Myoview

Myoview Manufacturers

• Medi-physics Inc. Dba Ge Healthcare
  

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  Myoview | Medi-physics Inc. Dba Ge Healthcare

  

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  The recommended dose range for MYOVIEW is 5-33 mCi (185-1221 MBq).

  For stress and rest imaging, 2 separate doses of MYOVIEW are used. When rest and stress injections are administered on the same day, the first dose should be 5-12 mCi (185-444 MBq) and followed by the second dose of 15-33 mCi (555-1221 MBq) given approximately 1 to 4 hours later.

  Imaging may begin 15 minutes following administration of the agent.

  Dose adjustment has not been established in renally or liver impaired, pediatric or geriatric patients.

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• Medi-physics Inc. Dba Ge Healthcare
  

  ×

  Myoview | Medi-physics Inc. Dba Ge Healthcare

  

  ---

  The recommended dose range for MYOVIEW is 5-33 mCi (185-1221 MBq).

  For stress and rest imaging, 2 separate doses of MYOVIEW are used. When rest and stress injections are administered on the same day, the first dose should be 5-12 mCi (185-444 MBq) and followed by the second dose of 15-33 mCi (555-1221 MBq) given approximately 1 to 4 hours later.

  Imaging may begin 15 minutes following administration of the agent.

  Dose adjustment has not been established in renally or liver impaired, pediatric or geriatric patients.

  RADIATION DOSIMETRY

  Based on human data, the absorbed radiation doses to an average human adult (70 kg) from intravenous injections of the agent under exercise and resting conditions are listed in Table 5. The values are listed in descending order as rad/mCi and µGy/MBq and assume urinary bladder emptying at 3.5 hours.

  Table 5 Estimated Absorbed Radiation Dose (Technetium Tc99m Tetrofosmin Injection) Absorbed radiation dose Exercise Rest Target organ rad/mCi µGy/MBq rad/mCi µGy/MBq Gall bladder wall 0.123 33.2 0.180 48.6 Upper large intestine 0.075 20.1 0.113 30.4 Bladder wall 0.058 15.6 0.071 19.3 Lower large intestine 0.057 15.3 0.082 22.2 Small intestine 0.045 12.1 0.063 17.0 Kidney 0.039 10.4 0.046 12.5 Salivary glands 0.030 8.04 0.043 11.6 Ovaries 0.029 7.88 0.035 9.55 Uterus 0.027 7.34 0.031 8.36 Bone surface 0.023 6.23 0.021 5.58 Pancreas 0.019 5.00 0.018 4.98 Stomach 0.017 4.60 0.017 4.63 Thyroid 0.016 4.34 0.022 5.83 Adrenals 0.016 4.32 0.015 4.11 Heart wall 0.015 4.14 0.015 3.93 Red marrow 0.015 4.14 0.015 3.97 Spleen 0.015 4.12 0.014 3.82 Muscle 0.013 3.52 0.012 3.32 Testes 0.013 3.41 0.011 3.05 Liver 0.012 3.22 0.015 4.15 Thymus 0.012 3.11 0.009 2.54 Brain 0.010 2.72 0.008 2.15 Lungs 0.008 2.27 0.008 2.08 Skin 0.008 2.22 0.007 1.91 Breasts 0.008 2.22 0.007 1.83

  Dose calculations were performed using the standard MIRD method (MIRD Pamphlet No.1 (rev),Society of Nuclear Medicine, 1976). Effective dose equivalents (EDE) were calculated in accordance with ICRP 53 (Ann. ICRP 18 (1-4),1988) and gave values of 8.61 × 10-3 mSV/MBq and 1.12 × 10-2 mSV/MBq after exercise and rest, respectively.

  INSTRUCTIONS FOR THE PREPARATION OF MYOVIEW 30 mL INJECTION

  USE ASEPTIC TECHNIQUE THROUGHOUT.

  The user should wear waterproof gloves and use shielding at all times when handling the reconstituted vial or syringes containing the radioactive agent.

  The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

  1) Place one of the MYOVIEW 30 mL vials in a suitable shielding container and sanitize the rubber septum with an isopropyl alcohol swab. Insert a sterile needle (if using a venting needle) through the rubber septum (see Cautionary note 1). 2) Using sterile, suitable shielded syringes, inject the required activity of up to 2.4 Ci (89 GBq) technetium Tc99m generator eluate and Sodium Chloride Injection, USP, if needed as diluent into the shielded vial to result in a final Tc99m radioactive concentration of no greater than 80 mCi/mL (2.96 GBq/mL) (see Cautionary notes 2, 3 and 4). Remove the venting needle. Mix gently for 10 seconds to ensure complete dissolution of the powder. 3) Incubate at room temperature for 15 minutes. 4) Assay the total activity, complete the user radiation label and attach it to the vial. 5) Visually inspect the reconstituted solution at a safe distance through leaded glass. Do not use if it is not clear or if it contains foreign particulate matter. 6) Withdrawals for administration should be made aseptically using a shielded, sterile syringe and needle (see Cautionary note 5). 7) Store the reconstituted MYOVIEW 30 mL vial at 2°-25°C (36°-77°F) and use within 12 hours of preparation. Store withdrawals for injection at 2°-25°C (36°-77°F) and use within the same 12 hour period as the reconstituted MYOVIEW 30 mL vial.

