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Haldol Decanoate 50 mg/ml solution for injection *
Pharmacy Only: Prescription

  • Company:

    Janssen Sciences Ireland

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Haloperidol decanoate

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

Updated on 18 August 2020

File name

haloperidol decanoate-PIL-IE-IA006-cleanC13_1597746446.pdf

Reasons for updating

  • Product/presentation re-marketed

Free text change information supplied by the pharmaceutical company

addition of 3 ml ampoule to PI

Updated on 18 August 2020

File name

haloperidol decanoate-SPC-IE-IA006-clean C14_1597746178.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

addition of 3 ml ampoule to PI

Updated on 20 June 2019

File name

Haldol Decanoate-IE-PIL-C12-10jun19-clean_1560931420.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 5 - how to store or dispose
  • 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 - manufacturer

Updated on 19 June 2019

File name

Haldol Decanoate-IE-SPC-100 mg-C13-10jun19-clean_1560931927.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • 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 6.5 - Nature and contents of container
  • 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 03 April 2019

File name

Haldol DEC-IE-PIL-C11-29mar19-MAH transfer-clean_1554277160.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number

Updated on 03 April 2019

File name

Haldol DEC-IE-SPC 100 MG-C12-29mar19-MAH transfer-clean_1554277429.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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

MAH Transfer

Updated on 03 April 2019

File name

Haldol DEC-IE-SPC 50 MG-C12-29mar19-MAH transfer-clean_1554277256.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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

MAH Transfer

Updated on 10 May 2018

Reasons for updating

  • New SPC for new product

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

Updated on 11 July 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 July 2017

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Correction of spelling/typing errors.

Updated on 13 June 2017

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.8 – Undesirable effects - how to report a side effect
  • 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 6.6 - 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

Change due to harmonisation of Summary of Product Characteristics in Europe (implementation of the outcome of a referral procedure under Article 30 of Directive 2001/83/EC).

Updated on 09 June 2017

File name

PIL_11486_322.pdf

Reasons for updating

  • New PIL for new product

Updated on 09 June 2017

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 - 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 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 23 April 2012

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 20 April 2012

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Addition of class labelling - neonate withdrawal syndrome.

Updated on 20 May 2011

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 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

Change to section 4.2 - Posology and method of administration

Haldol Decanoate is for use in adults only and has been formulated to provide one month’s therapy for most patients following a single deep intramuscular injection in the gluteal region. Haldol Decanoate should be administered deep intramuscularly with a 2 – 2.5 inch needle of at least 21 gauge. Haldol Decanoate must should not be administered intravenously.

 

Change to section 4.3 - Contraindications

Haldol Decanoate is contra-indicated in patients with a known hypersensitivity to haloperidol decanoate and other butyrophenones, or to any excipients (contains sesame oil) contained in the formulation.

Change to section 4.4 - Special warnings and precautions for use

The risk of QT prolongation and/or ventricular arrhythmias may be increased  with parenteral use, particularly intravenous administration. ECG monitoring should be performed for QT interval prolongation and for serious cardiac dysrhythmias if haloperidol is administered intravenously. Haldol Decanoate must not be administered intravenously.

 

Change to section 10 - Date of revision of the text

May2011

Updated on 04 June 2010

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



Change to section 4.4 - Special warnings and precautions for use

Increased Mortality in Elderly people with Dementia

Elderly patients with dementia-related psychosis treated with antipsychotic drugs (conventional and atypical) are at an increased risk of death.

Data from two large observational studies showed that elderly people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated. There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known.

 

Haldol Decanoate is not licensed for the treatment of dementia-related behavioural disturbances.

 

Venous thromboembolism

Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Haldol Decanoate and preventive measures undertaken

 

Change to section 4.8 - Undesirable effects

Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs- Frequency unknown.

 

Change to section 10 - Date of revision of the text

May 2010

Updated on 02 June 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 23 April 2010

Reasons for updating

  • 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

Change to section 6.6 - Refer to leaflet.
Change to section 10 - 19th April 2010

Updated on 22 April 2010

Reasons for updating

  • Change to date of revision
  • Improved electronic presentation

Updated on 11 September 2009

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 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • 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



Change to section 4.2 – Posology and |Method of Administration

Paediatric patients

There is no relevant indication for use of Haldol Decanoate in children.

