OxyNorm 50 mg/ml, solution for injection or infusion

  • Name:

    OxyNorm 50 mg/ml, solution for injection or infusion

  • Company:
    info
  • Active Ingredients:

    Oxycodone 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: 03/04/19

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Summary of Product Characteristics last updated on medicines.ie: 28/5/2019

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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories

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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 28 May 2019 SmPC

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 3 April 2019 PIL

Reasons for updating

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

Updated on 3 April 2019 SmPC

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 PIL

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 SmPC

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 2 January 2018 SmPC

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 2 January 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 10 October 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 10 October 2017 PIL

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 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 5 August 2015 SmPC

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 PIL

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 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 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 3 June 2014 PIL

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 SmPC

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 PIL

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 SmPC

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 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

Updated on 15 March 2012 PIL

Reasons for updating

  • New PIL for new product