WebSpherusol is a product approval information for the detection of delayed type hypersensitivity to C. immitis in individuals, 18-64 years of age, with a history of … WebPackage Insert C&S. Safety Data Sheet - C&S. Safety Data Sheet - C&S (OSHA) For Additional Support Please Contact Technical Support. Get In Touch With Us. Contact Us. Stay Up To …
APPROVEDPACKAGE INSERT - Pfizer
Web22. apr 2016 · Package inserts are essential for most IVDDs. The requirements for a package insert indicated in this section of the guidance document apply to the majority of devices for all classes of IVDDs. It is recognized that the extent of the information required in the package insert may depend upon the complexity and safety considerations of the test. WebThe package inserts compares the frequency of side effects in relation to those who took a placebo or inactive drug and those who took the active drug. They will also report on how often a side effect has been reported in any type of study or after it has been marketed. free ppt background templates
Guidance Document - Labelling of In Vitro Diagnostic Devices
WebPackage leaflet. The leaflet in every pack of medicine that contains information on the medicine for end-users, such as patients and animal owners. Languages. Frequently asked questions. Glossaries. About this website. Spherusol ® is administered as a 0.1 mL dose by intradermal injection to the volar surface of the forearm using a tuberculin syringe (0.5 or 1.0 mL) and a ½ inch 26-27 gauge needle. The needle should be inserted bevel side up in the skin at a 15-20 degree angle. Zobraziť viac Spherusol ® is a skin test antigen indicated for the detection of delayed-type hypersensitivity to Coccidioides immitis in individuals with a … Zobraziť viac 2.1 Preparation for Administration Spherusol ®is a clear, colorless sterile solution for intradermal administration. Parenteral drug … Zobraziť viac A severe allergic reaction (e.g., anaphylaxis) to Spherusol ®, or any component of Spherusol ®or other coccidioidin products is a contraindication to administration. Zobraziť viac Spherusol ® is a solution for intradermal injection supplied in a 1 mL multi-dose vial. Each 0.1 mL dose contains 1.27 mcg of spherule … Zobraziť viac Web15. máj 2015 · The PI is different from the Patient Package Insert (PPI), which contains information intended for patients, notwithstanding that the PPI may be required as part of the FDA-approved labeling for the drug. 4 The latest requirements for “Content and Format of Labeling for Human Prescription Drug and Biological Products” went into effect on June … farmhouse caledonia mn daily menu