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Allergenic Extracts Standardized Mite
Overview
What is Allergenic Extracts Standardized Mite?
Greer Standardized Mite () extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy units/mL of sterile mite extract (), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer.
For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline.
Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin.
The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Unit/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Unit/mL.
What does Allergenic Extracts Standardized Mite look like?
What are the available doses of Allergenic Extracts Standardized Mite?
For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline. For intradermal testing extracts may be diluted in normal saline, buffered saline, or albumin saline.
Greer Standardized Mite Extract and Greer Standardized Mite Extract are supplied as stock concentrates containing 10,000 Allergy Unit/mL and Greer Standardized Mite Extract mixture ( and ) is supplied as a stock mixture concentrate containing 5,000 Allergy Units/mL of each species for use in percutaneous skin testing.
Greer Standardized Mite Extract and Greer Standardized Mite Extract are supplied as stock concentrates containing 5,000, 10,000, or 30,000 Allergy Unit/mL. Greer Standardized Mite Extract mixture ( and ) is supplied as a stock mixture concentrate containing 5,000 and 15,000 Allergy Units/mL of each species for use in intradermal testing and immunotherapy.
What should I talk to my health care provider before I take Allergenic Extracts Standardized Mite?
How should I use Allergenic Extracts Standardized Mite?
Greer Standardized Mite ( and/or ) Extracts are allergenic extracts indicated for
For immunotherapy, patients must show hypersensitivity to or based on their clinical history, allergen exposure history, and skin test reactivity.
Do not inject intravenously.
Greer Standardized Mite extracts are diluted with sterile diluent for allergenic extracts when used for intradermal testing or subcutaneous immunotherapy. Dosages vary by mode of administration, and by individual response and tolerance. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Greer Standardized Mite Extracts should be a light brown solution that is free of particulate matter. If particulate matter is observed then the solution should be discarded.
What interacts with Allergenic Extracts Standardized Mite?
Sorry No Records found
What are the warnings of Allergenic Extracts Standardized Mite?
Sorry No Records found
What are the precautions of Allergenic Extracts Standardized Mite?
Sorry No Records found
What are the side effects of Allergenic Extracts Standardized Mite?
Sorry No records found
What should I look out for while using Allergenic Extracts Standardized Mite?
None.
What might happen if I take too much Allergenic Extracts Standardized Mite?
For all allergenic extracts the therapeutic dose varies per indiviual. If a dose exceeds the window for a particular patient this may be considered an overdose and the patient may experience anaphylaxis. Systemic reactions are uncommon after injection, but if the patient receives more extract than can be tolerated at that particular time, and begins to experience immediate hypersensitivity anaphylaxis, institute emergency treatment by trained personnel.
Overdosage may occur because of an error in the volume of extract or incorrect diluents injected. An overdose may also occur when, in addition to immunotherapy, the patient is exposed concomitantly to similar environmental allergens. In the event of a systemic reaction, the preparation of allergen and dosage schedule should be carefully reviewed.
How should I store and handle Allergenic Extracts Standardized Mite?
Store dust mite extract at 2°-8 °C (36° to 46°F).Keep dust mite extract at 2°-8 °C (36° to 46°F) during office use.Dilutions of concentrated extract result in a glycerin content of less than 50% which results in reduced stability of the extracts. 1:100 dilutions should be kept no longer than a month, and more dilute solutions no more than a week. The potency of a dilution can be checked by skin test comparison to a fresh dilution of the extract on a known mite allergic individual.Store dust mite extract at 2°-8 °C (36° to 46°F).Keep dust mite extract at 2°-8 °C (36° to 46°F) during office use.Dilutions of concentrated extract result in a glycerin content of less than 50% which results in reduced stability of the extracts. 1:100 dilutions should be kept no longer than a month, and more dilute solutions no more than a week. The potency of a dilution can be checked by skin test comparison to a fresh dilution of the extract on a known mite allergic individual.Store dust mite extract at 2°-8 °C (36° to 46°F).Keep dust mite extract at 2°-8 °C (36° to 46°F) during office use.Dilutions of concentrated extract result in a glycerin content of less than 50% which results in reduced stability of the extracts. 