DYNASTAT Powder for solution for injection (2021)
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Περιεχόμενα
Name of the medicinal product
Dynastat 40 mg powder for solution for injection.
Qualitative and quantitative composition
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. Excipient ...
Pharmaceutical form
Powder for solution for injection (powder for injection). White to off-white powder.
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
Disodium hydrogen phosphate Phosphoric acid and/or sodium hydroxide (for pH adjustment)
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
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 for up ...
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
Type I colourless glass vials (5 ml) with a butyl rubber stopper, sealed with a purple polypropylene flip-off cap on the aluminium overseal. Dynastat is available in packs containing 10 vials.
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 Acceptable solvents for reconstitution of Dynastat are: ...
Marketing authorization holder
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Marketing authorization number(s)
EU/1/02/209/005
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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