Haldol Decanoate 50 mg/ml solution for injection * Pharmacy Only: Prescription
Company:
Janssen Sciences IrelandStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 07 February 2023
File name
63e253dd3a047.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
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
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
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
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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.
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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 DementiaElderly 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
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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.
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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
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.
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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.
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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
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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)