1:100 dilutions should be kept no longer than a month, and more dilute solutions no more than a week. The potency of a dilution can be checked by skin test comparison to a fresh dilution of the extract on a known mite allergic individual.QUADRAMET is supplied frozen in a single-dose 10 mL glass vial containing 1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of samarium-153, at calibration.QUADRAMET is available in the following size:NDC# 57902-860-01 3mL fill size with total activity of 5550 MBq (150mCi).The vial is shipped in a lead shield; a package insert is included.The drug product expires 56 hours after the time of calibration noted on the label, or 8 hours after thawing, whichever is earlier.STORAGE:Storage and disposal of QUADRAMET should be controlled in a manner that complies with the appropriate regulations of the government agency authorized to license the use of this radionuclide. This radioactive drug is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.537 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.THIS PRODUCTINFORMATION ISSUED May 2009.Mfd by:LantheusMedical Imaging N. Billerica, MA 01862Mfd for:For Product Inquiries, call 1-800-833-3533Printed in U.S.A.QUADRAMET is supplied frozen in a single-dose 10 mL glass vial containing 1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of samarium-153, at calibration.QUADRAMET is available in the following size:NDC# 57902-860-01 3mL fill size with total activity of 5550 MBq (150mCi).The vial is shipped in a lead shield; a package insert is included.The drug product expires 56 hours after the time of calibration noted on the label, or 8 hours after thawing, whichever is earlier.STORAGE:Storage and disposal of QUADRAMET should be controlled in a manner that complies with the appropriate regulations of the government agency authorized to license the use of this radionuclide. This radioactive drug is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.537 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.THIS PRODUCTINFORMATION ISSUED May 2009.Mfd by:LantheusMedical Imaging N. Billerica, MA 01862Mfd for:For Product Inquiries, call 1-800-833-3533Printed in U.S.A.QUADRAMET is supplied frozen in a single-dose 10 mL glass vial containing 1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of samarium-153, at calibration.QUADRAMET is available in the following size:NDC# 57902-860-01 3mL fill size with total activity of 5550 MBq (150mCi).The vial is shipped in a lead shield; a package insert is included.The drug product expires 56 hours after the time of calibration noted on the label, or 8 hours after thawing, whichever is earlier.STORAGE:Storage and disposal of QUADRAMET should be controlled in a manner that complies with the appropriate regulations of the government agency authorized to license the use of this radionuclide. This radioactive drug is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.537 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.THIS PRODUCTINFORMATION ISSUED May 2009.Mfd by:LantheusMedical Imaging N. Billerica, MA 01862Mfd for:For Product Inquiries, call 1-800-833-3533Printed in U.S.A.QUADRAMET is supplied frozen in a single-dose 10 mL glass vial containing 1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of samarium-153, at calibration.QUADRAMET is available in the following size:NDC# 57902-860-01 3mL fill size with total activity of 5550 MBq (150mCi).The vial is shipped in a lead shield; a package insert is included.The drug product expires 56 hours after the time of calibration noted on the label, or 8 hours after thawing, whichever is earlier.STORAGE:Storage and disposal of QUADRAMET should be controlled in a manner that complies with the appropriate regulations of the government agency authorized to license the use of this radionuclide. This radioactive drug is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.537 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.THIS PRODUCTINFORMATION ISSUED May 2009.Mfd by:LantheusMedical Imaging N. Billerica, MA 01862Mfd for:For Product Inquiries, call 1-800-833-3533Printed in U.S.A.QUADRAMET is supplied frozen in a single-dose 10 mL glass vial containing 1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of samarium-153, at calibration.QUADRAMET is available in the following size:NDC# 57902-860-01 3mL fill size with total activity of 5550 MBq (150mCi).The vial is shipped in a lead shield; a package insert is included.The drug product expires 56 hours after the time of calibration noted on the label, or 8 hours after thawing, whichever is earlier.STORAGE:Storage and disposal of QUADRAMET should be controlled in a manner that complies with the appropriate regulations of the government agency authorized to license the use of this radionuclide. This radioactive drug is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.537 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.THIS PRODUCTINFORMATION ISSUED May 2009.Mfd by:LantheusMedical Imaging N. Billerica, MA 01862Mfd for:For Product Inquiries, call 1-800-833-3533Printed in U.S.A.QUADRAMET is supplied frozen in a single-dose 10 mL glass vial containing 1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of samarium-153, at calibration.QUADRAMET is available in the following size:NDC# 57902-860-01 3mL fill size with total activity of 5550 MBq (150mCi).The vial is shipped in a lead shield; a package insert is included.The drug product expires 56 hours after the time of calibration noted on the label, or 8 hours after thawing, whichever is earlier.STORAGE:Storage and disposal of QUADRAMET should be controlled in a manner that complies with the appropriate regulations of the government agency authorized to license the use of this radionuclide. This radioactive drug