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Allergenic Extracts Alum Precipitated (Center-Al - Dactylis Glomerata Pollen)

Trade Name : CENTER-AL - DACTYLIS GLOMERATA POLLEN

ALK-Abello, Inc.

INJECTION, SUSPENSION, NON-STANDARDIZED ALLERGENIC

Strength 20000 [PNU]/mL

DACTYLIS GLOMERATA POLLEN Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Allergenic Extracts Alum Precipitated (Center-Al - Dactylis Glomerata Pollen) which is also known as CENTER-AL - DACTYLIS GLOMERATA POLLEN and Manufactured by ALK-Abello, Inc.. It is available in strength of 20000 [PNU]/mL per ml. Read more

Allergenic Extracts Alum Precipitated (Center-Al - Dactylis Glomerata Pollen) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • DIRECTIONS FOR USE OF CENTER - ALu00ae THERAPEUTICALLERGENIC EXTRACTS ALUM PRECIPITATEDOFn n n S AND n DOSAGE BASED ONPROTEIN NITROGEN CONTENT
  • This allergenic extract is intended for use by physicians who are experienced in the administration of allergenic extracts for immunotherapy and the emergency care of anaphylaxis, or for use under the guidance of an allergy specialist. These 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. Patients being switched from other types of extracts such as aqueous extracts, glycerinated extracts, or alum precipitated extracts from other suppliers to this allergenic extract should be started as though they were coming under treatment for the first time. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physicianu2019s office if reaction symptoms occur. u00a0Patients should be observed for 20 to 30 minutes following treatment, and emergency measures, as well as personnel trained in their use, should be immediately available in the event of a life-threatening reaction.
  • Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death. Patients with unstable asthma or steroid dependent asthmatics and patients with underlying cardiovascular disease are at greater risk to a fatal outcome from a systemic allergic reaction. If treated, these high risk patients should be started at lower (more conservative) doses and be progressed more slowly to a maintenance dose. Usually this is a lower dose than for those patients without these predispositions. (See )
  • This product should not be injected intravenously. Deep subcutaneous routes have proven to be safe. See the warnings, precautions, adverse reactions and over-dosage sections below.
  • Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require theophylline, oxygen, intubation and the use of life support systems. Parenteral fluid and/or plasma expanders may be utilized for treatment of shock. Adrenocorticosteroids may be administered parenterally or intravenously. Refer to the warnings, precautions and adverse reaction sections below.
  • Abellu00f3
  • Port Washington, NY 11050
  • U.S. Government License No. 1256
  • Center-Alu00ae (Allergenic extracts, Alum Precipitated) is prepared from aqueous allergenic extracts by the formation of an aluminum hydroxide precipitated complex. It is supplied as a sterile suspension in multiple dose vials for subcutaneous injection. 0.4% Phenol is added as a preservative.
  • This product is compounded and diluted on a PNU basis. Extracts containing Short Ragweed Pollen also bear a labeled potency declaration in terms of Antigen E content.
  • Numerous studies have confirmed Antigen E (AgE) as the major antigen associated with Short Ragweed pollinosis. In a well-controlled study, purified Antigen E was significantly superior to placebo in amelioration of symptoms associated with Short Ragweed pollinosis.u00b9u00a0Therefore, it is essential that the physician be aware of AgE content of allergenic extracts administered for hyposensitization therapy.
  • Some studies have indicated that for most patients a cumulative Antigen E dosage of less than 0.1 unit is not immunizing (sufficient to stimulate specific IgG antibodies).u00b2u00a0This, however, does not suggest that a 0.1 unit is a maximum tolerated dose. Most moderately sensitive patients may tolerate a dosage ten to fifty times greater. For exquisitely sensitive patients who cannot tolerate an immunizing dose of this preparation, the physician should consider immunotherapy with alternatives to conventional aqueous allergenic extract.
  • Alum precipitated bacterial and viral vaccines and alum precipitated toxoids have been effectively and routinely used in immunization injections for many years. The explanation usually given for the effect of such preparations is that the physical chemical absorption of an antigen onto an alum complex results in a slower release of the antigen with a consequent prolongation of the antigenic stimulus.
  • The 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 demonstrated the safety of u00a0extracts and effectiveness in terms of symptom reduction and IgG response consistent with dose administered.u00b3u00a0
  • In a controlled study with u00a0Ragweed given pre-seasonally, patients were selected and matched by histamine release to Antigen E and assigned to treatment groups: Aqueous, , and Placebo. All patients were highly sensitive to Ragweed Antigen E, reacting to <0.001 mcg Antigen E/mL as determined by intradermal skin testing. These patients received a pre-seasonal course of immunotherapy and achieved a mean cumulative dose of 52 units of Antigen E (27,365 PNU) in 13 to 19 injections. Starting doses in these patients were 10 PNU or approximately 0.02 units of AgE. This dosage was found to be significantly superior to Placebo as measured by symptom scores during the ragweed pollen season.
