Fludeoxyglucose F-18

Fludeoxyglucose F-18 Manufacturers

• University Of North Dakota
  

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  Fludeoxyglucose F-18 | University Of North Dakota

  

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  [ 18F]FDG uptake may be changed by fasting or by blood sugar changes associated with diabetic mellitus. Blood glucose levels should be stabilized in non-diabetic patients by fasting before [ 18F]FDG injection. Diabetic patients may need stabilization of blood glucose on the day preceding and on the day of the [ 18F]FDG scan.

  The recommended dose of [ 18F]FDG for an adult (70 kg) is within the range 185-370 MBq (5-10 mCi), intravenous injection. In children doses as low as 2.6 mCi have been given. Optimal dose reductions for children have not been confirmed.

  The optimum rate of administration and upper safe dose for [ 18F]FDG have not been established. The time interval between doses of [ 18F]FDG should be long enough to allow substantial decay (physical and biological) of previous administrations.

  It is recommended that PET imaging be initiated within 40 minutes of [ 18F]FDG injection.

  The final dose for the patient should be calculated using proper decay factors from the time of the EOS, and measured by a suitable radioactivity calibration system before administration. See decay factors in Table 3.

  [ 18F]FDG, like other parenteral drug products, should be inspected visually for particulate matter and discoloration before administration, whenever solution and container permit. Preparations containing particulate matter or discoloration should not be administered. They should be disposed of in a safe manner, in compliance with applicable regulations.

  [ 18F]FDG should be stored upright in a lead shielded environment at controlled room temperature.

  Aseptic techniques and effective shielding should be employed in withdrawing doses for administration to patients. Waterproof gloves and effective shielding should be worn when handling the product.

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• Shertech Laboratories, Llc
  

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  Fludeoxyglucose F-18 | Glenmark Generics Inc., Usa

  

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  2.1 General Dosing Recommendations

  Ropinirole tablets can be taken with or without food [see Clinical Pharmacology (12.3)]. If a significant interruption in therapy with ropinirole tablets has occurred, retitration of therapy may be warranted.

  2.2 Dosing for Parkinson's Disease

  The recommended starting dose for Parkinson’s disease is 0.25 mg three times daily. Based on individual patient therapeutic response and tolerability, if necessary, the dose should then be titrated with weekly increments as described in Table 1. After Week 4, if necessary, the daily dose may be increased by 1.5 mg/day on a weekly basis up to a dose of 9 mg/day, and then by up to 3 mg/day weekly up to a maximum recommended total daily dose of 24 mg/day (8 mg three times daily). Doses greater than 24 mg/day have not been tested in clinical trials.

  Table 1. Ascending-Dose Schedule of Ropinirole Tablets for Parkinson’s Disease

  Week

  Dosage

  Total Daily Dose

  1

  0.25 mg 3 times daily

  0.75 mg

  2

  0.5 mg 3 times daily

  1.5 mg

  3

  0.75 mg 3 times daily

  2.25 mg

  4

  1 mg 3 times daily

  3 mg

  Ropinirole tablets should be discontinued gradually over a 7-day period in patients with Parkinson’s disease. The frequency of administration should be reduced from three times daily to twice daily for 4 days. For the remaining 3 days, the frequency should be reduced to once daily prior to complete withdrawal of ropinirole tablets.

  Renal Impairment

  No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance of 30 to 50 mL/min). The recommended initial dose of ropinirole for patients with end- stage renal disease on hemodialysis is 0.25 mg three times a day. Further dose escalations should be based on tolerability and need for efficacy. The recommended maximum total daily dose is 18 mg/day in patients receiving regular dialysis. Supplemental doses after dialysis are not required. The use of ropinirole tablets in patients with severe renal impairment without regular dialysis has not been studied.

  2.3 Dosing for Restless Legs Syndrome

  The recommended adult starting dose for RLS is 0.25 mg once daily 1 to 3 hours before bedtime. After 2 days, if necessary, the dose can be increased to 0.5 mg once daily, and to 1 mg once daily at the end of the first week of dosing, then as shown in Table 2 as needed to achieve efficacy. Titration should be based on individual patient therapeutic response and tolerability, up to a maximum recommended dose of 4 mg daily. For RLS, the safety and effectiveness of doses greater than 4 mg once daily have not been established.

