- 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
- INTEGA PTE LTD
- Licence Holder
- INTEGA PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- **2 DOSAGE AND ADMINISTRATION**
**2.1 General Dosing Information**
Administer intramuscularly at a dose of 150 mg single dose.
It is not necessary to adjust dosage based on body surface area or body weight.
NALDEBAIN is an extended-release formulation, it should be taken into consideration that it takes 12~24 hours to achieve therapeutic concentration.
NALDEBAIN is not adequate for administration in patients with urgent analgesics need.
NALDEBAIN is fixed-dose package and only for single-dose use. Safety and effectiveness for repeat-dose use have not been established.
Except for nalbuphine and ketorolac, studies of concomitant use with other drugs including general anesthetic have not been conducted.
**2.2 Instructions for Use**
NALDEBAIN should be administered only via the intramuscular route.
Instructions for administration:
1. Clean the vial top with an alcohol swab before use.
2. Draw up 2 mL of drug into syringe.
3. After preparing the skin, inject in the upper outer quadrant of the gluteus maximus. The solution is viscous and oily. Slow injection is recommended.
4. Slightly applying pressure to the injection site to prevent drug solution leakage.
5. Do not massage the injection site.
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- **1 INDICATIONS AND USAGE**
**NALDEBAIN** is indicated for the relief of moderate to severe acute postsurgical pain. _\[see Clinical studies (13)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_.
- Contraindications
- **4 CONTRAINDICATION**
NALDEBAIN is for administration via the intramuscular route. It is prohibited for intravenous administration.
NALDEBAIN is contraindicated in patients with:
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
- Known or suspected gastrointestinal obstruction, including paralytic ileus
- Hypersensitivity to nalbuphine, sesame oil or benzyl benzoate in NALDEBAIN.
- Atc Code
- Pending
- Atc Item Name
- xpending
- Pharma Manufacturer Name
- INTEGA PTE. LTD.
- Company Detail Path
- /organization/75b0751b6c84fa27/intega-pte-ltd
