GMP Certified Ondansetron Hydrochloride Injection 8mg/4ml

• Customization: Available
• Application: Internal Medicine
• Usage Mode: I.M./I.V.
• Model NO.: ONDANS
• State: Liquid
• Shape: Sterile Liquid Injection
• Type: Organic Chemicals
• Pharmaceutical Technology: Chemical Synthesis
• Drug Reg./Approval No.: Available
• Drug Ad Approval No.: Available
• Shelf Time: 3 Years
• Quality Standard: IP/Cp
• Certificate: GMP/ISO
• Transport Package: AMPS/Box/Carton
• Specification: 8mg: 4ml
• Trademark: OEM
• Origin: China
• HS Code: 3004909099
• Production Capacity: 100000pices/Day

Product Description

 

1. Name of the medicinal product 
Ondansetron 2 mg/ml Solution for Injection or Infusion
2. Qualitative and quantitative composition
Each ml of solution for injection or infusion contains 2mg ondansetron (as ondansetron hydrochloride dihydrate)
Each ampoule with 2ml contains 4mg ondansetron (as ondansetron hydrochloride dihydrate).
Each ampoule with 4ml contains 8mg ondansetron (as ondansetron hydrochloride dihydrate).
Excipient with known effect: 1 ml solution for injection or infusion contains 3.62 mg of sodium as sodium citrate, sodium chloride and sodium hydroxide.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for Injection or Infusion
Clear colourless solution
4. Clinical particulars

4.1 Therapeutic indications
Adults:
Management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, Prevention and treatment of post-operative nausea and vomiting (PONV).
Paediatric Population:
Management of chemotherapy-induced nausea and vomiting in children aged ≥6 months.
Prevention and treatment of post-operative nausea and vomiting in children aged ≥ 1 month.
4.2 Posology and method of administration
Posology
Chemotherapy and radiotherapy induced nausea and vomiting:
Adults: The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The route of administration and dose of ondansetron should be flexible in the range of 8-32 mg a day and selected as shown below.
Emetogenic chemotherapy and radiotherapy:
Ondansetron can be given either by rectal, oral (tablets or syrup), intravenous or intramuscular administration.
For most patients receiving emetogenic chemotherapy or radiotherapy, ondansetron 8 mg should be administered as a slow intravenous injection (in not less than 30 seconds) or intramuscular injection, immediately before treatment followed by 8 mg orally twelve hourly.
To protect against delayed or prolonged emesis after the first 24 hours, oral or rectal treatment with ondansetron should be continued for up to 5 days after a course of treatment.
Highly emetogenic chemotherapy: For patients receiving highly emetogenic chemotherapy, e.g. high-dose cisplatin, ondansetron can be given either by oral, rectal, intravenous or intramuscular administration. Ondansetron has been shown to be equally effective in the following dose schedules over the first 24 hours of chemotherapy:
• A single dose of 8 mg by slow intravenous injection (in not less than 30 seconds) or intramuscular injection immediately before chemotherapy.
• A dose of 8 mg by slow intravenous injection (in not less than 30 seconds) or intramuscular doses of 8 mg two to four hours apart, or by a constant infusion of 1 mg/hour for up to 24 hours.
• A maximum initial intravenous dose of 16 mg diluted in 50-100 ml of saline or other compatible infusion fluid (see section 6.6) and infused over not less than 15 minutes immediately before chemotherapy. The initial dose of ondansetron may be followed by two additional 8 mg intravenous doses (in not less than 30 seconds) or intramuscular doses four hours apart.
• A single dose greater than 16 mg must not be given due to dose dependent increase of QT-prolongation risk (see sections 4.4, 4.8 and 5.1)
The selection of dose regimen should be determined by the severity of the emetogenic challenge.
The efficacy of ondansetron in highly emetogenic chemotherapy may be enhanced by the addition of a single intravenous dose  phosphate, 20 mg administered prior to chemotherapy.
To protect against delayed or prolonged emesis after the first 24 hours, oral or rectal treatment with ondansetron should be continued for up to 5 days after a course of treatment.
Paediatric Population:
CINV in children aged ≥6 months and adolescents:
The dose of CINV can be calculated based on body surface area (BSA) or weight - see below. In paediatric clinical studies, ondansetron was given by IV infusion diluted in 25 to 50 ml of saline or other compatible infusion fluid and infused over not less than 15 minutes.
Weight-based dosing results in higher total daily doses compared to BSA-based dosing - see sections 4.4 and 5.1
Ondansetron hydrochloride should be diluted in 5% dextrose or 0.9% sodium chloride or other compatible infusion fluid (see section 6.6) and infused intravenously over not less than 15 minutes.
There are no data from controlled clinical trials on the use of Ondansetron Injection in the prevention of delayed or prolonged CINV. There are no data from controlled clinical trials on the use of Ondansetron Injection for radiotherapy-induced nausea and vomiting in children.
Dosing by BSA:
Ondansetron should be administered immediately before chemotherapy as a single intravenous dose of 5 mg/m². The single intravenous dose must not exceed 8 mg.
Oral dosing can commence twelve hours later and may be continued for up to 5 days. (Table 1).
The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg.
Table 1: BSA-based dosing for Chemotherapy - Children aged ≥6 months and adolescents

