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Sinclair IS Pharma

Office Village, Chester Business Park, Chester , CH4 9QZ
Telephone: +44 (0) 1244 625 150
Fax: +44 (0) 1244 625 151
WWW: http://www.ispharma.plc.uk
Medical Information Direct Line: +44 (0) 1244 625 152
Medical Information e-mail: enquiries@ispharma.plc.uk
Customer Care direct line: +44 (0) 1244 625 152
Medical Information Fax: +44 (0) 1748 828 801

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 17/08/2010
SPC Variquel 1mg powder and solvent for solution for injection

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 17/08/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   04-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

  • Septic shock has moved from section 4.3 (Contraindications) to 4.4 (Special warnings and precautions for use).
  • Section 4.4 (Special warnings and precautions for use), changes to advice regarding use in children.
  • Section 4.8 (Undesirable effects), hyponatraemia changed from common to uncommon.
  • Section 4.8, tachycardia changed from common to uncommon.
  • Section 4.8, following disorders added: atrial fibrillation; ventricular extrasystoles; chest pain; myocardial infarcation; fluid overload; with pulmonary oedema; caridiac failure; Torsade de Pointes; peripheral vasoconstriction; facial pallor; intestinal ischaemia; peripheral cyanosis; hot flushes; distress; respiratory failure; transient abdominal cramps; transient diarrhoea; transient nausea; transient vomiting; skin necrosis unrelated to the site of administration.
  • Section 4.8, Pregnancy, puerperium and perinatal conditions added.
Updated on 06/07/2009 and displayed until 17/08/2010
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  terlipressin acetate