NOVERON SOLUTION FOR INJECTION 10MG/ML

PT. Novell Pharmaceutical Laboratories (INDONESIA REP OF)🇸🇬 Health Sciences Authority

Approval Date: Jun 12, 2024
Approval ID: 9313266e8f596986
Company: PT. Novell Pharmaceutical Laboratories (INDONESIA REP OF)
Type: Therapeutic

Approval Details

Approval Id: 9313266e8f596986
Drug Name: NOVERON SOLUTION FOR INJECTION 10MG/ML
Product Name: NOVERON SOLUTION FOR INJECTION 10MG/ML
Approval Number: SIN17025P
Approval Date: 2024-06-12
Registrant: GOLDPLUS UNIVERSAL PTE LTD
Licence Holder: GOLDPLUS UNIVERSAL PTE LTD
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: INJECTION, SOLUTION
Dosage: DOSAGE AND ADMINISTRATION Like other neuromuscular blocking agents, Noveron should only be administered by, or under supervision of, experienced clinicians who are familiar with the action and use of these drugs. As with other neuromuscular blocking agents, the dosage of Noveron should be individualized in each patient. The method of anesthesia and the expected duration of surgery, the method of sedation and the expected duration of mechanical ventilation, the possible interaction with other drugs that are administered concomitantly, and the condition of the patient should be taken into account when determining the dose. The use of an appropriate neuromuscular monitoring technique is recommended for the evaluation of neuromuscular block and recovery. Inhalational anesthetics do potentiate the neuromuscular blocking effects of Noveron. This potentiation however, becomes clinically relevant in the course of anesthesia, when the volatile agents have reached the tissue concentrations required for this interaction. Consequently, adjustments with Noveron should be made by administering smaller maintenance doses at less frequent intervals or by using lower infusion rates of Noveron during long lasting procedures (longer than 1 hour) under inhalational anesthesia (see section “Interaction with Other Medicinal Products and Other Forms of Interaction” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Risk of Medication Errors: Accidental administration of neuromuscular blocking agents may result in serious adverse events, including fatal outcomes. Store Noveron with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product (see section “Special Warnings and Precautions for Use” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). In adult patients the following dosage recommendations may serve as a general guideline for tracheal intubation and muscle relaxation for short to long lasting surgical procedures and for use in the intensive care unit. Surgical Procedures Tracheal intubation The standard intubating dose during routine anesthesia is 0.6 mg.kg-1 rocuronium bromide, after which adequate intubation conditions are established within 60 seconds in nearly all patients. A dose of 1.0 mg.kg-1 of rocuronium bromide is recommended for facilitating tracheal intubation conditions during rapid sequence induction of anesthesia, after which adequate intubation conditions are established within 60 seconds in nearly all patients. If a dose of 0.6 mg.kg-1 rocuronium bromide is used for rapid sequence induction of anesthesia, it is recommended to intubate the patient 90 seconds after administration of rocuronium bromide. For use of rocuronium bromide during rapid sequence induction of anesthesia in patients undergoing Cesarean section reference is made to section “Pregnancy and Lactation” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Maintenance dosing The recommended maintenance dose is 0.15 mg.kg-1 rocuronium bromide; in the case of long-term inhalational anesthesia, this should be reduced to 0.075–0.1 mg.kg-1 rocuronium bromide. The maintenance doses should best be given when twitch height has recovered to 25% of control twitch height, or when 2 to 3 responses to train of four stimulations are present. Continuous infusion If rocuronium bromide is administered by continuous infusion, it is recommended to give a loading dose of 0.6 mg.kg-1 rocuronium bromide and, when neuromuscular block starts to recover, to start administration by infusion. The infusion rate should be adjusted to maintain twitch response at 10% of control twitch height or to maintain 1 to 2 responses to train of four stimulations. In adults under intravenous anesthesia, the infusion rate required to maintain neuromuscular block at this level ranges from 0.3–0.6 mg.kg-1.h-1 and under inhalational anesthesia the infusion rate ranges from 0.3–0.4 mg.kg-1.h-1. Continuous monitoring of neuromuscular block is recommended since infusion rate requirements vary from patient to patient and with the anesthetic method used. Pediatric