BYFAVO POWDER FOR SOLUTION FOR INJECTION 20MG [SIN17317P]

Product Info

BYFAVO POWDER FOR SOLUTION FOR INJECTION 20MG

[SIN17317P]

Indication

[INDICATION AND USAGE]

1. The induction and maintenance of general anesthesia in adults

2. The induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less

Dosing

[DOSAGE AND ADMINISTRATION]

1. General Anesthesia
   BYFAVO should be administered in combination with other analgesics and muscle relaxants as appropriate. [See Precautions for Use 5. General Warnings – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]

   1. Induction of General Anesthesia
      For adult patients: Administer remimazolam intravenously at the infusion rate of 6 mg/kg/hr (0.1 mg/kg/min) or 12 mg/kg/hr (0.2 mg/kg/min) until the loss of consciousness while observing general condition of the patient.
      Infusion rate and dose should be adjusted based on general condition of the patient.

   2. Maintenance of General Anesthesia
      For adult patients: Administer remimazolam intravenously at the infusion rate of 1 mg/kg/hr once loss of consciousness is achieved, and adjust the infusion rate appropriately while observing general condition of the patient to maintain the adequate depth of anesthesia (up to maximum 2 mg/kg/hr). Infusion rate should be adjusted based on general condition of the patient.

2. Procedural Sedation
   Remimazolam dosing should be individually titrated to an effective dose which provides the desired level of sedation and minimizes adverse reactions.
   In case of procedural sedation with opioid,

   1. Induction: For adult patients, administer opioid and wait 1–2 min. Initial dose should be 5 mg (2 mL) injection over 1 min and wait 2 min. For elderly≥65 years of age and/or with ASA-PS III–IV and/or body weight<50 kg, administer opioid and wait 1–2 min. Initial dose should be 2.5–5 mg (1–2 mL) injection over 1 min and wait 2 min.

   2. Maintenance/titration: For adult patients, administer 2.5 mg (1 mL) injection over 15 sec. For elderly≥65 years of age and/or with ASA-PS III–IV and/or body weight<50 kg, administer 1.25–2.5 mg (0.5–1 mL) injection over 15 sec.

   3. For adult patients, maximal total dose administrated in the clinical trials was 33 mg. For elderly≥65 years of age and/or with ASA-PS III–IV and/or body weight<50 kg, maximal total dose administrated in the clinical trials was 17.5 mg.

   In case of procedural sedation without opioid,

   1. Induction: For adult patients, administer 7 mg (2.8 mL) Injection over 1 min and wait 2 min. For elderly≥65 years of age and/or with ASA-PS III–IV and/or body weight<50 kg, administer 2.5–5 mg (1–2 mL) injection over 1 min and wait 2 min.

   2. Maintenance/titration: For adult patients, administer 2.5 mg (1 mL) injection over 15 sec. For elderly≥65 years of age and/or with ASA-PS III–IV and/or body weight<50 kg, administer, administer 1.25–2.5 mg (0.5–1 mL) injection over 15 sec.

   3. For adult patients, maximal total dose administrated in the clinical trials was 33 mg. For elderly≥65 years of age and/or with ASA-PS III–IV and/or body weight<50 kg, maximal total dose administrated in the clinical trials was 17.5 mg.
      Additional doses can be administered as needed to induce or maintain the desired level of sedation. At least 2 minutes should elapse prior to administration of any supplemental dose in order to fully assess the sedative effect. If 5 doses of remimazolam within 15 minutes do not result in the desired level of sedation then an additional or another sedative should be considered. Remimazolam is associated with fast onset and offset of sedation. In clinical trials, peak sedation occurred 3–3.5 minutes after the initial bolus and patients became fully alert 12–14 minutes from last dose of remimazolam.
      Opioid co-administered medicinal products are known to increase the sedative effect of remimazolam and to depress the ventilatory response to carbon dioxide stimulation.

3. Geriatric Patients
   Elderly, American Society of Anesthesiologists Physical Status (ASA-PS) III–IV patients and patients with body weight < 50 kg
   Elderly patients and patients with ASA-PS III–IV may be more sensitive to the effects of sedatives. Before administration of remimazolam a careful assessment of the overall condition of patients ≥65 years of age and/or with ASA-PS III–IV, especially with low body weight (< 50 kg), is therefore of particular relevance when deciding upon individualised dosage adjustments for these patients.

4. Patients with Hepatic Impairment
   Dose adjustment is not required in patients with mild to severe hepatic impairment based on Child-Pugh classification.
   However, infusion rate and dose should be carefully adjusted based on general condition of the patient with severe hepatic impairement. [See Precautions for Use 10. Hepatic Impairement – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]

5. Patients with Renal Impairment
   Dose adjustment is not required in patients with renal impairment.

6. Preparation

   1. For General Anesthesia:

      1. In Prior to administration, reconstitute BYFAVO by adding 4.05 mL sterile Sodium Chloride Injection (0.9% w/v) to the vial and dissolve the contents fully. The reconstituted product will deliver a final concentration of 5.0 mg/mL solution of BYFAVO. [See Precautions for Use 13. Precautions for Administration – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]

      2. If needed, a further dilution to the final concentration of 1.0 mg/mL is allowed.

   2. For Procedural Sedation:
      In Prior to administration, reconstitute BYFAVO by adding 8.2 mL sterile Sodium Chloride Injection (0.9% w/v) to the vial and dissolve the contents fully. The reconstituted product will deliver a final concentration of 2.5 mg/mL solution of BYFAVO. [See Precautions for Use 13. Precautions for Administration – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]

   3. BYFAVO must be immediately used after opening and discarded after use. Stability of the reconstituted BYFAVO has not been established.

Contraindications

2. Contraindications
Patients with

1. Severe hypersensitivity to BYFAVO, other benzodiazepine drugs, or the composition of BYFAVO

2. Acute narrow-angle glaucoma

3. In shock or coma

4. Acute alcoholism with suppressed vital signs

5. Sleep apnea syndrome

6. Alcohol or drug dependence

7. Severe or acute respiratory failure

8. Genetic disorders, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption (BYFAVO contains lactose)

9. History of severe hypersensitivity to dextran 40 [See Precautions for Use 5. General Warning – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]

10. Unstable myasthenia gravis