PHYSIONEAL 35 Glucose 2.27% w/v / 22.7 mg/ml Clear-Flex, Solution for peritoneal dialysis *

When a pharmaceutical company changes any document, 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 02 April 2019

File name

ie-spc-2019-03-phys35227cf-2299022011-c_1554196159.pdf

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 23 July 2018

File name

ie-spc-2018-07-phys35227cf-167101008-ibg038-c.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 22 February 2017

Reasons for updating

  • 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 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

6.2 - text added  - Aminoglycosides (eg. netilmycin, gentamycin, tobramycin) should not be mixed with penicillins due to chemical incompatibility.

6.3 text added "After opening / dilution:

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C for: cefazolin (750 mg/l), heparin (2500 IU/L), low molecular weight heparin (Innohep 2500 IU/L), netilmycin (60 mg/l) and vancomycin (1000 mg/l).

Chemical and physical in-use stability has been demonstrated for 6 hours at 25°C for insulin (Actrapid 4 IU/L, 10 IU/L, 20 IU/L and 40 IU/L).

Gentamicin (60 mg/l) and tobramycin (60 mg/l) can be added if the solution is used immediately after drug addition.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the  responsibility of the user and would normally not be longer than 24 hours, unless reconstitution / dilution (etc) has taken place in controlled and validated aseptic conditions

6.4 Text added - For storage conditions of the reconstituted medicinal product, see section 6.3.

6.6 Text added - In the case of damage, the container should be discarded.

Updated on 22 February 2017

Reasons for updating

  • 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 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

6.2 - text added  - Aminoglycosides (eg. netilmycin, gentamycin, tobramycin) should not be mixed with penicillins due to chemical incompatibility.

6.3 text added "After opening / dilution:

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C for: cefazolin (750 mg/l), heparin (2500 IU/L), low molecular weight heparin (Innohep 2500 IU/L), netilmycin (60 mg/l) and vancomycin (1000 mg/l).

Chemical and physical in-use stability has been demonstrated for 6 hours at 25°C for insulin (Actrapid 4 IU/L, 10 IU/L, 20 IU/L and 40 IU/L).

Gentamicin (60 mg/l) and tobramycin (60 mg/l) can be added if the solution is used immediately after drug addition.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the  responsibility of the user and would normally not be longer than 24 hours, unless reconstitution / dilution (etc) has taken place in controlled and validated aseptic conditions

6.4 Text added - For storage conditions of the reconstituted medicinal product, see section 6.3.

6.6 Text added - In the case of damage, the container should be discarded.

Updated on 22 February 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 01 September 2016

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided

Updated on 01 September 2016

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided