eMC Medicine Guides  
The electronic Medicines Compendium (eMC) contains information about UK licensed medicines.
go to eMC homepage
Search for:  
  Advanced Search

Kyowa Hakko Kirin UK Ltd
258 Bath Road, Slough, Berkshire, SL1 4DX
Telephone: +44 (0)1753 566 020
Fax: +44 (0)1753 566 030
Medical Information e-mail: medinfo@kyowa-kirin.co.uk.
Medical Information Fax: +44 (0)1753 566 030

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: 02/06/2009
SPC Mitomycin-C Kyowa, 2mg, 10mg, 20mg or 40mg powder 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 02/06/2009 and displayed until Current
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:   03-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

In Section 7, the name of the Marketing Authorisation Holder has been changed from:

Kyowa Hakko UK Ltd. to Kyowa Hakko kirin UK Ltd.

In Section 10, the Date of Revision of the Text has been revised from:

November 2007 to April 2009

 
Updated on 03/12/2007 and displayed until 02/06/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   11/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8 - Under the heading of Undesirable effects
General weakness and lethargy have been reported on rare occasions.  Other reported effects include anorexia, weight loss, diarrhoea, constipation, abdominal discomfort, pyrexia, stomatitis, pulmonary fibrosis, haemolytic-uraemic syndrome, microangiopathic haemolytic anaemia syndrome, bone marrow depression such as leucopenia, thrombocytopenia, neutropenia, pancytopenia, erythrocytopenia, haemorrhage and anaemia, myelodysplastic syndrome, hypertension, oedema, albuminuria, haematuria, liver and biliary tract disorders, hepatic damage, serious nephropathy and acute renal failure. has been removed.
 
A new heading of Administration related undesirable effects has been added - and under that heading, bladder contracted bladder (pollakiuria, dysuria) and calcinosis have been added along with cholangitis (also sclerosing), biloma which have alsos been added.
 
Also added

Other reported effects, not already described in the text above, include the following:

 

Infections and Infestations

 

Bacterial, viral or fungal infections, sepsis and septic shock

Neoplasms benign and malignant

 

Myelodysplastic syndrome, acute myeloid leukaemia, acute leukaemia

Blood and lymphatic system disorders

 

Bone marrow depression, pancytopenia, neutropenia, granulocytopenia, febrile neutropenia, erythropenia, microangiopathic haemolytic anaemia, haemolytic uraemic syndrome, thrombotic thrombocytopenic purpura.

Immune system disorders

 

Hypersensitivity

Vascular disorders

 

Flushing, hypertension

Respiratory and mediastinal disorders

 

Respiratory disorders such as interstitial lung disease, bronchospasm, pneumonitis,

Gastrointestinal disorders

 

Diarrhoea, constipation, abdominal discomfort, stomatitis

Hepatobiliary disorders

 

Parenchymatous liver disorder, cholecystitis, jaundice

Skin and subcutaneous tissue disorders

 

Rash,  pruritus

Renal and urinary disorders

 

Acute renal failure, renal disorder, cystitis, haemturia, proteinuria, serious nephropathy, albuminuria

General disorders

 

Pyrexia, chills, malaise, injection site phlebitis, oedema, generalised weakness and lethargy
Updated on 05/09/2007 and displayed until 03/12/2007
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 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   07/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 (Special Warnings and Precautions for Use)
Extravascular leakage may cause induration or necrosis at the injection site.  Intraarterial administration may cause skin disorders such as pain, redness, erythema, blisters, erosion and ulceration which may lead to skin/muscle necrosis.  Since the influx of the drug solution into other sites than the targeted site in the administration to the hepatic artery may cause gastroduodenal ulcer, haemorrhage, perforation, etc, the location of the end of the catheter and drug distribution area should be confirmed photographically or by other means, paying attention to possible deviation or shift of the catheter and infusion rate.  Administration should be discontinued and appropriate measures should be taken, if any of such symptoms develops. has been added - as well as -
The safety of Mitomycin-C injection in children has not been established.  Special attention should be paid to the manifestation of adverse reactions when administered in children.   also -

