Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1739
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Palladone (Capsule, Extended Release)
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Special Precautions: Palladone���Capsules contain the potent Schedule II opioid agonist, hydromorphone. Schedule II opioid agonists, which include hydromorphone, fentanyl, methadone, morphine, oxycodone, and oxymorphone, have the highest risk of fatal overdoses from respiratory depression, as well as the highest potential for abuse. Hydromorphone, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion. Consuming alcohol while taking Palladone Capsules or taking broken, chewed, dissolved or crushed Palladone���Capsules or its contents can lead to the rapid release and absorption of a potentially fatal dose of hydromorphone. Overestimating the Palladone dose when converting patients from another opioid medication can result in fatal overdose with the first dose. Due to the mean apparent 18-hour elimination half-life of Palladone, patients who receive an overdose will require an extended period of monitoring and treatment that may go beyond 18 hours. Even in the face of improvement, continued medical monitoring is required because of the possibility of extended effects. Palladone���Capsules are for use in OPIOID-TOLERANT patients only. Use in non-opioid-tolerant patients may lead to FATAL RESPIRATORY DEPRESSION.<br/>General Principles: Palladone���Capsules are indicated for the management of persistent, moderate to severe pain in patients requiring continuous, around-the-clock analgesia with a high potency opioid for an extended period of time, generally weeks to months, or longer. Palladone���Capsules should only be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a minimum total daily dose of opiate medication equivalent to 12 mg of oral hydromorphone. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, or at least 30 mg oral oxycodone/day, or at least 8 mg oral hydromorphone/day, or an equianalgesic dose of another opioid, for a week or longer. It is usually appropriate to treat a patient with only one opioid for around-the-clock therapy. Palladone���Capsules are not intended to be used on an as needed basis or as the first opioid product prescribed for a patient, or in patients who require opioid analgesia for a short period of time. The extended-release nature of the formulation allows it to be administered once every 24 hours . Physicians should individualize treatment using a progressive plan of pain management such as outlined by the World Health Organization, the American Pain Society and the Federation of State Medical Boards Model Policy. Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring .<br/>Initiation of Therapy: Palladone���Capsules are for use in opioid-tolerant patients ONLY. It is critical to initiate the dosing regimen individually for each patient, taking into account the patient's prior opioid treatment. Overestimating the Palladone dose when converting patients from another opioid medication can result in fatal overdose with the first dose. Due to the mean apparent 18-hour elimination half-life of Palladone, patients who receive an overdose will require an extended period of monitoring and treatment that may go beyond 18 hours. Even in the face of improvement, continued medical monitoring is required because of the possibility of extended effects. Attention should be given to: The total daily (24-hour) dose of the patient's previous opioid should be determined. No fixed conversion ratio is likely to be satisfactory in all patients, especially patients receiving large opioid doses. The recommended doses are only a starting point, and close observation and frequent titration is indicated until a satisfactory dose is obtained on the new therapy. Most patients given around-the-clock therapy with controlled-release opioids may need to have immediate-release medication available for exacerbations of pain or to treat or prevent pain that occurs predictably during certain patient activities (incident pain). Palladone���Capsules can be safely used concomitantly with usual doses of non-opioid analgesics and analgesic adjuvants, provided care is taken to select a proper initial dose .<br/>Conversion from Transdermal Fentanyl to Palladone���Capsules: Eighteen hours following the removal of the transdermal fentanyl patch, Palladone���Capsule treatment can be initiated. A conservative hydromorphone dose, approximately 12 mg once a day of Palladone���, should be initially substituted for each 50��g/hr of transdermal fentanyl. The patient should be observed closely for early titration as there is very limited clinical experience with this conversion.<br/>Conversion from Opioid Combination Drugs: Patients currently receiving around-the-clock fixed-combination-opioid analgesics, and greater than or equal to a daily dose of 45 mg of oxycodone or hydrocodone equivalents or 300 mg daily dose of codeine equivalents, may be started on 12 mg of Palladone���Capsules once daily. The non-opioid component of the combination product may be continued as a separate drug. Alternatively, a different non-opioid analgesic may be selected.<br/>Supplemental (Rescue) Analgesics: Most patients given around-the-clock therapy with controlled-release opioids may need to have immediate-release medication available for exacerbations of pain or to treat or prevent pain that occurs predictably during certain patient activities (incident pain).