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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories

Millbank House, Arkle Road, Sandyford, Dublin 18, Ireland
Telephone: +353 1 206 3800
Medical Information e-mail: info@mundipharma.ie


Summary of Product Characteristics last updated on medicines.ie: 14/08/2015
SPC OxyNorm solution for Injection or Infusion


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1. NAME OF THE MEDICINAL PRODUCT

OxyNorm 10 mg/ml solution for injection or infusion.


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Oxycodone hydrochloride 10 mg/ml (equivalent to 9 mg of oxycodone base).

Each 1 ml ampoule contains 10 mg of oxycodone hydrochloride.

Each 2 ml ampoule contains 20 mg of oxycodone hydrochloride (10 mg/ml).

Each 20 ml ampoule contains 200 mg of oxycodone hydrochloride (10 mg/ml).

This medicinal product contains 0.121 mmol sodium (2.78 mg) per ml.

For the full list of excipients, see section 6.1.


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3. PHARMACEUTICAL FORM

Solution for injection or infusion.

A clear, colourless solution.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the treatment of severe pain. OxyNorm injection is indicated in adults only.


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4.2 Posology and method of administration

Posology:

Prescribers should consider concomitant treatment with antiemetics and laxatives for the prevention of nausea, vomiting and constipation.The dose should be adjusted according to the severity of pain, the total condition of the patient and previous or concurrent medication.

Adults:

The following starting doses are recommended for opioid-naïve patients. The initial dose should be adjusted to previous or concurrent medication (especially if the patient has been treated with other opioids before), the total condition of the patient, and the severity of pain. A gradual increase in dose may be required if analgesia is inadequate or if pain severity increases.

•  i.v. (bolus): Dilute to 1 mg/ml in 0.9% saline, 5% dextrose or water for injections. Administer a bolus dose of 1 to 10 mg slowly over 1-2 minutes. Doses should not be administered more frequently than every 4 hours.

•  i.v. (infusion): Dilute to 1 mg/ml in 0.9% saline, 5% dextrose or water for injections. A starting dose of 2 mg/hour is recommended.

•  i.v. (PCA): Dilute to 1 mg/ml in 0.9% saline, 5% dextrose or water for injections. Bolus doses of 0.03 mg/kg should be administered with a minimum lock-out time of 5 minutes.

•  s.c. (bolus): Use as 10 mg/ml concentration. A starting dose of 5 mg is recommended, repeated at 4 hourly intervals as required.

•  s.c. (infusion): Dilute in 0.9% saline, 5% dextrose or water for injections if required. A starting dose of 7.5 mg/day is recommended in opioid naïve patients, titrating gradually according to symptom control.

Cancer patients transferring from oral oxycodone may require much higher doses (see below).

Transferring patients between oral and parenteral oxycodone:

The dose should be based on the following ratio: 2 mg of oral oxycodone is equivalent to 1 mg of parenteral oxycodone. It must be emphasised that this is a guide to the dose required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.

Elderly:

The lowest dose should be administered with careful titration to pain control.

Controlled pharmacokinetic studies in elderly patients (aged over 65 years) have shown that compared with younger adults the clearance of oxycodone is only slightly reduced. No untoward adverse drug reactions were seen based on age, therefore adult doses and dosage intervals are appropriate.

Patients with renal or hepatic impairment:

The dose initiation should follow a conservative approach in these patients. The recommended adult starting dose should be reduced by 50% (for example a total daily dose of 10 mg orally in opioid naïve patients), and each patient should be titrated to adequate pain control according to their clinical situation.

Unlike morphine preparations, the administration of oxycodone does not result in significant levels of active metabolites. However, the plasma concentration of oxycodone in this patient population may be increased compared with patients having normal renal or hepatic function.

Studies involving other intravenous oxycodone preparations, administered by bolus injection to six patients with end-stage liver cirrhosis and ten patients with end-stage renal failure have been reported in the literature. In each case, the elimination of oxycodone was impaired.

Paediatric population:

There are no data on the use of OxyNorm injection in patients under 18 years of age.

Method of administration:

Subcutaneous injection or infusion.

Intravenous injection or infusion.

Duration of treatment

Oxycodone should not be used for longer than necessary.

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.


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4.3 Contraindications

Hypersensitivity to oxycodone or to any of the excipients listed in section 6.1.

Oxycodone must not be used in any situation where opioids are contraindicated: severe respiratory depression with hypoxia, elevated carbon dioxide levels in the blood (hypercarbia), head injury, paralytic ileus, acute abdomen, delayed gastric emptying, severe chronic obstructive lung disease, severe bronchial asthma, cor pulmonale, known sensitivity to morphine or other opioids.


