (Active Moiety)
- POPULUS FREMONTII POLLEN (UNII: 426RHB4302)
- POPULUS FREMONTII POLLEN (UNII: 426RHB4302) (Active Moiety)
- POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN (UNII: 5928LJ1441)
- POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN (UNII: 5928LJ1441) (Active Moiety)
- EUPATORIUM CAPILLIFOLIUM POLLEN (UNII: B67NF86HF0)
- EUPATORIUM CAPILLIFOLIUM POLLEN (UNII: B67NF86HF0) (Active Moiety)
- ULMUS CRASSIFOLIA POLLEN (UNII: G82398SD3I)
- ULMUS CRASSIFOLIA POLLEN (UNII: G82398SD3I) (Active Moiety)
- ULMUS PUMILA POLLEN (UNII: 030R993R8E)
- ULMUS PUMILA POLLEN (UNII: 030R993R8E) (Active Moiety)
- EUCALYPTUS GLOBULUS POLLEN (UNII: 7XW7TB10X9)
- EUCALYPTUS GLOBULUS POLLEN (UNII: 7XW7TB10X9) (Active Moiety)
- CORYLUS AMERICANA POLLEN (UNII: ZGS382Y3AV)
- CORYLUS AMERICANA POLLEN (UNII: ZGS382Y3AV) (Active Moiety)
- ROBINIA PSEUDOACACIA POLLEN (UNII: 8003NOJ82F)
- ROBINIA PSEUDOACACIA POLLEN (UNII: 8003NOJ82F) (Active Moiety)
- MELALEUCA QUINQUENERVIA POLLEN (UNII: NX974IRT8E)
- MELALEUCA QUINQUENERVIA POLLEN (UNII: NX974IRT8E) (Active Moiety)
- CHENOPODIUM AMBROSIOIDES POLLEN (UNII: WIB701MW2H)
- CHENOPODIUM AMBROSIOIDES POLLEN (UNII: WIB701MW2H) (Active Moiety)
- QUERCUS AGRIFOLIA POLLEN (UNII: VOT5MA71M7)
- QUERCUS AGRIFOLIA POLLEN (UNII: VOT5MA71M7) (Active Moiety)
- SCHINUS MOLLE POLLEN (UNII: M0G28FH9K1)
- SCHINUS MOLLE POLLEN (UNII: M0G28FH9K1) (Active Moiety)
- AMARANTHUS SPINOSUS POLLEN (UNII: 380W4HYR6N)
- AMARANTHUS SPINOSUS POLLEN (UNII: 380W4HYR6N) (Active Moiety)
- CASUARINA EQUISETIFOLIA POLLEN (UNII: OZJ4OE173N)
- CASUARINA EQUISETIFOLIA POLLEN (UNII: OZJ4OE173N) (Active Moiety)
- PINUS ECHINATA POLLEN (UNII: 96LRW14765)
- PINUS ECHINATA POLLEN (UNII: 96LRW14765) (Active Moiety)
- AMBROSIA ACANTHICARPA POLLEN (UNII: U2AI3H2J5Y)
- AMBROSIA ACANTHICARPA POLLEN (UNII: U2AI3H2J5Y) (Active Moiety)
- AMBROSIA TENUIFOLIA POLLEN (UNII: 57W5SO585B)
- AMBROSIA TENUIFOLIA POLLEN (UNII: 57W5SO585B) (Active Moiety)
- AMBROSIA BIDENTATA POLLEN (UNII: M3S672G75O)
- AMBROSIA BIDENTATA POLLEN (UNII: M3S672G75O) (Active Moiety)
- AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L)
- AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (Active Moiety)
- LOLIUM MULTIFLORUM POLLEN (UNII: VJI0WKK736)
- LOLIUM MULTIFLORUM POLLEN (UNII: VJI0WKK736) (Active Moiety)
- ARTEMISIA FRIGIDA POLLEN (UNII: 5AN5LR8L3F)
- ARTEMISIA FRIGIDA POLLEN (UNII: 5AN5LR8L3F) (Active Moiety)
- DISTICHLIS SPICATA POLLEN (UNII: GOA51670YV)
- DISTICHLIS SPICATA POLLEN (UNII: GOA51670YV) (Active Moiety)
- HOLCUS LANATUS POLLEN (UNII: 70O1TP6H01)
- HOLCUS LANATUS POLLEN (UNII: 70O1TP6H01) (Active Moiety)
- JUGLANS REGIA POLLEN (UNII: ARW43087I1)
- JUGLANS REGIA POLLEN (UNII: ARW43087I1) (Active Moiety)
- TRITICUM AESTIVUM POLLEN (UNII: F1KAH8374D)
- TRITICUM AESTIVUM POLLEN (UNII: F1KAH8374D) (Active Moiety)
- ARTEMISIA ANNUA POLLEN (UNII: 36R82U4DL6)
- ARTEMISIA ANNUA POLLEN (UNII: 36R82U4DL6) (Active Moiety)
- AMARANTHUS TUBERCULATUS POLLEN (UNII: 92N6W6KO2G)