 

Change to section 4.3 – Contra-indications

Haldol Decanoate is contra-indicated in patients with a known hypersensitivity to haloperidol decanoate and other butyrophenones, or to any excipients contained in the formulation.

 

Change to section 4.4 – Special Warnings and Precautions for Use

Haldol Decanoate contains sesame oil, which may rarely cause severe allergic reactions.

And revised section completely

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

Revised section completely

Change to section 4.8 – Undesirable effects

Updated into one table of ADR’s

Change to section 5.3 - Preclinical Safety Data

Revised section completely

Change to section 10 – Date of revision of text
August 2009

Updated on 10 September 2009

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 10 February 2009

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

X

Change to section 2 quantitative and qualitative composition

Excipient: contains Benzyl Alcohol 15.0mg/ml and Sesame Oil 1.0ml.

For a full list of excipients, see 6.1.

 

X

Change to section 6.3 Shelf Life

Unopened:3 years.

Product should be used immediately after opening and any remaining contents discarded.

 

Change to section 6.6   Instructions for use, handling and disposal

For single use only. Discard any remaining contents immediately after use.

 

X

Change to section 9 Date of Renewal of Authorisation

50 mg/ml: Date of first authorisation: 10 October 1983/ Date of last renewal: 08 October 2008

100 mg/ml: Date of first authorisation: 03 August 1989/ Date of last renewal: 08 October 2008
                                                                                                                                                                   

Updated on 10 February 2009

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

X

Change to section 2 quantitative and qualitative composition

Excipient: contains Benzyl Alcohol 15.0mg/ml and Sesame Oil 1.0ml.

For a full list of excipients, see 6.1.

 

X

Change to section 6.3 Shelf Life

Unopened:3 years.

Product should be used immediately after opening and any remaining contents discarded.

 

X

Change to section 6.6   Instructions for use, handling and disposal

For single use only. Discard any remaining contents immediately after use.

 

X

Change to section 9 Date of Renewal of Authorisation

50 mg/ml: Date of first authorisation: 10 October 1983/ Date of last renewal: 08 October 2008

100 mg/ml: Date of first authorisation: 03 August 1989/ Date of last renewal: 08 October 2008

Updated on 10 February 2009

Reasons for updating

  • Change of inactive ingredient
  • Change to date of revision

Updated on 04 July 2008

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

Change to section 10 – Date of revision of text

June 2008

Change to section 7 – Marketing Authorisation Holder

Change to MAH address

Updated on 04 July 2008

Reasons for updating

  • Change to marketing authorisation holder
  • Change to date of revision

Updated on 31 August 2007

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 29 August 2007

Reasons for updating

  • 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 4.8 - 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

Change to section 4.3 – Contra-indications

Additional cardiac disorders

 

Change to section 4.4 – Special Warnings and Precautions for Use

Cardiac effects and electrolyte monitoring

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

Interaction with other QT prolonging drugs

Change to section 4.6 – Pregnancy and Lactation

Reversible extrapyramidal symptoms

Change to section 4.8 – Undesirable effects

Additional cardiac effects.

 

Change to section 10 – Date of revision of text

April 2007

Updated on 11 September 2006

Reasons for updating

  • New PIL for medicines.ie

Updated on 18 August 2006

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic 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

1.

NAME OF THE MEDICINAL PRODUCT

Add strength to product name

 

3.

PHARMACEUTICAL FORM

Slightly amber, slightly viscous oily solution for intramuscular injection.

 

4.5

Interaction with other medicinal products and other forms of interaction

Phenobarbitone name change to phenobarbital

 

5.1

Pharmacodynamic properties

Add:

Pharmacotherapeutic group: Butyrophenone Derivatives

ATC Code:N05A D01

 

10.

DATE OF REVISION OF THE TEXT

 

 

01 August 2005

 

Updated on 04 November 2003

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)

Updated on 05 June 2003

Reasons for updating

  • New SPC for medicines.ie

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