is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.537 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.THIS PRODUCTINFORMATION ISSUED May 2009.Mfd by:LantheusMedical Imaging N. Billerica, MA 01862Mfd for:For Product Inquiries, call 1-800-833-3533Printed in U.S.A.QUADRAMET is supplied frozen in a single-dose 10 mL glass vial containing 1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of samarium-153, at calibration.QUADRAMET is available in the following size:NDC# 57902-860-01 3mL fill size with total activity of 5550 MBq (150mCi).The vial is shipped in a lead shield; a package insert is included.The drug product expires 56 hours after the time of calibration noted on the label, or 8 hours after thawing, whichever is earlier.STORAGE:Storage and disposal of QUADRAMET should be controlled in a manner that complies with the appropriate regulations of the government agency authorized to license the use of this radionuclide. This radioactive drug is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.537 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.THIS PRODUCTINFORMATION ISSUED May 2009.Mfd by:LantheusMedical Imaging N. Billerica, MA 01862Mfd for:For Product Inquiries, call 1-800-833-3533Printed in U.S.A.QUADRAMET is supplied frozen in a single-dose 10 mL glass vial containing 1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of samarium-153, at calibration.QUADRAMET is available in the following size:NDC# 57902-860-01 3mL fill size with total activity of 5550 MBq (150mCi).The vial is shipped in a lead shield; a package insert is included.The drug product expires 56 hours after the time of calibration noted on the label, or 8 hours after thawing, whichever is earlier.STORAGE:Storage and disposal of QUADRAMET should be controlled in a manner that complies with the appropriate regulations of the government agency authorized to license the use of this radionuclide. This radioactive drug is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.537 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.THIS PRODUCTINFORMATION ISSUED May 2009.Mfd by:LantheusMedical Imaging N. Billerica, MA 01862Mfd for:For Product Inquiries, call 1-800-833-3533Printed in U.S.A.QUADRAMET is supplied frozen in a single-dose 10 mL glass vial containing 1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of samarium-153, at calibration.QUADRAMET is available in the following size:NDC# 57902-860-01 3mL fill size with total activity of 5550 MBq (150mCi).The vial is shipped in a lead shield; a package insert is included.The drug product expires 56 hours after the time of calibration noted on the label, or 8 hours after thawing, whichever is earlier.STORAGE:Storage and disposal of QUADRAMET should be controlled in a manner that complies with the appropriate regulations of the government agency authorized to license the use of this radionuclide. This radioactive drug is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.537 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.THIS PRODUCTINFORMATION ISSUED May 2009.Mfd by:LantheusMedical Imaging N. Billerica, MA 01862Mfd for:For Product Inquiries, call 1-800-833-3533Printed in U.S.A.QUADRAMET is supplied frozen in a single-dose 10 mL glass vial containing 1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of samarium-153, at calibration.QUADRAMET is available in the following size:NDC# 57902-860-01 3mL fill size with total activity of 5550 MBq (150mCi).The vial is shipped in a lead shield; a package insert is included.The drug product expires 56 hours after the time of calibration noted on the label, or 8 hours after thawing, whichever is earlier.STORAGE:Storage and disposal of QUADRAMET should be controlled in a manner that complies with the appropriate regulations of the government agency authorized to license the use of this radionuclide. This radioactive drug is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.537 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.THIS PRODUCTINFORMATION ISSUED May 2009.Mfd by:LantheusMedical Imaging N. Billerica, MA 01862Mfd for:For Product Inquiries, call 1-800-833-3533Printed in U.S.A.QUADRAMET is supplied frozen in a single-dose 10 mL glass vial containing 1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of samarium-153, at calibration.QUADRAMET is available in the following size:NDC# 57902-860-01 3mL fill size with total activity of 5550 MBq (150mCi).The vial is shipped in a lead shield; a package insert is included.The drug product expires 56 hours after the time of calibration noted on the label, or 8 hours after thawing, whichever is earlier.STORAGE:Storage and disposal of QUADRAMET should be controlled in a manner that complies with the appropriate regulations of the government agency authorized to license the use of this radionuclide. This radioactive drug is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.537 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.THIS PRODUCTINFORMATION ISSUED May 2009.Mfd by:LantheusMedical Imaging N. Billerica, MA 01862Mfd for:For Product Inquiries, call 1-800-833-3533Printed in U.S.A.QUADRAMET is supplied frozen in a single-dose 10 mL glass vial containing 1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of samarium-153, at calibration.QUADRAMET is available in the following size:NDC# 57902-860-01 3mL fill size with total activity of 5550 MBq (150mCi).The vial is shipped in a lead