Pabal 100 micrograms/ml solution for injection
*Company:
Ferring Ireland LimitedStatus:
No Recent UpdateLegal 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 17 January 2024
File name
Pabal_Approved PIL_IA034_clean_Oct2023.pdf
Reasons for updating
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Correction to the date of revision
Updated on 03 November 2023
File name
Pabal_Approved PIL_IA034_clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 02 November 2023
File name
Pabal_Approved PIL_IA034_clean.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Updates to sections 4.0 and 6.0
Updated on 02 November 2023
File name
Pabal_Approved SPC (IA034)_October2023.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Updated on 11 November 2019
File name
Pabal SPC in line with licence dated 10 11 2019.pdf
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 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- 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 5.3 - Preclinical safety data
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Extensive updates to SPC, to include:
-Expanded indication, to include use in vaginal deliveries in addition to caesarean sections
-New method of administration (intramuscular injection in addition to intravenous injection)
-Remove pre-eclampsia and eclamsia as contraindications in Section 4.3 - now included in Section 4.4 as a warning/precaution
-Addition of tachycardia, bradycardia, arrhythmia, myocardial ischaemia and QT prolongation as adverse events in Section 4.8
-Addition of new adverse events table for intramuscular administration in Section 4.8
-Update to Section 5.1, to include additional safety and efficacy data and a paragraph on paediatric populations
-Update to Section 5.2, to include information on intramuscular administration
-Update to Section 6.3, to state that from a microbiological point of view, the product should be used immediately upon opening
-Other administrative and typographical updates
Updated on 01 August 2018
File name
Pabal SPC_in line with license dated 25 8 2017.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)