PALLADONE

Method of administration Intravenous injection or infusion Subcutaneous injection or infusion The medicinal product is to be visually inspected prior to use. Only clear solutions free from particles should be used. 3). 6. Posology The dosing of Palladone injection has to be adjusted to the patients’ severity of pain and to their individual response.

The dose should be titrated until optimum analgesic effect is achieved. While the dose to be administered should be sufficient to achieve appropriate analgesia, the aim should also be to keep the dose as small as possible in the individual case.

Duration of treatment:

Palladone injection should not be administered longer than absolutely necessary.

Treatment goals and discontinuation:

Before initiating treatment with Palladone injection, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines.

During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed in order to minimise the risk of addiction and drug withdrawal syndrome.

When a patient no longer requires therapy with hydromorphone, it may be advisable to taper the daily dose gradually to prevent withdrawal symptoms. 4). Palladone 10 mg/ml injection is not suitable for initial opioid therapy. This higher strength may only be used as individual doses in patients who have no longer sufficiently responded to lower doses of hydromorphone preparations (Palladone 2 mg) or comparably strong analgesics within the scope of chronic pain therapy.

The reservoir of a pain pump can also be filled with individual doses of 10 mg/ml as the dose control is secured by the pump calibration. c. v. c. 2 mg bolus, stop interval 5-10 min. Paediatric population (< 12 years) Not recommended Transferring patients between oral and parenteral hydromorphone: Switching patients from parenteral hydromorphone to oral hydromorphone should be guided by the sensitivity of the individual patient.

2).

Paediatric population:

Palladone injection is not recommended for use in children under 12 years of age as the safety and efficacy has not yet been established. No data are available. Elderly patients Elderly patients (as a rule over 75 years) may require a lower dosage than other adults to achieve adequate analgesia.

Patients with hepatic and/or renal impairment These patients may require lower doses than other patient groups to achieve adequate analgesia. 2).

c. 6. Description of selected adverse reactions Drug dependence Repeated use of Palladone injection can lead to drug dependence, even at therapeutic doses. 4). 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

, Addison’s disease) • Severely impaired renal function • Severely impaired hepatic function • Convulsive disorders • Alcoholism • Delirium tremens • Biliary tract diseases, biliary or ureteric colic • Obstructive or inflammatory bowel disorders • Reduced respiratory reserve • Constipation In all these patients, reduced dosage may be advisable.

Sleep-related breathing disorders The major risk of opioid excess is respiratory depression. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. 8). 8). In patients who present with CSA, consider decreasing the total opioid dosage.

Risk from concomitant use of sedative medicines such as benzodiazepines (and other CNS depressants) Concomitant use of Palladone injection and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.

Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Palladone injection concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.

The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). Tolerance and Opioid Use Disorder (abuse and dependence) Tolerance, physical and/or psychological dependence may develop upon repeated administration of opioids such as hydromorphone.

Repeated use of Palladone injection can lead to Opioid Use Disorder (OUD). A higher dose and longer duration of opioid treatment can increase the risk of developing OUD. Abuse or intentional misuse of Palladone injection may result in overdose and/or death.

g. major depression, anxiety and personality disorders). 2). Before and during treatment the patient should also be informed about the risks and signs of OUD. If these signs occur, patients should be advised to contact their physician.

g. too early requests for refills). This includes the review of concomitant opioids and psycho-active drugs (like benzodiazepines). For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered.

Drug dependence, tolerance and potential for abuse For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses. g. major depression). Additional support and monitoring may be necessary when prescribing for patients at risk of opioid misuse.

A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on- line, and past and present medical and psychiatric conditions. Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced.

Patients may also supplement their treatment with additional pain relievers. These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death.

It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else. Patients should be closely monitored for signs of misuse, abuse or addiction.

The clinical need for analgesic treatment should be reviewed regularly. Drug withdrawal syndrome Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with hydromorphone.

Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months.

The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.

If women take this drug during pregnancy there is a risk that their newborn infants will experience neonatal […]

1. • Severe respiratory depression with hypoxia and/or hypercapnia • Severe chronic obstructive pulmonary disease • Severe bronchial asthma • Cor pulmonale, • Coma • Acute abdomen • Paralytic ileus • Concurrent administration of mono-amine oxidase inhibitors or within two weeks of discontinuation of their use.