 

BSA	Day 1^a,b	Days 2-6^(b)
< 0.6 m^2	5 mg/m^2 IV plus 2 mg syrup after 12 hrs	2 mg syrup every 12 hrs
≥0.6 m^2 to ≤ 1.2 m^2	5 mg/m^2 IV plus 4 mg syrup after 12 hrs	4 mg syrup or tablet every 12 hrs
> 1.2 m^2	5 mg/m^2IV plus 8 mg syrup or tablet after 12 hours	8 mg syrup or tablet every 12 hours

^a The intravenous dose must not exceed 8 mg.
^b The total daily dose over 24 hours ( given as divided doses) must not exceed adult dose of 32 mg.
Please note: Not all pharmaceutical forms may be available.
Dosing by bodyweight:
Weight-based dosing results in higher total daily doses compared to BSA-based dosing (see sections 4.4 and 5.1).
Ondansetron should be administered immediately before chemotherapy as a single intravenous dose of 0.15 mg/Kg. The single intravenous dose must not exceed 8 mg.
Two further intravenous doses may be given in 4-hourly intervals.
Oral dosing can commence 12 hours later and may be continued for up to 5 days. (Table 2).
The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg.
Table 2: Weight-based dosing for Chemotherapy - Children aged ≥6 months and adolescents

 

Weight	Day1^(a,b)	Days 2-6^(b)
≤10 kg	Up to 3 doses of 0.15 mg/kg IV every 4-hrs	2 mg syrup every 12 hrs
> 10 kg	Up to 3 doses of 0.15 mg/kg IV every 4-hrs	4 mg syrup or tablet every 12 hrs

^a The intravenous dose must not exceed 8 mg.
^b The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg.
Please note: Not all pharmaceutical forms may be available.
Elderly:
In patients 65 to 74 years of age, the dose schedule for adults can be followed. All intravenous doses should be diluted in 50-100 ml of saline or other compatible infusion fluid (see section 6.6) and infused over 15 minutes.
In patients 75 years of age or older, the initial intravenous dose of Ondansetron should not exceed 8 mg. All intravenous doses should be diluted in 50-100 ml of saline or other compatible infusion fluid (see section 6.6) and infused over 15 minutes.
The initial dose of 8 mg may be followed by two further intravenous doses of 8 mg, infused over 15 minutes and given no less than four hours apart. (see section 5.2)
Patients with renal impairment:
No alteration of daily dosage or frequency of dosing, or route of administration is required.
Patients with Hepatic impairment:
Clearance of ondansetron is significantly reduced and serum half-life significantly prolonged in subjects with moderate or severe impairment of hepatic function. In such patients a total daily dose of 8 mg should not be exceeded and therefore parenteral or oral administration is recommended.
Patients with poor sparteine/debrisoquine metabolism:
The elimination half-life of ondansetron is not altered in subjects classified as poor metabolisers of sparteine and debrisoquine. Consequently in such patients repeat dosing will give drug exposure levels no different from those of the general population. No alteration of daily dosage or frequency of dosing is required.
Post-operative nausea and vomiting (PONV):
Adults:
For the prevention of PONV: Ondansetron can be administered orally or by intravenous or intramuscular injection.