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Swedish Orphan Biovitrum Ltd

Suite 2, Building 3, Riverside Site, Granta Park, Great Abington,, Cambridgeshire, CB21 6AD
Telephone: +44 (0) 1223 891854
Fax: +44 (0) 1223 893554
WWW: http://www.sobi.com
Medical Information Direct Line: +44 (0) 1748 828863
Medical Information e-mail: sobi@professionalinformation.co.uk
Customer Care direct line: +44 (0) 1748 828863
Medical Information Facsimile: +44 (0) 1223 893554
Summary of Product Characteristics last updated on medicines.ie: 13/10/2017
SPC Cyanokit 5g

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

Updated on 13/10/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   20-Jul-2017
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



4.            Pharmacological properties

4.4          Special warnings and precautions for use

 

Inserted: Renal disorders

Oxalate crystals have been observed in the urine of healthy volunteers given hydroxocobalamin. Cases of acute renal failure with acute tubular necrosis, renal impairment and urine calcium oxalate crystals present have been reported in patients treated with hydroxocobalamin following known or suspected cyanide poisoning. In some situations, hemodialysis was required to achieve recovery (see section 4.8).

Therefore, as a precaution, after Cyanokit administration, regular monitoring of renal function (including blood urea nitrogen and serum creatinine) should be performed until 7 days after drug onset.

 

 

4.8          Undesirable effects

 

Deleted: Most patients will experience a reversible red colouration of the skin and mucous membranes that may last up to 15 days after administration of Cyanokit. All patients will show a dark red colouration of the urine quite marked during the three days following administration. Urine colouration may last up to 35 days after administration of Cyanokit.

 

Skin and subcutaneous tissue disorders

 

Inserted: Reversible red colouration of the skin and mucous membranes: most patients will experience it up to 15 days after administration of Cyanokit.

Pustular rashes, which may last for several weeks, affecting mainly the face and the neck.

 

Renal and urinary disorders

 

·                Acute renal failure with acute tubular necrosis, renal impairment, urine calcium oxalate crystals present (see section 4.4).

·                Chromaturia: all patients will show a dark red colouration of the urine quite marked during the first three days following administration. Urine colouration may last up to 35 days after administration of Cyanokit (see section 4.4).

 

 

10.       DATE OF REVISION OF THE TEXT

 

Deleted: 06/2015

Inserted: 20/07/2017

Updated on 14/07/2015 and displayed until 13/10/2017
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   22-Jun-2015
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



From (previous MAH):  Merck Santé s.a.s.

                                        37, rue Saint-Romain

                                        69379 Lyon Cedex 08

                                        France

 

To (current MAH):         SERB S.A.

                                        Avenue Louise 480

                                        1050 Brussels

                                        Belgiento

 

Approval date:   2015-06-22

Updated on 10/03/2015 and displayed until 14/07/2015
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   28-Nov-2014
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

rev of text date updated to 11 2014
Updated on 09/12/2014 and displayed until 10/03/2015
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   31-Jul-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

revision of text. formatting.
Updated on 21/11/2011 and displayed until 09/12/2014
Reasons for adding or updating:
  • Addition of joint SPC covering all presentations
Date of revision of text on the SPC:  
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Hydroxocobalamin