Baraclude 0.05 mg/ml oral solution

Product Information *

  • Company:

    Bristol-Myers Squibb Pharma EEIG
  • Status:

    No Recent Update
  • Active Ingredients * :

    *Additional information is available upon request

  • Legal Category:

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

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 04 May 2020

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

  1. to add Swords Laboratories T/A Bristol-Myers Squibb Pharmaceutical Operations, External Manufacturing [Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland] as an alternative site responsible for batch release
  2. to change the name and amend the address of the site responsible for batch release from Bristol-Myers Squibb S.r.l. [Contrada Fontana del Ceraso, 03012 Anagni (FR), Italy] to CATALENT ANAGNI S.R.L. [Loc. Fontana del Ceraso snc, Strada Provinciale 12 Casilina, 41 03012 Anagni (FR), Italy].

Updated on 04 May 2020

Reasons for updating

  • 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

Approved Product Information (PI) changes:

  • to briefly reflect data in the final clinical study reports for Study AI463-080
  • to remove information on the PK of ETV in lamivudine-experienced paediatric patients currently presented in section 5.2 (as requested by CHMP)
  • to remove the word “ongoing” from the descriptions of studies AI463-028 and AI463-189

Updated on 03 February 2020

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

4.       Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Patients treated with Baraclude have reported the following side effects:

Adults

  • common (at least 1 in 100 patients): headache, insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (sleepiness), vomiting, diarrhoea, nausea, dyspepsia (indigestion), and increased blood levels of liver enzymes.
  • uncommon (at least 1 in 1,000 patients): rash, hair loss.
  • rare (at least 1 in 10,000 patients): severe allergic reaction.

Children and adolescents

The side effects experienced in children and adolescents are similar to those experienced in adults as described above with the following difference:

Very common (at least 1 in 10 patients): low levels of neutrophils (one type of white blood cells, which are important in fighting infection).

 

Updated on 03 February 2020

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 medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.8     Undesirable effects

d. Paediatric Population

The safety of entecavir in paediatric patients from 2 to < 18 years of age is based on two ongoing clinical trials in subjects with chronic HBV infection; one Phase 2 pharmacokinetic trial (study 028) and one Phase 3 trial (study 189). These trials provide experience in 195 HBeAg-positive nucleoside-treatment-naïve subjects treated with entecavir for a median duration of 99 weeks. The adverse reactions observed in paediatric subjects who received treatment with entecavir were consistent with those observed in clinical trials of entecavir in adults .(see a. Summary of the safety profile and section 5.1) with the following exception in the paediatric patients:

  • very common adverse reactions: neutropenia.

Updated on 21 May 2019

Reasons for updating

  • Change to section 6 - date of revision

Updated on 25 February 2019

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 22 February 2019

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

The address of the Marketing Authorisation Holder has been changed.

Updated on 07 February 2019

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 20 September 2018

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 20 September 2018

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Updated on 20 September 2018

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Updated on 03 July 2018

Reasons for updating

  • New PIL for new product

Updated on 26 April 2016

Reasons for updating

  • New SPC for new product

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