shield; a package insert is included.The drug product expires 56 hours after the time of calibration noted on the label, or 8 hours after thawing, whichever is earlier.STORAGE:Storage and disposal of QUADRAMET should be controlled in a manner that complies with the appropriate regulations of the government agency authorized to license the use of this radionuclide. This radioactive drug is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.537 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.THIS PRODUCTINFORMATION ISSUED May 2009.Mfd by:LantheusMedical Imaging N. Billerica, MA 01862Mfd for:For Product Inquiries, call 1-800-833-3533Printed in U.S.A.QUADRAMET is supplied frozen in a single-dose 10 mL glass vial containing 1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of samarium-153, at calibration.QUADRAMET is available in the following size:NDC# 57902-860-01 3mL fill size with total activity of 5550 MBq (150mCi).The vial is shipped in a lead shield; a package insert is included.The drug product expires 56 hours after the time of calibration noted on the label, or 8 hours after thawing, whichever is earlier.STORAGE:Storage and disposal of QUADRAMET should be controlled in a manner that complies with the appropriate regulations of the government agency authorized to license the use of this radionuclide. This radioactive drug is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.537 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.THIS PRODUCTINFORMATION ISSUED May 2009.Mfd by:LantheusMedical Imaging N. Billerica, MA 01862Mfd for:For Product Inquiries, call 1-800-833-3533Printed in U.S.A.QUADRAMET is supplied frozen in a single-dose 10 mL glass vial containing 1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of samarium-153, at calibration.QUADRAMET is available in the following size:NDC# 57902-860-01 3mL fill size with total activity of 5550 MBq (150mCi).The vial is shipped in a lead shield; a package insert is included.The drug product expires 56 hours after the time of calibration noted on the label, or 8 hours after thawing, whichever is earlier.STORAGE:Storage and disposal of QUADRAMET should be controlled in a manner that complies with the appropriate regulations of the government agency authorized to license the use of this radionuclide. This radioactive drug is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.537 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.THIS PRODUCTINFORMATION ISSUED May 2009.Mfd by:LantheusMedical Imaging N. Billerica, MA 01862Mfd for:For Product Inquiries, call 1-800-833-3533Printed in U.S.A.QUADRAMET is supplied frozen in a single-dose 10 mL glass vial containing 1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of samarium-153, at calibration.QUADRAMET is available in the following size:NDC# 57902-860-01 3mL fill size with total activity of 5550 MBq (150mCi).The vial is shipped in a lead shield; a package insert is included.The drug product expires 56 hours after the time of calibration noted on the label, or 8 hours after thawing, whichever is earlier.STORAGE:Storage and disposal of QUADRAMET should be controlled in a manner that complies with the appropriate regulations of the government agency authorized to license the use of this radionuclide. This radioactive drug is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.537 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.THIS PRODUCTINFORMATION ISSUED May 2009.Mfd by:LantheusMedical Imaging N. Billerica, MA 01862Mfd for:For Product Inquiries, call 1-800-833-3533Printed in U.S.A.QUADRAMET is supplied frozen in a single-dose 10 mL glass vial containing 1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of samarium-153, at calibration.QUADRAMET is available in the following size:NDC# 57902-860-01 3mL fill size with total activity of 5550 MBq (150mCi).The vial is shipped in a lead shield; a package insert is included.The drug product expires 56 hours after the time of calibration noted on the label, or 8 hours after thawing, whichever is earlier.STORAGE:Storage and disposal of QUADRAMET should be controlled in a manner that complies with the appropriate regulations of the government agency authorized to license the use of this radionuclide. This radioactive drug is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.537 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.THIS PRODUCTINFORMATION ISSUED May 2009.Mfd by:LantheusMedical Imaging N. Billerica, MA 01862Mfd for:For Product Inquiries, call 1-800-833-3533Printed in U.S.A.QUADRAMET is supplied frozen in a single-dose 10 mL glass vial containing 1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of samarium-153, at calibration.QUADRAMET is available in the following size:NDC# 57902-860-01 3mL fill size with total activity of 5550 MBq (150mCi).The vial is shipped in a lead shield; a package insert is included.The drug product expires 56 hours after the time of calibration noted on the label, or 8 hours after thawing, whichever is earlier.STORAGE:Storage and disposal of QUADRAMET should be controlled in a manner that complies with the appropriate regulations of the government agency authorized to license the use of this radionuclide. This radioactive drug is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.537 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.THIS PRODUCTINFORMATION ISSUED May 2009.Mfd by:LantheusMedical