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4.4 Special warnings and precautions for use

The major risk of opioid excess is respiratory depression.

Caution must be exercised when administering oxycodone to the debilitated elderly; patients with severely impaired pulmonary function, impaired hepatic or renal function; patients with myxoedema, hypothyroidism, Addison's disease, toxic psychosis, adrenocortical insufficiency, prostate hypertrophy, head injury (due to the risk of raised intracranial pressure), convulsive disorders, delirium tremens, disorders of consciousness, hypotension, hypovolaemia. Use with caution in opioid dependent patients, diseases of the biliary tract, biliary or ureteric colic, pancreatitis, obstructive and inflammatory bowel disorders, chronic obstructive airways disease, reduced respiratory reserve, alcoholism, or patients taking MAO inhibitors. In patients in whom caution is required, a reduction in dosage may be advisable.

OxyNorm injection should not be used where there is a possibility of paralytic ileus occurring. Should paralytic ileus be suspected or occur during use, OxyNorm injection should be discontinued immediately (see section 4.3). 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.

As with all opioid preparations, oxycodone products should be used with caution following abdominal surgery as opioids are known to impair intestinal motility and should not be used until the physician is assured of normal bowel function.

As with all opioid preparations, patients about to undergo additional pain relieving procedures (e.g. surgery, plexus blockade) should not receive OxyNorm injection for six hours prior to the intervention. If further treatment with OxyNorm injection is indicated then the dosage should be adjusted to the new post-operative requirement.

The patient may develop tolerance to the drug with chronic use and require progressively higher doses to maintain pain control. Prolonged use of this product may lead to physical dependence and a withdrawal syndrome may occur upon abrupt cessation of therapy. When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. Withdrawal symptoms may include yawning, mydriasis, lacrimation, rhinorrhoea, tremor, hyperhidrosis, anxiety, agitation, convulsions and insomnia.

Hyperalgesia that will not respond to a further dose increase of oxycodone may occur, particularly in high doses. An oxycodone dose reduction or change to an alternative opioid may be required.

Oxycodone has an abuse profile similar to other strong agonist opioids. Oxycodone may be sought and abused by people with latent or manifest addiction disorders. There is potential for development of psychological dependence (addiction) to opioid analgesics, including oxycodone. OxyNorm injection should therefore be used with particular care in patients with a history of alcohol and drug abuse.

Concomitant use of alcohol and OxyNorm injection may increase the undesirable effects of OxyNorm injection; concomitant use should be avoided.

It should be emphasised that patients, once titrated to an effective dose of a certain opioid, should not be changed to other opioid analgesic preparations without clinical assessment and careful retitration as necessary. Otherwise, a continuous analgesic action is not ensured.

This medicinal product contains 0.121 mmol sodium (2.78 mg) per ml. To be taken into consideration by patients on a controlled sodium diet.


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4.5 Interaction with other medicinal products and other forms of interaction

Interaction studies have only been performed in adults.

There can be an enhanced CNS depressant effect during concomitant therapy with drugs which affect the CNS such as phenothiazines, antidepressants, anaesthetics, hypnotics, sedatives, muscle relaxants, other opioids, neuroleptic drugs, antihypertensives and SSRIs. Oxycodone should be used with caution and the dosage may need to be reduced in patients using these medications.

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.

Monoamine oxidase inhibitors are known to interact with narcotic analgesics, producing CNS excitation or depression associated with hypertensive or hypotensive crisis (see section 4.4). Oxycodone should be used with caution in patients administered MAO-inhibitors or who have received MAO-inhibitors during the last two weeks (see section 4.4).

Alcohol may enhance the pharmacodynamic effects of OxyNorm injection; concomitant use should be avoided.

Oxycodone is metabolised mainly by CYP3A4, with a contribution from CYP2D6. The activities of these metabolic pathways may be inhibited or induced by various co-administered drugs or dietary elements.

CYP3A4 inhibitors, such as macrolide antibiotics (e.g. clarithromycin, erythromycin and telithromycin), azol-antifungals (e.g. ketoconazole, voriconazole, itraconazole, and posaconazole), protease inhibitors (e.g. boceprevir, ritonavir, indinavir, nelfinavir and saquinavir), cimetidine and grapefruit juice may cause a reduced clearance of oxycodone that could cause an increase of the plasma concentrations of oxycodone. Therefore the oxycodone dose may need to be adjusted accordingly.

