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Boehringer Ingelheim Limited
Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS
Telephone: +44 (0)1344 424 600
Fax: +44 (0)1344 741 298
WWW: http://www.boehringer-ingelheim.co.uk
Medical Information Direct Line: +44 (0)1344 741 286
Medical Information e-mail: medinfo@bra.boehringer-ingelheim.com

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: 20/01/2012
SPC Immukin

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 20/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.4 Special warnings and precautions for use
“(see section 4.5)” has been added into paragraphs 7 and 10.

4.5 Interaction with other medicinal products and other forms of interaction
“The concomitant administration of heterologous serum protein preparations or immunological preparations (e.g. vaccines) may increase the immunogenicity of Immukin (see section 4.4).” has been added to the 3rd paragraph.

4.6 Fertility, pregnancy and lactation
A Fertility paragraph has been added.

4.7 Effects on ability to drive and use machines
Paragraph has been updated.

4.8 Undesirable effects
Frequency section have been extensively updated.

5.3 Preclinical safety data
The following paragraphs have been added to the section:

“Interferon gamma caused increased apoptosis in rat uterus and placenta and in human cytotrophoblast cells. Teratogenicity was observed in mice at lower doses than human dose. No teratogenicity was observed in rats and in primates up to 100 times the human dose.

Administration of very high doses of interferon gamma to juvenile male mice caused reduced epididymal and testes weights, reduced sperm counts, sperm abnormalities and reduced mating performance and fertility. These effects are considered not relevant for human use at the indicated dose levels.”

10 Date of revision
Date updated to January 2012
Updated on 07/07/2008 and displayed until 20/01/2012
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.9 - Overdose
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   29-Sep-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 2        

Statement amended to:

“For a full list of excipients, see section 6.1.”

 

Section 4.2

The following statement added:

“The experience in children is limited (see sections 4.4 and 5.1)”

 

Section 4.3

Reworded

 

Section 4.5

Paragraph 1 reworded

 

Section 4.6

Second half of paragraph 1 reworded

 

Section 4.7

Reworded

 

Section 4.8

Table of adverse reactions layout updated

 

Section 4.9

Paragraph added:

 

“Further undesirable effects which may occur as a consequence of overdosing as observed in respective clinical trials in other than the registered indications are outlined in section 4.8 above.”

 

Section 6.3

Paragraph from 6.4 added:

 

“Immukin is for single use only.

The formulation does not contain a preservative. Once opened, the content of a vial should be used immediately. The unused portion of any vial should be discarded.”

Section 6.4

Paragraph deleted and moved to section 6.3:

 

“Immukin is for single use only.

 

The formulation does not contain a preservative. Once opened, the content of a vial should be used immediately. The unused portion of any vial should be discarded.”

 

Section 6.6

Paragraph added:

 

“Any unused product or waste material should be disposed of in accordance with local requirements.”

 

Section 9

Date amended

 

Section 10

Date amended
Updated on 21/07/2006 and displayed until 07/07/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   06/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2: Deletion of  "Safety and effectiveness in children under the age of 6 months have not been established in patients with CGD, but have been estabilished in patients with severe, malignant osteopetrosis."
 
Section 4.4: Addition of "  Elevations of AST and/or ALT (up to 25-fold) have been observed during Immukin therapy.  The incidence appeared to be higher in patients less than 1 year of age compared to older children with 6 out of 10 developing elevated enzyme levels.  In one case this occurred as early as 7 days after starting therapy.  Treatment with Immukin was interrupted in all 6 of these patients and restarted at a reduced dosage in 4.  Liver transaminase values returned to baseline in all patients and did not recur with rechallenge except in one patient.  Caution should be especially observed in patients with hepatic insufficiency.
 
Reversible neutropenia and thrombocytopenia that can be severe and may be dose related have been observed during Immukin therapy.  Caution should be exercised when administering Immukin to patients with myelosuppression."
 
Section 4.8: Changes to Adverse Reactions table.
 
Section 5.1: Addition of "Data on the safety and efficacy of Immukin in 37 CGD patients under the age of 3 years was pooled from 4 uncontrolled post-marketing studies and 2 sequential post-marketing surveillance studies.  The rate of serious infections per patient-year in this uncontrolled group was similar to the rate observed in the Immukin treatment groups in controlled trials."
 
1b added throughout, ie. interferon gamma-1b.
Updated on 23/09/2004 and displayed until 21/07/2006
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.6 - Pregnancy and Lactation
Updated on 17/07/2003 and displayed until 23/09/2004
Reasons for adding or updating:
  • 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 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.2 - Incompatibilities
  • 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
Updated on 09/08/2001 and displayed until 17/07/2003
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 09/07/2001 and displayed until 09/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 26/01/2000 and displayed until 09/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 26/01/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  interferon gamma-1b