Imaging N. Billerica, MA 01862Mfd for:For Product Inquiries, call 1-800-833-3533Printed in U.S.A.QUADRAMET is supplied frozen in a single-dose 10 mL glass vial containing 1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of samarium-153, at calibration.QUADRAMET is available in the following size:NDC# 57902-860-01 3mL fill size with total activity of 5550 MBq (150mCi).The vial is shipped in a lead shield; a package insert is included.The drug product expires 56 hours after the time of calibration noted on the label, or 8 hours after thawing, whichever is earlier.STORAGE:Storage and disposal of QUADRAMET should be controlled in a manner that complies with the appropriate regulations of the government agency authorized to license the use of this radionuclide. This radioactive drug is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.537 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.THIS PRODUCTINFORMATION ISSUED May 2009.Mfd by:LantheusMedical Imaging N. Billerica, MA 01862Mfd for:For Product Inquiries, call 1-800-833-3533Printed in U.S.A.QUADRAMET is supplied frozen in a single-dose 10 mL glass vial containing 1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of samarium-153, at calibration.QUADRAMET is available in the following size:NDC# 57902-860-01 3mL fill size with total activity of 5550 MBq (150mCi).The vial is shipped in a lead shield; a package insert is included.The drug product expires 56 hours after the time of calibration noted on the label, or 8 hours after thawing, whichever is earlier.STORAGE:Storage and disposal of QUADRAMET should be controlled in a manner that complies with the appropriate regulations of the government agency authorized to license the use of this radionuclide. This radioactive drug is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.537 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.THIS PRODUCTINFORMATION ISSUED May 2009.Mfd by:LantheusMedical Imaging N. Billerica, MA 01862Mfd for:For Product Inquiries, call 1-800-833-3533Printed in U.S.A.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Dust mites belonging to the genus are indoor allergens found in humid geographic locations worldwide. and occur widely with most homes in the United States coinhabited by both species.
Non-Clinical Toxicology
None.The potential for additive bone marrow toxicity of QUADRAMET with chemotherapy or external beam radiation has not been studied. QUADRAMET should not be given concurrently with chemotherapy or external beam radiation therapy unless the benefit outweighs the risks. QUADRAMET should not be given after either of these treatments until there has been time for adequate marrow recovery. (See Section).
All concentrates of Greer Standardized Mite Extracts have the ability during skin testing and immunotherapy to elicit serious systemic reactions including anaphylactic shock and death [].
A review of the literature indicates that the incidence of near-fatal reactions to immunotherapy, defined as severe respiratory compromise, hypotension, or both, and requiring emergency treatment with epinephrine, has been estimated as 5.4 events per million injections in a 10-year retrospective survey of allergists. Fatalities from immunotherapy injections have been estimated to occur at a rate of approximately one death per 2.0 to 2.8 million injections in 4-, 10- and 12-year retrospective surveys of allergists.
Because of the danger of serious reactions, caution is required in testing and treating high risk patients and those with medical conditions that reduce their ability to survive a serious systemic adverse event.
High-risk patients are defined as those patients:
High risk patients have had fatal reactions. In addition, patients not high-risk but on beta blockers have had fatal reactions because beta blockers interfere with beta adrenergics such as epinephrine used in treatment or anaphylaxis.
Patients should be kept under observation for a minimum of 30 minutes after receiving allergenic extracts so that any adverse reaction can be observed and properly handled.
Medications to treat systemic reactions, as well as emergency equipment should be available for immediate use. Extracts must only be administered by persons who are aware of the risk of systemic reactions, including anaphylaxis; are capable of handling such reactions; and have the necessary drugs and equipment on hand to do so.
Systemic reactions consist primarily of allergic symptoms, such as generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, and hypotension. Additional symptoms that are not usually associated with allergy also may occur, such as nausea, emesis, abdominal cramps, and diarrhea. Serious reactions may cause shock, loss of consciousness, and even death. Based on published studies, systemic reactions occur in less than 1% of patients receiving conventional immunotherapy to greater than 36% in some studies of patients receiving rush immunotherapy.
Local reactions at the injections site are the most commonly occurring reactions (e.g., erythema, itching, swelling, tenderness, pain). Although most adverse systemic reactions occur within 30 minutes of injection (some within minutes of extract exposure), such reactions also can occur up to six hours after skin tests or immunotherapy [see ].
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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