RE: Shortage of DBL MORPHINE SULFATE 30mg/1mL injection BP ampoule and alternative supply arrangement under Section 19A of the Therapeutic Goods Act

Transcription

1 22 January 2019 RE: Shortage of DBL MORPHINE SULFATE 30mg/1mL injection BP ampoule and alternative supply arrangement under Section 19A of the Therapeutic Goods Act Dear Healthcare Professional, This notification is sent by LINK to inform your organisation that due to a shortage of the Australian registered DBL MORPHINE SULFATE 30mg/1mL injection BP ampoule (AUST R ), LINK has arranged the supply of an alternative product. LINK can supply Morphine Sulfate Injection BP 30mg in 1mL ampoules, registered and marketed in the United Kingdom. Morphine Sulfate Injection BP 30mg in 1mL ampoules are NOT registered in Australia and supply is granted under an exemption granted by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act, 1989 until 30 June Morphine Sulfate Injection BP 30mg in 1mL ampoules are approved for use under Section 19A for the following indication(s): For the relief of severe pain not responsive to non-opioid analgesics. NOTE: Morphine Sulfate Injection BP 30mg in 1mL ampoules is not indicated for use as a preoperative medication or as an analgesic adjunct in general anaesthesia. Morphine Sulfate Injection BP 30mg in 1mL ampoules is not recommended for children under 6 years. Note: The formulation of the Morphine Sulfate Injection BP 30mg in 1mL ampoules from the UK, contains a preservative and consequently must NOT be administered via the epidural or intrathecal route. It is approved for intravenous (IV), intramuscular (IM) and subcutaneous (SC) routes of administration only. The Australian registered DBL MORPHINE SULFATE 30mg/1mL injection BP ampoule formulation is preservative free. WARNING UK registered Morphine Sulfate Injection BP 30mg in 1mL ampoules CONTAINS PRESERVATIVE NOT FOR EPIDURAL or INTRATHECAL USE.

2 The UK registered Morphine Sulfate Injection BP 30mg in 1mL ampoules will have an over-stick on the front of the outer packaging, warning clinicians that this product can be used for SC, IV and IM use only. Please refer to the adjacent image for an illustration of the front panel of the packaging with the over-sticker. Morphine Sulfate Injection BP 30mg in 1mL ampoules are registered in the United Kingdom and are packaged in English language. Please refer to the package leaflet within the carton and the SmPC (UK prescribing information) attached to this letter for more information. Adverse Event Reporting Reporting any suspected adverse event is important for the continued monitoring of the safety of all medicines. Any adverse events which are Morphine Sulfate Injection BP 30mg in 1mL ampoules should be reported by healthcare professionals and patients to Link Healthcare Medical Information. This information can also be reported to the TGA at Link Healthcare Medical Information can be contacted by phone on or via at For further information please contact Link Healthcare Customer Service on or via at We would appreciate if you could distribute this information to those in your organisation who would be affected by the shortage of morphine sulfate ampoules. Yours sincerely, Danielle Kaminski B.Pharm Senior Regulatory Affairs Associate

3 1. NAME OF THE MEDICINAL PRODUCT Morphine Sulfate Injection BP 30mg in 1ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Morphine Sulfate BP 3.0 % w/v 3. PHARMACEUTICAL FORM Solution for Injection 4. CLINICAL PARTICULARS 4.1. Therapeutic Indications For the relief of severe pain Posology and Method of Administration By intramuscular, subcutaneous or intravenous injection. Adults Initially 10-20mg, the dose may be repeated every 4-6 hours. In cases of terminal pain higher doses may be required. The Elderly Caution is advised. A reduction of dose is advisable. Children Not recommended for children under 6 years For children 6-12 years (after risk/benefit assessment) 5-10 mg by subcutaneous or intramuscular routes only 4.3 Contra-Indications Hypersensitivity to any of the products ingredients. Acute respiratory depression or Chronic Obstructive Airways Disease. Asthma attack. Acute alcoholism. Biliary colic. Head injuries or increased intracranial pressure. Heart failure secondary to lung disease. Monoamine oxidase inhibitors (including moclobemide), or within two weeks of their withdrawal. Risk of paralytic ileus. Phaeochromocytoma Special Warnings and Special Precautions for Use

