Octreotide 100 micrograms/1 ml Solution for Injection
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
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 18 October 2024
File name
Reg PIL gxOC All 12_0 IE Clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
The PIL has been updated to reflect the SPC change for the MAH name and address.
Updated on 18 October 2024
File name
Reg SPC gxOC 100 mcg 8_0 IE Clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 7 Change of MAH name and address
Updated on 20 June 2024
File name
Reg SPC gxOC 100 mcg 7_1 IE CLEAN.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- 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 20 June 2024
File name
Reg PIL gxOC All 11_1 IE CLEAN.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 13 March 2024
File name
Reg PIL gx OC All 10 1 IE CLEAN.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 10 June 2022
File name
RegSPCgxOC100mcg60IEClean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.9 - Overdose
- 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
The SPC has been updated as follows:
PRAC recommendations on signals – Atrioventricular block:
PRAC considers a casual relationship between Octreotide and atrioventricular block, is at least a reasonable possibility, when Octreotide is administered at high doses. A variation was submitted to amend the product information as described below:
Section 4.4 – Atrioventricular blocks information is added to “Special warnings and precautions for use”.
Section 4.9 - Atrioventricular blocks information is added to "Overdose"
Section 10 – Date of Revision of the Text.
Updated on 10 June 2022
File name
RegPILgxOCAll90IEClean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 6 - date of revision
Updated on 15 March 2022
File name
Reg PIL gxOC All 8_0 IE CLEAN.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 15 March 2022
File name
Reg SPC gxOC 100 mcg 5_0 IE 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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
|
Section 4.4 – Pancreatic function information is added to “Special warnings and precautions for use”. Section 10 – Date of Revision of the Text. |
|
|
Updated on 10 May 2021
File name
DEC202131011_Reg SPC gxOC 100 mcg 4_1 IE_clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 2: Removal of Excipients with known effect statement
Section 4.4: Addition of Sodium Content as “This medicinal product contains less than 1 mmol (23 mg) sodium per dose. Patients on low sodium diets can be informed that this medicinal product is essentially ‘sodium-free’”.
Updated on 10 May 2021
File name
DEC202131011_Reg PIL gxOC All 7_0 IE_clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 08 February 2021
File name
DEC202108457_Reg PIL gxOC All 6_0 IE-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 06 November 2020
File name
Reg PIL gxOC All 5_2 IE-clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 29 April 2019
File name
DEC201921954_Reg PIL gxOC All 4_0 UK & IE_clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
Updated on 29 April 2019
File name
DEC201921954_Reg SPC gxOC 100 mcg 3_0 IE_clean.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 4.4 - Special warnings and precautions for use
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
|
The SPC has been updated as follows: Update all occurrences of 'Octreotide Pfizer' to 'Octreotide' Section 2: Update to include excipient details Section 4: 4.1 Therapeutic indications Minor typo corrections in ‘Treatment of TSH-secreting pituitary adenomas’ 4.2 Posology and method of administration Minor text addition. Update to include excipient details 4.4 Special warnings and precautions for use Include details of Choleithiasis Include reference to ‘specis’ specific local site reactions Include details of sodioum content 4.8 Undesirable Effects Update Post Marketing section to include Blood and lymphatic system disorders ‘Thrombocytopenia’ Include additional details on ‘Gallbladder and related reactions’ and ‘Hypersensitivity and anaphylactic reactions’. Include details on Bradycardia. Include detaisl on Thrombocytopenia Include MHRA reporting details (in UK SPC’s only) Section 5 5.1 Pharmacodynamic Properties Minor typo updates 5.2 Pharmacokinetic Properties Minor typo updates 5.3 Pharmacokinetic Properties Minor typo updates |
Updated on 02 October 2018
File name
Reg PIL gxOC 3_1 UK IE-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 02 October 2018
File name
Reg SPC gxOC 100 mcg 2_0 IE-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
|
The SPC has been updated as follows: Section 7 has been updated from Current MAH to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number. |
Updated on 02 October 2018
File name
Reg SPC gxOC 100 mcg 2_0 IE-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
|
The SPC has been updated as follows: Section 7 has been updated from Current MAH to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number. |
Updated on 19 September 2018
File name
Reg PIL gxOC All 2_0 UK & IE_clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 30 August 2018
File name
Reg SPC gxOC 100 mcg IE_clean.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 4.5 - 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 5.3 - Preclinical safety data
- 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
SECTION NO HEADING
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5.1 Phamacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical data
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.6 Special precautions for disposal and other handling
10 DATE OF REVISION OF THE TEXT
Updated on 20 June 2018
File name
Reg_SPC_gxOC_100mg_IE_clean.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 4.3 - 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 5.3 - Preclinical safety data
- 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)
Updated on 20 June 2018
File name
Reg PIL gxOC All UK & IE_clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- 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 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 12 September 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 September 2017
File name
PIL_17285_540.pdf
Reasons for updating
- New PIL for new product