Some specific examples are provided below:

• Itraconazole, a potent CYP3A4 inhibitor, administered 200 mg orally for five days, increased the AUC of oral oxycodone. On average, the AUC was approximately 2.4 times higher (range 1.5 - 3.4).

• Voriconazole, a CYP3A4 inhibitor, administered 200 mg twice-daily for four days (400 mg given as first two doses), increased the AUC of oral oxycodone. On average, the AUC was approximately 3.6 times higher (range 2.7 - 5.6).

• Telithromycin, a CYP3A4 inhibitor, administered 800 mg orally for four days, increased the AUC of oral oxycodone. On average, the AUC was approximately 1.8 times higher (range 1.3 – 2.3).

• Grapefruit Juice, a CYP3A4 inhibitor, administered as 200 ml three times a day for five days, increased the AUC of oral oxycodone. On average, the AUC was approximately 1.7 times higher (range 1.1 – 2.1).

CYP3A4 inducers, such as rifampicin, carbamazepin, phenytoin and St John´s Wort may induce the metabolism of oxycodone and cause an increased clearance of oxycodone that could cause a reduction of the plasma concentrations of oxycodone. The oxycodone dose may need to be adjusted accordingly.

Some specific examples are provided below:

• St Johns Wort, a CYP3A4 inducer, administered as 300 mg three times a day for fifteen days, reduced the AUC of oral oxycodone. On average, the AUC was approximately 50% lower (range 37-57%).

• Rifampicin, a CYP3A4 inducer, administered as 600 mg once-daily for seven days, reduced the AUC of oral oxycodone. On average, the AUC was approximately 86% lower

Drugs that inhibit CYP2D6 activity, such as paroxetine and quinidine, may cause decreased clearance of oxycodone which could lead to an increase in oxycodone plasma concentrations.


4.6 Fertility, pregnancy and lactation

Use of this medicinal product should be avoided to the extent possible in patients who are pregnant or lactating.

Pregnancy

There are limited data from the use of oxycodone in pregnant women. Infants born to mothers who have received opioids during the last 3 to 4 weeks before giving birth should be monitored for respiratory depression. Withdrawal symptoms may be observed in the newborn of mothers undergoing treatment with oxycodone.

Oxycodone penetrates the placenta. Oxycodone should not be used during pregnancy and labour due to impaired uterine contractility and the risk of neonatal respiratory depression. For animal studies see section 5.3.

Breast-feeding

Oxycodone may be secreted in breast milk and may cause respiratory depression in the newborn. Oxycodone should, therefore, not be used in breast-feeding mothers.

Fertility

Non-clinical toxicology studies in rats have not shown any effects upon fertility (see section 5.3).


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4.7 Effects on ability to drive and use machines

Oxycodone may impair the ability to drive and use machines. Oxycodone may modify patients' reactions to a varying extent depending on the dosage and individual susceptibility. If affected, patients should not drive or operate machinery.


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4.8 Undesirable effects

The most commonly reported adverse reactions are nausea and constipation. If nausea or vomiting are troublesome, oxycodone may be combined with an antiemetic. Constipation should be anticipated as with any strong opioid, and treated appropriately with laxatives. Should opioid related adverse events persist, they should be investigated for an alternative cause.

Adverse drug reactions are typical of full opioid agonists, and tend to reduce with time, with the exception of constipation. Anticipation of adverse drug reactions and appropriate patient management can improve acceptability.

The most serious adverse reaction, as with other opioids, is respiratory depression (see section 4.9). This is most likely to occur in elderly, debilitated or opioid-intolerant patients.

The adverse drug reactions seen during clinical trials and from spontaneous reports are listed below.

The following frequency categories form the basis for classification of the undesirable effects:

Term

Frequency

Very common

Common

Uncommon

Rare

Very rare

Not known

≥ 1/10

≥ 1/100 to <1/10

≥ 1/1,000 to <1/100

≥1/10,000 to <1/1,000

<1/10,000

Cannot be estimated from the available data

Very Common

Common

Uncommon

Rare

Not known

Immune system disorders

hypersensitivity

anaphylactic responses

Endocrine disorders

syndrome of inappropriate antidiuretic hormone secretion (SIADH)

Metabolism and nutrition disorders

decreased appetite

dehydration, weight fluctuation

Psychiatric disorders

abnormal dreams, abnormal thinking, anxiety, confusional state, depression, insomnia, nervousness

agitation, depersonalisation, affect lability, euphoric mood, hallucinations, decreased libido, drug dependence (see section 4.4)

aggression

Nervous system disorders

somnolence, dizziness, headache

tremor, lethargy

amnesia, convulsion, hyperkinesia, hypertonia, hypoaesthesia, hypotonia, involuntary muscle contractions, speech disorder, stupor, paraesthesia, dysgeusia, syncope

hyperalgesia

Eye disorders

lacrimation disorder, miosis, visual impairment

Ear and labyrinth disorders

tinnitus, vertigo

Cardiac disorders

palpitations (in the context of withdrawal syndrome)