  • Although maximum tolerated doses for u00a0expressed in AgE content have not specifically been studied, one investigator reported maximum tolerated doses with ragweed at 2,000-5,000 PNU (4-10 units of Antigen E) with previously untreated patients.u00a0u00a0At least three investigators using mixed (tall and short) ragweed extracts demonstrated a maximum tolerated peak dose of 2,000 to 10,000 PNU in 10-13 injections in moderately sensitive patients.u00a0u00a0Thisu00a0was achieved by roughly doubling the dose in each successive injection at low dosages (<1,000 PNU) and if well tolerated, increasing the dosage approximately 50% until maximum tolerated dose for each patient was achieved.
  • Reaction rates for these patients were significantly lower than patients treated with aqueous extracts with the same or more conservative dosage regimen.n
  • 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.
  • Prior to the initiation of therapy, clinical sensitivity should be established by careful evaluation of the patientu2019s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can be easily avoided.
  • A patient should not be immunized against a substance which the patient has not demonstrated symptoms and/or tissue-fixed IgE antibodies as demonstrated by skin testing. Immunotherapy should not be attempted in patients with active asthma, severe respiratory obstruction, or cardiovascular disease.
  • There is some evidence, although inconclusive, that routine immunizations may exacerbate autoimmuneu00a0diseases. Hyposensitization should be given cautiously to patients with this predisposition. The physician must weigh risk to benefit in these rare cases.
  • Patients with Alzheimeru2019s disease, Downu2019s syndrome and renal insufficiency are theoretically at risk from aluminum intake, including alum precipitated allergenic extracts.
  • Patients should always be observed for at least 20-30 minutes after any injection. In the event of a marked systemic reaction, application of a tourniquet above the injection site and administration of 0.2 mL to 1.0 mL of Epinephrine injection (1:1,000) are recommended. Maximal recommended dose for children under 2 years of age is 0.3 mL.u00a0u00a0Maximal recommended dose for children between 2 and 12 years of age is 0.5 mL. The tourniquet is then gradually released. Patients under treatment with beta-blockers may be refractory to the usual dose of epinephrine.
  • No data
  • Center-Al
  • Center-Al
  • Patients receiving beta-blockers may not be responsive to epinephrine or an inhaled bronchodilator.
  • 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:n- Arrayn- u00a0n- Arrayn- u00a0n- Arrayn- u00a0u00a0
  • Systemic reactions are characterized by one or more of the following symptoms: sneezing, mild to severe generalized urticaria, itching other than at the injection site, extensive or generalized edema, wheezing, asthma, dyspnea, cyanosis, tachycardia, lacrimation, marked perspiration, cough, hypotension, syncope and upper airway obstruction. Symptoms may progress to shock and death. Patients should always be observed for at least 20-30 minutes after any injection.
  • Volume expanders and vasopressor agents may be required to reverse hypotension. Inhalational bronchodilator and parenteralu00a0aminophyllineu00a0may be required to reverse bronchospasm. Severe airway obstruction, unresponsive to bronchodilator, may require tracheal intubation.
  • In the event of a marked systemic reaction, application of a tourniquet above the injection site and administration of 0.2 mL to 1.0 mL of Epinephrine Injection (1:1,000) are 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 is then gradually released.
  • 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.
  • Adverse Events should be reported via MedWatch (1-800-FDA-1088), Adverse Event Reporting, Food & Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9787.
  • The starting dose for immunotherapy is related directly to a patientu2019s sensitivity as determined by carefully executed percutaneous (prick/puncture) and intracutaneous (intradermal) skin testing with non-alum adsorbed allergenic extract. A general rule is to begin at 1/10 of the intradermal dose that produces sum of erythema of 50 mm (approximately a 2+ positive skin test reaction). Patientu2019s response to skin testing is graded on the basis of the size of the erythema and wheal. Refer to the diagnostic allergenic extract package enclosure for specific information.
  • nttu00a0u00a0u00a0u00a0u00a0ntTRANSFER OF PATIENTS FROM OTHER AQUEOUSu00a0EXTRACTS TO u00a0EXTRACTS
  • Patients may be transferred from other aqueous allergens to u00a0Alum Precipitated Extracts during treatment. To avoid untoward reactions, it may be necessary to initiate treatment as though the patient were previously untreated. In transferring from standardized extracts, the more rapid rate of decline in activity of aqueous extract relative to alum precipitated extract must be considered in cautiously transferring patients to alum precipitated extract.