  Cautionary notes:

  1) If a venting needle is not used, remove an adequate volume of gas from the vial head space using the same syringe used for the injection of Sodium Chloride Injection, USP or Tc99m generator eluate to avoid over-pressurizing the vial. 2) The volume of (diluted) technetium Tc99m generator eluate (plus Sodium Chloride Injection, USP as diluent if needed) added to the vial must be in the range 10-30 mL. 3) If Sodium Chloride Injection, USP, is added directly to the Myoview vial as a diluent , it must be added immediately prior to the addition of Tc99m generator eluate to the vial. 4) Sodium Chloride Injection, USP must be used as the diluent if needed. The use of bacteriostatic sodium chloride as a diluent for sodium pertechnetate Tc99m injection may adversely affect the radiochemical purity and hence the biological distribution of the MYOVIEW Injection. 5) A 21 gauge or finer needle is recommended for patient dose preparation. 6) The pH of the prepared injection should be in the range 7.5-9.0. 7) Safety and effectiveness of MYOVIEW Injection were established using investigational material shown to have a radiochemical purity of at least 90% prior to administration to patients in clinical studies. 8) The contents of the MYOVIEW vial are not radioactive. However, after the sodium pertechnetate Tc99m is added adequate shielding of the final preparation must be maintained. 9) The technetium Tc99m labeling reaction involved in the preparation of MYOVIEW Injection depends on maintaining tin in the divalent (reduced) state. Any oxidant present in the sodium pertechnetate Tc99m used may adversely affect the quality of the preparation. Sodium pertechnetate Tc99m containing oxidants should not be used for the preparation of the labeled product. 10) The contents of the MYOVIEW vial are sterile and pyrogen-free. The vial contains no bacteriostatic preservative. It is essential that the user follow the directions carefully and adhere to aseptic procedures during the preparation of the radiopharmaceutical.

  Quality Control

  An assay of the radiochemical purity of the prepared injection can be performed using the following chromatographic procedure.

  Equipment and eluent

  (1) Varian SA TLC strip (2 cm × 20 cm) – Do not heat activate (2) Ascending chromatography tank and cover (3) 65:35% v/v mixture of acetone and dichloromethane (prepared freshly) (4) 1 ml syringe with 22-25 G needle (5) Suitable counting equipment

  Method

  (1) Pour the 65:35% v/v acetone:dichloromethane mixture into the chromatography tank to a depth of 1 cm and cover the tank to allow the solvent vapor to equilibrate. (2) Mark a Varian SA TLC strip with a pencil line at 3 cm from the bottom and, using an ink marker pen, at 15 cm from the pencil line. The pencil line indicates the origin where the sample is to be applied and movement of color from the ink line will indicate the position of the solvent front when upward elution should be stopped. (3) Cutting positions at 3.75 cm and 12 cm above the origin (Rfs 0.25 and 0.8 respectively) should also be marked in pencil. (4) Using a 1 ml syringe and needle, apply a 10 µl sample of the prepared injection at the origin of the strip. Do not allow the spot to dry. Place the strip in the chromatography tank immediately and replace the cover. Ensure that the strip is not adhering to the walls of the tank.
  Note: A 10 µl sample will produce a spot with a diameter of approximately 10 mm. Different sample volumes have been shown to give unreliable radiochemical purity values. (5) When the solvent reaches the ink line, remove the strip from the tank and allow it to dry. (6) Cut the strip into 3 pieces at the marked cutting positions and measure the activity on each using suitable counting equipment. Try to ensure similar counting geometry for each piece and minimize equipment dead time losses. (7) Calculate the radiochemical purity from: % MYOVIEW = Activity of center piece   ×  100 Total activity of all 3 pieces Do not use material if the radiochemical purity is less than 90%.
  
  Note: Free Tc99m pertechnetate runs to the top piece of the strip. MYOVIEW runs to the center piece of the strip. Reduced hydrolyzed Tc99m and any hydrophilic complex impurities remain at the origin in the bottom piece of the strip.

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