- Approval Id
- 70dbe9bdccc50ce6
- Drug Name
- ALOXI® SOLUTION FOR INJECTION 50MCG/ML
- Product Name
- ALOXI® SOLUTION FOR INJECTION 50MCG/ML
- Approval Number
- SIN14038P
- Approval Date
- 2011-10-24
- Registrant
- JUNIPER HEALTHCARE PTE LTD
- Licence Holder
- JUNIPER HEALTHCARE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong><br>
<strong>Recommended Dosing</strong><br>
<u>Chemotherapy-Induced Nausea and Vomiting</u></p>
<img src="/TGIF/Aloxi-Table1_190724.png" alt="Aloxi Dosage Table 1" /><br><br>
<p>The safety and efficacy of Aloxi in children aged less than 1 month have not been established. No data are available. There is limited data on the use of Aloxi in the prevention of nausea and vomiting in children under 2 years of age.</p>
<p><u>Postoperative Nausea and Vomiting</u><br>
Dosage for Adults – a single 0.075 mg I.V. dose administered over 10 seconds immediately before the induction of anesthesia.</p>
<p><strong>Instructions for I.V. Administration</strong><br>
<em><strong>Aloxi</strong></em>® is supplied ready for intravenous administration at a concentration of 0.05 mg/mL (50 mcg/mL). <em><strong>Aloxi</strong></em>® should not be mixed with other drugs. Flush the infusion line with normal saline before and after administration of <em><strong>Aloxi</strong></em>®.</p>
<p>Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever solution and container permit.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>INDICATIONS AND USAGE</strong><br>
<strong>Chemotherapy-Induced Nausea and Vomiting in Adults</strong><br>
<em><strong>Aloxi</strong></em>® is indicated for:</p>
<ul>
<li>Moderately emetogenic cancer chemotherapy -- prevention of acute and delayed nausea and vomiting associated with initial and repeat courses</li>
<li>Highly emetogenic cancer chemotherapy -- prevention of acute nausea and vomiting associated with initial and repeat courses</li>
</ul>
<p><strong>Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients Aged 1 month to Less than 17 Years</strong><br>
<em><strong>Aloxi</strong></em>® is indicated for:</p>
<ul>
<li>Prevention of acute nausea and vomiting associated with initial and repeat courses of moderately or highly emetogenic cancer chemotherapy</li>
</ul>
<p><strong>Postoperative Nausea and Vomiting in Adults</strong><br>
<em><strong>Aloxi</strong></em>® is indicated for:</p>
<ul>
<li>Prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.</li>
</ul>
<p>As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and vomiting must be avoided during the postoperative period, <em><strong>Aloxi</strong></em>® is recommended even where the incidence of postoperative nausea and/or vomiting is low.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong><br>
<em><strong>Aloxi</strong></em>® is contraindicated in patients known to have hypersensitivity to the drug or any of its components. [<em>see Adverse Reactions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>]</p>
- Atc Code
- A04AA05
- Atc Item Name
- palonosetron
- Pharma Manufacturer Name
- juniper healthcare pte ltd