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Rifadin Intravenous 600mg Powder and Solvent for Concentrate for Solution for Infusion

*
Pharmacy Only: Prescription

  • Company:

    SANOFI

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Rifampicin

    *Additional information is available within the SPC or upon request to the company

Updated on 21 March 2024

File name

1.3.1 IE Rifadin IV SmPC IES23.346_clean_EOP texts.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 21 March 2024

File name

1.3.1. Rifadin IV-- PIL_ IES23.346 CCDS 18_Clean_EOP texts.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 05 July 2022

File name

1.3.1. Rifadin IV-- PIL- IES21 143 CCDS 15 WS NL-H-xxxx-WS-529 clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • 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 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 05 July 2022

File name

1.3.1 IE Rifadin IV SmPC IES21 143 CCDS 15 WS NL-H-xxxx-WS-529 Clean.pdf

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 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 03 May 2022

File name

1.3.1. Rifadin IV-PIL- agnani site update_clean.pdf

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 09 December 2021

File name

1.3.1 IE Rifadin IV SmPC CCDS V14 IE1261 clean (1).pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 09 December 2021

File name

1.3.1. Rifadin IV-PIL- IE 1261-CCDS 14 (2).pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • 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 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 01 April 2021

File name

1.3.1 IE Rifadin IV SmPC clean- CCDS V13 IE1190.pdf

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

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 01 April 2021

File name

crop Rifadin IV 803051.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • 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 2 - excipient warnings

Updated on 02 December 2019

File name

Rifadin 600mg powder and solvent SmPC.pdf

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 medical prescription which may not be renewed (A)

Updated on 02 December 2019

File name

Rifadin 600mg powder and solvent PIL.pdf

Reasons for updating

  • 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 4 - possible side effects

Updated on 21 June 2019

File name

PIL Rifadin IV IE667.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink

Updated on 21 June 2019

File name

SPC Rifadin IV 600mg IE667 .pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

  • Section 4.3 Contra-indications & 4.5 Interactions with other Medicaments and other forms of Interaction -updated with the information on rifampicin interactions with hepatitis C therapy

 

  • Section 4.5 Interactions with other Medicaments and other forms of Interaction - is reorganized and updated to reflect a review which assessed rifampicin regarding its potential as a perpetrator of drug interactions, primarily via induction of drug metabolizing enzymes and transporters   (note a table outlining this has been added to the SmPC)

 

  • Section 4.5 of SPC updated regarding the analgesic effect of morphine accordance with  CMD guidance for Rifampicin containing products which states the following :

Updated on 05 September 2018

File name

Rifadin IV 89032892.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • 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 2 - excipient warnings

Updated on 30 July 2018

File name

Rifadin Intravenous 600mg Solution for Infusion SPC.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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 Special Warnings and Precautions for Use to include reference to severe bullous reactions

 

Section 4.8 Undesirable Effects to include adverse event acute generalized exanthematous pustulosis (AGEP)

Updated on 07 March 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 07 March 2018

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

Added:- produce discolouration (yellow, orange, red, brown) of the teeth

Removed:-reddish

Section 4.8

Gastrointestinal disorders:-

Added:-tooth discolouration(which may be permanent)

Investigations:-

Added:-(yellow, orange, red, brown) teeth.

Removed:-reddish

Added:-Endocrine disorders - Gynecomastia

Updated on 06 March 2018

File name

PIL_14353_885.pdf

Reasons for updating

  • New PIL for new product

Updated on 06 March 2018

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 10 October 2017

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 medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

6.3 amended

Shelf life reduced from 4 years to 3 years

Updated on 30 March 2017

Reasons for updating

  • 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

Date of revision of text updated

Updated on 15 March 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

Type II.C.1.4 - CCDSv7 Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet due to new quality, pre-clinical, clinical or pharmacovigilance data

Updated on 08 March 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 01 July 2014

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Type 1B No. C.I.3.a bulk variation to update SPC section 4.2 to reflect the dosing recommendations of the above mentioned products in line with the conclusion of the European Medicines Agency (EMA) review of World Health Organisation dosing recommendations for anti-tuberculosis medicines used in children.

Updated on 26 June 2014

Reasons for updating

  • Change to dosage and administration

Updated on 13 May 2011

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 6.4 - Special precautions for storage

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to Sections 4.3, 4.5, 4.7, 4.8, 5.1 and 6.4 of the SPC

Updated on 12 May 2011

Reasons for updating

  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about driving or using machinery

Updated on 08 April 2011

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Modification of Patient information leaflet – User Testing

Updated on 08 April 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 04 August 2009

Reasons for updating

  • Improved electronic presentation
  • Change to section 1 - Name of medicinal product

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Name updated to incorporate the full pharmaceutical form.
Improved electronic presentation.

Updated on 04 August 2009

Reasons for updating

  • New PIL for medicines.ie

Updated on 10 March 2008

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update section 6.1 Excipients and 10 Date of revision.

Updated on 10 November 2006

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

Update section 7 - Change MAH to sanofi-aventis Ireland Ltd.
Update section 10 - Date of revision

Updated on 02 August 2006

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 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

Update sections -
4.3 - addition of contraindication when used with concurrently with ritonavir/saquinavir.
4.5 - addition of interaction when used with ritonavir/saquinavir.
4.8 - update skin reactions to include urticaria, pemphigoid reactions, erythema mulitforme including Stevens Johnson syndrome, toxic epidermal necrolysis, vasculitis and agranulocytosis.
4.9 - additional information on symptoms of overdose and supportive measures.
10 - change in date of revision of SPC.

Updated on 10 May 2005

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 28 January 2005

Reasons for updating

  • 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 4.8 - Undesirable effects
  • 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 06 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)