Last Updated on eMC 13-12-2016 View medicine  | Ipsen Ltd 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 1 - Name of the medicinal product
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-07-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Amendments to add pre-filled syringe.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:12-06-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

$0In section 4.8 Undesirable effects - how to report a side effect - The following information has been added:$0$0Reporting of suspected adverse reactions$0$0Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard$0

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 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:14-02-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

$0In section 4.1Therapeutic Indications– The wording has been changed to the following:$0$0This medicinal product is for diagnostic use only.$0$0Hexvix blue light fluorescence cystoscopy isindicated as adjunct to standard white light cystoscopy to contribute to thediagnosis and management of bladder cancer in patients with known or high suspicionof bladder cancer. See Section 5.1$0$0In section 4.2 Posologyand method of administration– The following information has been added:$0$0The cystoscopic examination should not be performedmore than 3 hours after Hexvix is instilled in the bladder. Also if theretention time in the bladder is considerably shorter than one hour,examination should start no earlier than after 60 minutes. No minimum retentiontime has been identified making examination non-informative. For optimalvisualisation it is recommended to examine and map the entire bladder underboth white and blue light before any surgical measures are initiated. Biopsiesof all mapped lesions should normally be taken under white light and completeresection should be verified by switching to blue light.$0$0In section 4.3Contraindications –The following information has been deleted:$0$0Womenof childbearing potential (see section 4.6).$0$0In section 4.4 Specialwarnings and precautions for use– The following information has been added:$0$0Post-marketing experience with repeated use ofHexvix does not indicate that it represents a risk when used in follow-up inpatients with bladder cancer, however no specific studies have been conducted.$0$0In section 4.6Fertility, pregnancy and lactation– The following information has been added:$0$0Pregnancy$0$0There are no or limited data on the use ofhexaminolevulinate in pregnant women. Animal studies do not indicate direct orindirect harmful effects with respect to the reproductive toxicity (see section5.3).$0$0As a precautionary measure, it is preferable toavoid the use of Hexvix during pregnancy.$0$0Breast-feeding$0$0It is unknown whetherhexaminolevulinate/metabolites are excreted in human milk. A risk to the newborns/infantscannot be excluded. Breast-feeding should be discontinued during the treatment withHexvix.$0$0In section 4.8Undesirable effects –The number of patients reporting bladder spasm has changed from 3.8 to 2.4%.The number of patients reporting dysuria has changed from 3.3 to 1.8%. Thenumber of patients reporting bladder pain has changed from 2.7 to 1.7%. Thenumber of patients reporting haematuria is 1.7%.$0$0Diarrhoeahas been added as a common AE under Gastrointestinal disorders. Back pain hasbeen added as uncommon AE under Muscoskeletal and connective tissue disorders.Pollakuria has changed from a common to an uncommon AE under Renal and urinarybladder disorders and micturition urgency and urinary tract disorder havebeen added as uncommon AEs. Balantis has been added as an uncommon AE under Reproductive system and breastdisorders. Post procedural pain has changed from an uncommon to common AE underInjury, poisoning and procedural complications and post-operative fever hasbeen added as an uncommon AE.$0$0In section 5.1Pharmacodynamic properties –The following information has been added:$0$0A randomized, white light only comparative studywas undertaken in patients with papillary tumours and increased risk ofrecurrence. A within patient comparison showed that a total of 16.4% (47/286) ofpatients with pTa/pT1 lesions had additional such lesions detected with Hexvixblue light cystoscopy only. Patients with pTa/pT1 lesions were followed for 9months after cystoscopy, and the proportion of patients with recurrence waslower in the Hexvix group (47%, 128/271) than in the white light onlycystoscopy group (56.1%, 157/280) in the ITT population, where all patientswith missing data were assumed to have recurrence. The number of patients withmissing data in the study was too high (56/128 and 59/157, in the Hexvix andcontrol groups respectively) for the difference to be considered statisticallyrobust (p=0.03-0.06 pending on ways to handle missing data). Further follow up informationwas obtained for 86% of the participants. Median follow-up in the white lightonly and Hexvix groups were 53 and 55 months, respectively. The patients in theHexvix group had a median of 7 months longer time to recurrence andrecurrence-free survival (16 months in the Hexvix group versus 9 months in thewhite light group, p=0.04-0.06, pending on handling of missing data and deaths).$0$0In section 5.3Preclinical safety data– The following information has been added:$0$0Alocal lymph node assay in mice has demonstrated that hexaminolevulinate has apotential to cause skin sensitisation.$0$0Reproductivetoxicity has been investigated in rats and rabbits. The incidences ofembryo-fetal mortality, fetal weights, and the fetal abnormalities andvariants, including skeletal ossification parameters did not indicate anyobvious effect of treatment. There were no effects on female fertility and onearly embryonic development when investigated in rats.$0$0In section 6.6 Specialprecautions for disposal and other handling – The following information has been added:$0$0Nospecial requirements for disposal.$0$0Handling instructions for the pharmacist or otherhealthcare professionals:$0$0All steps should be performed with sterileequipment and under aseptic conditions.$0$01. Withdraw 50.0 mL of the solvent for Hexvix intoa sterile 50 mL syringe.$0$02. Inject about 10 mL of this solvent into the vialof Hexvix powder.$0$03. Without withdrawing the needle from the vial,hold the powder vial and the syringe in a firm grip and shake gently to ensurecomplete dissolution.$0$04. Withdraw all of the dissolved solution from thepowder vial into the syringe. Gently mix the contents of the syringe.$0$05. Hexvix is now reconstituted and ready for use. Theappearance of the reconstituted solution is clear to slightly opalescent, andcolourless to pale yellow.$0$0In section 9 Date offirst authorisation/Renewal of the authorisation – The following information has beenadded:$0$0Dateof first authorisation: 17 September 2004$0$0Dateof latest renewal: 10 September 2009$0$0In section 10 Date ofrevision – 14thFebruary 2013$0

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

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

Legal Category:POM

Black Triangle (CHM): NO