<br/>Individualization of Dosage: Once therapy is initiated, pain relief and other opioid effects should be assessed frequently. Palladone���Capsules should be titrated to adequate effect (generally mild or less pain with the regular use of no more than two doses of supplemental analgesics per 24 hours). Rescue medication should be available (see Supplemental [Rescue] Analgesics). Because steady-state plasma concentrations are achieved within approximately 2 to 3 days of therapy with Palladone���, dosage adjustment can be carried out as frequently as every two days, when clinically necessary. If more than two doses of rescue medication are needed within a 24 hour period for two consecutive days, the dose of Palladone���should usually be titrated upward. This formulation should be administered once every 24 hours. As a guideline, the total daily hydromorphone dose (including rescue) usually can be increased by 25% to 50% of the current dose at each upward titration. If signs of excessive opioid-related adverse experiences are observed, the dose may be reduced. If this adjustment leads to inadequate analgesia, a supplemental dose of immediate-release opioid analgesic may be given. Alternatively, non-opioid analgesic adjuvants may be administered. Dose adjustments should be made to obtain an appropriate balance between pain relief and opioid-relatedadverse experiences. If common opioid-related adverse events occur before the therapeutic goal of pain relief is achieved, the events should be effectively treated prior to continuing upward titration of Palladone���Capsules. Once adverse events are under control, upward titration should continue to an acceptable level of pain control. During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient and the caregiver/family.<br/>Managing Expected Opioid Adverse Reactions: Many patients receiving opioids will experience adverse reactions. Frequently the adverse reactions from Palladone���Capsules are transient, but often they require evaluation and management. Certain opioid adverse reactions such as constipation should be anticipated and effectively and prophylactically treated with a stimulant laxative and/or stool softener. Patients do not usually become tolerant to the constipating effects of opioids. Other opioid-related adverse reactions such as sedation and nausea are usually self-limited and often do not persist beyond the first few days. If nausea persists and is unacceptable to the patient, treatment with antiemetics or other modalities may relieve these symptoms and should be considered.<br/>Continuation of Therapy: The intent of the titration period is to establish a patient-specific daily dose that will provide adequate analgesia with acceptable side effects and minimal rescue doses (2 or less) for as long as pain relief is necessary. Should pain recur, the dose can be increased to re-establish pain control. The method of therapy adjustment outlined above should be employed to regain pain control. During chronic around-the-clock opioid therapy, patients should be followed closely and their pain should be reassessed as clinically indicated. Patients should continue to be assessed for their clinical risks for opioid abuse or addiction, particularly with high-dose formulations.<br/>Cessation of Therapy: When the patient no longer requires therapy with Palladone���Capsules, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient. Proper disposal of unused capsules should be ensured by flushing them down the toilet.<br/>Conversion from Palladone���Capsules to Parenteral Opioids: To avoid overdose, conservative dose conversion ratios should be followed.
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Palladone���(hydromorphone hydrochloride extended-release) Capsules are an opioid analgesic supplied in 12 mg, 16 mg, 24 mg, and 32 mg capsule strengths for oral administration. The pellet formulation is the same for all capsule strengths. The strength designation of each capsule indicates the amount of hydromorphone hydrochloride salt. The structural formula, molecular description, and molecular weight are shownbelow: The chemical name is 4,5��-epoxy-3-hydroxy-17 methylmorphinan-6-one hydrochloride. Hydromorphone, a fine, white (or nearly white), crystalline powder, is a semi-synthetic congener of morphine. The inactive ingredients in the pellets are ammonio methacrylate copolymer type B, ethylcellulose, and stearyl alcohol. The inactive ingredients in the capsules and the inks used to imprint them are FD&C blue #2 (24 mg strength capsule only), gelatin, red iron oxide (12 mg and 16 mg strength capsules only), synthetic black iron oxide, and titanium dioxide. Palladone���Capsules are based on a controlled-release melt extrusion technology in which pellets containing hydromorphone HCl and co-melted excipients release the active ingredient significantly more slowly and for a longer period than an immediate-release product. Palladone���Capsules are designed to provide controlled delivery of hydromorphone over 24 hours. The 12 mg, 16 mg, 24 mg, and 32 mg capsules are filled with identical pellets using different fill weights to achieve different strengths. Palladone���Capsules are for use in opioid-tolerant patients only. Use in non-opioid-tolerant patients may lead to fatal respiratory depression.
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Hydromorphone is a pure opioid agonist whose principal therapeutic action is analgesia. Other members of the class known as opioid agonists include substances such as morphine, oxycodone, fentanyl, codeine, and hydrocodone. Pharmacological effects of opioid agonists include anxiolysis, euphoria, feelings of relaxation, respiratory depression, constipation, miosis, cough suppression, and analgesia. Like all pure opioid agonist analgesics, with increasing doses there is increasing analgesia, unlike with mixed agonist/antagonists or non-opioid analgesics, where there is a limit to the analgesic effect with increasing doses. With pure opioid agonist analgesics, there is no defined maximum dose; the ceiling to analgesic effectiveness is imposed only by side effects, the more serious of which may include somnolence and respiratory depression.<br/>Central Nervous System: The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and play a role in the analgesic effects of this drug. Hydromorphone produces respiratory depression by direct action of brain stem respiratory centers. The respiratory depression involves both a reduction in the responsiveness of the brain stem to increases in carbon dioxide and to electrical stimulation. Hydromorphone depresses the cough reflex by direct effect on the cough center in the medulla. Antitussive effects may occur with doses lower than those usually required for analgesia. Hydromorphone causes miosis even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in the setting of Palladone���Capsule overdose .<br/>Gastrointestinal System: Hydromorphone causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and in the duodenum. Digestion of food is delayed in the small intestine and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm resulting in constipation. Other opioid induced-effects may include a reduction in gastric, biliary and pancreatic secretions, spasm of the sphincter of Oddi, and transient elevations in serumamylase.<br/>Cardiovascular System: Hydromorphone may produce release of histamine with or without associated peripheral vasodilation. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension.<br/>Endocrine System: Opioid agonists have been shown to have a variety of effects on the secretion of hormones. Opioids inhibit the secretion of ACTH, cortisol, and luteinizing hormone (LH) in humans. They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon in humans and other species, rats and dogs. Thyroid stimulating hormone (TSH) has been shown to be both inhibited and stimulated by opioids.
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Palladone���Capsules are contraindicated:
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Palladone���(hydromorphone hydrochloride extended-release) Capsules 12 mg are cinnamon-colored capsules imprinted with P-XL on the cap and 12 mg on the body. They are available in multiple-use containers, not intended for dispensing directly to the patient. They are supplied as follows: NDC 59011-312-60: opaque plastic bottles of 60 capsulesNDC 59011-312-20: Unit dose packaging with 20 capsules; 10 individually numbered blister units per card: two cards per carton Palladone���(hydromorphone hydrochloride extended-release) Capsules 16 mg are pink capsules imprinted with P-XL on the cap and 16 mg on the body. They are available in multiple-use containers, not intended for dispensing directly to the patient. They are supplied as follows: NDC 59011-313-60: opaque plastic bottles of 60 capsulesNDC 59011-313-20: Unit dose packaging with 20 capsules; 10 individually numbered blister units per card; two cards per carton Palladone���(hydromorphone hydrochloride extended-release) Capsules 24 mg are blue capsules imprinted with P-XL on the cap and 24 mg on the body. They are available in multiple-use containers, not intended for dispensing directly to the patient. They are supplied as follows: NDC 59011-314-60: opaque plastic bottles of 60 capsulesNDC 59011-314-20: Unit dose packaging with 20 capsules; 10 individually numbered blister units per card; two cards per carton Palladone���(hydromorphone hydrochloride extended-release) Capsules 32 mg are white capsules imprinted with P-XL on the cap and 32 mg on the body. They are available in multiple-use containers, not intended for dispensing directly to the patient. They are -supplied as follows: NDC 59011-315-60: opaque plastic bottles of 60 capsulesNDC 59011-315-20: Unit dose packaging with 20 capsules; 10 individually numbered blister units per card; two cards per carton Store at 25��C (77��F); excursions permitted to 15��-30��C (59��-86��F) [See USP Controlled Room Temperature]. Avoid temperatures above 40��C (104��F) [See USP Excessive Heat] Dispense in a tight, light-resistant container.
