Riik: Singapur
keel: inglise
Allikas: HSA (Health Sciences Authority)
Parecoxib Sodium 42.36mg eqv Parecoxib
PFIZER PRIVATE LIMITED
M01AH04
40mg
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Parecoxib Sodium 42.36mg eqv Parecoxib 40mg
INTRAVENOUS, INTRAMUSCULAR
Prescription Only
Pharmacia & Upjohn Company LLC
ACTIVE
2012-05-14
DYNASTAT ® TABLE OF CONTENT _Please click on either of the following links to access the required information: _ PRESCRIBING INFORMATION PATIENT INFORMATION LEAFLET Page 1 of 14 DYNASTAT ® 1. NAME OF THE MEDICINAL PRODUCT Dynastat Powder and Solvent for Solution for Injection 40 mg. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 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. Each ampoule contains 2 mL of sodium chloride 9 mg/mL. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Parecoxib is indicated for the short-term treatment of acute post-operative pain. There is limited clinical experience with parecoxib treatment beyond three days. 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. 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. 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 every 6 to 12 hours, as required. The maximum daily dosage is 60 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. Concomitant Use with Opioid Analgesics: Opioid analgesics can be used concurrently with parecoxib, do Lugege kogu dokumenti
DYNASTAT ® 1. NAME OF THE MEDICINAL PRODUCT Dynastat Powder for Solution for Injection 40 mg. Dynastat Powder and Solvent for Solution for Injection 40 mg. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 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. Each ampoule contains 2 mL of sodium chloride 9 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 the short term treatment of acute post-operative pain. There is limited clinical experience with parecoxib treatment beyond three days. 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. 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. 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 every 6 to 12 hours, as required. The maximum daily dosage is 60 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. 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 significa Lugege kogu dokumenti