- AMARANTHUS TUBERCULATUS POLLEN (UNII: 92N6W6KO2G) (Active Moiety)
- ACREMONIUM STRICTUM (UNII: 3F36V0451W)
- ACREMONIUM STRICTUM (UNII: 3F36V0451W) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 1013964 - bald cypress pollen extract 50 MG/ML Injectable Solution
- RxCUI: 1013964 - bald cypress pollen extract 0.05 GM/ML Injectable Solution
- RxCUI: 1013964 - Taxodium distichum pollen extract 0.05 GM/ML Injectable Solution
- RxCUI: 1013964 - Taxodium distichum pollen extract 50 MG/ML Injectable Solution
- RxCUI: 1014194 - cedar elm pollen extract 50 MG/ML Injectable Solution
Botrytis Cinerea Inactive Ingredients UNII Codes
- GLYCERIN (UNII: PDC6A3C0OX)
- PHENOL (UNII: 339NCG44TV)
- SODIUM CHLORIDE (UNII: 451W47IQ8X)
- SODIUM BICARBONATE (UNII: 8MDF5V39QO)
- HYDROCHLORIC ACID (UNII: QTT17582CB)
- SODIUM HYDROXIDE (UNII: 55X04QC32I)
Pharmacologic Class(es)
* Please review the disclaimer below.
Botrytis Cinerea Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
- WARNING
- DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS AND USAGE
- CONTRAINDICATIONS
- INFORMATION FOR PATIENTS:
- GENERAL:
- PREGNANCY - CATEGORY C:
- PEDIATRIC USE:
- GERIATRIC USE:
- NURSING MOTHERS:
- CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY:
- DRUG INTERACTIONS:
- ADVERSE REACTIONS
- LOCAL:
- SYSTEMIC REACTIONS:
- OVERDOSAGE
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- STORAGE
- REFERENCES
- PRINCIPAL DISPLAY PANEL
Warning
This product is intended for use by physicians who are experienced in the administration of allergenic extracts and the emergency care of anaphylaxis, or for use under the guidance of an allergy specialist.
As with all allergenic extracts, severe systemic reactions may occur. In certain individuals these life-threatening reactions may result in death. Fatalities associated with skin testing have been reported. Patients should be observed for at least 20 - 30 minutes following testing. Emergency measures and adequately trained personnel should be immediately available in the event of a life-threatening reaction.
Patients with unstable asthma or steroid dependent asthmatics and patients with underlying cardiovascular disease are at greater risk to a fatal outcome from a systemic allergic reaction.
Sensitive patients may experience severe anaphlactic reactions resulting in respiratory obstruction, shock, coma and/or death. Adverse events are to be reported to MedWatch (1-800-FDA-1088), Adverse Event Reporting, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9787. This product should not be injected intravenously. Patients receiving beta blockers may not be responsive to epinephrine or inhaled bronchodilators. Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require theophylline, oxygen, intubation and the use of life support systems. Parenteral fluid and/or plasma expanders may be utilized for the treatment of shock. Adrenocorticosteroids may be administered parenterally or intravenously. Refer to WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections below.
