Standardized Mite D. farinae

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Overview

What is Standardized Mite D. farinae?

Allergenic Extract Standardized Mite in the accompanying vial is a sterile solution and contains glycerin 50% v/v and phenol 0.4% (preservative). Inert ingredients include sodium chloride for isotonicity and sodium bicarbonates, as a buffer. The mites (D. farinae and/or D. pteronyssinus), used as source material for this extract, were cultured by Biopol Laboratories on a medium consisting of yeast and pork. The whole-body mites were separated from the culture medium and the harvested mites contained less than 1% culture medium material.

Several manufacturers submitted to FDA, intradermal skin test data on Biopol Laboratory’s mite medium extract using patients who were puncture test positive (sum of erythema equal to or greater than 40 mm) to either D. farinae or D. pteronyssinus extracts. By intradermal testing, there was 1 positive (sum of erythema equal to or greater than 20 mm) in 44 individuals at an estimated 1% level of medium contamination of mites, and 4 positives in 40 individuals at an estimated 10% contamination. Two of the individuals who were skin test positive also skin tested by the puncture method with an extract of yeast (Saccharomyces sp) and were positive.

In ten mite sensitive patients, ALK-Abelló, Inc. observed no puncture or intradermal reactions to media from the same source at a carryover concentration equivalent to 1% of the mite extract.

For ease in use, and for lot to lot consistency, potency value is expressed in allergy units per milliliter.

This ELISA standardized mite extract was compared to a mite reference preparation supplied by FDA which was labeled 10,000 AU/mL based on skin testing. The relative potency of this mite extract was determined by ELISA inhibition in comparison to the FDA Mite reference and is labeled in AU's (Allergy Units/mL). Dilutions made from this product can be administered intradermally for testing, or subcutaneously for immunotherapy.

In addition to the total allergen activity as described above, each Lot of Mite Extract @ 10,000 AU/mL is tested for two important specific allergens, Group I and Group II (Der f 1; Der p 1 and Der 2) by sandwich ELISA .

Specific Lot values of these allergens are available from ALK-Abelló, Inc. by calling the Scientific Affairs Department.

Phone # or fax #

The tables below provide summary data of released lots including coefficient of variation (% CV), range (min and max), and ratios on lots manufactured from 2002 through 2006.

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How should I use Standardized Mite D. farinae?

This product is indicated for the diagnosis and treatment of hypersensitivity in patients with symptoms compatible with dust mite allergy.

Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations where the offending allergen cannot be avoided. Mixtures of standardized mite (D. farinae and D. pteronyssinus) should be considered for treatment of patients who are sensitive to both species.

Prior to the initiation of therapy, clinical sensitivity should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can be easily avoided.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

When diluting bulk extracts, use of either Sterile Diluent for Allergenic Extracts or Sterile Diluent for Allergenic Extracts Normal Saline with HSA 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 or initiation and continuation of immunotherapy. For example, transferring 0.5 mL of a 10,000 AU/mL extract into 4.5 mL of diluent will yield 5 mL of extract @ 1,000 AU/mL. Prepare as many additional serial dilutions as necessary to reach the appropriate concentration.

Care should be exercised to avoid cross contamination of allergens if mixing with other allergenic extracts. The use of separate syringes for each allergen and diluent when compounding patient mixes is recommended.

Diagnosis

An excellent method of recording results is to cover the skin reaction with transparent tape, outline the erythema first then the wheal with an indelible pen, then remove the tape and transfer it to the patient's permanent record. For preferred results, it is recommended that the actual measurement of the extent of both responses be recorded. This can be accomplished by measuring the longest erythema diameter, then selecting the mid - point of that line and measuring at a 90 angle to that line to determine the orthogonal diameter. The sum of these two measurements is the sum of erythema (∑E); the sum of wheal diameters is determined in a similar manner.

Patient's response is graded on the basis of the size of erythema and/or wheal.

Percutaneous (prick/scratch/puncture) test:

Prick, scratch, or puncture skin tests should be performed initially using an extract specially made for this purpose. The usual dose is one drop.

In a skin test study of 10 patients who were determined to be allergic to mite (D. farinae), the mean puncture test (using a bifurcated needle) to a solution containing 10,000 AU/mL had a sum of erythema of 73 mm (range 43 - 138 mm) and a sum of wheal of 17 mm (range 7 - 31 mm).

In another skin test study of 11 patients who were determined to be allergic to mite (D. pteronyssinus), the mean puncture test (using a bifurcated needle) to a solution containing 10,000 AU/mL had a sum of erythema of 84 mm (range 56 - 112 mm) and a sum of wheal of 20 mm (range 7 - 33 mm).

What follows are general guidelines 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.

Intradermal test:

On the forearm or upper outer aspect of the arm, using a 26 - 27 gauge, short bevel needle, inject intradermally .05 mL of the intradermal test solution. Skin whealing responses should be observed 10 - 20 minutes after administering the test.

In a skin test study of the 10 mite puncture reactive patients (D. farinae) described above, the mean intradermal dose for ∑E = 50 mm was 0.01 AU/mL ( range = <0.0003 to 0.4 AU/mL).

In the skin test study of the 11 mite puncture reactive patients (D. pteronyssinus) described above, the mean intradermal dose for ∑E = 50 mm was 0.006 AU/mL ( range = <0.0007 to 0.05 AU/mL).

Intradermal testing should start with a dilute solution, usually in the range of 1 AU or less.

Glycerinated extracts diluted for intradermal testing may be diluted at least 25 fold to less than 2% glycerin (by volume) as glycerin above this level can cause false positive intradermal skin tests.

A negative skin test is one where the sum of erythema was 0 or equal to the sum of the wheal. As a negative control, the diluent should be tested and included in the interpretation of the skin reactions.

Immunotherapy

A general rule is to begin at 1/10 of the dose that produces sum of erythema of 50 mm (approximately a 2+ positive skin test reaction). For example, if a patient exhibits a 2+ intradermal reaction to

1 AU/mL, the first dose should be no higher than 0.05 mL of 0.1 AU/mL. Dosage may be increased by 0.05 mL each time until 0.5 mL is reached, at which time the next 10-fold more concentrated dilution can be used, beginning with 0.05 mL, if no untoward reaction is observed. (See beginning of section for instructions in preparing dilutions of concentrates.)

If a tolerated dose of allergenic extract has been established, the initial dose from the new extract should be reduced by 75% of the previously well tolerated dose (see also ).

Interval between doses in the early stages of immunotherapy is no more than once to twice a week, and may gradually be increased to once every two weeks. Generally, maintenance injections may be given as infrequently as once every two weeks to once a month. The progress of patients on immunotherapy should be closely monitored. If improvement is realized a usual course of treatment may be from 3 to 5 years. If progress is unsatisfactory for a year or more, discontinuation of immunotherapy should be considered.

Injections are given subcutaneously preferably in the arm. It is advantageous to give injections in alternate arms and routinely in the same area. In some patients, a local tolerance to the allergen may develop thus preventing a possible severe local reaction.

After inserting the needle, but before injecting the dose, pull plunger of the syringe slightly, if blood returns in the syringe, discard the syringe and contents and repeat injection at another site.

Bulk concentrated extracts must be diluted for initial therapy and intradermal skin testing. For recommended diluent, refer to the beginning of the section.

Use standard aseptic precautions when making dilutions. The first dose of the new extract should be reduced at least 50% - 75% of the amount of the dosage from the previous extract.

Stability studies for diluted and undiluted forms of this product are not complete. Indications are the undiluted product will retain its potency under recommended storage conditions at least until the expiration date on the vial label is reached. It is recommended that minimal amounts of the concentrate be diluted so that the diluted product is used up within a relatively short period of time, i.e., preferably not more than four weeks.

HOW SUPPLIED

For percutaneous testing, 5 mL vial, 10,000 AU/mL in glycerin 50% (V/V).

For immunotherapy, 10 mL, 30 mL and 50 mL vials of bulk concentrate, 10,000 AU/mL in glycerin 50% (V/V).

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What should I look out for while using Standardized Mite D. farinae?

