OxyNorm 50 mg/ml solution for injection or infusion

*
Pharmacy Only: Prescription

Updated on 14 December 2023

File name

OxyNorm Inj 50 mgml - SPC-clean.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 5.3 - 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

Updated to implement the outcome of an Article 45 procedure FR/W/0010/pdWS/01.

Amendments made to include the text concerning the addition of the paediatric indication in the paediatric subset 12 to 18 years of age.

Updated on 14 December 2023

File name

OxyNorm 50 mgml solution for injection or infusion PIL - clean.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Updated to implement the outcome of an Article 45 procedure FR/W/0010/pdWS/01.

Amendments made to include the text concerning the addition of the paediatric indication in the paediatric subset 12 to 18 years of age.

Updated on 08 August 2023

File name

OxyNorm 50mg-ml-injection-PIL-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 5 - how to store or dispose

Updated on 09 May 2023

File name

OxyNorm Inj 50 mgml - SPC-clean.pdf

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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

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

Updated on 09 May 2023

File name

OxyNorm Inj 50 mgml- PIL - clean.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 30 March 2023

File name

Oxynorm Inj 50mgml - SPC - IE - clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 30 March 2023

File name

Oxynorm Inj 50mgml - PIL - IE - clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 12 May 2022

File name

pil 50 mgml.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Section 2 - Updates to warning regarding addiction, addition of warning for smokers, addition of warning regarding mental illness, addition of warning section on sleep apnoea.

Section 4 - Update to wording of sleep apnoea possible side effect.

Updated on 12 May 2022

File name

spc 50 mgml.pdf

Reasons for updating

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

Section 4.4 - Update to warnings regarding sleep apnoea and addition of section on opioid use disorder in line with PRAC recommendations.

Section 4.8 - Change in assigned system organ class for central sleep apnoea syndrome from nervous system disorders to respiratory, thoracic and mediastinal disorders.

Updated on 23 September 2021

File name

pil 50mgml.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Section 2 - Addition of warnings in relation to brain inury or tumour, constipation and sleep apnoea.

Section 4 - Addition of sleep apnoea as a possible side effect.

Updated on 23 September 2021

File name

spc 50mgml.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • 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)

Free text change information supplied by the pharmaceutical company

Section 4.4 - Addition of warnings in relation to raised intracranial pressure, intracranial lesions, constipation and sleep apnoea. Addition of warnings regarding concomitant use of MAOIs.

Section 4.6 - Addition of statement that no human data on fertility are available.

Section 4.8 - Addition of sleep apnoea as a possible side effect. Update to HPRA contact details.

Updated on 24 June 2021

File name

pil 50mgml.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 - interactions with other medicines, food or drink
  • 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
  • Change to information for healthcare professionals
  • Improved presentation of PIL

Free text change information supplied by the pharmaceutical company

Section 2 - Contraindications - Addition of increased carbon dioxide in the blood as a contraindicated condition.

Section 2 - Warnings and Precautions - Addition of low blood volume as a precaution. Replacement of bullet point on tolerance with a paragraph providing further detail. Clarification of existing warnings.

Section 2 - Interactions - Reorganisation of section for improved readability.

Section 2 - Driving and Using Machines - Addition of dizziness as a possible side effect.

Section 2 - Excipient Warnings - Update to sodium warning in line with current guidelines.

Section 4 - Possible Side Effects - Addition of information on respiratory depression. Clarification of existing potential side effects.

Section 4 - How to Report - Update to HPRA contact details in line with current guidelines.

Information for Healthcare Professionals - Deletion of information not relevant to technical use of the injection. Addition of information on overdose and dilution information.

Minor administrative updates.

Updated on 24 June 2021

File name

spc 50mgml.pdf

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 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

Section 4.2 - Clarification that the dose should be adjusted based on the individual patient requirements, and that the lowest effective dose should be used. Addition of dilution information. Addition of paragraph on conversion from morphine.

Section 4.4 - Update to sodium warning in line with current guidelines.

Section 4.5 - Addition of gabapentinoids as potential interacting medicines, and administrative updates.

Section 5.2 - Reorganisation of section into ADME format .

Section 5.3 - Addition of preclinical data from company core datasheet.

Updated on 28 May 2019

File name

Approved_SPC_Clean_Solution_for_Injection_or_Infusion_English_OxyNorm_50_mg_ml_serotonergic_med_ie.pdf

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

Update to revision date following HPRA notificationn of approval 

Updated on 03 April 2019

File name

Approved_package leaflet_clean_Injection_OxyNorm 50 mgml_serotonergic drugs_medicines_ie.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 03 April 2019

File name

Approved_SPC_Clean_Solution_for_Injection_or_Infusion_English_OxyNorm_50_mg_ml_serotonergic_med_ie.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 to section 4.5 of the SPC to include concomitant administration of oxycodone with serotonin agents.

Updated on 27 February 2019

File name

Approved_ie-pl-cleanoxynorm50mgmlsfoen_medicines ie.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 27 February 2019

File name

Approved_ie-spc-cleanoxynorm50mgmlsfoen_medicines ie.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)

Free text change information supplied by the pharmaceutical company

Update to sections 4.4 and 4.5 of the SPC to include information on concomitant use of benzodiazepines/benzodiazepine like products and opioids

Updated on 02 January 2018

Reasons for updating

  • New SPC for new product

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

Updated on 02 January 2018

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 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

