Transcription of ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal PRODUCT is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Shingrix powder and suspension for suspension for injection Herpes zoster vaccine (recombinant, adjuvanted) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, one dose ( mL) contains: Varicella Zoster Virus1 g lycoprotein E antigen2,3 50 micrograms 1 Varicella Zoster Virus = VZV 2 adjuvanted with AS01B containing: plant extract Quillaja saponaria Molina, fraction 21 (QS-21) 50 micrograms 3- O-desacyl-4 -monophosphoryl lipid A (MPL) from Salmonella minnesota 50 micrograms 3 glycoprotein E (gE) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology For the full list of excipients, see section 3.
The suspension is an opalescent, colourless to pale brownish liquid. 4. CLINICAL PARTICULARS . 4.1 Therapeutic indications Shingrix is indicated for prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN), in: ... As a precautionary measure, it is preferable to avoid the use of Shingrix during pregnancy. ...
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