There are no known absolute contraindications to immunotherapy. However, a patient should not be immunized with preparations of allergens to which the patient has not demonstrated symptoms and positive skin tests. In most cases, immunotherapy is not indicated for those allergens that can be eliminated or minimized by environmental control.

Also, there is some evidence, although inconclusive, that routine immunizations may exacerbate autoimmune diseases. Hyposensitization should be given cautiously to patients with this predisposition. Patients with severe cardiorespiratory symptoms are at additional risk during a systemic reaction. The physician must weigh the risk to benefit in these cases.

Patients on beta-blockers are not candidates for immunotherapy, as they can be non-responsive to beta-agonists that may be required to reverse a systemic reaction. Also, see section.

In the presence of active symptoms such as rhinitis, wheezing, dyspnea, etc., the indications of immunotherapy must be weighed carefully against the risk of temporarily aggravating the symptoms by the injection itself.

See at the beginning of this package insert. Standardized allergenic extracts are not directly interchangeable with allergenic extracts of the same labeled potency from different manufacturers. The patient must be re-evaluated with the newly selected extract.

A reduction in starting dose is recommended in the following circumstances:

Withhold allergenic extracts temporarily or reduce the dose in patients with any one of the following conditions:

- Severe rhinitis or asthma symptoms;

- Infection or flu accompanied by fever;

- Exposure to excessive amounts of clinically relevant allergen prior to therapy.

Allergenic extracts slowly become less potent with age. During the course of treatment, it may be necessary to continue therapy with a vial of extract bearing a later expiration date. The initial dose of the extract bearing the later expiration date should be lowered to a safe non-reaction-eliciting level. When switching one standardized extract with another, at least 75% reduction in dose is suggested.

Patients should always be observed for at least 20 to 30 minutes after any injection. In the event of a marked systemic reaction such as urticaria, angioedema, wheezing, dyspnea, respiratory obstructions, hypotension and coma, application of a tourniquet above the injection site and administration of 0.2 mL to 1.0 mL (0.01 mg/kg) of Epinephrine Injection (1:1000) is recommended. Maximal recommended dose for children between 2 and 12 years of age is 0.3 mL. The tourniquet 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 cases of respiratory obstruction, oxygen and intubation may be necessary. Life-threatening reactions unresponsive to the above may require cardiopulmonary resuscitation. .

Mite Extracts (D. farinae and/or D. pteronyssinus) contain small (<1%) amounts of residual media components (pork and yeast). The physician should proceed with caution when using mite extract in mite sensitive individuals that also demonstrate sensitivity to these media components and only if clearly warranted.

In the presence of active symptoms such as rhinitis, wheezing, dyspnea, etc., the indications of immunotherapy must be weighed carefully against the risk of temporarily aggravating the symptoms by the injection itself. If the protective action of allergenic extract injections is considered essential for the patient's welfare, appropriate symptomatic therapy with antihistaminic, adrenergic or other drugs might be needed either prior to or in conjunction with allergenic extract injections.

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Clinical Information

Chemical Structure

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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. The more mediator release, the larger the reaction (wheal and erythema).

Treatment consists of the subcutaneous injection of gradually increasing doses of the allergens to which the patient is allergic. It has been demonstrated that this method of treatment induces an increased tolerance to the allergens responsible for the symptoms on subsequent exposure. Although the exact relationships between allergen, skin sensitizing antibody (IgE) and the blocking antibody (IgG) have not been precisely established, clinically confirmed immunological studies have adduced evidence of the efficacy of hyposensitization therapy.

Numerous controlled studies have demonstrated the clinical efficacy of immunotherapy with cat, dust mites and some pollen extracts. Nevertheless, responses are not uniform but variable, and in a few studies, the majority of the patients reported no appreciable improvement.

Non-Clinical Toxicology

There are no known absolute contraindications to immunotherapy. However, a patient should not be immunized with preparations of allergens to which the patient has not demonstrated symptoms and positive skin tests. In most cases, immunotherapy is not indicated for those allergens that can be eliminated or minimized by environmental control.

Also, there is some evidence, although inconclusive, that routine immunizations may exacerbate autoimmune diseases. Hyposensitization should be given cautiously to patients with this predisposition. Patients with severe cardiorespiratory symptoms are at additional risk during a systemic reaction. The physician must weigh the risk to benefit in these cases.

Patients on beta-blockers are not candidates for immunotherapy, as they can be non-responsive to beta-agonists that may be required to reverse a systemic reaction. Also, see section.

In the presence of active symptoms such as rhinitis, wheezing, dyspnea, etc., the indications of immunotherapy must be weighed carefully against the risk of temporarily aggravating the symptoms by the injection itself.

See at the beginning of this package insert. Standardized allergenic extracts are not directly interchangeable with allergenic extracts of the same labeled potency from different manufacturers. The patient must be re-evaluated with the newly selected extract.

A reduction in starting dose is recommended in the following circumstances:

Withhold allergenic extracts temporarily or reduce the dose in patients with any one of the following conditions:

- Severe rhinitis or asthma symptoms;

- Infection or flu accompanied by fever;

- Exposure to excessive amounts of clinically relevant allergen prior to therapy.

Allergenic extracts slowly become less potent with age. During the course of treatment, it may be necessary to continue therapy with a vial of extract bearing a later expiration date. The initial dose of the extract bearing the later expiration date should be lowered to a safe non-reaction-eliciting level. When switching one standardized extract with another, at least 75% reduction in dose is suggested.

Patients should always be observed for at least 20 to 30 minutes after any injection. In the event of a marked systemic reaction such as urticaria, angioedema, wheezing, dyspnea, respiratory obstructions, hypotension and coma, application of a tourniquet above the injection site and administration of 0.2 mL to 1.0 mL (0.01 mg/kg) of Epinephrine Injection (1:1000) is recommended. Maximal recommended dose for children between 2 and 12 years of age is 0.3 mL. The tourniquet 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 cases of respiratory obstruction, oxygen and intubation may be necessary. Life-threatening reactions unresponsive to the above may require cardiopulmonary resuscitation. .

Mite Extracts (D. farinae and/or D. pteronyssinus) contain small (<1%) amounts of residual media components (pork and yeast). The physician should proceed with caution when using mite extract in mite sensitive individuals that also demonstrate sensitivity to these media components and only if clearly warranted.

In the presence of active symptoms such as rhinitis, wheezing, dyspnea, etc., the indications of immunotherapy must be weighed carefully against the risk of temporarily aggravating the symptoms by the injection itself. If the protective action of allergenic extract injections is considered essential for the patient's welfare, appropriate symptomatic therapy with antihistaminic, adrenergic or other drugs might be needed either prior to or in conjunction with allergenic extract injections.

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 to several days.

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 (See ).

Other Drugs: Short acting steroids, inhaled beta agonists, theophylline and cromolyn do not seem to affect skin test response.

Patients should be instructed to describe any active allergic symptoms such as rhinitis, wheezing, dyspnea, etc., prior to injection including any late reactions from previous administration. Patients should remain in doctor's office for 20-30 minutes following injections and be instructed to report any local or systemic symptoms before leaving. Also, see and Sections.

If the protective action of allergenic extract injections is considered essential for the patient's welfare, appropriate symptomatic therapy with antihistaminic, adrenergic or other drugs might be needed either prior to or in conjunction with the allergenic extract injections.

Local:

Delayed reactions start several hours after injection with local edema, erythema, itching or pain. They are usually at their peak at 24 hours and usually require no treatment. Antihistamine drugs may be administered orally.

The next therapeutic dose should be reduced to the dose which did not elicit a reaction, and subsequent doses increased more slowly, i.e., use of intermediate dilutions.

Systemic:

Systemic reactions are characterized by one or more of the following symptoms: Sneezing, mild to severe general urticaria, itching other than at the injection 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 20 to 30 minutes after any injection. 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 0.2 mL to 1.0 mL of Epinephrine Injection (1:1000) is recommended. Maximal recommended dose for children under 2 years of age is 0.3 mL. Maximal recommended dose for children between 2 and 12 years of age is 0.5 mL. The tourniquet should not be left in place without loosening for 90 seconds every 15 minutes.

The next therapeutic injection of extract should be reduced to the dose which did not elicit a reaction, and subsequent doses increased more slowly, i.e., use of intermediate dilutions.

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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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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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