| Dossier: | Ctd |
|---|---|
| Transport Package: | Free |
| Specification: | 40mg |
| Trademark: | Sinolead |
| Origin: | China |
| Samples: |
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| Customization: |
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Audited Supplier 
| Generic Name | Parecoxib Sodium for Injection 40mg |
| Strength | 40mg |
| Packing | 1 vial+1 Ampoule/box |
| Origin | China |
This product is white or white freeze-dried lump.
For short-term treatment of pain after surgery.
Before deciding to use selective COX-2 inhibitors, a patient's overall risk should be assessed.
Usage and dosage:
The recommended dose is 40 mg, administered intravenously (IV) or intramuscular (IM), followed by 20 mg or 40 mg at 6-12 hour intervals as needed, with a total dose not exceeding 80 mg per day. Rapid intravenous infusion can be administered directly or through an existing intravenous access. Intramuscular injection should choose deep muscle slow injection.
Limited clinical experience using this product for more than three days.
Combination with opioid analgesics: Opioid analgesics can be used in conjunction with parecoxib, the dosage of this product is referred to above. In all clinical evaluations, parecoxib was dosed at fixed intervals, whereas opioids were dosed as needed.
Because the risk of cardiovascular events with selective COX-2 inhibitors increases with dose and duration of exposure, the shortest course and lowest daily effective dose should be used.
Because parecoxib precipitates when mixed with other drugs in solution, it is strictly prohibited to mix Parecoxib with other drugs either during dissolution or injection. If parecoxib and other drugs are used in the same intravenous access, the intravenous access should be fully flushed with a compatible solution before and after injection of parecoxib solution.
Compatibility of intravenous access solutions
When formulated with the appropriate solution, parecoxib solution can only be administered intravenously, intramuscularly, or intravenously with the addition of the following fluids:
Sodium chloride solution 9 mg/ml(0.9%)
Glucose Injection 50 g/L(5%)
Sodium chloride 4.5 mg/ml(0.45%) and glucose 50g/L(5%) injection
Lactate Ringer's fluid
It is not recommended to add parecoxib to lactate Ringer's solution containing 50 g/L(5%) glucose or to other intravenous pathways where no solution is listed because it can precipitate in solution.
Elderly patients: In general, dose adjustment is not necessary for elderly patients (≥65 years). However, for older patients weighing less than 50 kg, the initial dose of parecoxib should be reduced to half of the conventional recommended dose and the maximum daily dose should be reduced to 40 mg.
Liver impairment: Usually, patients with mild liver impairment (Child-Pugh score 5-6) do not have to undergo dose adjustment. Patients with moderate liver impairment (Child-Pugh score 7-9) should use parecoxib with caution, and the dose should be reduced to half of the conventional recommended dose and the maximum daily dose to 40 mg. There is no clinical experience in patients with severe liver function impairment (Child-Pugh score ≥10), and the use of parecoxib is therefore prohibited in such patients.
Renal impairment: Depending on the pharmacokinetics of parrecoxib, dose adjustment is not necessary in patients with mild to moderate (creatinine clearance 30-80 ml/min) or severe (creatinine clearance [30 ml/min]) renal impairment. However, patients with renal impairment and those with a tendency to fluid retention should be closely monitored.
Children and adolescents: There is no experience with use in children or adolescents, so it is not recommended for use in this population.
Instructions for use and disposal (including disposal)
Parecoxib sodium for injection must be reformulated before use. Because it contains no preservatives. Therefore, aseptic technology is required for preparation.
Solvent preparation:
Solvents that can be used to formulate parecoxib sodium for injection include:
Sodium chloride solution 9 mg/ml(0.9%)
Glucose Injection 50 g/L(5%)
Sodium chloride 4.5 mg/ml(0.45%) Glucose 50 g/L(5%) injection
Preparation process:
Parecoxib freeze-dried powder (parecoxib sodium) was prepared by aseptic technique. Remove the yellow (20 mg)/purple (40 mg) clasp cap to expose the central part of the rubber stopper of the Paracxib glass bottle. Use a sterile syringe and needle to draw the appropriate solvent (20 mg of parecoxib sodium prepared with 1 ml of solvent, 40 mg of parecoxib sodium prepared with 2 ml of solvent), then insert the needle into the center of the rubber stopper and inject the solvent into the bottle. Rotate the bottle gently to dissolve the powder completely and check the prepared solution carefully before use. Drain all the liquid from the bottle for single administration.
After preparation, the parecoxib sodium solution should be visually inspected before use to determine if the solution has insoluble particles or discoloration. If discoloration, flocculent or insoluble particles are observed, do not use.
It has been proved that the physical and chemical stability of the prepared liquid can be maintained for 24 hours at 25ºC. From a microbiological point of view, aseptically formulated solutions should be used immediately, and users must control their storage time and conditions before use. In general, it should not be stored at 25 ° C for more than 12 hours, unless the solution is prepared in a strictly controlled and verified sterile environment, after preparation, the parecoxib solution should be used within 24 hours, otherwise it should be discarded.
The parecoxib sodium solution after preparation was isotonic solution.
The prepared solution is for single use only. Any unused solutions, solvents, or discarded items after preparation should be disposed of in accordance with local requirements.
Drug incompatibility
Parecoxib should not be mixed with any drug other than those listed in the Guidelines for Use and Disposal (including Disposal).
Parecoxib should not be mixed with opioids in the same syringe.
Prepared with lactate Ringer's solution or lactate Ringer's solution containing 50 g/L(5%) glucose, Parecoxib will precipitate in solution, so it is not recommended.
The use of sterilized water for injection is not recommended because the resulting solution is not isotonic.
The parecoxib solution should not be injected into the intravenous channels of other drugs. Intravenous access should be fully flushed with a compatible solution before and after injection of parecoxib solution.
