Cat Hair, Standardized

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Overview

What is Cat Hair, Standardized?

Standardized cat hair extract is manufactured from source material obtained from the wash of cat hair clippings, which is then concentrated and absorbed onto powdered cat hair. Cat albumin and other serum-related non-Fel d 1 allergens, found in cat pelt extracts, have not been included in this extract. Cat albumin is not an important allergen for 80% of cat-sensitive patients. They are supplied as sterile solutions for scratch, intradermal or subcutaneous administration. The inactive ingredients are as shown in Table 1.

Standardized cat hair extracts containing 10 to19.9 Fel d 1 units per ml are assigned 10,000 Bioequivalent Allergy Units per ml (BAU/mI) based on quantitative skin testing. Standardized cat hair extracts containing 5 to 9.9 Fel d 1 units per ml are assigned 5,000 BAU/ml.

Isoelectric focusing (IEF) patterns of these standardized cat extracts have been shown to be predictive of the presence of non-Fel d 1 allergens. IEF has been adopted by the FDA as a release criterion. Therefore, all lots of Standardized Cat Hair extract are required to be compared by IEF to Center for Biologics Evaluation and Research (CBER) Cat Hair Extract Reference.

Allergenic extracts must be diluted before use in intradermal diagnosis or in the initial stages of treatment

What does Cat Hair, Standardized look like?

What are the available doses of Cat Hair, Standardized?

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What should I talk to my health care provider before I take Cat Hair, Standardized?

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How should I use Cat Hair, Standardized?

Standardized Cat Hair allergenic extracts are indicated for the diagnostic skin testing and immunotherapy of patients whose histories indicate that they experience allergic symptoms upon natural exposure to the specific allergens.

Allergenic extract concentrates must be diluted before use in intradermal skin testing or the initial stages of immunotherapy. As with any parenteral product, always use careful aseptic technique in preparing dilutions, assuring that the vials, diluents, and syringes are sterile, and that the dilutions are prepared under aseptic conditions, Sterile diluents that can be used include Normal Saline, Buffered Saline, 50% glycerin or Albumin Saline (HSA).

To obtain the concentrations required for intradermal testing or for the initial stages of immunotherapy, prepare serial 5 or 10 fold dilutions of the concentrate, to achieve the concentrations specified in Table 2 or 3, below. The relatively small 0.5 ml volume conserves the original concentrate, and is convenient because sterile diluent is readily available in prefilled 2.0 and 4.5 ml volumes.

For each vial, record the date of dilution on the label.

What interacts with Cat Hair, Standardized?

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What are the warnings of Cat Hair, Standardized?

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What are the precautions of Cat Hair, Standardized?

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What are the side effects of Cat Hair, Standardized?

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What should I look out for while using Cat Hair, Standardized?

The product is contraindicated for use in subjects who are not clinically allergic to the specified allergen, or who are not reactive to ALK-Abelló extract. No other absolute contraindications to immunotherapy with allergenic extracts are known.

However, the risk of serious systemic anaphylactic reactions to any potent allergenic extract suggests a number of preexisting conditions that should be considered relative contraindications. Among those conditions are acute infections, immune disease, severe cardiac disease pulmonary diseases such as asthma with a significant irreversible component, and treatment with β-adrenergic antagonist drugs (''beta-blockers''). See also , , and .

See additional warnings given in the box at the beginning of this insert.

Do not use this extract or allow its use until you have read this insert, and have taken adequate precautions to prevent inadvertent dosage errors. See for further information.

Some patients are highly sensitive to allergenic extracts, and in such patients even a small skin test dose could result in a serious systemic reaction. Adequate means to treat such reactions must be immediately available, including the following equipment: stethoscope and sphygmomanometer; tourniquets, syringes, hypodermic needles, and large-bore (14 gauge) needles; aqueous epinephrine HCI 1:1000;oxygen, intravenous fluids and the equipment for administering them; oral airway; diphenhydramine or similar antihistamine; aminophylline and corticosteroids for intravenous injection; and vasopressor.

Observing the following precautions will reduce the risk of serious systemic reactions:

DO NOT GIVE INTRAVENOUSLY. After inserting the needle subcutaneously, but before injecting the dose, retract the plunger of the syringe slightly. If blood appears in the syringe, discard the syringe and its contents and repeat the injection at another site. Subcutaneous injection is recommended because intracutaneous or intramuscular injections are more likely to produce local reactions.

Observe the patient at 20 to 30 minutes after injection, and be alert for the signs of impending reaction. Make sure the patient understands that serious delayed reactions can occur later on, how to recognize them, and what to do if they occur.