Vascular disorders

vasodilatation

hypotension, orthostatic hypotension

Respiratory, thoracic and mediastinal disorders

dyspnoea, bronchospasm

rhinitis, epistaxis, hiccup, voice alteration, respiratory depression

Gastrointestinal disorders

constipation, nausea, vomiting

abdominal pain, diarrhoea, dry mouth, dyspepsia

dysphagia, flatulence, gastritis, mouth ulceration, eructation, ileus, stomatitis

dental caries

Hepatobiliary disorders

hepatic enzyme increased

biliary colic, cholestasis

Skin and subcutaneous tissue disorders

pruritus

rash, hyperhidrosis

dry skin

urticaria

Renal and urinary disorders

urinary disorders

urinary retention

Reproductive system and breast disorders

erectile dysfunction, hypogonadism

amenorrhoea

General disorders and administration site conditions

asthenia, fever, fatigue

chills, chest pain, drug withdrawal syndrome, gait disturbance, malaise, oedema, peripheral oedema, drug tolerance, thirst

drug withdrawal syndrome neonatal

Tolerance may occur in patients treated with oxycodone. Patients requiring marked dose escalation should have their pain control regimen carefully reviewed.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie


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4.9 Overdose

Acute overdose with oxycodone can be manifested by respiratory depression, somnolence progressing to stupor or coma, hypotonia, miosis, bradycardia, hypotension, pulmonary oedema and death.

Treatment of oxycodone overdose: A patent airway must be maintained. The pure opioid antagonists such as naloxone are specific antidotes against symptoms from opioid overdose. Other supportive measures should be employed as needed.

In the case of massive overdose, administer naloxone 0.8 mg intravenously. Repeat at 2-3 minute intervals as necessary, or by an infusion of 2 mg in 500 ml of normal saline or 5% dextrose (0.004 mg/ml).

The infusion should be run at a rate related to the previous bolus doses administered and should be in accordance with the patient's response. However, because the duration of action of naloxone is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably re-established.

For less severe overdose, administer naloxone 0.2 mg intravenously followed by increments of 0.1 mg every 2 minutes if required.

Naloxone should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to oxycodone overdose. Naloxone should be administered cautiously to persons who are known, or suspected, to be physically dependent on oxycodone. In such cases, an abrupt or complete reversal of opioid effects may precipitate pain and an acute withdrawal syndrome.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Natural opium alkaloid, opioid, analgesics

ATC code: N02AA05

Oxycodone is a full opioid agonist with no antagonist properties and has an affinity for kappa, mu and delta opiate receptors in the brain and spinal cord. Its effects are similar to those of morphine. The therapeutic effect is mainly analgesic, anxiolytic, antitussive and sedative. The mechanism of action involves CNS opioid receptors for endogenous compounds with opioid-like activity.

Gastrointestinal System

Opioids may induce spasm of the sphincter of Oddi.

Endocrine system

Opioids may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone. Clinical symptoms may be manifest from these hormonal changes.

Other pharmacological effects

In vitro and animal studies indicate various effects of natural opioids, such as morphine, on components of the immune system; the clinical significance of these findings is unknown. Whether oxycodone, a semi-synthetic opioid, has immunological effects similar to morphine is unknown.


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5.2 Pharmacokinetic properties

Pharmacokinetic studies in healthy subjects demonstrated an equivalent availability of oxycodone from OxyNorm injection when administered by the intravenous and subcutaneous routes, as a single bolus dose or a continuous infusion over 8 hours.

Following absorption, oxycodone is distributed throughout the entire body. Approximately 45% is bound to plasma protein.

Oxycodone is metabolized in the liver to produce noroxycodone, oxymorphone and noroxymorphone, which are subsequently glucuronidated. CYP3A4 and CYP2D6 being the primary enzymes responsible for the formation of noroxycodone, oxymorphone and noroxymorphone. The in vitro drug-drug interaction studies with noroxymorphone using human liver microsomes resulted in no significant inhibition of CYP2D6 and CYP3A4 activities, which suggest that noroxymorphone may not alter the metabolism of other drugs that are metabolized by CYP2D6 and CYP3A4. Noroxymorphone has been shown to bind to mu opioid receptors. Although oxymorphone has been shown to be active, the analgesic effects of the metabolites are thought to be clinically insignificant.

