GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW) | ||||||
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13:01 Jan 3, 2017 |
Spanish to English translations [PRO] Medical - Medical: Pharmaceuticals | |||||||
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| Selected response from: Charles Davis Spain Local time: 08:30 | ||||||
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Summary of answers provided | ||||
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4 +3 | presentation |
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4 | format |
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presentation Explanation: I know you said you think this doesn't sound right, but it is used. Presentación is neither just dosage form nor just packaging, but the combination of the two. Here's a European (UK) example in an SPC: "Presentations: 10 mg: 1 vial with 467 mg powder for solution for injection and infusion 1 vial with 10 ml of water for injections" [...] Not all presentations may be marketed." https://www.medicines.org.uk/emc/medicine/308 And a US one from a package insert: 16.1 How Supplied Each product presentation includes a package insert and the following components: Presentation.............Carton.....................Components .................................NDC Number Pre-Filled Syringe.....33332-316-01............• Ten 0.5 mL single-dose syringes fitted with a Luer-Lok™ attachment without needles [NDC 33332-316-02] Multi-Dose Vial..........33332-416-10...........• One 5 mL vial, which contains ten 0.5 mL doses [NDC 33332-416-11]" http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines... |
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