4 Repeated use can cause tolerance and dependence. Caution in use should be excercised and a reduction in dose may be advisable in the elderly and in the following cases: Hypotension. Hypothyroidism. Depressed respiratory reserve. Prostatic hypertrophy. Hepatic or renal impairment. ( Avoid or reduce dose). Convulsive disorders Interactions with other Medicinal Products and other Forms of Interaction Alcohol : Enhanced sedative and hypertensive effects. Antidepressants: The use of morphine should be avoided or used with caution in patients receiving monoamine oxidase inhibitors (including moclobemide), or within two weeks of their withdrawal. Anxiolytics, Hypnotics and other CNS Depressants: Sedative effects may be enhanced by simultaneous use of morphine. Ciprofloxacin: Morphine Sulfate should not be used as a premedication when ciprofloxacin is used for surgical prophylaxis as serum levels of ciprofloxacin are reduced and adequate cover may not be obtained during surgery Pregnancy and Lactation Morphine should not be used during pregnancy or lactation as it crosses the placenta and is secreted in breast milk and can cause respiratory depression in the neonate. 4.7 Effects on ability to drive and use machines May cause drowsiness, if affected patients should not drive or operate machinery. This medicine can impair cognitive function and can affect a patient s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act When prescribing this medicine, patients should be told: The medicine is likely to affect your ability to drive Do not drive until you know how the medicine affects you It is an offence to drive while under the influence of this medicine However, you would not be committing an offence (called statutory defence ) if: o The medicine has been prescribed to treat a medical or dental problem and o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and o It was not affecting your ability to drive safely 4.8. Undesirable Effects Hallucinations, confusion, mood changes, dysphoria and dependence.

5 Headache, vertigo, dizziness and drowsiness. Sweating and postural hypotension. Miosis. Bradycardia, palpitations, tachycardia and facial flushing. Respiratory depression. Constipation, nausea, vomiting and a dry mouth. Ureteric or biliary spasm. Rashes, pruritis and urticaria. Anaphylaxis and bronchospasm. Decrease in libido or potency. Difficulty with micturition. Hypothermia. Myoclonus with higher doses Overdose Symptoms: Treatment: Pin point pupils, respiratory depression and hypotension. Convulsions, especially in children and rhabdomyolysis leading to renal failure. Circulatory failure and coma may occur in severe cases. Treat with intravenous Naloxone. Maintain fluid and electrolyte levels and provide assisted respiration if necessary 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmacodynamic Properties Morphine is a powerful analgesic and narcotic and has central stimulant action. It depresses the thalamus, sensory cortex, respiratory and cough centres but stimulates the vomiting centre. Morphine increases the tone of involuntary muscles especially the sphincters of the gastro-intestinal tract Pharmacokinetic Properties Morphine is distributed throughout the body but mainly in the kidneys, liver, lungs and spleen. It crosses the placenta and traces are found in sweat and milk. It is about 35% plasma protein bound. The plasma half life is 2-3 hours and about 60% of the dose is excreted in the urine after 24 hours. A small proportion of this is free morphine (higher in alkaline urine) and about 60-70% is conjugated. A small amount may be excreted in the bile Pre-clinical Safety Data No additional pre-clinical data of relevence to the prescriber. 6. PHARMACEUTICAL PARTICULARS

6 6.1. List of Excipients Sodium Chloride, Sodium Metabisulphite and Water for Injection. The ph may be adjusted with Sodium Hydroxide or Sulphuric Acid Solution Incompatibilities None stated Shelf Life 36 months 6.4. Special Precautions for Storage Do not store above 25 C and protect from light Nature and Content of Container Clear, colourless 1ml glass ampoules containing sufficient solution to permit the removal of 1ml. 10 ampoules are packed into a cardboard carton Instructions for Use, Handling and Disposal None stated. ADMINISTRATIVE DATA 7. MARKETING AUTHORISATION HOLDER Macarthys Laboratories Ltd t/a Martindale Pharmaceuticals, Bampton Road, Harold Hill, Romford RM3 8UG 8. MARKETING AUTHORISATION NUMBER PL 1883/6178R 9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION First authorised: 19 th January, 1982 Last renewal: 19 th August 2002

7 10 DATE OF REVISION OF THE TEXT 24/07/2014