Patients should always be observed for at least 20 - 30 minutes after skin testing. In the event of a marked systemic reaction such as urticaria, angioedema, wheezing, dyspnea, respiratory obstruction, hypotension, coma and death (see ADVERSE REACTIONS), applications of a tourniquet above the injection site and administration of 0.2 mL to 1 mL (0.01 mg/kg) of epinephrine injection (1:1,000) are recommended. Maximal recommended dose for children between 2 and 12 years of age is 0.5 mL. The tourniquet is then gradually released at 15 minute intervals. Patients under treatment with beta blockers may be refractory to the usual dose of epinephrine.
Volume expanders and vasopressor agents may be required to reverse hypotension, inhalation bronchodilators and parenteral aminophylline may be required to reverse bronchospasm. In case of respiratory obstruction, oxygen and intubation may be necessary. Life-threatening reactions unresponsive to the above may require cardiopulmonary resuscitation.
Description
Sterile diagnostic extracts are supplied in either phenol-saline diluent for Intradermal Testing or in diluent containing glycerin 50% (v/v) for Percutaneous Testing and phenol 0.4% (preservative). Inactive ingredients may include: sodium chloride for isotonicity, glycerin, and sodium bicarbonate as a bufferPollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and after final packaging, they are tested for sterility and safety. Molds are individually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline.Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety.
Molds (fungi) are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously.
Foods, miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline or glycerin, filtered aseptically and after final packaging are tested for sterility and safety.
Clinical Pharmacology
Diagnostically (for skin testing) the allergen combines with IgE antibodies fixed to mast cells in the skin. This complexing causes an increase in cellular permeability and degranulation of the mast cells releasing chemical mediators. These mediators (such as histamine) are responsible for a local inflammatory response of wheal and erythema typical of a positive skin test reaction and also, the symptoms commonly associated with allergic disease.1 The more mediator release, the larger the reaction (wheal and erythema).
Indications And Usage
These products are for diagnostic use only. Diagnostic allergenic extracts are indicated for use in skin testing to establish the clinical relevance of specific allergens to which the patient has been exposed. By measuring skin test response the physician may assess the degree of sensitivity that patients have to the allergens. For extracts standardized in AU and BAU, see individual directions for use. Allergenic extracts for diagnostic use only of coffee, mosquito, cottonseed, and flaxseed have not been shown by adequate data to be safe and effective for therapeutic use.
Contraindications
Patients on beta blockers can be non-responsive to beta agonists that may be required to reverse a systemic reaction (also, see boxed WARNING statement and ADVERSE REACTIONS). The physician should carefully weigh the benefit derived from skin testing vs. the risk to the patient should a systemic reaction arise.
Patients with unstable asthma or steroid dependent asthmatics and patients with underlying cardiovascular disease are at greater risk to a fatal outcome from a systemic allergic reaction2,3. See also PRECAUTIONS and ADVERSE REACTIONS.
Information For Patients:
Patients should be instructed to describe any active allergic symptoms such as rhinitis, wheezing, dyspnea, etc. prior to testing. Also, see ADVERSE REACTIONS and WARNINGS Sections.
Patients should always be observed 20 to 30 minutes after testing.
General:
- In the presence of active symptoms such as rhinitis, wheezing, dyspnea, etc., the indications for skin testing must be weighed carefully against the risk of temporarily aggravating the symptoms by the testing itself. Objective assessment of pulmonary function such as Peak Expiratory Flow Rate (PEFR) before allergen administration and prior to discharge may be useful in unstable asthmatics to reduce the chances of exacerbation of the patient’s asthma. Patients should be instructed to describe any active allergic symptoms as described above prior to skin testing and encouraged to report any late reactions from this testing. Also, see ADVERSE REACTIONS and WARNING sections.
- Store allergenic extracts between 2°-8°C at all times, even during use.
- Care must be taken to avoid drawing blood.
- For percutaneous testing, if blood is observed, immediately wipe the allergen from the site.
- For intradermal skin testing, pull gently on the syringe plunger and note if any blood enters the syringe. If blood is obtained, reposition the needle and repeat before injecting (see DOSAGE AND ADMINISTRATION).
