- #Netspot radiopharmaceutical generator
- #Netspot radiopharmaceutical full
- #Netspot radiopharmaceutical trial
Vial 1 to the outlet line of the generator by pushing the needle through the rubber septum. Vial 1 with 3.9 mL of sterile water for injection as prepared in Table 1. Connect a sterile needle to the outlet tube of the generator, turn the button by 90˚ to loading position then wait 10 seconds before turning the button back to the initial position.
Set the generator for the elution according to manufacturer instructions. Reconstitution with IRE Galli Eo generator Withdraw the syringe and the 0.22 micron sterile air venting filter. Vial 1 by removing the needle from the rubber septum, and immediately (do not delay buffer addition more than 10 min) add the kit reaction buffer in the 1 mL sterile syringe (the amount of reaction buffer was determined in Table 1). At the end of the elution, disconnect the generator from. Perform the elution manually or by means of a pump. Vial 1 according to the instructions for use of the GalliaPharm generator that are supplied by Eckert & Ziegler, in order to reconstitute the lyophilized powder with 5 mL of eluate. Vial 1 directly to the outlet line of the GalliaPharm generator by pushing the needle through the rubber septum and place the vial in a lead shield container. Connect the male luer of the outlet line of the GalliaPharm generator to a sterile needle. Reconstitution with Eckert & Ziegler GalliaPharm generator Then continue with the incubation step h. Follow the generator specific reconstitution procedures below. Vial 1 septum with a sterile needle connected to a 0.22 micron sterile vented filter (not supplied) to maintain atmospheric pressure within the vial during the reconstitution process. Reaction buffer volume in mL = HCl volume in mL x HCl molarity (1.1 mL x 0.1 N = 0.11 mL of reaction buffer). Solutions for use with IRE Galli Eo generator Reaction buffer volume in mL = HCl volume in mL x HCl molarity (5 mL x 0.1 N = 0.5 mL of reaction buffer). Solutions for use with Eckert & Ziegler GalliaPharm generatorĥ mL of 0.1 N sterile HCl supplied by the generator manufacturerĬalculate the volume (in mL) by multiplying the volume of HCl used for the elution of the generator in mL by its molarity: Solutions for Generator Elution and Radiolabeling Reaction Prior to piercing vial septums, flip-off cap and swab the top of the vial closure with alcohol to disinfect the surface, and allow the stopper to dry. Prepare syringes for elution and reconstitution steps per Table 1 below. Set the temperature of the shielded dry bath to 203 ☏ (95 ☌), and wait for the temperature to reach the set point and stabilize.Į. Ge 68 breakthrough and other gamma emitting radionuclides should be ≤ 0.001%.ĭ. Test periodically (weekly) the Ga 68 chloride eluate for Ge 68 breakthrough by suitable method. Use suitable shielding to reduce radiation exposure.Ĭ. Prepare Ga 68 dotatate for intravenous injection according to the following aseptic procedure:Ī. 
Vial 2 (buffer vial) contains: 60 mg formic acid 56.5 mg sodium hydroxide and water for injection. Vial 1 (reaction vial with lyophilized powder) contains: 40 mcg dotatate, 5 mcg 1,10-phenanthroline 6 mcg gentisic acid 20 mg mannitol. The Ge 68/Ga 68 generators are not supplied with the NETSPOT kit. IRE ELiT Galli Eo Germanium 68/Gallium 68 (Ge 68/Ga 68) generator. Eckert & Ziegler GalliaPharm Germanium 68/Gallium 68 (Ge 68/Ga 68) generator. Which allows for direct preparation of Ga 68 dotatate injection with the eluate from one of the following generators (see below for specific instructions for use with each generator): #Netspot radiopharmaceutical full
Sections or subsections omitted from the full prescribing information are not listed.
#Netspot radiopharmaceutical trial
FULL PRESCRIBING INFORMATION: CONTENTS * RECENT MAJOR CHANGES 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Radiation Safety 2.2 Recommended Dosage and Administration Instructions 2.3 Drug Preparation 2.4 Administration 2.5 Specifications and Quality Control 2.6 Image Acquisition 2.7 Image Interpretation 2.8 Radiation Dosimetry 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Radiation Risk 5.2 Risk for Image Misinterpretation 6 ADVERSE REACTIONS 6.1 Clinical Trial Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION
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