The active drug and its metabolites are excreted in both urine and faeces.

The plasma concentrations of oxycodone are only nominally affected by age, being 15% greater in elderly as compared with young subjects.

Female subjects have, on average, plasma oxycodone concentrations up to 25% higher than males on a body weight adjusted basis.

When compared with normal subjects, patients with mild to severe hepatic dysfunction may have higher plasma concentrations of oxycodone and noroxycodone, and lower plasma concentrations of oxymorphone. There may be an increase in the elimination half-life of oxycodone, and this may be accompanied by an increase in drug effects.

When compared with normal subjects, patients with mild to severe renal dysfunction (creatinine clearance <60 ml/min) may have higher plasma concentrations of oxycodone and its metabolites. There may be an increase in the elimination half-life of oxycodone and this may be accompanied by an increase in drug effects.


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5.3 Preclinical safety data

Teratogenicity

Oxycodone was not teratogenic in rats in doses of as high as 8 mg/kg/day or in rabbits in doses as high as 125 mg/kg/day. In a peri- and post-natal study in rats, body weights of offspring from maternal rats that received pharmacotoxic doses of oxycodone (6 mg/kg/day) were decreased.

Carcinogenicity

Studies of oxycodone in animals to evaluate its carcinogenic potential have not been conducted.

Mutagenicity

Oxycodone was not mutagenic in bacterial mutation tests or in in-vivo micronucleus assay(s) in mice. As is the case with other opioids, oxycodone was shown to be genotoxic in some in-vitro assays (e.g. mouse lymphoma and human lymphocyte chromosomal aberration assays).


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Citric acid monohydrate

Sodium citrate

Sodium chloride

Hydrochloric acid, dilute

Sodium hydroxide

Water for injections


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6.2 Incompatibilities

When cyclizine at concentrations of up to 3 mg/ml 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 is used as a diluent, as cyclizine will precipitate in the presence of 0.9 % saline.

Prochlorperazine is chemically incompatible with OxyNorm injection.

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.


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6.3 Shelf life

5 years unopened

After opening use immediately.

For further information see section 6.6.


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6.4 Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light.

For further information on use after opening see section 6.6.


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6.5 Nature and contents of container

1 ml - Clear, Type I Ph Eur glass ampoules with a white breakline and a yellow identification line.

2 ml - Clear, Type I Ph Eur glass ampoules with a white breakline and a red identification line.

Pack sizes: 5 ampoules.


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6.6 Special precautions for disposal and other handling

Each ampoule is for single use in a single patient. The injection should be given immediately after opening the ampoule, and any unused portion should be discarded. Chemical and physical in-use stability has been demonstrated for 24 hours at 15 – 25°C room temperature.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution, dilution, etc has taken place in controlled and validated aseptic conditions.

No evidence of incompatibility was observed between OxyNorm injection and representative brands of injectable forms of the following drugs, when stored in high and low dose combinations in polypropylene syringes over a 24 hour period at ambient temperature.

Hyoscine butylbromide

Hyoscine hydrobromide

Dexamethasone sodium phosphate

Haloperidol

Midazolam hydrochloride

Metoclopramide hydrochloride

Levomepromazine hydrochloride

Glycopyrronium bromide

Ketamine hydrochloride

OxyNorm injection, undiluted or diluted to 1 mg/ml with 0.9% w/v saline, 5% w/v dextrose or water for injections, is physically and chemically stable when in contact with representative brands of polypropylene or polycarbonate syringes, polyethylene or PVC tubing and PVC or EVA infusion bags, over a 24 hour period at room temperature.

The injection, whether undiluted or diluted to 1 mg/ml in the infusion fluids used in these studies and contained in the various assemblies, does not need to be protected from light.

Inappropriate handling of the undiluted solution after opening of the original ampoule, or of the diluted solutions may compromise the sterility of the product.


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7. MARKETING AUTHORISATION HOLDER

Mundipharma Pharmaceuticals Limited

Millbank House

Arkle Road

Sandyford

Dublin 18

Ireland


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8. MARKETING AUTHORISATION NUMBER(S)

PA 1688/006/001


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 15 December 2006

Date of last renewal: 15 December 2011


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10. DATE OF REVISION OF THE TEXT

July 2015

® OxyNorm, Mundipharma and the Mundipharma logo are registered trade marks.

© 2008-2013 Napp Pharmaceuticals Ltd



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Active Ingredients

 
   Oxycodone Hydrochloride