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Treatment Set TS334972

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Overview

What is Treatment Set TS334972?

Allergenic extract in this vial is referred to as an individual treatment vial since it is designed primarily for the physician equipped to complete skin testing and supervise allergenic extract immunotherapy. The extract is sterile and intended for subcutaneous injection. The concentration of allergenic extract supplied will be based on the individual physician's prescription order and will be expressed in most cases on a weight/volume basis (or AU/ml with standardized extract) diluted either 1:10 or 1:5. Where mixtures of pollens and non-pollens have been ordered, the ingredients are listed on the final container label. To insure maximum potency for the entire dating period, dilutions will be prepared with 50% v/v glycerine unless otherwise specified.

Ingredients

Dating Period



What does Treatment Set TS334972 look like?



What are the available doses of Treatment Set TS334972?

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What should I talk to my health care provider before I take Treatment Set TS334972?

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How should I use Treatment Set TS334972?

When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to the cause of a person's allergic condition can be gleaned from a thorough history and careful physical examination. Diagnostic tests - in vitro or in vivo - serve only to confirm the physician's suspicions or to improve investigative skills. Specific diagnosis is especially indicated when the patient's symptoms are not controlled by medication. When immunotherapy is contemplated demonstration of sensitivity to a specific allergenic extract is necessary. An orderly approach to the use of diagnostic tests usually begins with direct skin testing.

THIS PRODUCT IS NOT INTENDED FOR TREATMENT OF PATIENTS WHO DO NOT MANIFEST IMMEDIATE HYPERSENSITIVITY REACTIONS TO THE ALLERGENIC EXTRACT FOLLOWING SKIN TESTING.

As a consequence of the discovery of IgE and the development of methods to identify and quantify anti-allergen IgE levels, interest in recent years has centered around the utilization of in vivo and in vitro diagnostic procedures.

Patients who react to a small quantity of antigen by skin testing can be classified as highly sensitive. Those who react only to large quantities of antigen can be classified as less sensitive. It would appear that there is at least a 50,000-fold range between the most and least sensitive individuals. On the other hand, certain patients who do not appear to have elevated quantities of specific anti-allergen IgE do have positive skin tests and have symptoms of allergic rhinitis. These patients are considerably less sensitive than patients with detectable levels of specific IgE antibody.

The current standard method of immunotherapy dates back to the earliest studies by Noon. As adapted for ragweed pollen extract, therapy is begun with a low dose, which has been shown to be tolerated by both experience and skin testing.

The physician who undertakes immunotherapy should be concerned with the degree of sensitivity of the patient. This can be measured by skin test, leukocyte histamine release, or anti-allergen IgE levels. Strongly positive skin tests or high initial ragweed IgE and total IgE may be risk factors for systemic reactions. Less aggressive immunotherapy schedules may be indicated for such patients. Maintenance dose potency must be established by the physician's clinical observation and experience.

Serial fivefold or tenfold dilutions of the extract are used to make more dilute extract concentrations. Other concentrations can be prepared by appropriate dilution. In brief, the allergist can prepare any dilution of extract that is considered appropriate for the patient.


What interacts with Treatment Set TS334972?

There are no absolute contraindications; however, extreme caution is necessary when using diagnostic skin tests or injection treatment in highly sensitive patients, who have experienced severe symptoms or anaphylaxis by natural exposure or previous skin testing or treatment.


This product is not intended for the treatment of patients who do not experience allergic symptoms upon natural exposure to the allergen. At the present time there has been no demonstrated adverse effects on the fetus when allergenic extract immunotherapy is administered during gestation to pregnant women.


100,000 AU/ml standardized allergenic extract should be used by physicians with experience in maximal dose immunotherapy and treatment of anaphylaxis.



What are the warnings of Treatment Set TS334972?

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Epinephrine 1:1000 should be available.

When changing immunotherapy from an unstandardized to an AU/ml standardized allergenic extract, dose adjustment, if indicated, should be based on the comparative potency of the extracts. Patient re-evaluation may be necessary.