  Table 2. Dose Titration Schedule for Ropinirole Tablets of Restless Legs Syndrome

  Day/Week

  Dose to be taken once daily, 1 to 3 hours before bedtime

  Days 1 and 2

  0.25 mg

  Days 3 to 7

  0.5 mg

  Week 2

  1 mg

  Week 3

  1.5 mg

  Week 4

  2 mg

  Week 5

  2.5 mg

  Week 6

  3 mg

  Week 7

  4 mg

  In clinical trials of patients treated for RLS with doses up to 4 mg once daily, ropinirole tablets was discontinued without a taper.

  Renal Impairment

  No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance of 30 to 50 mL/min). The recommended initial dose of ropinirole for patients with end- stage renal disease on hemodialysis is 0.25 mg once daily. Further dose escalations should be based on tolerability and need for efficacy. The recommended maximum total daily dose is 3 mg/day in patients receiving regular dialysis. Supplemental doses after dialysis are not required. The use of ropinirole hydrochloride in patients with severe renal impairment without regular dialysis has not been studied.

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• Lantheus Medical Imaging, Inc.
  

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  Fludeoxyglucose F-18 | Lantheus Medical Imaging, Inc.

  

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  Fludeoxyglucose F 18 Injection emits radiation. Use procedures to minimize radiation exposure. Calculate the final dose from the end of synthesis (EOS) time using proper radioactive decay factors. Assay the final dose in a properly calibrated dose calibrator before administration to the patient [see Description (11.2)].

  2.1 Recommended Dose for Adults

  Within the oncology, cardiology and neurology settings, the recommended dose for adults is 5 - 10 mCi (185 - 370 MBq) as an intravenous injection.

  2.2 Recommended Dose for Pediatric Patients

  Within the neurology setting, the recommended dose for pediatric patients is 2.6 mCi, as an intravenous injection. The optimal dose adjustment on the basis of body size or weight has not been determined [see Use in Special Populations (8.4)].

  2.3 Patient Preparation To minimize the radiation absorbed dose to the bladder, encourage adequate hydration. Encourage the patient to drink water or other fluids (as tolerated) in the 4 hours before their PET study. Encourage the patient to void as soon as the imaging study is completed and as often as possible thereafter for at least one hour. Screen patients for clinically significant blood glucose abnormalities by obtaining a history and/or laboratory tests [see Warnings and Precautions (5.2)]. Prior to Fludeoxyglucose F 18 PET imaging in the oncology and neurology settings, instruct patient to fast for 4 - 6 hours prior to the drug's injection. In the cardiology setting, administration of glucose-containing food or liquids (e.g., 50 - 75 grams) prior to Fludeoxyglucose F 18 Injection facilitates localization of cardiac ischemia. 2.4 Radiation Dosimetry

  The estimated human absorbed radiation doses (rem/mCi) to a newborn (3.4 kg), 1-year old (9.8 kg), 5-year old (19 kg), 10-year old (32 kg), 15-year old (57 kg), and adult (70 kg) from intravenous administration of Fludeoxyglucose F 18 Injection are shown in Table 2-1. These estimates were calculated based on human data and using the data published by the International Commission on Radiological Protection for Fludeoxyglucose 18F.1,2 The dosimetry data show that there are slight variations in absorbed radiation dose for various organs in each of the age groups. These dissimilarities in absorbed radiation dose are due to developmental age variations (e.g., organ size, location, and overall metabolic rate for each age group). The identified critical organs (in descending order) across all age groups evaluated are the urinary bladder, heart, pancreas, spleen, and lungs.

