| Product Name: | Buprenorphine Hydrochloride Injection IP |
| Brand Name: | Generic |
| Strength: | 0.3mg/ml |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 1ml, 2ml Ampoule |
| Route of Administration: | For I.M./ slow I.V use |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Product Permission, Stability Studies, GMP |
| Therapeutic use: | Analgesic |
| Indication: | Buprenorphine hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Buprenorphine is a medication approved by the Food and Drug Administration (FDA) to treat Opioid Use Disorder (OUD) as a medication-assisted treatment (MAT). |
| Storage: | Store below 30°C. Do not Refrigerate. Protected from light. |
GENERIC NAME OF MEDICINAL PRODUCT
- Buprenorphine Hydrochloride Injection IP 0.3mg/ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Buprenorphine Hydrochloride Injection IP 0.3mg/ml
Each ml contains:
Buprenorphine Hydrochloride IP
Equivalent to Buprenorphine ……………………………………..0.3mg
Water for Injections IP………………………..q.s.
THERAPEUTIC INDICATION:
Buprenorphine hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Buprenorphine is a medication approved by the Food and Drug Administration (FDA) to treat Opioid Use Disorder (OUD) as a medication-assisted treatment (MAT).
DIRECTION OF USE:
For I.M./ slow I.V use
CAUTION AND SCHEDULE:
CAUTION: Do not use if solution is not clear or has suspended matter.
Not to be used in the newly born or premature infants.
Discard any unused portion
SCHEDULE H1 PRESCRIPTION DRUG CAUTION: It is dangerous to take this preparation except in accordance with medical advice. Not to be sold by retail without the prescription of Registered Medical Practitioner.
STORAGE AND DOSAGE:
STORAGE: Store below 30°C. Do not Refrigerate. Protected from light.
KEEP OUT OF REACH OF CHILDREN.
DOSAGE: As directed by Physician.