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Octreotide 200 micrograms/ml Solution for Injection

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Pharmacy Only: Prescription
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Updated on 10 May 2021

File name

DEC202131011_Reg SPC gxOC 200 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 200 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 4.3 - Contraindications
  • 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 12 March 2019

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 200 mcg 2_0 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 200 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 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 200 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_200mcg_clean_IE.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 06 October 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

Pfizer Healthcare Ireland Unlimited Company

Pfizer Healthcare Ireland Unlimited Company