Last Updated on eMC 28-11-2017 View medicine  | Bristol-Myers Squibb Pharmaceuticals Limited Contact details

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.

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:14-11-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

New MAH Holder name and MHRA license number: Bristol-Myers Squibb Pharmaceuticals Limited; PL 11184/0138

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • 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:21-11-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

QRD updates - sections 2, 4.2, 4.6

Additionally,
section 4.4 was updated;
- To detail Reports of neurological events such as arachnoiditis, myelopathy, paresis and paralysis have been associated with the intrathecal route of administration.
- To detail the sodium content.

section 4.5 was updated;
- to remove the information that the hypokalaemia following use of amphotericin B may potentiate the toxicity of anti-arrhythmic agents.

Section 4.8 was updated to appropriately reflect the Meddra classes and frequencies of ADRs.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:14-05-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update to section 4.8 to include the ADR reporting statement.

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Date of revision of text on the SPC:21-10-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



To align with the current CCDS, the following sections have been updated:

Section 4.2 Posology and method of administration regarding pediatric population, has been amended to provide all available information to healthcare professionals regarding use in the pediatric population.The justification for the inclusion of this information can be found in the Clinical Overview, Section 4 Overview of Efficacy. In addition, intrathecal use of Amphotericin B has been updated to align with the CCDS and is supported by several published scientific journals. The justification for this can be found in the Clinical Overview, Section 5 Overview of Safety. Please note, The Preparation of solutions and CAUTION sections have also been moved from Section 4.2 to Section 6.Pharmaceutical particulars.

Section 4.4 special warnings and precautions for use has been amended to state in each case, that the possible life-saving benefit must be balanced against its untoward and dangerous side effects, to alert healthcare professionals of the need to assess potential benefit and risk at the individual case level. The justification for the inclusion of this information can be found in the Clinical Overview, Section 4 Overview of Efficacy.

Section 4.5 Interaction with other medicinal products and other forms of interaction has been amended to provide healthcare professionals with available information on potential drug interactions that may affect the use of this product. The justification for the inclusion of this information can be found in the Clinical Overview, Section 4 Overview of Efficacy.

Section 4.6 Fertility, pregnancy and lactation has been amended to provide available information relevant to drug exposure during breastfeeding and provide recommendations when appropriate. The justification for the inclusion of this information can be found in the Clinical Overview, Section 4 Overview of Efficacy.

Section 4.8 Undesirable effects has been updated to provide appropriate information on the safety profile of the product, including a description of the use of pethidine in patients to decrease intensity and duration of shaking chills and fever following amphotericin B therapy. The justification for the inclusion of the additional information in this section can be found in the Clinical Overview, Section 4 Overview of Efficacy and also an additional clinical overview detailing the safety databse review and analysis of all post-marketing events, as well as a review of the scientific literature to support this change. Finally, for information, a review and analysis of adverse events of Fungizone from the coporate product labelling profile (CPLP) has been also been provided.

 

To align with the current QRD template, the flowing sections have been updated: Sections 2; 4.2; 4.3; 4.6; 4.7; 4.9; 5.1; 6.1; 6.2; 6.6 and 9.

Finally, to correct for the INN for ingredients amphotericin B, the following sections have been updated: Section 4.1; 4.2; 4.4; 4.5; 4.9; 5.1 and 5.2.

Please note:

•The insertion of text in Section 6.2, has been moved from Section 4.2 Posology and method of administration

•The insertion of text in Section 6.3, has been moved from Section 4.2 Posology and method of administration

•The insertion of text in Section 6.6, has been moved from Section 4.2 Posology and method of administration

Reasons for adding or updating:

  • Addition of legal category

Date of revision of text on the SPC:27-02-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Addn of legal category

Reasons for adding or updating:

  • Change to section 6.1 - List of Excipients
  • Change to section 6. 5 - Nature and Contents of Container

Date of revision of text on the SPC:27-02-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The updates are as follows:

 

6.1 List of Excipients

Other ingredients: desoxycholic acid, concentrated phosphoric acid, sodium

hydroxide, disodium phosphate dodecahydrate, monosodium phosphate dehydrate,

water.

 

6.5 Nature and contents of container

Type I flint glass vials closed with a grey chlorobutyl rubber stopper.

Vials of 50mg

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:22-12-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Sections updated are as follows:

1.         Name of the medicinal product

 

Fungizone 50mg Powder for Sterile Concentrate

 

3.         Pharmaceutical form

 

Powder for Concentrate for Solution for Infusion. (Powder for Sterile Concentrate)

 

4.2       Posology and method of administration

 

CAUTION:

 

Under no circumstances should a total daily dose of 1.5mg/kg be exceeded. Amphotericin B overdoses can result in potentially fatal cardiac or cardiorespiratory arrest (see section 4.4 & 4.9).  The recommended concentration for intravenous infusion is 10mg/100ml.

 

4.4       Special warnings and precautions for use

 

Care must be taken when administering Fungizone Intravenous to prevent overdose, which can result in potentially fatal cardiac or cardiorespiratory arrest. Verify the product name and dosage pre-administration, especially if the dose prescribed exceeds 1.5mg/kg (see section 4.2 Posology and Method of Administration and section 4.9 Overdose Symptoms, Emergency Procedures, Antidotes).

 

4.9       Overdose symptoms, emergency procedures, antidotes

 

Amphotericin overdoses can result in potentially fatal cardiac or cardio-respiratory arrest.  If an overdose is suspected, discontinue therapy and monitor the patient's clinical status (e.g., cardio-respiratory, renal, and liver function, haematologic status serum electrolytes) and administer supportive therapy as required.  Amphotericin is not haemodialysable.  Prior to reinstituting therapy, the patient's condition should be stabilised (including correction of electrolyte deficiencies, etc.)

 

10.       Date of revision of the text

 

22 December 2009

 

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

 Section 4.8  Abnormal renal function (including renal impairment, renal insufficiency, acute renal failure and nephrogenic diabetes insipidus) added.

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Reasons for adding or updating:

  • Transferred from eMC version 1

Reasons for adding or updating:

  • No reasons supplied