patients For infants (28 days–23 months), children (2–11 years) and adolescents (12–18 years) the recommended intubation dose during routine anesthesia and maintenance dose are similar to those in adults. For continuous infusion in pediatrics, the infusion rates, with exception of children, are the same as for adults. For children higher infusion rates might be necessary. For children the same initial infusion rates as for adults are recommended and this should be adjusted to maintain twitch response at 10% of control twitch height or to maintain 1 or 2 responses to train of four stimulations during the procedure. There are insufficient data to support dose recommendations for the use of rocuronium bromide in neonates (0–1 month). The experience with rocuronium bromide in rapid sequence induction in pediatric patients is limited. Rocuronium bromide is therefore not recommended for facilitating tracheal intubation conditions during rapid sequence induction in pediatric patients. Geriatric patients and patients with hepatic and/or biliary tract disease and/or renal failure The standard intubation dose for geriatric patients and patients with hepatic and/or biliary tract disease and/or renal failure during routine anesthesia is 0.6 mg.kg-1 rocuronium bromide. A dose of 0.6 mg.kg-1 should be considered for rapid sequence induction of anesthesia in patients in which a prolonged duration of action is expected. Regardless of the anesthetic technique used, the recommended maintenance dose for these patients 1s 0.075–0.1 mg.kg-1 rocuronium bromide, and the recommended infusion rate is 0.3–0.4 mg.kg-1.h-1 (see Continuous infusion). (See also section “Special Warnings and Precautions for Use” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Overweight and obese patients When used in overweight or obese patients (defined as patients with a body weight of 30% or more above ideal body weight) doses should be reduced taking into account ideal body weight. Intensive Care Procedures Tracheal intubation For tracheal intubation, the same doses should be used as described above under surgical procedures. Maintenance dosing The use of an initial loading dose of 0.6 mg.kg-1 rocuronium bromide is recommended, followed by a continuous infusion as soon as twitch height recovers to 10% or upon reappearance of 1 to 2 twitches to train of four stimulations. Dosage should always be titrated to effect in the individual patient. The recommended initial infusion rate for the maintenance of a neuromuscular block of 80–90% (1 to 2 twitches to TOF stimulation) in adult patients is 0.3–0.6 mg.kg-1.h-1 during the first hour of administration, which will need to be decreased during the following 6–12 hours, according to the individual response. Thereafter, individual dose requirements remain relatively constant. A large between patient variability in hourly infusion rates has been found in controlled clinical studies, with mean hourly infusion rates ranging from 0.2–0.5 mg.kg-1.h-1 depending on nature and extent of organ failure(s), concomitant medication and individual patient characteristics. To provide optimal individual patient control, monitoring of neuromuscular transmission is strongly recommended. Administration up to 7 days has been investigated. Special populations Noveron is not recommended for the facilitation of mechanical ventilation in the intensive care in pediatric and geriatric patients due to a lack of data on safety and efficacy. Administration Noveron is administered intravenously either as a bolus injection or as a continuous infusion (see section “Instructions for Handling of the Product” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Route Of Administration: INTRAVENOUS
Indication Info: INDICATION Noveron is indicated as an adjunct to general anesthesia to facilitate endotracheal intubation, to provide skeletal muscle relaxation and to facilitate mechanical ventilation in adults, children and infants from one month of age. Noveron is also indicated as an adjunct in the intensive care unit (ICU) to facilitate mechanical ventilation as part of Rapid Sequence Induction, however, this has not been stuled in infants and children.
Contraindications: CONTRAINDICATION Noveron is contraindicated in patients known to have hypersensitivity to rocuronium or to the bromide ion or to any of the excipients.
Atc Code: M03AC09
Pharma Manufacturer Name: GOLDPLUS UNIVERSAL PTE LTD

Active Ingredients

Rocuronium Bromide

10mg/ml

Rocuronium Bromide

10mg/ml

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Jun 12, 2024

Approval ID

9313266e8f596986

Type

Therapeutic

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