- Approval Id
- 4705dad44ee6b979
- Drug Name
- NALDEBAIN® EXTENDED RELEASE INJECTION 75MG/ML
- Product Name
- NALDEBAIN® EXTENDED RELEASE INJECTION 75MG/ML
- Approval Number
- SIN16058P
- Approval Date
- 2020-12-15
- Registrant
- TAEVAS LIFE SCIENCES PTE LTD
- Licence Holder
- TAEVAS LIFE SCIENCES PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- <p><strong>2 DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>2.1 General Dosing Information</strong><br>
Administer intramuscularly at a dose of 150 mg single dose.<br>
It is not necessary to adjust dosage based on body surface area or body weight.<br>
NALDEBAIN is an extended-release formulation, it should be taken into consideration that it takes 12~24 hours to achieve therapeutic concentration.<br>
NALDEBAIN is not adequate for administration in patients with urgent analgesics need.<br>
NALDEBAIN is fixed-dose package and only for single-dose use. Safety and effectiveness for repeat-dose use have not been established.<br>
Except for nalbuphine and ketorolac, studies of concomitant use with other drugs including general anesthetic have not been conducted.</p>
<p><strong>2.2 Instructions for Use</strong><br>
NALDEBAIN should be administered only via the intramuscular route.</p>
<p>Instructions for administration:</p>
<ol>
<li>Clean the vial top with an alcohol swab before use.</li>
<li>Draw up 2 mL of drug into syringe.</li>
<li>After preparing the skin, inject in the upper outer quadrant of the gluteus maximus. The solution is viscous and oily. Slow injection is recommended.</li>
<li>Slightly applying pressure to the injection site to prevent drug solution leakage.</li>
<li>Do not massage the injection site.</li>
</ol>
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- <p><strong>1 INDICATIONS AND USAGE</strong></p>
<p><strong>NALDEBAIN</strong> is indicated for the relief of moderate to severe acute postsurgical pain. <em>[see Clinical studies (13)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
- Contraindications
- <p><strong>4 CONTRAINDICATION</strong></p>
<p>NALDEBAIN is for administration via the intramuscular route. It is prohibited for intravenous administration.<br>
NALDEBAIN is contraindicated in patients with:</p>
<ul class="dash">
<li>Significant respiratory depression</li>
<li>Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment</li>
<li>Known or suspected gastrointestinal obstruction, including paralytic ileus</li>
<li>Hypersensitivity to nalbuphine, sesame oil or benzyl benzoate in NALDEBAIN.</li>
</ul>
- Atc Code
- Pending
- Atc Item Name
- xpending
- Pharma Manufacturer Name
- INTEGA PTE. LTD.
- Company Detail Path
- /organization/intega-pte-ltd
