Kytron

Kytron Dosage/Direction for Use

granisetron

Manufacturer:

Duopharma (M)

Distributor:

Duopharma HAPI
Full Prescribing Info
Dosage/Direction for Use
Standard Dosage Chemotherapy Induced Nausea and Vomiting (CINV): Adults Prevention: A dose of 1-3 mg (10-40 mcg/kg) of Kytron Solution for Injection/Infusion 3 mg/3 ml should be administered either as a slow intravenous injection (over 30 seconds) or as an intravenous infusion diluted in 20 to 50 ml infusion fluid and administered over 5 minutes, prior to the start of chemotherapy.
Treatment: A dose of 1-3 mg (10-40 mcg/kg) Kytron Solution for Injection/Infusion 3 mg/3 ml should be administered either as a slow intravenous injection (over 30 seconds) or as an intravenous infusion diluted in 20 to 50 ml infusion fluid and administered over 5 minutes. Further treatment doses of Kytron Solution for Injection/Infusion 3 mg/3 ml may be administered, if required, at least 10 minutes apart. The maximum dose Kytron Solution for Injection/Infusion 3 mg/3 ml to be administered over 24 hours should not exceed 9 mg.
Pediatrics Prevention and treatment: A dose of 10-40 mcg/kg body weight (up to 3 mg) should be administered as an intravenous infusion, diluted in 10 to 30 ml infusion fluid and administered over 5 minutes prior to the start of chemotherapy. One additional dose may be administered within a 24 hour period if required. This additional dose should not be administered until at least 10 minutes after the initial infusion.
Radiotherapy Induced Nausea and Vomiting (RINV): Adults Prevention: A dose of 1-3 mg (10-40 mcg/kg) of Kytron Solution for Injection/Infusion 3 mg/3 ml should be administered either as a slow intravenous injection (over 30 seconds) or as an intravenous infusion diluted in 20 to 50 ml infusion fluid and administered over 5 minutes, prior to the start of radiotherapy.
Treatment: There is insufficient information to recommend the intravenous administration of Kytron Solution for Injection/Infusion 3 mg/3 ml in the treatment of RINV in adult patients.
Pediatrics: There is insufficient information to recommend intravenous administration of Kytron Solution for Injection/Infusion 3 mg/ 3ml in the prevention and treatment of RINV in children.
Post-operative Nausea and Vomiting (PONV): Adults Prevention: A dose of 1 mg (10 mcg/kg) of Kytron Solution for Injection/Infusion 3 mg/3 ml should be administered as a slow intravenous injection (over 30 seconds) prior to induction of anesthesia. Treatment: A dose of 1 mg (10 mcg/kg) of Kytron Solution for Injection/Infusion 3 mg/3 ml should be administered by slow intravenous injection (over 30 seconds). The maximum dose for patients undergoing anesthesia for surgery is a total dose of 3 mg of Kytron Solution for Injection/Infusion 3 mg/3 ml i.v. in one day.
Pediatrics: There is insufficient information to recommend intravenous administration of Kytron Solution for Injection/Infusion 3 mg/3 ml in the prevention and treatment of postoperative nausea and vomiting in pediatric patients.
Special Dosage Instructions: Geriatrics: No dosage adjustments required.
Renal impairment: No dosage adjustments required.
Hepatic Impairment: No dosage adjustments required.
Preparing the Solution with Compatible Diluent: Adults: To prepare the dose of 3 mg, withdraw 3 ml from the ampoule and dilute with a compatible infusion fluid to a total volume of 20 to 50 ml, in any of the following solutions: 0.9% sodium chloride, 0.18% sodium chloride and 4% glucose, 5% glucose, Hartmann's solution and mannitol.
Paediatric patients: To prepare the dose of 40 μg/kg, the appropriate volume is withdrawn (up to 3 ml from the ampoule) and diluted with infusion fluid (as for adults) to a total volume of 10 to 30 ml.
The injectable presentations contain no antimicrobial agent. Use once and discard any residue.
In order to reduce microbiological hazards it is recommended that the prepared infusion be commenced as soon as practicable after its preparation and should be completed within 24 hours. If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 25°C.
As a general precaution, Kytron Solution for Injection/Infusion 3 mg/3 ml should not be mixed in solution with other drugs other than dexamethasone sodium phosphate.
Admixtures of granisetron hydrochloride and dexamethasone sodium phosphate are compatible at concentrations of 10 to 60 μg/mL granisetron and 80 to 480 μg/mL dexamethasone phosphate in either 0.9% sodium chloride or 5% glucose intravenous infusion fluids. Stability data have been provided to demonstrate the physical and chemical stability of these solutions when stored at 25°C exposed to light for up to 24 hours. To reduce microbiological contamination hazards, it is recommended that admixing should be effected immediately prior to use and infusion commenced as soon as practicable after preparation. The admixture will have a shelf-life of 24 hours.
Parenteral drug products should be inspected visually for particulate matter and discolouration before administration whenever solution and container permit.
Route of Administration: IV Injection and IV Infusion.
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