Label Changes for:
Synagis (palivizumab) For Intramuscular Administration
August 2008
Changes have been made to the ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2008
| The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. |
Sections Modified
ADVERSE REACTIONS
- Postmarketing Experience
- Blood and Lymphatic System Disorders
- Severe Thrombocytopenia (platelet count <50,000/microliter)
- General Disorders and Administration Site Conditions
- Injection Site Reactions
- Immune System Disorders
- Severe acute hypersensitivity reactions and anaphylaxis...
- Blood and Lymphatic System Disorders
