Country: United States
Language: English
Source: NLM (National Library of Medicine)
COMMON CARP (UNII: ZB2SV6JJY5) (COMMON CARP - UNII:ZB2SV6JJY5)
Nelco Laboratories, Inc.
COMMON CARP
COMMON CARP 0.1 g in 1 mL
INTRADERMAL
PRESCRIPTION DRUG
Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again. Allergenic extracts should not be used if the patient has asthma, cardiovascular disease, emphysema, diabetes, bleeding diathesis or pregnancy, unless a specific diagnosis of t
Allergenic extracts are supplied with units listed as: Weight/volume (W/V), Protein Nitrogen Units (PNU/ml), Allergy Units (AU/ml) or Bioequivalent Allergy Units (BAU/ml). Sizes: Diagnostic Scratch: 5 ml dropper application vials Diagnostic Intradermal: 5 ml or 10 ml vials. Therapeutic Allergens: 5 ml, 10 ml, 50 ml multiple dose vials.
Biologic Licensing Application
CARP - CARP INJECTION, SOLUTION CLAM - CLAM INJECTION, SOLUTION CODFISH - CODFISH INJECTION, SOLUTION CRAB - CRAB INJECTION, SOLUTION FLOUNDER - FLOUNDER INJECTION, SOLUTION HADDOCK - HADDOCK INJECTION, SOLUTION HALIBUT - HALIBUT INJECTION, SOLUTION HERRING - HERRING INJECTION, SOLUTION LOBSTER - LOBSTER INJECTION, SOLUTION MACKEREL - MACKEREL INJECTION, SOLUTION OYSTER - OYSTER INJECTION, SOLUTION RED SNAPPER - RED SNAPPER INJECTION, SOLUTION SALMON - SALMON INJECTION, SOLUTION SARDINE - SARDINE INJECTION, SOLUTION SCALLOP - SCALLOP INJECTION, SOLUTION SHRIMP - SHRIMP INJECTION, SOLUTION SWORD FISH - SWORD FISH INJECTION, SOLUTION TROUT - TROUT INJECTION, SOLUTION TUNA FISH - TUNA FISH INJECTION, SOLUTION WHITE FISH - WHITE FISH INJECTION, SOLUTION PIKE - PIKE INJECTION, SOLUTION SMELT - SMELT INJECTION, SOLUTION NELCO LABORATORIES, INC. ---------- ALLERGENIC EXTRACT WARNING Diagnostic and therapeutic allergenic extracts are intended to be administered by a physician who is an allergy specialist and experienced in allergenic diagnostic testing and immunotherapy and the emergency care of anaphylaxis. This product should not be injected intravenously. Deep subcutaneous routes have been safe. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death. (SEE ADVERSE REACTIONS) Serious adverse reactions should be reported to Nelco Laboratories immediately and a report filed to: MEDWATCH, THE FDA MEDICAL PRODUCT PROBLEM REPORTING PROGRAM, AT 5600 FISHERS LANE, ROCKVILLE, MD. 20852-9787, CALL 1-800-FDA-1088. Extreme caution should be taken when using allergenic extracts for patients who are taking beta- blocker medications. In the event of a serious adverse reaction associated with the use of allergenic extracts, patients receiving beta-blockers may not be responsive to epinephrine or inhaled brochodialators. (SEE PRECAUTIONS) Allergenic extracts should be used with caution for patients with unstable or steroid-dependent asthma or underlying cardiovascu Read the complete document