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#Netspot drug generator
#Netspot drug full

#Netspot drug generator

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 k. Follow the generator specific reconstitution procedures below. Vial 1 septum with a sterile needle connected to a 0.2 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 Generator Elution and Radiolabeling Reaction 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: 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. Use 1 mL low dead space plastic syringe to precisely measure the adequate volume of reaction buffer to be added during preparation. Radiolabeling of carrier molecules with gallium (Ga 68) chloride is very sensitive to the presence of trace metal impurities.

Use non-metallic or silicone coated needles to minimize trace metal impurity levels. Prepare syringes for elution and reconstitution steps per Table 1 below.į. Set the temperature of the shielded dry bath to 95☌ (203☏), 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. Ancillary supplies needed (not supplied in kit): 1 mL sterile plastic syringe, 5 mL sterile plastic syringe, non-metallic or silicone coated sterile needles, 0.2 micron sterile vented filter.Vial 2 (buffer vial) contains: 60 mg formic acid 56.5 mg sodium hydroxide and water for injection.Īncillary supplies (not included in the kit):.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 drug full

FULL PRESCRIBING INFORMATION: CONTENTS * 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 Hypersensitivity Reactions 5.3 Risk for Image Misinterpretation 6 ADVERSE REACTIONS 6.1 Clinical Trials 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 16.1 How Supplied 16.2 Storage and Handling 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed.