Interferon alfa-2a how supplied: Difference between revisions

Revision as of 01:57, 6 January 2014

Interferon alfa-2a
PEGASYS^® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

How Supplied

Storage and Handling

Store in the refrigerator at 2°C to 8°C (36°F to 46°F). Do not leave PEGASYS out of the refrigerator for more than 24 hours. Do not freeze or shake. Protect from light. Vials, prefilled syringes and autoinjectors are for single use only. Discard any unused portion remaining in the vial, prefilled syringe.

Disposal Instructions

If home use is prescribed, a puncture-resistant container for the disposal of used needles, syringes and autoinjectors should be supplied to the patients. Patients should be thoroughly instructed in the importance of proper disposal and cautioned against any reuse of any needles, syringes and autoinjectors. The full container should be disposed of according to the directions provided by the physician ^[1]

References

↑ "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5204lbl.pdf" (PDF). External link in |title= (help)

Adapted from the FDA Package Insert.

[1] "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5204lbl.pdf" (PDF). External link in |title= (help)

[1]

@@ Line 4: / Line 4: @@
 ==How Supplied==
+{|
+|-
+|[[File:QQ图片20140105205516.jpg|thumb|1600px|left]]
+|-
+|}
-Single Use Prefilled Syringes
+===Storage and Handling===
-(for subcutaneous administration)
+Store in the refrigerator at 2°C to 8°C (36°F to 46°F). Do not leave PEGASYS out of the refrigerator for more than 24 hours. Do not freeze or shake. Protect from light. Vials, prefilled syringes and autoinjectors are for single use only. Discard any unused portion remaining in the vial, prefilled syringe.
-million IU Roferon-A per syringe — Each 0.5 mL contains 3 MIU of Interferon alfa-2a, recombinant, 3.605 mg sodium chloride, 0.1 mg polysorbate 80, 5 mg benzyl alcohol as a preservative and 0.385 mg ammonium acetate. Boxes of 1 (NDC 0004-2015-09); Boxes of 6 (NDC 0004-2015-07).
+===Disposal Instructions===
+If home use is prescribed, a puncture-resistant container for the disposal of used needles, syringes and autoinjectors should be supplied to the patients. Patients should be thoroughly instructed in the importance of proper disposal and cautioned against any reuse of any needles, syringes and autoinjectors. The full container should be disposed of according to the directions provided by the physician <ref>{{Cite web | last = | first =|title = http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5204lbl.pdf| url =http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5204lbl.pdf | publisher = |date = | accessdate = }}</ref>
-million IU Roferon-A per syringe — Each 0.5 mL contains 6 MIU of Interferon alfa-2a, recombinant, 3.605 mg sodium chloride, 0.1 mg polysorbate 80, 5 mg benzyl alcohol as a preservative and 0.385 mg ammonium acetate. Boxes of 1 (NDC 0004-2016-09); Boxes of 6 (NDC 0004-2016-07).
-million IU Roferon-A per syringe — Each 0.5 mL contains 9 MIU of Interferon alfa-2a, recombinant, 3.605 mg sodium chloride, 0.1 mg polysorbate 80, 5 mg benzyl alcohol as a preservative and 0.385 mg ammonium acetate. Boxes of 1 (NDC 0004-2017-09); Boxes of 6 (NDC 0004-2017-07).
-===Storage===
-The prefilled syringe should be stored in the refrigerator at 36° to 46°F (2° to 8°C). Do not freeze or shake. Protect Roferon-A from light during storage.<ref>{{Cite web | last = | first =|title = http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5204lbl.pdf| url =http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5204lbl.pdf | publisher = |date = | accessdate = }}</ref>
 ==References==
 {{Reflist}}