- For percutaneous testing, if blood is observed, immediately wipe the allergen from the site.
- Allergenic extracts become less potent with age. Allergenic extracts containing glycerin 50% v/v are relatively stable. Non-glycerinated aqueous extracts, particularly dilute forms as used for intradermal skin testing, have been shown to be extremely unstable. Until such time as stability studies are complete with dilute allergens, new intradermal strength materials should be prepared every few weeks.
- Use standard aseptic precautions if making dilutions from stock concentrates to intradermal strength.
- For intradermal testing: Extracts in glycerin 50% v/v must be diluted with a non-glycerinated diluent and must be diluted at least 25-fold to less than 2% glycerin by volume, as glycerin above this level can cause false positive intradermal skin test results.
Pregnancy - Category C:
Animal reproduction studies have not been conducted with allergenic extracts. It is also not known whether allergenic extracts can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Controlled studies of hyposensitization with moderate to high doses of allergenic extracts during conception and all trimesters of pregnancy have failed to demonstrate any risk to the fetus or to the mother4. However, on the basis of histamine’s known ability to contract the uterine muscle, the release of significant amounts of histamine from allergen exposure to skin test overdose should be avoided on theoretical grounds. Therefore, allergenic extracts should be used cautiously in a pregnant woman and only if clearly needed.
Pediatric Use:
Allergenic extracts for diagnostic use have been given safely in infants and young children. Infants have lower skin test reactivity to histamine, as well as common allergens. Skin test reactivity gradually increases to age 6 and plateaus to age 60. Therefore, small skin test reactions should be anticipated in children under age 6.
Geriatric Use:
Skin test reactivity gradually decreases after age 60. Therefore, smaller skin test reactions should be anticipated in adults over age 60.
Nursing Mothers:
It is not known if allergens administered subcutaneously appear in human milk. Because many drugs are excreted in human milk, caution should be exercised when allergenic extracts are administered to a nursing woman.
Carcinogenesis, Mutagenesis, Impairment Of Fertility:
Studies in animals have not been performed.
Drug Interactions:
Drugs can interfere with the performance of skin tests5.
Antihistamines: Response to mediator (histamine) released by allergens is suppressed by antihistamines. The length of suppression varies and is dependent on individual patient, type of antihistamine and length of time the patient has been on antihistamines. The duration of this suppression may be as little as 24 hours (chlorpheniramine), and can be as long as 40 days (astemizole).
Tricyclic Antidepressants: These exert a potent and sustained decrease of skin reactivity to histamine which may last for a few weeks.
Beta2 Agonists: Oral terbutaline and parenteral ephedrine, in general, have been shown to decrease allergen induced wheal.
Dopamine: Intravenous infusion of dopamine may inhibit skin test responses.
Beta Blocking Agents: Propranolol can significantly increase skin test reactivity.
Other Drugs: Short acting steroids, inhaled beta2 agonists, theophylline and cromolyn do not seem to affect skin test response.
Adverse Reactions
Fatalities from skin testing in the United States have been extensively reviewed by Lockey.2 Six fatalities were associated with intradermal testing without previous percutaneous testing and one was associated with a combination of percutaneous (scratch) and intradermal skin testing. With careful attention to dosage and administration, fatal reactions occur infrequently, but it must be remembered that allergenic extracts are highly potent to sensitive individuals and overdosage could result in anaphylactic symptoms. Therefore it is imperative that physicians administering allergenic extracts for skin testing understand, and be prepared for the treatment of severe reactions.
Local:
Immediate wheal and erythema reactions are to be expected; but if very large, may be the first manifestation of a systemic reaction. In such cases, immediately wipe the test site(s) with sterile gauze or cotton to remove excess allergen.
Systemic Reactions:
Systemic reactions are characterized by one or more of the following symptoms: sneezing, mild to severe generalized urticaria, itching (other than at the skin test site), extensive or generalized edema, wheezing, asthma, dyspnea, cyanosis, hypotension, syncope, and upper airway obstruction. Symptoms may progress to shock and death. Patients should always be observed for at least 20 - 30 minutes after testing.
Volume expanders and vasopressor agents may be required to reverse hypotension. Inhalational bronchodilators and parenteral aminophylline may be required to reverse bronchospasm. Severe airway obstruction unresponsive to bronchodilator may require tracheal intubation and use of oxygen. In the event of a marked systemic reaction, application of a tourniquet above the injection site and the administration of 0.2 mL to 1.0 mL of epinephrine injection (1:1,000) is recommended. Maximum recommended dose for children between 2 and 12 years of age is 0.3 mL. The tourniquet should not be left in place without loosening for 90 seconds every 15 minutes.
Adverse events should be reported via MedWatch (1-800-FDA-1088), Adverse Event Reporting, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9787.
Overdosage
Signs and symptoms of overdose are typically large local and systemic reactions. For management of overdose reactions, refer to the ADVERSE REACTIONS section above.
Dosage And Administration
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Skin test techniques for immediate (Type I) hypersensitivity testing fall into two major categories: percutaneous, and intracutaneous.
Percutaneous techniques:
For percutaneous testing, in general, skin is scratched, punctured or pricked just before the allergen is applied or through a drop of test allergen. There are several devices available for this technique. Refer to the manufacturer or distributor’s circular for specific directions for their use.
In General:
- It is recommended that the test areas should be placed no closer than 4 - 5 cm apart to avoid interference of reactions when several tests are applied.
- Skin test areas should be cleansed with alcohol and air dried.
- Preferably, the allergen should be placed on the volar surface of the forearm, upper arm, or the patient’s back. The patient should be placed in a comfortable position prior to testing.
- For scratch testing, a sharp, clean, sterile instrument is used to abrade the skin, but not to draw blood. Each scratch should be about 2 - 4 mm in length. A small drop of extract is placed on the surface of the skin.
- Prick testing: For prick testing, a sharp, sterile instrument is used to puncture the skin slightly, applying it at a 15 - 20° angle to the skin. The instrument is gently raised, “tenting” the skin until it pops out, generally pricking through the drop of allergen. Do not draw blood.
- For puncture testing, a sharp, clean, sterile instrument must be used. Puncture the skin, through the drop of allergen, perpendicular to the skin. Do not draw blood.
- It is recommended that the test areas should be spaced no less than 5 cm apart to avoid interference with adjacent allergen or control.
- Skin should be cleansed with alcohol and air dried.
- A sterile 1 mL or 1/2 mL syringe with a 26 - 30 gauge needle should be used. A separate sterile syringe should be used for each extract and each patient.
- Care should be taken to eliminate air bubbles from the syringe prior to injecting the test dose. It is suggested that not more than 6 - 10 allergens of each different type be used at any one time. Very sensitive patients may show rapid response.
- The skin is held tensely, and the needle is inserted almost parallel to the skin, beveled side up far enough to cover the beveled portion. Slowly inject sufficient extract to make a small bleb of approximately 5 mm in diameter (0.01 - 0.02 mL).
- Read the test results in 15 minutes.
For all of the above techniques, a separate instrument must be used for each patient; if the instrument is to be used to pass through the allergen, to avoid cross-contamination, a separate instrument is to be used for each allergen. The test should be read in 15 minutes, measuring both wheal size and erythema.
Intracutaneous (intradermal) testing:
General: Intradermal testing is more sensitive than percutaneous testing and its specificity is dependent on dose. Intradermal testing is not intended as an initial screen unless used in highly dilute solutions. Intradermal testing is usually reserved for allergens that have demonstrated either negative or equivocal percutaneous skin test response in the face of positive or unclear history.
Intradermal testing of one allergen in several serial dilutions (beginning with the weakest to the more concentrated dilutions) may also be useful in assessing degree of patient sensitivity for the establishment of a safe starting dose for immunotherapy.
