Potassium Chloride 0.15 % w/v and Glucose 5% w/v Solution for Infusion -BP
*Company:
Baxter Holding B.V.Status:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 03 August 2023
File name
KCL 0.15 & G 5 PIL TH3002167_LABEL.pdf
Reasons for updating
- New PIL for new product
Updated on 26 January 2023
File name
ie-spc-2021-02-g5-kcl0.15-clean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 April 2021
File name
ie-spc-2021-02-g5-kcl0.15-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 18 November 2020
File name
ie_spc_Potassium Chloride 0.15 & Glucose 5_PA2299-009-002_Nov 2020.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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 4.5 - 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 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.2 - Incompatibilities
- 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)
Updated on 13 September 2019
File name
ie-spc-2019-03-g5-kcl0.15-PA2299009002-c.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 13 September 2019
File name
ie-spc-2019-03-g5-kcl0.15-PA2299009002-c.pdf
Reasons for 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 4.8 - Undesirable effects
- 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 04 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 January 2018
Reasons for 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 4.8 - Undesirable effects
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
- 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
Section 4.4 additional text added:
Due to the risk of pseudo-agglutination precipitated by its glucose content, Potassium Chloride 0.15% and Glucose 5% solution must not be added to or administered simultaneously through the same tubing with citrate anticoagulated/preserved blood.
Hypersensitivity/infusion reactions, including anaphylactoid reactions may occur. The infusion must be stopped immediately if signs or symptoms of a suspected hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated. Solutions containing glucose should be used with caution in patients with known allergy to corn or corn products (see section 4.8).
Text removed - Potassium Chloride 0.15% and Glucose 5% solution contains glucose derived from corn. It should be used with caution in patients with known corn allergies (see section 4.8).
Section 4.5 – text added (see section 4.4)
Section 4.8 – Reporting of Adverse reactions updated.
Section 6.2 text added (see section 4.4)
Section 6.3 – text deleted opened
Updated on 04 January 2018
Reasons for 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 4.8 - Undesirable effects
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Section 4.4 additional text added:
Due to the risk of pseudo-agglutination precipitated by its glucose content, Potassium Chloride 0.15% and Glucose 5% solution must not be added to or administered simultaneously through the same tubing with citrate anticoagulated/preserved blood.
Hypersensitivity/infusion reactions, including anaphylactoid reactions may occur. The infusion must be stopped immediately if signs or symptoms of a suspected hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated. Solutions containing glucose should be used with caution in patients with known allergy to corn or corn products (see section 4.8).
Text removed - Potassium Chloride 0.15% and Glucose 5% solution contains glucose derived from corn. It should be used with caution in patients with known corn allergies (see section 4.8).
Section 4.5 – text added (see section 4.4)
Section 4.8 – Reporting of Adverse reactions updated.
Section 6.2 text added (see section 4.4)
Section 6.3 – text deleted opened
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
Updated on 01 September 2016
Reasons for updating
- New SPC for medicines.ie