Kit dap amoxicilina-inglés suel

DAP® - AMOXICILLIN
DESCRIPTION
Main allergenic determinants implicated in type I or immediate hypersensitivity to Amoxicillin and related antibiotics (amino penicillins), dosed and stabilized by means of freeze-drying. To be exclusively used for the diagnosis of type I or immediate hypersensitivity to amino penicillins and related antibiotics (amino penicillins) by means of skin test (skin prick QUALITATIVE AND QUANTITATIVE COMPOSITION
Quali-quantitatively DAP® - AMOXICILLIN composition is the following:
PHARMACEUTICAL PRESENTATION AND PACKING CONTENT
Vials with freeze-dried powder and solvent for injectable solution.
DAP® - AMOXICILLIN contents:
• 3 or 6 vials with freeze-dried powder of Sodium Amoxicillin.
• 6 or 12 vials with solvent, each one of them containing 1 mL of saline ACTIVITY
For diagnostic use in type I hypersensitivity to amoxicillin and related HOLDER AND MANUFACTURER
Diater Laboratorio de Diagnóstico y Aplicaciones Terapéuticas S. A. Avda. Gregorio Peces Barba nº 2; Parque Tecnológico de Leganés THERAPEUTIC INDICATIONS
Diagnostic assessment by skin testing (skin prick test and intradermal
reaction), of allergic, sensitization, or type I hypersensitivity conditions in which allergy to amino penicillins antibiotics is suspected.
CONTRAINDICATIONS
Any pathologic dermal condition of the area chosen to perform skin
testing, as well as any other pathologic condition affecting the general well-being of the patient constitute a contraindication for carrying out skin testing. An ongoing acute allergic reaction due to any kind of allergenic substance is a contraindication for carrying out skin testing.
Antihistamines, corticosteroids, cromones, and in general any other medication having a secondary anti-allergic activity have to be discontinued for at least 1 week before skin testing.
Therapeutic use of beta-blockers and ACE inhibitors is also a contraindication for carrying out skin testing, so for in agreement with the prescribing physician and adequate blood pressure control, these medications have to be discontinued 48 hours before skin testing.
Pregnancy, breastfeeding and in general a patient’s age younger than 6 years represent a contraindication for carrying out skin testing, although they are left to the specialist’s criterion who will determine the convenience and the timing for diagnostic skin evaluation according to the risk-benefit ratio of any given situation. Contraindications derived from adrenalin administration have to be considered before the potential occurrence of a secondary allergic reaction.
PRECAUTIONS
Skin testing with Amoxicillin should be started by assessing the skin
reactivity by the skin prick test technique. The use of intradermal testing should only be started when skin prick tests have yielded negative results.
Skin testing should always be started with skin prick test with Amoxicillin.
Before performing intradermal testing, preventively, it is recommended to start with the application of a dilution panel, 1:100 and 1:10. In high-risk patients or patients with symptoms suggestive of a severe reaction, dilutions for skin testing should be started with the 1:1000 The following algorithm for assessing the sensitivity to amoxicillin andrelated antibiotics (amino penicillins) is recommended when using skintesting: Amoxicillin skin prick test ===> positive
(Undiluted)
Negative
Amoxicillin intradermal testing===> positive
(Recommended dilution 1:100)
Negative
Amoxicillin intradermal testing ===> positive
(Recommended dilution 1:10)
Negative
Amoxicillin intradermal testing ===> positive
(Undiluted)
Negative
Dilutions must be carried out observing the required appropriate asepticconditions and using the solvents that may be ordered for this purpose. INTERACTIONS
Antihistamines, corticosteroids, cromones, and in general any other medication having a secondary anti-allergic activity present an interacting capacity that may alter the results obtained from skin testing. In the particular case of oral antihistamines, it is required to discontinue their use The use of beta-blockers or ACE inhibitors should be discontinued 48 hours before skin testing, always in agreement with the prescribing physician WARNINGS
Performance of skin testing during pregnancy is not recommended given the additional risk that the potential induction of an anaphylactic reaction After carrying out the skin tests, the patient must remain under close supervision for at least 30 minutes. Besides, the patient should be advised to avoid alcohol consumption, hard physical exercising, and receiving hot baths or showers within several hours before and after skin testing. Given the case that a patient may be under allergen immunotherapy treatment, it is recommended that skin testing be performed with at least a 1-week interval since the administration of the last allergen vaccine shot.
Similarly, the time interval between skin testing and the administration of an allergen vaccine shot should be of 2-3 days.
INSTRUCTIONS FOR USE
Preparation of diagnostic solutions for skin testing
Select and check the sell-by dates and the state of the vials that will be reconstituted. Under sterility conditions and with sterile syringe and needle, 1 mL of solvent will be drawn and transferred to the vial with Amoxicillin freeze-dried powder that will be reconstituted, being thus Skin testing by the skin prick test technique
The skin prick test is one of the most common tests used to assess most of the allergic conditions with the lowest risk for anaphylaxis. This skin test, virtually free from an irritant effect, is carried out by applying one drop of the allergenic determinant on the volar aspect of the patient’s forearm skin and the epidermis is punctured perpendicularly with a special 1-mm long pointed lancet allowing in this way the solution to penetrate the skin, the excess of fluid being cleared immediately after. In no case, the result of the skin test should be read if blood springs. The occurrence of a small erythematous area around the puncture site is Skin testing by the intradermal technique
Intradermal testing consists in the administration of a dose of about 0.02-0.05 mL of the allergenic determinant into the dermis. For this purpose, a tuberculin syringe with a 4/10 gauge needle is used applying it onto the volar aspect of the patient’s forearm at a 10-15 degrees angle, thus creating a small blister which diameter must be delineated at the Care should be applied not to damage a blood vessel when performing the test; should this occur, the result would not be assessed. Patient’s conditions during skin testing
Although no special skin care is necessary before skin testing, the presence of dermographism should be assessed and the puncture site must be cleaned, preferably with water without hard rubbing.
Before skin testing, the patient should adjust to ambient conditions for 10 minutes.
Reading and interpreting the skin test results
Definitive skin test results must be read within 15-20 minutes from their
puncture, being regularly observed. The interpretation of skin prick test results is based on the wheal size induced, being considered as positive those tests with a wheal diameter of 3 mm or higher, or the appearance of pseudopodia around the wheal; the following assessment key may be applied:Major wheal diameter For intradermal testing, the test is considered positive when the difference between the initial diameter and the induced diameter is Supervision and control of the patient are paramount during thedevelopment of the skin responses and until their reading in order to beable to immediately intervene provided that any kind of adverse reaction,either local or systemic, may occur.
OVERDOSE
In case of accidental overdosing, or incorrect skin test performance,usually damage of a blood vessel with subsequent endovenousadministration, an adverse reaction of varying severity, includinganaphylaxis, may develop, which treatment is detailed under “adversereactions”. ADVERSE REACTIONS
Adverse reactions may be immediate or delayed in nature, depending onthe time of symptoms occurrence, seconds or minutes and hours,respectively, after skin testing, and they may classified as: Local reactions
From a symptomatic viewpoint, they consist in the development andpersistence of erythema, oedema, or inflammation, with or without itching,at the site of skin testing; they usually occur within 10-60 minutes andpersist for several hours. They usually do not require pharmacological treatment, although the useof oral antihistamines and/or topical corticosteroid-based creams may berecommended when the induration persists and is greater than 5 cm indiameter. The use of a tourniquet above the skin test site and adjacentadrenaline injection (1:1000 at a 0.01-mL/Kg of body weight dose S.C.)are recommended in the case of severe local reactions.