  Table 2-1 Estimated Absorbed Radiation Doses (rem/mCi) After Intravenous Administration of Fludeoxyglucose F 18 Injection* Organ Newborn
  (3.4 kg) 1-year old
  (9.8 kg) 5-year old
  (19 kg) 10-year old
  (32 kg) 15-year old
  (57 kg) Adult
  (70 kg) * MIRDOSE 2 software was used to calculate the radiation absorbed dose. Assumptions on the biodistribution based on data from Gallagher et al. and Jones et al. 3,1 † The dynamic bladder model with a uniform voiding frequency of 1.5 hours was used. ‡ LLI = lower large intestine; § ULI = upper large intestine Bladder wall† 4.3 1.7 0.93 0.60 0.40 0.32 Heart wall 2.4 1.2 0.70 0.44 0.29 0.22 Pancreas 2.2 0.68 0.33 0.25 0.13 0.096 Spleen 2.2 0.84 0.46 0.29 0.19 0.14 Lungs 0.96 0.38 0.20 0.13 0.092 0.064 Kidneys 0.81 0.34 0.19 0.13 0.089 0.074 Ovaries 0.80 0.80 0.19 0.11 0.058 0.053 Uterus 0.79 0.35 0.19 0.12 0.076 0.062 LLI wall‡ 0.69 0.28 0.15 0.097 0.060 0.051 Liver 0.69 0.31 0.17 0.11 0.076 0.058 Gallbladder wall 0.69 0.26 0.14 0.093 0.059 0.049 Small Intestine 0.68 0.29 0.15 0.096 0.060 0.047 ULI wall§ 0.67 0.27 0.15 0.090 0.057 0.046 Stomach wall 0.65 0.27 0.14 0.089 0.057 0.047 Adrenals 0.65 0.28 0.15 0.095 0.061 0.048 Testes 0.64 0.27 0.14 0.085 0.052 0.041 Red marrow 0.62 0.26 0.14 0.089 0.057 0.047 Thymus 0.61 0.26 0.14 0.086 0.056 0.044 Thyroid 0.61 0.26 0.13 0.080 0.049 0.039 Muscle 0.58 0.25 0.13 0.078 0.049 0.039 Bone Surfaces 0.57 0.24 0.12 0.079 0.052 0.041 Breast 0.54 0.22 0.11 0.068 0.043 0.034 Skin 0.49 0.20 0.10 0.060 0.037 0.030 Brain 0.29 0.13 0.09 0.078 0.072 0.070 Other tissues 0.59 0.25 0.13 0.083 0.052 0.042 2.5 Radiation Safety – Drug Handling Use waterproof gloves, effective radiation shielding, and appropriate safety measures when handling Fludeoxyglucose F 18 Injection to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel and other persons. Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. Calculate the final dose from the end of synthesis (EOS) time using proper radioactive decay factors. Assay the final dose in a properly calibrated dose calibrator before administration to the patient [see Description (11.2)]. The dose of Fludeoxyglucose F 18 Injection used in a given patient should be minimized consistent with the objectives of the procedure, and the nature of the radiation detection devices employed. 2.6 Drug Preparation and Administration Calculate the necessary volume to administer based on calibration time and dose. Aseptically withdraw Fludeoxyglucose F 18 Injection from its container. Inspect Fludeoxyglucose F 18 Injection visually for particulate matter and discoloration before administration, whenever solution and container permit. Do not administer the drug if it contains particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations. Use Fludeoxyglucose F 18 Injection within 12 hours from the EOS. 2.7 Imaging Guidelines Initiate imaging within 40 minutes following Fludeoxyglucose F 18 Injection administration. Acquire static emission images 30 – 100 minutes from the time of injection.

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• Precision Nuclear Llc
  

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  Fludeoxyglucose F-18 | Preferred Pharmaceuticals, Inc.

  

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  Cephalexin is administered orally.

  Adults — The adult dosage ranges from 1 to 4 g daily in divided doses. The 333 mg and 750 mg strengths should be administered such that the daily dose is within 1 to 4 grams per day. The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of cephalexin greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.

  Pediatric Patients — The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.

  In severe infections, the dosage may be doubled.

  In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required.

  In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of Cephalexin should be administered for at least 10 days.

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