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

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

  • New SPC for new product

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

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

  • 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 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

Updated on 01 September 2016

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided