Dynastat

parecoxib

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Dynastat. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Dynastat.

: Dynastat is a medicine that contains the active substance parecoxib. It is available as a powder to be made up into a solution for injection, in vials containing 20 or 40 mg of parecoxib, with or without a solvent.

: Dynastat is used in adults for the short-term treatment of pain after an operation.
The medicine can only be obtained with a prescription.

: Dynastat is given at a dose of 40 mg, followed by further doses of 20 or 40 mg as required every six to 12 hours, with a maximum dose of 80 mg a day. The injection may be given rapidly and directly into a vein or into an existing intravenous line (a thin tube running into a vein), or it can be given slowly and deeply into a muscle. Dynastat can be given at the same time as opioid painkillers (medicines that are related to morphine).
As with other medicines in the same group as Dynastat, the risk of heart and blood-vessel problems may increase with higher doses and longer durations of Dynastat treatment. The shortest duration possible and the lowest effective dose of Dynastat should be used.
For elderly patients weighing less than 50 kg and for patients with moderate liver problems, treatment is with half the usual recommended dose of Dynastat, with a maximum daily dose of 40 mg. Dynastat must not be used in patients with severe liver problems. In patients with severe kidney problems or who are likely to develop fluid retention, treatment should start with the lowest dose and the patient’s kidneys should be monitored closely.

: The active substance in Dynastat, parecoxib, is a ‘prodrug’ of valdecoxib. This means that it is converted to valdecoxib in the body. Valdecoxib is a non‑steroidal anti‑inflammatory drug (NSAID) that belongs to the group of medicines called ‘cyclo‑oxygenase‑2 (COX‑2) inhibitors’. It blocks the COX‑2 enzyme, resulting in a reduction in the production of prostaglandins, substances that are involved in the inflammation process. By reducing the production of prostaglandins, Dynastat helps to reduce the symptoms of inflammation, including pain.

: Dynastat has been studied in 2,582 adults who had undergone a variety of surgical procedures including dental, orthopaedic (bone), gynaecological or coronary (heart) bypass surgery. Dynastat was compared with placebo (a dummy treatment) as well as with other painkillers such as ketorolac, morphine, valdecoxib, ibuprofen and tramadol. Some of the studies also looked at the impact of giving Dynastat on the patient’s use of morphine for additional pain relief after surgery. The main measures of effectiveness were changes in pain scores as rated by the patients.

: Dynastat was effective in relieving moderate to severe pain after an operation. It was generally more effective than placebo and as effective as other painkillers. Dynastat was also shown to reduce the need for morphine, but this reduction did not seem to be accompanied with a reduction in the side effects associated with morphine.

The most common side effect with Dynastat (seen in more than 1 patient in 10) is nausea (feeling sick). For the full list of all side effects reported with Dynastat, see the package leaflet.

Dynastat must not be used in people who are hypersensitive (allergic) to parecoxib or any of the other ingredients. Dynastat must not be used in patients with:

a history of serious allergic reactions to medicines, especially skin reactions;
stomach ulcers or bleeding in the stomach or gut;
allergic-type reactions such as bronchospasm (excessive and prolonged contraction of the airway muscles), cold-like symptoms, polyps in the nose, swelling of the face or hives after taking aspirin or NSAIDs, including other COX-2 inhibitors;
severe liver disease;
inflammatory bowel disease;
heart failure (an inability of the heart to pump enough blood around the body), ischaemic heart disease (disease of the heart caused by failure in the blood supply), peripheral artery disease (obstruction of the arteries in the arms or legs), or cerebrovascular disease (problems affecting the blood vessels in the brain).

Dynastat must not be given to women during the last three months of pregnancy or to breast-feeding women. It must not be used after coronary bypass surgery.

: The CHMP decided that Dynastat’s benefits are greater than its risks and recommended that it be given marketing authorisation.

: The European Commission granted a marketing authorisation valid throughout the European Union for Dynastat on 22 March 2002.
For more information about treatment with Dynastat, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

List item

Dynastat : EPAR - Summary for the public (PDF/65.87 KB)

First published: 15/04/2009
Last updated: 09/02/2012
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More detail is available in the summary of product characteristics

This EPAR was last updated on 11/10/2018

Authorisation details

Product details
Name	Dynastat
Agency product number	EMEA/H/C/000381
Active substance	parecoxib sodium
International non-proprietary name (INN) or common name	parecoxib
Therapeutic area (MeSH)	Pain, Postoperative
Anatomical therapeutic chemical (ATC) code	M01AH04

Publication details
Marketing-authorisation holder	Pfizer Europe MA EEIG
Revision	27
Date of issue of marketing authorisation valid throughout the European Union	22/03/2002
Contact address	Boulevard de la Plaine 17 1050 Bruxelles Belgium

Product information

28/09/2018 Dynastat - EMEA/H/C/000381 - T/0073

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Dynastat : EPAR - Product Information (PDF/349.25 KB)

First published: 08/01/2010
Last updated: 11/10/2018
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  (PDF/366.9 KB)
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Annex I - Summary of product characteristics
Annex IIA - Manufacturing-authorisation holder responsible for batch release
Annex IIB - Conditions of the marketing authorisation
Annex IIIA - Labelling
Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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Dynastat : EPAR - All Authorised presentations (PDF/74.59 KB)

First published: 15/11/2005
Last updated: 24/08/2012
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Pharmacotherapeutic group

Anti inflammatory and antirheumatic products

Therapeutic indication

For the short-term treatment of postoperative pain in adults.

Assessment history

Changes since initial authorisation of medicine

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Dynastat : EPAR - Procedural steps taken and scientific information after authorisation (PDF/228.46 KB)

First published: 08/01/2010
Last updated: 11/10/2018
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Dynastat-H-C-381-II-0032 : EPAR - Scientific Discussion - Variation (PDF/629.1 KB)

Adopted

First published: 08/05/2009
Last updated: 08/05/2009
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Dynastat : EPAR - Steps taken after authorisation when a cutoff date has been used (PDF/93.65 KB)

First published: 15/11/2005
Last updated: 15/11/2005
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Dynastat-H-C-381-A18-20 : EPAR - Scientific Conclusion (PDF/102.91 KB)

First published: 15/11/2005
Last updated: 15/11/2005
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- Italian
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  (PDF/113.47 KB)
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  (PDF/123.74 KB)
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- Swedish
  (PDF/104.13 KB)

Initial marketing-authorisation documents

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Dynastat

Table of contents

Overview

Dynastat : EPAR - Summary for the public (PDF/65.87 KB)

Authorisation details

Product information

Dynastat : EPAR - Product Information (PDF/349.25 KB)

Contents

Dynastat : EPAR - All Authorised presentations (PDF/74.59 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Dynastat : EPAR - Procedural steps taken and scientific information after authorisation (PDF/228.46 KB)

Dynastat-H-C-381-II-0032 : EPAR - Scientific Discussion - Variation (PDF/629.1 KB)

Dynastat : EPAR - Steps taken after authorisation when a cutoff date has been used (PDF/93.65 KB)

Dynastat-H-C-381-A18-20 : EPAR - Scientific Conclusion (PDF/102.91 KB)

Initial marketing-authorisation documents

Dynastat : EPAR - Scientific Discussion (PDF/286.8 KB)

Dynastat : EPAR - Procedural steps taken before authorisation (PDF/88.79 KB)

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