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Translation - Chinese 1. NAME OF THE MEDICINAL PRODUCT
BEXTRA IM/IV, DYNASTAT, PRO-BEXTRA, PRO-VALDENE, RAYZON, VALDYNE, VALDUREIM
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
40 mg vial: Each vial contains 40 mg parecoxib (present as 42.36 mg parecoxib sodium) for reconstitution with 2 ml of solvent. After reconstitution, the final concentration of parecoxib is 20 mg/ml.
20 mg vial: Each vial contains 20 mg parecoxib (present as 21.18 mg parecoxib sodium) for reconstitution with 1 ml of solvent. After reconstitution, the final concentration of parecoxib is 20 mg/ml.
3. PHARMACEUTICAL FORM
Powder for solution for injection
Powder and solvent for solution for injection
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
Parecoxib is indicated for management of acute pain , pre-operatively (pre-emptive analgesia) to prevent or reduce post-operative pain, or concomitantly with opioid analgesics to reduce opioid requirements.
4.2. Posology and method of administration
Parecoxib may be administered as single or multiple IV or IM doses on a regular or as needed schedule. After initiation of therapy, dosage should be adjusted based on patient response. Clinical studies with parecoxib were conducted using up to 7 days of treatment. Parecoxib is only indicated for patients with a need for parenteral therapy and for whom a similar benefit could not be obtained from alternative oral therapy. It is recommended that patients be transitioned to alternative oral therapy as soon as clinically indicated.
As the cardiovascular (CV) risk of cyclooxygenase-2 (COX-2) specific inhibitors may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. However, the relevance of these findings for the short- term use of parecoxib in the postoperative setting has not been evaluated.
Management of Acute Pain: The recommended single or initial dose for treatment of acute pain is 40 mg, administered either IV or IM, followed by 20 mg or 40 mg every 6 to 12 hours, as required, up to a maximum daily dosage of 80 mg. The IV bolus injection may be given directly into a vein or into an existing IV line. The IM injection should be given slowly and deeply into the muscle.
Prevention or Reduction of Post-operative Pain: The recommended dose is 40 mg administered IV or IM (but preferably IV) 30 to 45 minutes prior to surgical incision. Continued medication with parecoxib post-operatively may be needed for adequate analgesic effect.
Concomitant Use with Opioid Analgesics: Opioid analgesics can be used concurrently with parecoxib, dosing as described above. In clinical trials, the daily requirement for opioids was significantly reduced (20%-40%) when coadministered with parecoxib. An optimal effect is achieved when parecoxib is given prior to opioid administration. In all clinical assessments parecoxib was administered at a fixed time interval whereas the opioids were administered on as needed basis (PRN).
Elderly: No dosage adjustment is generally necessary. However, for elderly patients weighing less than 50 kg, it is advisable to reduce the initial dose of parecoxib by 50%. The maximum daily dose should be reduced to 40 mg in elderly patients weighing less than 50 kg.
Hepatic Impairment: No dosage adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A). Treatment with parecoxib should be initiated at the lowest recommended dose in patients with moderate hepatic impairment (Child-Pugh Class B).
Patients with severe hepatic impairment (Child-Pugh Class C) have not been studied. The use of parecoxib in these patients is not recommended.
Renal Impairment: In patients with severe renal impairment (creatinine clearance
Chinese to English: 预灌封注射器组合件（带注射针） General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - Chinese YBB00112004 ·2015
Yuguanfeng Zhusheqi Zuhejian（Daizhushezhen
Assemblages for Prefilled Syringes（with Stainless Steel Needles)
【活塞滑动性能】取本品适量，将推杆活塞放入硅油润滑的针管中，以100mm/min± 5 mm/min的速度推动推杆。活塞滑动的启始力和活塞持续滑动的持续力应符合表1的规定。
规格（标示容量，ml） 启始力（Fmax, N） 持续力（Fmax, N）
Translation - English YBB00112004 -2015
Yuguanfeng Zhusheqi Zuhejian（Daizhushezhen）
Assemblages for Prefilled Syringe Assemblage（with Stainless Steel Needles)
This standard applies to prefilled syringe assemblages (with stainless steel needles), which consist of a glass syringe tube, a rubber piston, a stainless steel needle, a needle cap and a pusher.
Appearance: When inspected by bare eyes under bright natural light, the glass syringe tube cover should be free of cracks. The coil edges and the cone head should exhibit no deformation or fractures. Besides, the outer surface of the tube should exhibit no spots, stains, scratches or any unclear printing that may affect its use. The needle should exhibit no separation and obstruction, and it should position correctly without being upside down. The needle and its cap should not be separated.
Glass syringe tube: Must comply with the requirements for boron-silicon glass tubes for prefilled syringes (YBB00062004-2015).
Rubber pistons: Must comply with the requirements for butyl chloride rubber pistons for prefilled syringes (YBB00072004-2015) or brominated butyl rubber pistons for prefilled syringes (YBBM082004-2015).
Stainless steel needles: Must comply with the requirements for stainless steel injection needles for prefilled syringes (YBB00092004-2015).
Needle cap: Must comply with the requirements of polyheteride rubber needle cap for prefilled syringes (YBB00102004-2015).
The connection force between the needle and its seat: Locate and fix the syringe on the test machine, and perform needle pulling tests at a speed of 100±5mm/min and a pull force of not less than 22N. The stainless steel needle must not be loosened or separated from its pin seat.
The pull-out force of needle caps: Locate and fix the needle cap and the tube on the test machine, and perform pull-out tests at a speed of 100±5mm/min. The pull-out force should lie between 4.0-45.0N.The piston-pusher fitness (only for threaded pistons): Connect the pusher to the piston, and fully insert the piston into a prefilled syringe lubricated by silicone oil and half-filled with water to eject air. Put the needle cap on the syringe, and slowly withdraw the piston back for about 3mm. The pusher should remain stable and not separated from the piston.Piston Lubricity: Insert the piston into the syringe tube lubricated by silicone oil, and push the piston fully inside the syringe tube with a push rod. The piston should move smoothly without sudden resistance.
Piston Sliding: Insert the piston into the syringe tube lubricated by silicone oil, and push the piston inside at a speed of 100±5 mm/min. The start and continuous forces for piston sliding should comply with Table 1.
Table 1 Sliding Performance Specifications
Tube Volume (marked capacity, ml) Start Force (Fmax, N) Continuous Force (Fmax, N)
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