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SPC: DYNASTAT Powder and solvent for solution for injection (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Dynastat 40 mg powder and solvent for solution for injection.

Qualitative and quantitative composition

Powder vial: Each vial contains 40 mg parecoxib (as 42.36 mg parecoxib sodium). After reconstitution, the concentration of parecoxib is 20 mg/ml. Each 2 ml of reconstituted powder contains 40 mg of parecoxib. ...

Pharmaceutical form

Powder and solvent for solution for injection (powder for injection). White to off-white powder. Solvent: clear and colourless solution.

Therapeutic indications

For the short-term treatment of postoperative pain in adults. The decision to prescribe a selective cyclooxygenase-2 (COX-2) inhibitor should be based on an assessment of the individual patients overall ...

Posology and method of administration

Posology The recommended dose is 40 mg administered intravenously (IV) or intramuscularly (IM), followed every 6 to 12 hours by 20 mg or 40 mg as required, not to exceed 80 mg/day. As the cardiovascular ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. History of previous serious allergic drug reaction of any type, especially cutaneous reactions such as Stevens-Johnson ...

Special warnings and precautions for use

Dynastat has been studied in dental, orthopaedic, gynaecologic (principally hysterectomy) and coronary artery bypass graft surgery. There is limited experience in other types of surgery, for example gastrointestinal ...

Interaction with other medicinal products and other forms of interaction

Pharmacodynamic interactions Anticoagulant therapy should be monitored, particularly during the first few days after initiating Dynastat therapy in patients receiving warfarin or other anticoagulants, ...

Fertility, pregnancy and lactation

Pregnancy Parecoxib is suspected to cause serious birth defects when administered during the last trimester of pregnancy because as with other medicinal products known to inhibit prostaglandin, it may ...

Effects on ability to drive and use machines

Patients who experience dizziness, vertigo or somnolence after receiving Dynastat should refrain from driving or operating machines.

Undesirable effects

Summary of the safety profile The most common adverse reaction for Dynastat is nausea. The most serious reactions occur uncommonly to rarely, and include cardiovascular events such as myocardial infarction ...

Overdose

Reporting of overdose with parecoxib has been associated with adverse reactions which have also been described with recommended doses of parecoxib. In case of overdose, patients should be managed by symptomatic ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, Coxibs ATC code: M01AH04 Parecoxib is a prodrug of valdecoxib. Valdecoxib is a selective COX-2 inhibitor within the clinical dose ...

Pharmacokinetic properties

Following IV or IM injection, parecoxib is rapidly converted to valdecoxib, the pharmacologically active substance, by enzymatic hydrolysis in the liver. Absorption Exposure of valdecoxib following single ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology or repeated dose toxicity at 2-fold the maximum human exposure to parecoxib. However, in the repeated ...

List of excipients

Powder: Disodium hydrogen phosphate Phosphoric acid and/or sodium hydroxide (for pH adjustment) Solvent: Sodium chloride Hydrochloric acid or sodium hydroxide (for pH adjustment) Water for injection

Incompatibilities

This medicinal product must not be mixed with other medicinal products except for those mentioned in section 6.6. Dynastat and opioids should not be administered together in the same syringe. Use of Ringer-Lactate ...

Shelf life

Shelf life The shelf life of the unreconstituted product is 3 years. Chemical and physical in-use stability of the reconstituted solution, which should not be refrigerated or frozen, have been demonstrated ...

Special precautions for storage

This medicinal product does not require any special storage conditions prior to reconstitution. For storage conditions of the reconstituted medicinal product see section 6.3.

Nature and contents of container

Parecoxib sodium vials: Type I colourless glass vials (5 ml) with a butyl rubber stopper, sealed with a purple polypropylene flip-off cap on the aluminium overseal. Solvent ampoules: 2 ml ampoule: colourless ...

Special precautions for disposal and other handling

Dynastat must be reconstituted before use. Dynastat is preservative free. Aseptic technique is required for its preparation. Reconstitution solvents Reconstitute Dynastat 40 mg with 2 ml sodium chloride ...

Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Marketing authorization number(s)

EU/1/02/209/006-008

Date of first authorization / renewal of the authorization

Date of first authorisation: 22 March 2002 Date of latest renewal: 24 January 2012

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