Levact 25mg and 100 mg powder for concentrate for solution for infusion

  • Name:

    Levact 25mg and 100 mg powder for concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Bendamustine Hydrochloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 23/01/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 23/1/2019

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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories

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Medicine Name Levact 25mg and 100 mg powder for concentrate for solution for infusion Active Ingredients Bendamustine Hydrochloride
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Medicine Name OxyNorm Concentrate Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm Dispersa 5, 10, 20 mg orodispersible tablets Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm liquid 1 mg/ml oral solution Active Ingredients Oxycodone Hydrochloride
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Medicine Name Palladone SR Capsules Active Ingredients Hydromorphone Hydrochloride
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1 - 0 of 31 items.Total: Infinity pages

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 23 January 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 23 January 2019 SmPC

Reasons for updating

  • 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

MAH address change

Updated on 21 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 21 February 2018 SmPC

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

$0Section 2$0$0‘a’ has beenreplaced by ‘the’ in ‘For the full list of excipients, seesection 6.1’$0$0 $0$0Section 4.2$0$0The text underlined in the section below has been added: $0$0‘Posology$0$0Monotherapy forchronic lymphocytic leukaemia $0$0100 mg/m² body surfacearea bendamustine hydrochloride on days 1 and 2; every 4 weeks up to 6times. $0$0 $0$0Monotherapy forindolent non-Hodgkin’s lymphomas refractory to rituximab$0$0120 mg/m² body surfacearea bendamustine hydrochloride on days 1 and 2; every 3 weeks for at least6 times.$0$0 $0$0Multiple myeloma$0$0120 - 150 mg/m² bodysurface area bendamustine hydrochloride on days 1 and 2, 60 mg/m² body surfacearea prednisone i.v. or per os on days 1 to 4; every 4 weeks for at least 3times.$0$0 $0$0Section 4.4$0$0This text below has been added to the text regardinginfections within section 4.4:$0$0 In case of low CD4-positive T-cell counts(<200/µl) Pneumocystis jirovecii pneumonia (PJP) prophylaxis should beconsidered.’ $0$0‘All’ has replaced‘Therefore,’ in ‘All patients should bemonitored for respiratory signs and symptoms throughout the treatment…’$0$0$0$0The text below that is underlined has been added to the textregarding skin reactions in section 4.4:$0$0‘A number of skinreactions have been reported. These events have included rash, severecutaneous reactions toxic skin reactions and bullousexanthema. Cases of Stevens – Johnson syndrome (SJS) and Toxic EpidermalNecrolysis (TEN) and Drug Reaction with Eosinophilia and Systemic Symptoms(DRESS), some fatal, have been reported with the use of bendamustinehydrochloride. Patients should be advised of the signs and symptoms of thesereactions by their prescribers and should be told to seek medical attentionimmediately if they develop these symptoms.’$0$0$0$0 $0$0Section 4.8$0$0An addition to the organ class which has been underlinedbelow:$0$0 ‘Neoplasms benign, malignant and unspecified (including cyst andpolyp)$0$0$0$0Respiratory, thoracic and mediastinal disorders$0$0‘Pneumonitis’ and ‘Pulmonary alveolar haemorrhage’ addedto this subsection under ‘Not known’$0$0 $0$0Skin and subcutaneous tissue disorders$0$0‘Urticaria’ added tothis subsection under ‘Common’$0$0‘Drug reaction witheosinophilia and systemic symptoms (DRESS)*’ added to this subsection under‘Not known’$0$0‘*’ removed from ‘NOS*’and added to ‘Drug reaction witheosinophilia and systemic symptoms (DRESS)*’$0$0‘(*=combinationtherapy with rituximab) has been added to the section$0$0 $0$0Section 5.1$0$0The text below that is underlined has been added to the textregarding Multiple myeloma in section 5.1:$0$0‘In a prospective,multi-centre, randomised, open study 131 patients with advanced multiplemyeloma (Durie-Salmon stage II with progression or stage III) were included.The first line therapy with bendamustine hydrochloride in combination withprednisone (BP) was compared to treatment with melphalan and prednisone (MP). Neithertransplant-eligibility nor the presence of specific co-morbidities played arole for inclusion into the trial. Tolerability in both treatmentarms was in line with the known safety profile of the respective medicinalproducts with significantly more dose reductions in the BP arm.$0$0 $0$0Section 5.2$0$0‘Biotransformation’ replaces‘Metabolism’ as a subheading withinsection 5.2$0$0 $0$0Section 10$0$0Date of revision updated to ’14 February 2018’$0

Updated on 21 February 2018 PIL

Reasons for updating

  • 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 4 - possible side effects
  • Change to section 6 - what the product contains
  • 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 26 July 2017 SmPC

Reasons for updating

  • 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 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

in section 4.2 (posology and method of administration) the entire section has been re-written.$0in section 4.3 (contraindications) the brackets have been ommitted from 'see section 6.1'$0$0in section 4.4 (special warnings and precautions for use) infections - text changed and added. Skin reactions - text added. Cardiac Disorders - text added. Tumour Lysis syndrome - text added.$0$0in section 4.5 (interaction with other medicinal products and other forms of interaction) paediatric population and interaction studies..... text added.$0$0in section 4.6 (fertility, pregnancy and lactation) Fertility heading used instead of 'Woman of childbearing potential/contraception'.$0$0in section 4.7 (effects on ability to drive and use machines) text added.$0$0in section 4.8 (undesirable effects) ADR information moved to bottom of paragraph. ADR table updated with additional text. Text changed under 'description of selected adverse reactions'$0$0in section 10 (date of revision of the text) date updated.$0

Updated on 26 July 2017 PIL

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 - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 20 February 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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)

Free text change information supplied by the pharmaceutical company

Section 4.4 has been rewritten

Section 4.8 has been changed extensively

Updated on 15 February 2017 PIL

Reasons for updating

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

Updated on 11 August 2015 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • Change to section 11 - Dosimetry

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

Free text change information supplied by the pharmaceutical company

            Section 4.8 Undesirable effects

            Hepatobiliary disorders has been added.

            Section 6.5 Nature and contents of container - the following text in red has been added

Type I brown glass vials of 25/26 ml or 60 ml with rubber stopper and an aluminium flip-off cap.

25/26 ml-vials contain 25 mg bendamustine hydrochloride and are supplied in packs of 5, 10 and 20 vials

Section10 Date of Revision of the Text has been changed to November 2014

Section 11 The following text in red has been added

 

            ® LEVACT, MUNDIPHARMA and the ‘mundipharma’ device (logo) are Registered Trade Marks.

            © 2010- 2014 Napp Pharmaceuticals Limited.

    

 

 

Updated on 6 February 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration
  • Change to name of manufacturer

Updated on 23 November 2010 PIL

Reasons for updating

  • New PIL for new product

Updated on 25 October 2010 SmPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided