GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Remifentanil HCL Dry Powder for Injection (Lyophilized) 1mg
b) Remifentanil HCL Dry Powder for Injection (Lyophilized) 2mg
c) Remifentanil HCL Dry Powder for Injection (Lyophilized) 5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A)Remifentanil HCL Dry Powder for Injection (Lyophilized) 1mg
Each vial contains:
Remifentanil HCL……………………………..1mg
Excipients……………………………………..q.s.
B. Remifentanil HCL Dry Powder for Injection (Lyophilized) 2 mg Each vial contains:
Remifentanil HCL……………………………..2mg
Excipients……………………………………..q.s.
C. Remifentanil HCL Dry Powder for Injection (Lyophilized) 5 mg Each vial contains:
Remifentanil HCL……………………………..5mg
Excipients……………………………………..q.s.

THERAPEUTIC INDICATIONS:

Remifentanil hydrochloride for injection is an opioid agonist indicated for intravenous administration: As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures.

CAUTION & SCHEDULE:

CAUTION: Single dose only Risks of Use in Patients with Biliary Tract Disease, including acute pancreatitis: Monitor patients for worsening symptoms. Increased Risk of Seizures in Patients with Seizure Disorders: Monitor patients for worsened seizure control. Rapid Offset of Action: Standard monitoring should be maintained in the postoperative period to ensure adequate recovery without stimulation.
SCHEDULE: Not to be sold by retail without the prescription of registered Medical Practitioner.

STORAGE & DOSAGE:

Storage:protected from light.
Dosage: See package insert for dosage information.
As directed by Physician

Remifentanil HCL Dry Powder for Injection (Lyophilized) 1mg Technical Specification:

Product Name:Remifentanil HCL Dry Powder for Injection (Lyophilized)
Brand Name:Generics
Strength:1mg, 2mg, 5mg
Dosage Form:Dry Powder Injection (Sterile)
Packing:LYOPHILIZED Powder
Route of Administration:FOR IV USE Only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Anaesthetics
Indication: Remifentanil hydrochloride for injection is an opioid agonist indicated for intravenous administration: As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures.
Storage:Store Protected from moisture at a temperature not exceeding 30°C

GENERIC NAME OF MEDICINAL PRODUCT:

  • Remifentanil HCL Dry Powder for Injection (Lyophilized) 1mg
  • Remifentanil HCL Dry Powder for Injection (Lyophilized) 2mg
  • Remifentanil HCL Dry Powder for Injection (Lyophilized) 5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Remifentanil HCL Dry Powder for Injection (Lyophilized) 1mg
    Each vial contains:
    Remifentanil HCL……………………………..1mg
    Excipients……………………………………..q.s.
  • Remifentanil HCL Dry Powder for Injection (Lyophilized) 2 mg
    Each vial contains:
    Remifentanil HCL……………………………..2mg
    Excipients……………………………………..q.s.
  • Remifentanil HCL Dry Powder for Injection (Lyophilized) 5 mg
    Each vial contains:
    Remifentanil HCL……………………………..5mg
    Excipients……………………………………..q.s.

THERAPEUTIC INDICATION:

Remifentanil hydrochloride for injection is an opioid agonist indicated for intravenous administration: As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures.

CAUTION & SCHEDULE:

CAUTION:Single dose only Risks of Use in Patients with Biliary Tract Disease, including acute pancreatitis: Monitor patients for worsening symptoms.
Increased Risk of Seizures in Patients with Seizure Disorders: Monitor patients for worsened seizure control.
Rapid Offset of Action: Standard monitoring should be maintained in the postoperative period to ensure adequate recovery without stimulation.
SCHEDULE:Not to be sold by retail without the prescription of registered Medical Practitioner.

STORAGE & DOSAGE:

Storage:protected from light.
Dosage:See package insert for dosage information.
As directed by Physician.