Patients who are receiving beta-blocking medication are high-risk patients for immunotherapy, because systemic reactions to the extract may be more severe in such patients, and because the beta-blocker may impair the ability to reverse the reaction in such patients. This risk should be carefully weighed before a decision to treat is reached. Care should also be taken with patients with unstable or steroid-dependent asthma or with underlying cardiovascular disease.

This and any allergenic extract should be temporarily withheld or its dosage reduced under any of these conditions:

Allergic patients differ widely in their sensitivity to this or any allergenic extract, and no single dosage regimen can be recommended for all patients. Progression to the next higher dose requires tolerance of the previous one, and the regimen must be modified if any of the conditions described above occur. Such modifications should include weaker dilutions and smaller dosage increments.

What might happen if I take too much Cat Hair, Standardized?

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How should I store and handle Cat Hair, Standardized?

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .These allergenic extract concentrates are supplied as sterile solutions in rubber stoppered glass vials. The concentrate is available in 5, 10, 30 and 50 ml size serum vials for Immunotherapy at 5,000 BAU/ml and 10,000 BAU/mI; intradermal dilution is available in vial sizes of 1, 5 and 10 ml at a concentration of 100 BAU/ml; and the Scratch test products are available in 3 ml and 5 ml dropper vials at a concentration of 10,000 BAU/ml.To ensure maximum potency for the entire dating period, extract concentrates contain 50% glycerin (v/v) unless otherwise instructed by the physician.Diluted extracts, special mixtures and prescription treatment sets are available at tile request of the physician.Storage: The extract concentrate and all dilutions should be kept refrigerated at 2-8ºC. Do not freeze, and do not use the extract concentrate after the expiration date printed on the vial label. Extracts that contain less than 50% v/v glycerin are less stable,These allergenic extract concentrates are supplied as sterile solutions in rubber stoppered glass vials. The concentrate is available in 5, 10, 30 and 50 ml size serum vials for Immunotherapy at 5,000 BAU/ml and 10,000 BAU/mI; intradermal dilution is available in vial sizes of 1, 5 and 10 ml at a concentration of 100 BAU/ml; and the Scratch test products are available in 3 ml and 5 ml dropper vials at a concentration of 10,000 BAU/ml.To ensure maximum potency for the entire dating period, extract concentrates contain 50% glycerin (v/v) unless otherwise instructed by the physician.Diluted extracts, special mixtures and prescription treatment sets are available at tile request of the physician.Storage: The extract concentrate and all dilutions should be kept refrigerated at 2-8ºC. Do not freeze, and do not use the extract concentrate after the expiration date printed on the vial label. Extracts that contain less than 50% v/v glycerin are less stable,These allergenic extract concentrates are supplied as sterile solutions in rubber stoppered glass vials. The concentrate is available in 5, 10, 30 and 50 ml size serum vials for Immunotherapy at 5,000 BAU/ml and 10,000 BAU/mI; intradermal dilution is available in vial sizes of 1, 5 and 10 ml at a concentration of 100 BAU/ml; and the Scratch test products are available in 3 ml and 5 ml dropper vials at a concentration of 10,000 BAU/ml.To ensure maximum potency for the entire dating period, extract concentrates contain 50% glycerin (v/v) unless otherwise instructed by the physician.Diluted extracts, special mixtures and prescription treatment sets are available at tile request of the physician.Storage: The extract concentrate and all dilutions should be kept refrigerated at 2-8ºC. Do not freeze, and do not use the extract concentrate after the expiration date printed on the vial label. Extracts that contain less than 50% v/v glycerin are less stable,These allergenic extract concentrates are supplied as sterile solutions in rubber stoppered glass vials. The concentrate is available in 5, 10, 30 and 50 ml size serum vials for Immunotherapy at 5,000 BAU/ml and 10,000 BAU/mI; intradermal dilution is available in vial sizes of 1, 5 and 10 ml at a concentration of 100 BAU/ml; and the Scratch test products are available in 3 ml and 5 ml dropper vials at a concentration of 10,000 BAU/ml.To ensure maximum potency for the entire dating period, extract concentrates contain 50% glycerin (v/v) unless otherwise instructed by the physician.Diluted extracts, special mixtures and prescription treatment sets are available at tile request of the physician.Storage: The extract concentrate and all dilutions should be kept refrigerated at 2-8ºC. Do not freeze, and do not use the extract concentrate after the expiration date printed on the vial label. Extracts that contain less than 50% v/v glycerin are less stable,

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Non-Clinical Toxicology

The product is contraindicated for use in subjects who are not clinically allergic to the specified allergen, or who are not reactive to ALK-Abelló extract. No other absolute contraindications to immunotherapy with allergenic extracts are known.