Because it can cause parecoxib to precipitate in solution, it is not recommended to add parecoxib to lactate Ringer's solution containing 50 g/L (5%) glucose or other intravenous access not listed in [Guidelines for Use and Disposal (including disposal)].
Matters needing attention:
The recommended dose is 40 mg, administered intravenously (IV) or intramuscular (IM), followed by 20 mg or 40 mg at 6-12 hour intervals as needed, with a total dose not exceeding 80 mg per day. Rapid intravenous infusion can be administered directly or through an existing intravenous access. Intramuscular injection should choose deep muscle slow injection.
Limited clinical experience using this product for more than three days.
Combination with opioid analgesics: Opioid analgesics can be used in conjunction with parecoxib, the dosage of this product is referred to above. In all clinical evaluations, parecoxib was dosed at fixed intervals, whereas opioids were dosed as needed.
Because the risk of cardiovascular events with selective COX-2 inhibitors increases with dose and duration of exposure, the shortest course and lowest daily effective dose should be used.
Because parecoxib precipitates when mixed with other drugs in solution, it is strictly prohibited to mix Parecoxib with other drugs either during dissolution or injection. If parecoxib and other drugs are used in the same intravenous access, the intravenous access should be fully flushed with a compatible solution before and after injection of parecoxib solution.
Compatibility of intravenous access solutions
When formulated with the appropriate solution, parecoxib solution can only be administered intravenously, intramuscularly, or intravenously with the addition of the following fluids:
Sodium chloride solution 9 mg/ml(0.9%)
Glucose Injection 50 g/L(5%)
Sodium chloride 4.5 mg/ml(0.45%) and glucose 50g/L(5%) injection
Lactate Ringer's fluid
It is not recommended to add parecoxib to lactate Ringer's solution containing 50 g/L(5%) glucose or to other intravenous pathways where no solution is listed because it can precipitate in solution.
Elderly patients: In general, dose adjustment is not necessary for elderly patients (≥65 years). However, for older patients weighing less than 50 kg, the initial dose of parecoxib should be reduced to half of the conventional recommended dose and the maximum daily dose should be reduced to 40 mg.
Liver impairment: Usually, patients with mild liver impairment (Child-Pugh score 5-6) do not have to undergo dose adjustment. Patients with moderate liver impairment (Child-Pugh score 7-9) should use parecoxib with caution, and the dose should be reduced to half of the conventional recommended dose and the maximum daily dose to 40 mg. There is no clinical experience in patients with severe liver function impairment (Child-Pugh score ≥10), and the use of parecoxib is therefore prohibited in such patients.
Renal impairment: Depending on the pharmacokinetics of parrecoxib, dose adjustment is not necessary in patients with mild to moderate (creatinine clearance 30-80 ml/min) or severe (creatinine clearance [30 ml/min]) renal impairment. However, patients with renal impairment and those with a tendency to fluid retention should be closely monitored.
Children and adolescents: There is no experience with use in children or adolescents, so it is not recommended for use in this population.
Instructions for use and disposal (including disposal)
Parecoxib sodium for injection must be reformulated before use. Because it contains no preservatives. Therefore, aseptic technology is required for preparation.
Solvent preparation:
Solvents that can be used to formulate parecoxib sodium for injection include:
Sodium chloride solution 9 mg/ml(0.9%)
Glucose Injection 50 g/L(5%)
Sodium chloride 4.5 mg/ml(0.45%) Glucose 50 g/L(5%) injection
Preparation process:
Parecoxib freeze-dried powder (parecoxib sodium) was prepared by aseptic technique. Remove the yellow (20 mg)/purple (40 mg) clasp cap to expose the central part of the rubber stopper of the Paracxib glass bottle. Use a sterile syringe and needle to draw the appropriate solvent (20 mg of parecoxib sodium prepared with 1 ml of solvent, 40 mg of parecoxib sodium prepared with 2 ml of solvent), then insert the needle into the center of the rubber stopper and inject the solvent into the bottle. Rotate the bottle gently to dissolve the powder completely and check the prepared solution carefully before use. Drain all the liquid from the bottle for single administration.
After preparation, the parecoxib sodium solution should be visually inspected before use to determine if the solution has insoluble particles or discoloration. If discoloration, flocculent or insoluble particles are observed, do not use.
It has been proved that the physical and chemical stability of the prepared liquid can be maintained for 24 hours at 25ºC. From a microbiological point of view, aseptically formulated solutions should be used immediately, and users must control their storage time and conditions before use. In general, it should not be stored at 25 ° C for more than 12 hours, unless the solution is prepared in a strictly controlled and verified sterile environment, after preparation, the parecoxib solution should be used within 24 hours, otherwise it should be discarded.
The parecoxib sodium solution after preparation was isotonic solution.
The prepared solution is for single use only. Any unused solutions, solvents, or discarded items after preparation should be disposed of in accordance with local requirements.
Drug incompatibility
Parecoxib should not be mixed with any drug other than those listed in the Guidelines for Use and Disposal (including Disposal).
Parecoxib should not be mixed with opioids in the same syringe.
Prepared with lactate Ringer's solution or lactate Ringer's solution containing 50 g/L(5%) glucose, Parecoxib will precipitate in solution, so it is not recommended.
The use of sterilized water for injection is not recommended because the resulting solution is not isotonic.
The parecoxib solution should not be injected into the intravenous channels of other drugs. Intravenous access should be fully flushed with a compatible solution before and after injection of parecoxib solution.
Because it can cause parecoxib to precipitate in solution, it is not recommended to add parecoxib to lactate Ringer's solution containing 50 g/L (5%) glucose or other intravenous access not listed in [Guidelines for Use and Disposal (including disposal)].
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Audited Supplier 
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