  • Caution should be observed since the u00a0preparation may be more potent than the aqueous product.
  • nttu00a0u00a0u00a0u00a0u00a0ntTRANSFER OF PATIENTS FROM OTHER ALUM-COMPLEXEDu00a0EXTRACTS TO u00a0EXTRACTS
  • Patients may be transferred from other alum-complexed allergenic extracts to Alum Precipitated extracts. In order to avoid untoward reactions, it is recommended that previous therapy be disregarded and therapy with u00a0be initiated as though the patient were previously untreated. The first dose of u00a0should be related to the patientu2019s sensitivity, determined by history and confirmed by skin testing. CAUTION: u00a0Alum Precipitated extracts should not be mixed with other alum precipitated or aqueous extracts.
  • PRE-SEASONAL AND PERENNIAL METHOD OF TREATMENT
  • The use of u00a0Allergenic extract, Alum Precipitated, in the treatment of patients by the pre-seasonal method should be started 10 to 12 weeks prior to the usual onset of symptoms. Therapy should be initiated early enough to permit a graduated series of doses at weekly intervals. It is recommended that the larger doses be spaced 2 to 3 weeks apart and that the top dose be reached prior to the season.
  • Increased tolerance acquired through hyposensitization can vary from a few to several months. To assure prolongation of this acquired tolerance, perennial or year-round treatment is recommended. Some physicians continue therapy into or through the season by repeating a reduced MAINTENANCE dose at 4 to 6 week intervals.
  • SUGGESTED DOSAGE SCHEDULE
  • A treatment schedule is related directly to the patientu2019s degree of sensitivity, determined initially by clinical history and skin testing, and continuously by response to therapeutic doses. Thus, an individual treatment schedule for each patient must be established during the course of therapy. Maximum protection can be obtained with a dosage kept constantly below the patientu2019s limit of tolerance. Every precaution should be taken to avoid a systemic or generalized reaction which in addition to being dangerous, may depress rather than increase the patientu2019s tolerance.
  • FOR ALL PREPARATIONS (EXCEPT SHORT RAGWEED ANDn- u00a0n- MIXED SHORT AND TALL RAGWEED)
  • Labeled Antigen E content of extracts containing Short Ragweed at a weight/volume concentration more dilute than 1:10 may have been obtained by calculation from the Antigen E assay value of a more concentrated extract that was analyzed, officially released by the Office of Biologics, and subsequently diluted.
  • Below is listed a suggested dosage schedule for Pre-Seasonal Treatment. A column has been left blank for AgE dosage of short ragweed containing extracts.
  • Note:
  • nttu00a0u00a0u00a0u00a0u00a0ntAgE dosage can be monitored by using the formula:
  • nttu00a0u00a0u00a0u00a0u00a0ntn n u00a0u00a0X dose in PNU = dose in AgE Labeled PNU/mL
  • Note:
  • NO SINGLE DOSE SHOULD EXCEED 5,000 PNU. For continuing therapy with extracts containing Short Ragweed, see following section on Dosage Adjustments.
  • nttu00a0u00a0u00a0u00a0u00a0ntSHORT RAGWEED EQUAL PARTS MIXES OF SHORT AND TALLu00a0RAGWEED (DOSAGE BASED ON ANTIGEN CONTENT)
  • nttu00a0u00a0u00a0u00a0u00a0ntSuggested dosage schedule for Short Ragweed and Equal Part Mixture of Short and Tall Ragweed:
  • NO SINGLE DOSE SHOULD EXCEED 20 UNITS
  • DOSAGE ADJUSTMENTS(FOR PRODUCTS CONTAINING SHORT RAGWEED)
  • AgE is important in adjusting dosage of Short Ragweed extracts to accurately transfer a patient from older extracts to fresher material. In such cases, the dosage of AgE should be considered in addition to the protein nitrogen units. Antigen E concentration continuously declines in Short Ragweed Pollen extracts at a rate that varies with the formulation of the product. Aqueous extracts retain Antigen E potency less effectively than 50% glycinerated or Alum Precipitated extracts. Antigen E is most stable in freeze-dried extracts. These differences are reflected in the expiration date declared on the vial label. The continuous decline should be considered. Also, where Ragweed is a component of an allergen mixture, clinical response to the other components must be considered in adjustment of dosage based on AgE content alone.
  • CAUTION: A small percent of individuals allergic to Short Ragweed are more sensitive to minor antigens such as Ra3 and Ra5 than AgE. There is no correlation between the amount of these antigens and either AgE or PNU content.
  • Therapeuticu00a0u00a0Allergenicu00a0Extracts, Alum Precipitated, are supplied in 10 mL and 30 mL vials, in concentrations of 10,000 PNU/mL and 20,000 PNU/mL. Prescription treatment sets for individual patients are also available. u00a0must be stored continuously at 2u00b0 to 8u00b0C.u00a0DO NOT FREEZE. Diluent: Sterile Diluent for allergenic extracts (Phenol-Saline) is provided in vials of 4.5 mL, 9.0 mL, and 30 mL.u00a0
  • STORAGE:
  • Revision: June 2013
  • u00a9 ALK-Abello, Inc. 2013
  • 168H
  • Distributed in Canada by:ALK-Abellou00a0Pharmaceuticals, Inc. #35-151 Brunel Road Mississauga, OntarioCanada L4Z 2H6
  • Allergenic Extract, Alum PrecipitatedCenter-ALDIN 0064892230 mL Sterile Multiple Dose Vial

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