Section 4.4$0$0$0$0Addition of -benzodiazepines, other CNS depressants (including alcohol) or'$0$0$0$0$0Addition of - 'Opioids, such as oxycodonehydrochloride, may influence the hypothalamic-pituitary-adrenal or – gonadalaxes.  Some changes that can be seeninclude an increase in serum prolactin, and decreases in plasma cortisol andtestosterone.  Clinical symptoms maymanifest from these hormonal changes.'$0$0$0$0Section 4.5$0$0$0$0$0$0$0Addition of - 'whichcan result in profound sedation, respiratory depression, coma and death' , 'benzodiazepinesor other' , 'alcohol', 'non-benzodiazepine' .$0$0$0$0$0Section 5.1$0$0$0$0$0Removal of - 'Opioids may influence the hypothalmic pituitary adrenal or gonadal axes. Some changes that can be seen include an increase in serum prolactin and decrease in plasma cortisol and testosterone. Clinical symptoms may be manifest from these hormonal changes.' See section 4.4$0$0$0$0$0Section 10$0$0$0$0$0Date change tp 15th September 2017$0

Updated on 10 October 2017

File name

PIL_15287_44.pdf

Reasons for updating

  • New PIL for new product

Updated on 10 October 2017

Reasons for updating

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

Updated on 20 July 2016

Reasons for updating

  • Change to name of manufacturer

Updated on 05 August 2015

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 4.8 – Undesirable effects - how to report a side effect
  • 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

Red text has been deleted

4.2  Deleted: Route of administration
New heading 'Posology'
Deleted: Children under 18 years added 'Paediatric population'
Added: New heading ' Method of Administration'

Section 4.4

Hyperalgesia that will not respond to a further dose increase of oxycodone may very rarely occur

There can be an enhanced CNS depressant effect during concomitant therapy with drugs which affect the CNS such as phenothiazines, tricyclic antidepressants, anaesthetics, hypnotics, sedatives, muscle relaxants, other opioids, neuroleptic drugs, antihypertensives and

The following has been added:

Concomitant administration of oxycodone with anticholinergics or medicines with anticholinergic activity (e.g. tricyclic anti-depressants, antihistamines, antipsychotics, muscle relaxants, anti-Parkinson drugs) may result in increased anticholinergic adverse effects.  Oxycodone should be used with caution and the dosage may need to be reduced in patients using these medications.

Section 4.8

Frequency  unknown has been changed to frequency Not known

Nervous system disorders - lethargy has been added to common

General disorders and administration site conditions - fatigue has been added to common

The information regarding reporting of suspected adverse reactions has been changed.

Section 5.1 

    The following has been added:
    Gastrointestinal system
    Opioids may induce spasm of the sphincter of Oddi.

    Endocrine system

Updated on 21 July 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to name of manufacturer
  • Addition of information on reporting a side effect.

Updated on 30 July 2014

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 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

The following sections have been re-written

4.2 Posology and method of administration

4.3 Contraindications

4.4 Special warning and precautions for use

4.5 Interaction with other medicinal products and other forms of interaction

4.6 Pregnancy and lactation

4.7 Effects on ability to drive and use machines

4.8 Undesirable effects

4.9 Overdose

Updated on 03 June 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation

Updated on 31 July 2013

Reasons for updating

  • 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

In section 6.3 the shelf life has been changed from 3 to 5 years.

Updated on 16 July 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision

Updated on 31 January 2013

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.5 - Nature and contents of container
  • 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

Text in red has been added, Text in blue has been deleted

 

Section 2

Oxycodone hydrochloride 50 mg/ml (equivalent to 45 mg of oxycodone base).

Each 1 ml ampoule contains 50 mg of oxycodone hydrochloride.

 The following has been deleted “50 mg (equivalent to 45 mf of Oxycodone base.”

This medicinal product contains 0.043 mmol sodium(0.998 mg) per ml.

Section 4.1

OxyNorm injection is indicated in adults only.

Section 4.2

Prescribers should consider concomitant treatment with antiemetics and laxatives for the prevention of nausea, vomiting and constipation.

Discontinuation of treatment:

When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

(a 10 mg/ml injection is also available which may be more appropriate for patients who require a lower dosage or require an administration over a shorter time interval).

Section 4.3

(see Section 4.5)

Section 4.4

impaired pulmonary function, reduced respiratory reserve, acute alcoholism, chronic renal and

The word acute has been deleted.

Due to an increased perioperative risk of ileus and respiratory depression OxyNorm injection should be used with caution pre- or intra-operatively and within the first 24 hours post-operatively.

OxyNorm injection should therefore be used with particular care in patients with a history of alcohol and or drug abuse.

This medicine medicinal product contains less than 1mmol 0.043 mmol sodium (23 0.998 mg) per ml.  To be taken into consideration by patients on a controlled sodium diet.

Sections 4.5 & 4.6 have been rewritten.

Section 4.8 has been rewritten and reformatted throughout.

Section 5.1

Pharmacotherapeutic group: Natural opium alkaloid, opioid, analgesics

Whether oxycodone, a semi-synthetic opioid, has immunological effects similar to natural opioids morphine is unknown.

Section 5.3 has been rewritten

Section 6.2

When cyclizine at concentrations of up to 3 mg/ml or less is mixed with OxyNorm injection, no sign of precipitation has been shown over a period of 24 hours storage at room temperature.  When cyclizine at concentrations greater than 3 mg/ml is mixed with OxyNorm injection, precipitation has been shown to occur.

 

It is recommended that water for injection be is used as a diluent, as cyclizine will precipitate in the presence of 0.9% saline.

 

Section 6.5

 

1 ml - Clear, Type I Ph Eur glass ampoules with a white breakline and two orange identification lines.

Section 6.6

Each ampoule is for single use in a single patient.  The injection should be given immediately after opening the ampoule, and  Once opened any unused portion should be discarded. 

OxyNorm 50mg/ml injection, undiluted or diluted to 1 3 mg/ml with 0.9% w/v saline, 5%

Updated on 20 March 2012

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

Updated on 15 March 2012

Reasons for updating

  • New PIL for new product