Elderly patients often have reduced physiological function, bone marrow depression, which may be protracted, so administer Mitomycin-C Kyowa with caution in this population while closely monitoring patient’s condition

Section 4.8 (Undesirable Effects)
Shock or anaphylactoid reaction may occur, patients should be carefully observed.  If symptoms such as itching, rash, hot flush, sweating, dyspnoea and decreased blood pressure occur, treatment should be immediately discontinued and appropriate measures should be taken. has been added along with 

 

 

·        Abnormal x-ray findings

·        Constipation

·        Abdominal discomfort

·        Pyrexia

·        Pulmonary fibrosis

·        Hepatic damage

·        Serious nephropathy

  as well as

 Administration to the hepatic artery may cause liver and biliary tract disorders such as cholecystitis, bile duct necrosis and parenchymatous liver disorder.  Drug distribution area should be confirmed photographically or by other means, and treatment should be discontinued and appropriate measures taken if any abnormal signs are noted.

Section 6.6 has been changed with reference to accidental eye contact - 8.4% sodium bicarbonate has been removed and replaced with saline solution. 
   

 
 
Updated on 03/10/2006 and displayed until 05/09/2007
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   06/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 1: FROM:  Mitomycin-C TO: Mitomycin-C Kyowa, 2mg, 10mg, 20mg or 40mg powder for solution for injection.
 
Updated on 29/09/2006 and displayed until 03/10/2006
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   06/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 10 - Date of revision of the text now reads 29/06/2006.
Updated on 27/06/2006 and displayed until 29/09/2006
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   06/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

1.      Name of the Medicinal Product – now includes  “powder for solution for injection”

2.      Qualitative and Quantitive Composition – now includes “For excipients, see 6.1”

3.      Pharmaceutical Form – now includes “blue crystalline powder”

4.2     Posology and Method of Administration – now includes statement on disease progression

4.3     Contraindications – text now includes “or any components of the product”

4.4     Special Warnings and Precautions for Use – text added as follows :

        Mitomycin-C Kyowa should be administered with care in children and patients with the following:

·       Hepatic or renal dysfunction as adverse reactions may be enhanced
·       Bone marrow depression and bleeding tendency as these may be exacerbated
·       Infections as these may be aggravated due to bone marrow depression
·       Varicella as fatal systemic disorders may occur

In case administration of this drug is required in children or patients with reproductive possibility, potential effects on gonad should be considered.

Occurrence of acute leukaemia (in some cases following preleukaemic phase) and myelodysplastic syndrome has been reported in the patients treated with Mitomycin-C Kyowa concomitantly with other antineoplastic agents.

Statement on skin and eye contamination moved to section 6.6

4.5     Interactions with other Medicinal Products and other forms of interaction – text added as follows :-

Mitomycin-C Kyowa should be administered with care when it is coadministered with other antineoplastic agents or irradiation. The adverse reactions of each drug may be enhanced, for example bone marrow depression. With vinca alkaloids adverse reactions of shortness of breath and bronchopspasm may be enhanced.

4.6.    Pregnancy and Lactation – now includes “who may possibly be pregnant”
4.8     Undesired Effects – list of side effects now more comprehensive
5.1     Pharmacodynamic Properties – now includes text “ATC Code: L01D

   Pharmacotherapeutic group: Other cytotoxic antibiotics

6.3     Shelf Life – statement on microbiological stability added
6.4     Special Precautions for Storage – now reads “Store in the original package.  The reconstituted solution should be protected from light and stored in a cool place (See Section 6.3)

6.5     Instructions for Use and Handling – Statement on skin and eye contamination moved from section 4.4

 
Updated on 29/09/2003 and displayed until 27/06/2006
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
Updated on 28/08/2001 and displayed until 29/09/2003
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 24/08/2001 and displayed until 28/08/2001
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 09/08/2001 and displayed until 24/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 25/09/2000 and displayed until 09/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 25/09/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  mitomycin-c