Ana-Kit® Anaphylaxis Emergency Treatment Kit is indicated for use by adult and pediatric patients under the following situations:

1. Allergic reactions including anaphylactic shock due to stinging insects (primarily of the Hymenoptera order, which includes bees, wasps, hornets, yellow jackets, bumble bees, and fire ants).

2. Severe allergic or anaphylactoid reactions due to allergy injections, exposures to pollens, dusts, molds, foods, drugs, and exercise or unknown substances (so-called idiopathic anaphylaxis).

3. Severe, life-threatening asthma attacks characterized by wheezing, dyspnea and inability to breathe. In the sensitive patient, severe allergic reactions and anaphylactic shock may occur within minutes of the insect sting or exposure to an allergenic substance. Symptoms may include bronchoconstriction, wheezing, sneezing, hoarseness, urticaria, angioedema, erythema, pruritis, tachycardia, thready pulse, falling blood pressure, sense of oppression or impending doom, disorientation, cramping abdominal pain, incontinence, faintness, loss of consciousness.

The Ana-Kit® is compactly designed to be carried and used by patients when severe symptoms arise, and the patient is out of reach of immediate attention by a doctor or hospital.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use Epinephrine Injection, USP, if it has a pinkish or darker than slightly yellow color or contains a precipitate.

The physician who prescribes the Ana-Kit® should review the package insert in detail with the patient. This review should include the proper use of the 2-dose epinephrine syringe to insure that subcutaneous or intramuscular injections are given into the deltoid region of the arm or the anteriolateral aspect of the thigh. See also the PATIENT DIRECTIONS FOR USE.

EPINEPHRINE

For subcutaneous or intramuscular injection only. Adults and children over 12 years: 0.3 mL; 6-12 years: 0.2 mL; 2-6 years: 0.15 mL; Infants to 2 years: 0.05 to 0.1 mL. When syringe is properly set up, as directed in the Patient Instruction Sheet, a 0.3 mL dose is administered when plunger is pushed until it stops. Syringe barrel has 0.1 mL graduations so that smaller doses can be measured. (Operation of syringe is explained in the Patient Directions For Use section at the end of this package insert.)

If after 10 minutes from the first injection symptoms are not noticeably improved, administer a second dose of epinephrine from the syringe.

CHLO-AMINE®

Tablets are chewable antihistamines.

Adults and children over 12 years: 4 tablets;
Children 6-12 years: 2 tablets;
Children under 6 years: 1 tablet.

ANA-KIT® ANAPHYLAXIS EMERGENCY TREATMENT KIT CONTAINS:

SYRINGE: One sterile syringe containing 1 mL Epinephrine Injection, USP, (1 :1000). Syringe delivers two 0.3 mL doses.

TABLETS: Four 2 mg chewable Chlo-Amine® tablets, Chlorpheniramine Maleate Tablets.

DEVICES: Two sterile pads containing 70% isopropyl alcohol (by volume) and 1 tourniquet.

PROTECT FROM LIGHT. STORE AT ROOM TEMPERATURE, APPROX.25°C(77°F).PROTECT FROM FREEZING.

CAUTION: U.S. federal wlaw prohibits dispensing without prescription.

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