Injections should never be given intravenously. A 5/8 inch 25 gauge needle on a sterile syringe will allow deep subcutaneous injection. Precaution of withdrawing the plunger slightly after inserting the needle is advisable to determine if a blood vessel has been entered. Proper measurement of the dose and caution in making the injection will minimize reactions. Patients should be detained for twenty to thirty minutes after injection or advised to return to the office immediately if symptoms or reactions occur.

Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death.


What are the precautions of Treatment Set TS334972?

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What are the side effects of Treatment Set TS334972?

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.


What should I look out for while using Treatment Set TS334972?

There are no absolute contraindications; however, extreme caution is necessary when using diagnostic skin tests or injection treatment in highly sensitive patients, who have experienced severe symptoms or anaphylaxis by natural exposure or previous skin testing or treatment.

This product is not intended for the treatment of patients who do not experience allergic symptoms upon natural exposure to the allergen. At the present time there has been no demonstrated adverse effects on the fetus when allergenic extract immunotherapy is administered during gestation to pregnant women.

100,000 AU/ml standardized allergenic extract should be used by physicians with experience in maximal dose immunotherapy and treatment of anaphylaxis.

Epinephrine 1:1000 should be available.

When changing immunotherapy from an unstandardized to an AU/ml standardized allergenic extract, dose adjustment, if indicated, should be based on the comparative potency of the extracts. Patient re-evaluation may be necessary.

Injections should never be given intravenously. A 5/8 inch 25 gauge needle on a sterile syringe will allow deep subcutaneous injection. Precaution of withdrawing the plunger slightly after inserting the needle is advisable to determine if a blood vessel has been entered. Proper measurement of the dose and caution in making the injection will minimize reactions. Patients should be detained for twenty to thirty minutes after injection or advised to return to the office immediately if symptoms or reactions occur.

Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death.


What might happen if I take too much Treatment Set TS334972?

If a systemic or anaphylactic reaction does occur, apply a tourniquet above the site of injection and inject intramuscularly or subcutaneously 0.3 to 0.5 ml of 1:1000 epinephrine-hydrochloride into the opposite arm. The dose may be repeated in 5-10 minutes if necessary. Loosen the tourniquet at least every 10 minutes.

The epinephrine HCL 1: 1000 dose for infants to 2 years is 0.05 to 0.1 ml; for children 2 to 6 years it is 0.15 ml; for children 6 to 12 years it is 0.2 ml.

Patients unresponsive to epinephrine may be treated with theophylline. Studies on asthmatic subjects reveal that plasma concentrations of theophylline of 5 to 20 ug/ml are associated with therapeutic effects. Toxicity is particularly apparent at concentrations greater than 20 ug/ml. A loading dose of aminophylline of 5.6 mg/kg intravenously followed by 0.9 mg/kg per hour results in plasma concentrations of approximately 10 ug/ml. (Mitenko and Ogilive 1973b; Nicholoson and Chick 1973).

Other beta-adrenergic drugs such as isoproterenol, isoetharine, or albuterol may be used by inhalation. The usual dose to relieve broncho-constriction in asthma is 0.5 ml or the 0.5% solution for isoproterenol HCL; albuterol is longer acting than isoproterenol by any route of administration. The albuterol inhaler delivers approximately 90 mcg of albuterol from the mouthpiece. The usual dosage for adults and children would be two inhalations repeated every 4 to 6 hours. Isoetharine supplied in the Bronkometer unit delivers approximately 340 mcg isoetharine. The average adult dose is one to two inhalations.

Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators.


How should I store and handle Treatment Set TS334972?

Store bottles of 1000 SINGULAIR 5-mg chewable tablets and 8000 SINGULAIR 10-mg film-coated tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well-closed, light resistant container. Individual treatment sets as prescribed by the physician. The allergenic extract contains a variable number of individual doses depending on the patient's sensitivity and maximum tolerated maintenance treatment dose.