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WARNING:: Palladone���(hydromorphone hydrochloride extended-release) Capsules are indicated for the management of persistent, moderate to severe pain in patients requiring continuous, around-the-clock analgesia with a high potency opioid for an extended period of time (weeks to months) or longer. Palladone���Capsules should only be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a minimum total daily dose of opiate medication equivalent to 12 mg of oral hydromorphone. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, or at least 30 mg of oral oxycodone/day, or at least 8 mg oral hydromorphone/day, or an equianalgesic dose of another opioid, for a week or longer. Palladone���Capsules should be administered once every 24 hours. Appropriate patients for treatment with Palladone Capsules include patients who require high doses of potent opioids on an around-the-clock basis to improve pain control and patients who have difficulty attaining adequate analgesia with immediate-release opioid formulations. Palladone Capsules are contraindicated for use on an as needed basis (i.e., prn). Palladone���Capsules are NOT intended to be used as the first opioid product prescribed for a patient, or in patients who require opioid analgesia for a short period of time. Palladone���Capsules are for use in OPIOID-TOLERANT patients ONLY. Use in non-opioid-tolerant patients may lead to FATAL RESPIRATORY DEPRESSION. Overestimating the Palladone dose when converting patients from another opioid medication can result in fatal overdose with the first dose. Due to the mean apparent 18-hour elimination half-life of Palladone, patients who receive an overdose will require an extended period of monitoring and treatment that may go beyond 18 hours. Even in the face of improvement, continued medical monitoring is required because of the possibility of extended effects. Palladone���Capsules contain the potent Schedule II opioid agonist, hydromorphone. Schedule II opioid agonists (which include hydromorphone, fentanyl, methadone, morphine, oxycodone, and oxymorphone), have the highest risk of fatal overdoses due to respiratory depression, as well as the highest potential for abuse. Palladone can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing Palladone in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. All patients receiving opioids should be routinely monitored for signs of misuse, abuse and addiction. Patients at increased risk of opioid abuse may still be appropriately treated with modified-release opioid formulations; however these patients will require intensive monitoring for signs of misuse, abuse, or addiction. Palladone capsules are to be swallowed whole and are not to be broken, chewed, opened, dissolved or crushed. Consuming alcohol while taking palladone���capsules or taking broken, chewed, dissolved, or crushed palladone���capsules or its contents can lead to the rapid release and absorption of a potentially fatal dose of hydromorphone. Overestimating the palladone dose when converting the patient from another opioid medication can result in fatal overdose with the first dose. With the long half-life of palladone (18hours), patients who receive the wrong dose will require an extended period of monitoring and treatment that may go beyond 18 hours. Even in the face of improvement, continued medical monitoring is required because of the possibility of extended effects.
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hydromorphone hydrochloride
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Palladone (Capsule, Extended Release)
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The safety of Palladone���Capsules was evaluated in double-blind clinical trials involving 612 patients with moderate to severe pain. An open-label extension study involving 143 patients with cancer pain was conducted to evaluate the safety of Palladone���Capsules when used for longer periods of time in higher doses than in the controlled trials. Patients were treated with doses averaging 40 to 50 mg of Palladone���Capsules per day (ranging between 12 and 500 mg/day) for several months (range 1 to���52 weeks). Serious adverse reactions which may be associated with Palladone���Capsules therapy in clinical use are similar to those of other opioid analgesics, including respiratory depression, apnea, respiratory arrest, and to a lesser degree, circulatory depression, hypotension, shock or cardiac arrest .<br/>Adverse Events Reported in Controlled Trials: Table 3 lists treatment emergent signs and symptoms that were reported in at least 2% of patients in the placebo-controlled trials for which the rate of occurrence was greater for those treated with 12mg Palladone���Capsules than those treated with placebo.drug abuse and dependence (addiction)<br/>Adverse Events Observed in Clinical Trials: Palladone���Capsules have been administered to 785 individuals during completed clinical trials. The conditions and duration of exposure to Palladone���varied greatly, and included open-label and double-blind studies, uncontrolled and controlled studies, inpatient and outpatient studies, fixed dose and titration studies. Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing. These categories are used in the listing below. The frequencies represent the proportion of 785 patients from these trials who experienced that event while receiving Palladone���Capsules. All adverse events included in this tabulation occurred in at least one patient. Events are classified by body system and listed using the following definitions: frequent adverse events - those occurring in at least 1/100 patients; adverse events occurring with an incidence less than 1% are considered infrequent. These adverse events are not necessarily related to Palladone���Capsule treatment and in most cases were observed at a similar frequency in placebo-treated patients in the controlled studies.