Zemplar 5 microgram/ml Solution for Injection
*Company:
AbbVie LimitedStatus:
UpdatedLegal Category:
Product subject to restricted prescription (C)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 13 December 2024
File name
Zemplar IV 5mcgml_SmPC_December 2024.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Minor update to those sections to remove Zemplar 5mcg/ml solution for injection as sub-sections.
Updated on 13 December 2024
File name
Zemplar IV 5mcgml-PL-December 2024.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to date of revision
Free text change information supplied by the pharmaceutical company
PL was updated to remove reference to Zemplar 2mcg/ml solution for injection.
Updated on 03 July 2020
File name
Zemplar IV 5mcgml_SmPC_V95_July 2020.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 restricted prescription (C)
Updated on 03 July 2020
File name
Zemplar IV 5mcgml_PL_V95_July 2020.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 09 April 2019
File name
Zemplar IV 5mcgml_PL_V91_March 2019.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 27 March 2019
File name
Zemplar IV 5mcgml_PL_V91_March 2019.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 03 September 2018
File name
Zemplar IV 5mcgml_PIL_V86_QRD and serialisation_May 2018.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 18 July 2018
File name
Zemplar IV 5mcgml_SmPC_V90_July 2018.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to restricted prescription (C)
Updated on 17 July 2018
File name
Zemplar IV 5mcgml_SmPC_V90_July 2018.docx
Reasons for updating
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Description of change
SmPC was updated to reflect approval of Type IB - changes to mock-ups resulting from vial move from GSK to Avara + combining of Irish MA for vial and ampoule for Zemplar 5 micrograms/ml solution for injection.
The following is summary of the changes:
8. Marketing Authorisation Number
The MAs was combined to the first MA in the series PA1824/005/004; PA1824/005/005 will be withdrawn.
10. Date of Revision of Text
Update to July 2018.
Updated on 05 June 2018
File name
Zemplar IV 5mcgml_PIL_V86_QRD and serialisation_April 2018.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 30 May 2018
File name
Zemplar_IV_5mcgml_SmPC_V86_QRD_and_serialisation_May_2018.docx
Reasons for updating
- Other
Legal category:Product subject to restricted prescription (C)
Updated on 29 May 2018
File name
Zemplar_IV_5mcgml_PIL_V86_QRD_and_serialisation_April_2018.docx
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 - 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.2 - Incompatibilities
- 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 restricted prescription (C)
Free text change information supplied by the pharmaceutical company
SmPC for Zemplar 5mcg/ml solution for injection updated to reflect approval of V86 - Update to QRD and serialisation.
The following is summary of changes:
Section 2. Qualitative and Quantitative Composition
Minor changes to ensure consistency with the Zemplar capsule Product Information.
Section 4.1 Therapeutic indications
Minor change to ensure consistency with the Zemplar capsule Product Information.
Section 4.2 Posology and method of administration
Editorial changes
Section 4.4 Special warnings and precautions for use
Minor change to ensure consistency with the Zemplar capsule Product Information.
Section 4.5 Interaction with other medicinal products and other forms of interaction
Minor change to ensure consistency with the Zemplar capsule Product Information.
Section 4.6 Fertility, pregnancy and lactation
Minor change to ensure consistency with the Zemplar capsule Product Information.
Section 4.7 Effects on ability to drive and use machines
Minor editorial changes
Section 4.8 Undesirable effects
Minor change to ensure consistency with the Zemplar capsule Product Information
Section 4.9 Overdose
Correction of typos
Section 5.1 Pharmacodynamic properties
Correction of typos and editorial changes
Section 5.2 Pharmacokinetic properties
Minor editorial changes
Section 5.3 Preclinical safety data
Minor editorial changes and correction of typo
Section 6.2 Incompatibilities
Correction of typo
Section 6.5 Nature and content of container
Minor editorial changes
Section 10 - Date of Revision of Text
Updated to May 2018
Updated on 09 May 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Updated on 14 February 2018
File name
PIL_11993_977.pdf
Reasons for updating
- New PIL for new product
Updated on 14 February 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Updated on 14 February 2018
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 14 February 2018
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 11 April 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Section 4.2 - Posology and method of administration
Amend typing error in SmPC:
|
Suggested Dosing Guidelines (Dose adjustments at 2 to 4 week intervals) |
|
|
iPTH Level Relative to Baseline |
Paricalcitol Dose Adjustment |
|
Same or increased |
Increase by 2 to 4 micrograms |
|
Decreased by < 30% |
|
|
Decreased by ≥30%, ≤60% |
Maintain |
|
Decreased > 60% |
Decrease by 2 to 4 micrograms |
|
IPTH < 15.9 pmol/l (150 pg/mL) |
|
Updated on 11 March 2016
Reasons for updating
- Change to MA holder contact details
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Ø Update the IE MAH address:
|
Present: |
Proposed: |
|
AbbVie Limited Block B Liffey Valley Office Campus Quarryvale Co. Dublin
|
AbbVie Limited Citywest Business Campus Dublin 24 Ireland |
Updated on 10 March 2016
Reasons for updating
- Change to MA holder contact details
Updated on 17 November 2015
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
The changes include amendment to align with the current QRD V9 template headings and standard statements.