However, the risk of serious systemic anaphylactic reactions to any potent allergenic extract suggests a number of preexisting conditions that should be considered relative contraindications. Among those conditions are acute infections, immune disease, severe cardiac disease pulmonary diseases such as asthma with a significant irreversible component, and treatment with β-adrenergic antagonist drugs (''beta-blockers''). See also , , and .

See additional warnings given in the box at the beginning of this insert.

Do not use this extract or allow its use until you have read this insert, and have taken adequate precautions to prevent inadvertent dosage errors. See for further information.

Some patients are highly sensitive to allergenic extracts, and in such patients even a small skin test dose could result in a serious systemic reaction. Adequate means to treat such reactions must be immediately available, including the following equipment: stethoscope and sphygmomanometer; tourniquets, syringes, hypodermic needles, and large-bore (14 gauge) needles; aqueous epinephrine HCI 1:1000;oxygen, intravenous fluids and the equipment for administering them; oral airway; diphenhydramine or similar antihistamine; aminophylline and corticosteroids for intravenous injection; and vasopressor.

Observing the following precautions will reduce the risk of serious systemic reactions:

DO NOT GIVE INTRAVENOUSLY. After inserting the needle subcutaneously, but before injecting the dose, retract the plunger of the syringe slightly. If blood appears in the syringe, discard the syringe and its contents and repeat the injection at another site. Subcutaneous injection is recommended because intracutaneous or intramuscular injections are more likely to produce local reactions.

Observe the patient at 20 to 30 minutes after injection, and be alert for the signs of impending reaction. Make sure the patient understands that serious delayed reactions can occur later on, how to recognize them, and what to do if they occur.

Patients who are receiving beta-blocking medication are high-risk patients for immunotherapy, because systemic reactions to the extract may be more severe in such patients, and because the beta-blocker may impair the ability to reverse the reaction in such patients. This risk should be carefully weighed before a decision to treat is reached. Care should also be taken with patients with unstable or steroid-dependent asthma or with underlying cardiovascular disease.

This and any allergenic extract should be temporarily withheld or its dosage reduced under any of these conditions:

Allergic patients differ widely in their sensitivity to this or any allergenic extract, and no single dosage regimen can be recommended for all patients. Progression to the next higher dose requires tolerance of the previous one, and the regimen must be modified if any of the conditions described above occur. Such modifications should include weaker dilutions and smaller dosage increments.

Drugs can interfere with the performance of skin tests.

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.

Beta 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 beta agonists, theophylline and cromolyn do not seem to affect skin test response.

Patient compliance is an important consideration in the decision to initiate immunotherapy with any potent allergenic extract. Therapy should not be initiated if in the judgment of the physician the patient cannot be depended upon to respond promptly and properly to an impending adverse reaction, or to report such reactions.

Care must be taken to control the preparation, labeling, storage, and use of dilutions.

The ramifications of inadvertent overdosage are severe (see and ), and so procedural safeguards such as training programs, color-coded labeling, storage controls, and auditing are recommended.

As with the administration of any parental drug, observe all aspects of aseptic technique. In both testing and treatment, use a separate sterilized needle and syringe for each individual patient, to prevent transmission of hepatitis and other infectious agents from one person to another.

Severe anaphvlactic reactions to this extract can occur in extremely allergic patients and at any dosage level. Do not use this extract unless you are prepared to deal with these

reactions, and

until you have read and understood the warnings, precautions, and dosage and administration sections of this insert.

The most serious systemic reaction that can occur is anaphylactic shock which while rare, is life threatening and must be treated immediately. Among other systemic reactions that have occurred are laryngeal edema, fainting, pallor bradycardia, hypotension, bronchospasm, angioedema, cough, sneezing, conjunctivitis, rhinitis, and urticaria.

Should a serious systemic reaction occur:

These measures will almost always reverse the reaction but in the rare instances when they do not, then the full armamentarium of emergency medicine may be required, among them: direct laryngoscopy direct current cardioversion, tracheotomy, and intracardiac injection of drugs.

The occurrence of a severe systemic reaction to an injection of this extract does not contraindicate further therapy, but the next dose given should be reduced by at least 90% and raised very slowly thereafter. If a pattern of systemic reactions- even very mild ones- appears, then the benefits of continued treatment must be carefully weighed against the substantial demonstrated risk.

Local reactions, even relatively severe but transient redness, swelling and discomfort, are the normal physiologic response to the allergens and to the volume of the fluid injected, and in their milder forms are not unexpected. Local reactions generally subside quickly and do not require treatment, but application of cold to the injection site or other symptomatic measures may be useful. However, severe local reactions should be considered a warning of potential systemic reaction if that dosage is continued. Always reduce the dose substantially if such a local reaction occurs.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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