Bulk extracts must be diluted for intradermal testing. Use of Sterile Diluent for Allergenic Extracts or Sterile Diluent for Allergenic Extracts Normal Saline with HSA (albumin saline) is recommended. Dilutions should be made with sterile disposable syringes using aseptic technique. Commonly 10 fold dilutions are used to achieve a desired concentration for intradermal testing and continuation of immunotherapy. For example, transferring 0.5 mL of a 10,000 PNU/mL extract into 4.5 mL of diluent will yield 5 mL of extract at 1,000 PNU/mL. For weight volume products, a 1:100 w/v dilution may be prepared from a 1:10 w/v by transferring 0.5 mL of the 1:10 w/v to 4.5 mL of dilutent. Prepare as many additional serial dilutions as necessary to reach the appropriate concentration. As a general rule intradermal strength should begin at no higher than 1/100 to 1/1000 of the percutaneous strength that resulted in a negative skin test reaction.
Selection of the proper strength for intracutaneous testing: A general rule for the prevention of untoward reactions, particularly in extremely sensitive patients, is to screen by percutaneous methods initially, and begin intradermal testing at a strength not more than 1/100 of a negative or equivocal percutaneous reaction.
Controls:
In both percutaneous and intracutaneous tests, a negative control test with diluent alone should be performed because some patients exhibit dermographia, and/or other non-specific irritant responses.
As a positive control in the evaluation of allergenic skin testing, histamine 1 mg/mL (histamine base) should be used for percutaneous testing, and histamine 0.1 mg/mL (histamine base) should be used for intradermal testing.
Interpretation of results:
Patient’s response is graded on the basis of the size of erythema or wheal.6 General guidelines follow for percutaneous testing, different devices and/or techniques influence the size of the reaction, therefore it is important to refer to the device manufacturer’s or distributor’s instructions when grading reactions.
Percutaneous (prick or scratch) test:
0 No reaction or less than control.
+ Erythema greater than control, smaller than a nickel (21 mm diameter).
++ Erythema greater than a nickel in diameter, no wheal.
+++ Wheal and erythema without pseudopods.
++++ Wheal and erythema with pseudopods.
Intradermal test:
0 No reaction or less than negative control.
+ 3-4 mm wheal with erythema, or erythema alone larger than a nickel (21 mm diameter).
++ 4-8 mm wheal and erythema, without pseudopods.
+++ Over 8 mm wheal and erythema without pseudopods.
++++ Wheal and erythema with pseudopods.
How Supplied
For scratch and prick testing: 5 mL dropper applicator vials in 50% v/v glycerin or 10mL stoppered vial in 50% v/v glycerin. Available individually and in a complete set of the most common allergens. Available in either Protein Nitrogen Units (PNU/mL) or weight to volume (w/v).
For intracutaneous testing: 5 mL sterile vials, aqueous based, individually and in a complete set of the most common allergens. Available in either Protein Nitrogen Units (PNU/mL) or weight to volume (w/v).
Histatrol® Positive skin test control - histamine. 1 mg/mL and 0.1 mg/mL histamine base.
See Product Catalog for specific diagnostic concentrations available.
Storage
To maintain stability of allergenic extracts, proper storage conditions are essential. Bulk concentrates and diluted extracts are to be stored at 2° to 8°C even during use. Bulk or diluted extracts are not to be frozen. Do not use after the expiration date shown on the vial label.
References
- Holgate, S.T., Robinson, C. and Church, M.K. Mediators of immediate hypersensitivity. In Middleton et al: Allergy Principles and Practice, St. Louis, 1988, C.V. Mosby, p 135.
- Lockey, R.F., et al. Fatalities from immunotherapy (IT) and skin testing (ST). J. Allergy Clin. Immunol. 1987: 79: 660.
- Reid, M.J. et al. Survey of fatalities from skin testing and immunotherapy. 1985-1989. J. Allergy Clin Immunol. 1993; 92:6.
- DeBuske L. M. et al. Special problems regarding Allergen Immunotherapy in Immunology and Allergy Clinics of North America, Greenburger, P.A. Ed. February 1992; 145-149.
- Bousquet, J. In vivo methods for the study of allergy: skin test, techniques and interpretation. In: Middleton et al.: Allergy Principles and Practice 3rd Ed. St. Louis: CV Mosby, 1988:167.
- Freedman, S.O. Asthma and Allergic Rhinitis II. Clinical Aspects, in Freedman and Gold Clinical Immunology 2nd Ed. New York: Harper & Row, 1976: 131.
Revised April 2017 No. 112R
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