Moderate systemic reactions
From a symptomatic viewpoint, they consist in the development of bigsized wheals, erythema, and itching, which may progress to generalizedurticarial or exanthematous reaction together with ocular-nasal symptomsand Quincke’s oedema. The symptoms usually occur within few minutes to4-6 hours after skin testing.
A tourniquet must be applied above the puncture site and basic pharmacological therapy must be immediately implemented. In the case of occurrence of urticaria or Quincke’s oedema, the management consists in the administration of I.V. antihistamines and additionally I.V. corticosteroids (100 mg of prednisolone or equivalent doses of other glucocorticoids). In case of necessary, adrenaline (1:1000; at a 0.01-mL/Kg of body weight dose, S.C.) may be administered adjacent to the skin test puncture site, which may be repeated every 15 minutes; as well as the use of bronchodilating aerosols and slow theophylline I.V. infusion.
The patient’s arterial blood pressure and pulse must be constantly Severe systemic reactions: anaphylaxis
The main presentations of severe systemic reactions, which may develop within few minutes after skin testing, are bronchospasm, breathlessness, laryngeal oedema, and generalized urticaria.
Treatment involves placing a tourniquet above the site of skin test puncture and immediate adrenaline administration (1:1000; at a 0.01- mL/kg of body weight dose, subcutaneously or intramuscularly) adjacent to the puncture site, which may be repeated every 15 minutes in case of necessary. Also required is the administration of oral or I.M. antihistamines as well as high-dose corticosteroids (250-1000 mg of I.V. prednisolone) if marked malaise or oedema develop. If respiratory compromise, such as severe or refractory bronchospasm, onsets or coexists, beta-agonists bronchodilators and I.V. aminophylline (250-500 mg in adults and 5-7 mg/Kg of body weight in children, q.d.) must be administered. The patient’s arterial blood pressure and pulse must be constantly Anaphylaxis may develop immediately and sequentially few minutes after
having performed skin testing. It usually presents with prodromal symptoms such as itching on the palms of the hands and feet, as well as above and under the tongue, also affecting the throat and leading to intense and rapid collapse that involves several organ systems: Vascular collapse with marked hypotension; nasal congestion, laryngeal oedema and bronchospasm; generalized itching, urticaria and angioedema; abdominal cramps, nausea, vomiting and loose stools; metrorrhagia; tinnitus, dizziness; loss of sphincter control; seizures, and loss of The management comprises applying a tourniquet above the site of skintest puncture, positioning the patient in lateral recumbent position, andadministering adrenaline (1:1000; at a 0.01-mL/kg of body weight dose,subcutaneously or intramuscularly) that may repeated every 10-15minutes up to three times. If cardiac monitoring of the patient is available,adrenaline 1:1000 may be administered I.V. in a 1:10 dilution, which canbe repeated every 10-15 minutes up to three times, depending on thepatient’s clinical course. Oxygen and endovenous fluids with electrolyticsolutions may be considered depending on the patient’s clinical course, aswell as I.V. antihistamines and high-dose corticosteroids (250-1000 mg ofprednisolone). If asthma develops, beta-agonists bronchodilators and I.V.
aminophylline (250-500 mg in adults and 5-7 mg/Kg of body weight inchildren, q.d.) must be administered. Under certain circumstances and forreanimating purposes in case of circulatory failure, intubation ortracheotomy must be foreseen and be ready for immediate use.
The patient’s arterial blood pressure and pulse must be constantlymonitored.
SPECIAL PRECAUTIONS FOR STORAGE
The vials with Sodium Amoxicillin freeze-dried powder should not bestored at temperature above 25º C.
Once reconstituted or diluted, they must be stored in refrigerator between2ºC and 8ºC. Medications should be kept away from children’s reach and sight.
SHELF LIFE
Do not use the vials with freeze-dried powder or solvent after the expirydate specified on the label.
After the vials have been reconstituted or diluted, they must be usedwithin a maximum 24 hours period.
Text revised in: May 2011.

Source: https://www.ascomed.cz/files/1369304932.pdf