<br/>Frequent Adverse Events: Body as a Whole: headache, asthenia, pain, abdominal pain, fever, chest pain, infection, chills, malaise, neck pain, carcinoma, accidental injury Cardiovascular: vasodilatation, tachycardia, migraine Digestive: nausea, constipation, vomiting, diarrhea, dyspepsia, anorexia, dry mouth, nausea and vomiting, dysphagia, flatulence Hematologic and Lymphatic: anemia, leukopenia Metabolic and Nutritional: peripheral edema, dehydration, edema, generalized edema, hypokalemia, weight loss Musculoskeletal: arthralgia, bone pain, leg cramps, myalgia Nervous: somnolence, dizziness, nervousness, confusion, insomnia, anxiety, depression, hypertonia, hypesthesia, paresthesia, tremor, thinking abnormal, hallucinations, speech disorder, agitation, amnesia, tinnitus, abnormal gait Respiratory: dyspnea, cough increased, rhinitis, pharyngitis, pneumonia, epistaxis, hiccup, hypoxia, pleural effusion Skin and Appendages: pruritus, sweating, rash Special Senses: amblyopia, taste perversion Urogenital: dysuria, urinary incontinence
Infrequent Adverse Events<br/>Infrequent Adverse Events: Body as a Whole: face edema, ascites, allergic reaction, cellulitis, overdose, hypothermia, neoplasm, photosensitivity reaction, sepsis, flank pain Cardiovascular: hypertension, hypotension, syncope, deep thrombophlebitis, arrhythmia, postural hypotension, atrial fibrillation, pallor, bradycardia, electrocardiogram abnormal, myocardial infarction, palpitation, angina pectoris, congestive heart failure, QT interval prolonged, supraventricular tachycardia, thrombosis,cardiomegaly, hemorrhage Digestive: fecal impaction, intestinal obstruction, abnormal stools, fecal incontinence, hepatic failure, increased appetite, cholangitis, cholecystitis, colitis, enterocolitis, hepatomegaly, jaundice, liver function tests abnormal, biliary spasm, ileus, eructation, rectal hemorrhage, esophagitis, glossitis, melena, mouth ulceration, gastrointestinal hemorrhage, tongue edema Endocrine: adrenal cortex insufficiency Hematologic and Lymphatic: ecchymosis, thrombocytopenia, leukocytosis, lymphadenopathy, agranulocytosis, lymphoma like reaction, pancytopenia, petechia Metabolic and Nutritional: hyperglycemia, hyponatremia, cachexia, hypercalcemia, hypomagnesemia, cyanosis, diabetes mellitus, gout, respiratory acidosis, elevated liver enzymes, thirst Musculoskeletal: myasthenia Nervous: abnormal dreams, emotional lability, paranoid reaction, sleep disorder euphoria, incoordination, stupor, ataxia, convulsion, hallucination, hostility, myoclonus, psychosis, vertigo, withdrawal syndrome, apathy, delirium, dementia, drug dependence, nystagmus, twitching, depersonalization, aphasia, cerebrovascular accident, circumoral parasthesia, seizure, hyperkinesia, hypotonia, increased salivation, neuralgia Respiratory: hypoventilation, apnea, atelectasis, hemoptysis, asthma, hyperventilation, pulmonary embolus, laryngismus Skin and Appendages: urticaria, maculopapular rash, alopecia Special Senses: abnormal vision, diplopia, dry eyes, lacrimation disorder, hyperacusis Urogenital: urinary retention, hematuria, impotence, urinary frequency, urination impaired, dysmenorrhea, creatinine increased, urinary urgency<br/>Additional Adverse Events From Non-U.S. Experience: Addiction, blurred vision, drowsiness, dysphoria, sedation, seizure, physical dependence, biliary spasm, and ileus
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Palladone���Capsules are indicated for the management of persistent, moderate to severe pain in patients requiring continuous, around-the-clock analgesia with a high potency opioid for an extended period of time generally weeks to months or longer. Palladone���Capsules should only be used in patients who are already receiving opioid therapy, have demonstrated opioid tolerance, and who require a minimum total daily dose of opiate medication equivalent to 12 mg of oral hydromorphone. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, or at least 30 mg oral oxycodone/day, or at least 8 mg oral hydromorphone/day, or an equianalgesic dose of another opioid, for a week or longer. Appropriate patients for treatment with Palladone include patients who require high doses of potent opioids on an around-the-clock basis to improve pain control, and patients who have difficulty attaining adequate analgesia with immediate-release opioid formulations. Palladone���Capsules are NOT intended to be used: An evaluation of the appropriateness and adequacy of immediate-release opioids is advisable prior to initiating therapy with any modified-release opioid. Prescribers should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen, to opioids, in a plan of pain management such as outlined by the World Health Organization, the Agency for Health Research and Quality, the Federation of State Medical Boards Model Policy, or the American Pain Society. Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. Patients receiving opioids should be routinely monitored for signs of misuse, abuse, and addiction. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients at increased risk may still be appropriately treated with modified-release opioid formulations; however these patientswill require intensive monitoring for signs of misuse, abuse, or addiction.
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Palladone
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