Difference between revisions of "Tinzaparin (Innohep)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Low molecular weight heparin, binds to antithrombin III, accelerating its activity and inhibiting factor Xa and thrombin.<ref name="insert">[http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020484s014lbl.pdf Tinzaparin (Innohep) package insert]</ref><ref>[[ | + | Class/mechanism: Low molecular weight heparin, binds to antithrombin III, accelerating its activity and inhibiting factor Xa and thrombin.<ref name="insert">[http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020484s014lbl.pdf Tinzaparin (Innohep) package insert]</ref><ref>[[:File:Tinzaparin.pdf | Tinzaparin (Innohep) package insert (locally hosted backup)]]</ref><ref>[http://www.leo-pharma.com/Home/LEO-Pharma.aspx Innohep manufacturer's website]</ref> |
<br>Route: SC | <br>Route: SC | ||
<br>Extravasation: n/a | <br>Extravasation: n/a | ||
| − | For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. | + | For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref> |
==Patient drug information== | ==Patient drug information== | ||
| Line 12: | Line 12: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *07 | + | *2000-07-14: Initial FDA approval: treatment of acute symptomatic [[Venous thromboembolism|deep vein thrombosis with or without pulmonary embolism]] when administered in conjunction with [[Warfarin (Coumadin)]] |
| − | * | + | *2011-02-10: [http://www.leo-pharma.us/Files/Billeder/LEO_local_images/LEO-Pharma.US/10%20Feb%202011_Firm_Press_Release_LEO_Pharma_Inc.pdf Voluntary recall] as a voluntary measure after a dialogue with the FDA following an inspection at the production facility in Ballerup, Denmark. The dialogue concerned the production process and more specifically, the theoretical risk of presence of particulate matter in the released vials. |
*2011: [http://www.ashp.org/menu/DrugShortages/DrugsNoLongerAvailable/Bulletin.aspx?id=749 Withdrawn from US market]. "LEO Pharma discontinued marketing all Innohep presentations after the recall due to low usage of the products in the US." | *2011: [http://www.ashp.org/menu/DrugShortages/DrugsNoLongerAvailable/Bulletin.aspx?id=749 Withdrawn from US market]. "LEO Pharma discontinued marketing all Innohep presentations after the recall due to low usage of the products in the US." | ||
==Also known as== | ==Also known as== | ||
| − | + | *'''Brand name:''' Innohep, Tinprin | |
==References== | ==References== | ||
<references/> | <references/> | ||
| − | [[Category: | + | [[Category:Drugs]] |
| − | [[Category: | + | [[Category:Subcutaneous medications]] |
| − | + | ||
[[Category:Anticoagulants]] | [[Category:Anticoagulants]] | ||
[[Category:Heparins]] | [[Category:Heparins]] | ||
[[Category:Low molecular weight heparins]] | [[Category:Low molecular weight heparins]] | ||
| − | [[Category: | + | [[Category:Venous thromboembolism medications]] |
| + | |||
| + | [[Category:FDA approved in 2000]] | ||
| + | [[Category:Discontinued drugs]] | ||
Revision as of 13:18, 9 May 2023
Withdrawn from US market in 2011
General information
Class/mechanism: Low molecular weight heparin, binds to antithrombin III, accelerating its activity and inhibiting factor Xa and thrombin.[1][2][3]
Route: SC
Extravasation: n/a
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Patient drug information
History of changes in FDA indication
- 2000-07-14: Initial FDA approval: treatment of acute symptomatic deep vein thrombosis with or without pulmonary embolism when administered in conjunction with Warfarin (Coumadin)
- 2011-02-10: Voluntary recall as a voluntary measure after a dialogue with the FDA following an inspection at the production facility in Ballerup, Denmark. The dialogue concerned the production process and more specifically, the theoretical risk of presence of particulate matter in the released vials.
- 2011: Withdrawn from US market. "LEO Pharma discontinued marketing all Innohep presentations after the recall due to low usage of the products in the US."
Also known as
- Brand name: Innohep, Tinprin