Additionally, a new standard statement has also been added at the end of SPC Section 4.8 and PIL Section 4, regarding the reporting of suspected adverse reactions through use of the national reporting system.
Updated on 16 November 2015
Reasons for updating
- Improved electronic presentation
Updated on 23 September 2015
Reasons for updating
- Change to MA holder contact details
Updated on 29 July 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to joint SPC covering all presentations
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Update Section 4.4 Special warnings and precautions for use
Phosphate or vitamin D-related medicinal products should not be taken concomitantly with paricalcitol due to an increased risk of hypercalcaemia and Ca x P product elevation (see section 4.5).
Update to include both vial and ampoule presentations on the one SmPC.
Updated on 23 December 2014
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 15 August 2014
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 11 August 2014
Reasons for updating
- Change to packaging
- Addition of information on reporting a side effect.
Updated on 18 September 2013
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Section 8 has been updated with the new PA number PA1824/5/4
Updated on 17 September 2013
Reasons for updating
- Change of licence holder
Updated on 05 August 2011
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
SPC section 5.1 - updated to include 'Unlike calcitriol, paracalcitol is a selective Vitamin D receptor (VDR) activator' in line with WHO reclassification of paricalcitol from 'Vitamin D Analogs' (ATC Code: A11CC) to 'Anti-prarthyroid agents' (ATC Code: HO5BX).
Updated on 05 August 2011
Reasons for updating
- Change to instructions about overdose
Updated on 29 October 2010
Reasons for updating
- Change to instructions about overdose
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
Updated on 20 August 2010
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 6.2 - Incompatibilities
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 13 January 2010
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 26 June 2009
Reasons for updating
- Change to name of manufacturer
Updated on 13 November 2008
Reasons for updating
- Change to name of manufacturer
- Change to date of revision
Updated on 04 February 2008
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to restricted prescription (C)
Updated on 22 November 2007
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
6.3 Shelf life
2 years.
After opening, use immediately
Updated on 23 April 2007
Reasons for updating
- New PIL for new product
Updated on 20 April 2007
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
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and precautions for use
|
Body as a whole |
Common |
Headache |
|
Uncommon |
injection site pain, pain, asthenia, back pain, chest pain, fever, flu syndrome, infection, malaise, and sepsis |
Post -Marketing Adverse Reactions
Immune system disorders, hypersensitivity.
Angioedema, laryngeal oedema and urticaria have been reported rarely.
Updated on 05 October 2006
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Pediatric Use
Data in pediatric patients are limited and no data for children under the age of 5 are available. See Section 5.1 for study results.
5.1 Pharmacodynamic properties
Paediatric clinical data: The safety and effectiveness of Zemplar were examined in a 12-week randomised, double-blind, placebo-controlled study of 29 pediatric patients, aged 5-19 years, with end-stage renal disease on hemodialysis. The six youngest Zemplar-treated patients in the study were 5 - 12 years old. The initial dose of Zemplar was 0.04 mcg/kg 3 times per week, based on baseline iPTH level of less than 500 pg/mL, or 0.08 mcg/kg 3 times a week based on baseline iPTH level of ¡Ý 500 pg/mL, respectively. The dose of Zemplar was adjusted in 0.04 mcg/kg increments based on the levels of serum iPTH, calcium, and Ca x P. 67% of the Zemplar-treated patients and 14% placebo-treated patients completed the trial. 60% of the subjects in the Zemplar group had 2 consecutive 30% decreases from baseline iPTH compared with 21% patients in the placebo group. 71% of the placebo patients were discontinued due to excessive elevations in iPTH levels. No subjects in either the Zemplar group or placebo group developed hypercalcemia. No data are available for patients under the age of 5.
Updated on 25 May 2005
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
AbbVie Limited
Address:
Citywest Business Campus, Dublin 24, IrelandTelephone:
+353 1 428 7900Fax:
+353 1 428 7940