בלגיה - אנגלית - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

aop orphan pharmaceuticals gmbh - tetrabenazine 25 mg - tablet - 25 mg - tetrabenazine 25 mg - tetrabenazine

אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

aop orphan pharmaceuticals gmbh - tetrabenazine - tablet - 25 milligram(s) - other nervous system drugs; tetrabenazine

אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

aop orphan pharmaceuticals gmbh - naltrexone hydrochloride - film-coated tablet - 50 milligram(s) - drugs used in alcohol dependence; naltrexone

אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

aop orphan pharmaceuticals gmbh - naltrexone hydrochloride - film-coated tablet - 50 milligram(s) - drugs used in alcohol dependence; naltrexone

ארצות הברית - אנגלית - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - butorphanol tartrate (unii: 2l7i72ruhn) (butorphanol - unii:qv897jc36d) - butorphanol tartrate 1 mg in 1 ml - butorphanol tartrate injection is indicated: - as a preoperative or pre-anesthetic medication - as a supplement to balanced anesthesia - for the relief of pain during labor, and - for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve butorphanol tartrate injection for use in patients for whom alternative treatment options [e.g. non-opioid analgesics] - have not been tolerated, or are not expected to be tolerated - have not provided adequate analgesia, or are not expected to provide adequate analgesia butorphanol tartrate injection is contraindicated in: - patients with significant respiratory depression [see warnings ] - patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings ] - patients with known or suspected gastrointestinal obstruction, including paralytic ileus (see warnings ) - patients with hypersensitivity to butorphanol tartrate,the preservative benzethonium chloride in the multiple dose vial, or any of the formulation excipients (e.g., anaphylaxis) (see warnings ) butorphanol tartrate injection contains butorphanol, a schedule iv controlled substance. butorphanol tartrate injection contains butorphanol, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. butorphanol tartrate injection can be abused and is subject to misuse, addiction, and criminal diversion (see warnings ).all patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. “drug-seeking” behavior is very common in persons with substance use disorders. drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating health care provider(s). “doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. abuse and addiction are separate and distinct from physical dependence and tolerance. health care providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. in addition, abuse of opioids can occur in the absence of true addiction. butorphanol tartrate injection, like other opioids, can be diverted for non-medical use into illicit channels of distribution. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. abuse of butorphanol tartrate injection poses a risk of overdose and death. the risk is increased with concurrent abuse of butorphanol tartrate injection with alcohol and other central nervous system depressants. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. both tolerance and physical dependence can develop during chronic opioid therapy. tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. butorphanol should not be abruptly discontinued [see dosage and administration ]. if butorphanol is abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur. some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. other signs and symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see precautions; pregnancy ].

ישראל - אנגלית - Ministry of Health

aop orphan pharmaceuticals israel ltd, israel - nabilone - capsules - nabilone 1 mg - nabilone - canemes is indicated for the treatment of chemotherapy-induced vomiting and nausea in adult cancer patients, who do not respond adequately to other antiemetic treatments

ישראל - אנגלית - Ministry of Health

aop orphan pharmaceuticals israel ltd, israel - nabilone - capsules - nabilone 1 mg - nabilone - canemes is indicated for the treatment of chemotherapy-induced vomiting and nausea in adult cancer patients, who do not respond adequately to other antiemetic treatments

ישראל - אנגלית - Ministry of Health

aop orphan pharmaceuticals israel ltd, israel - nabilone - capsules - nabilone 1 mg - nabilone - canemes is indicated for the treatment of chemotherapy-induced vomiting and nausea in adult cancer patients, who do not respond adequately to other antiemetic treatments

ישראל - אנגלית - Ministry of Health

aop orphan pharmaceuticals israel ltd, israel - esmolol hydrochloride - solution for injection - esmolol hydrochloride 10 mg/ml - esmolol - esmolol amomed 100 mg/10 ml is indicated for supraventricular tachycardia (except for pre-excitation syndromes) and for the rapid control of the ventricular rate in adult patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other circumstances where short-term control of the ventricular rate with a short-acting agent is desirable.esmolol amomed 100 mg/10 ml is also indicated for tachycardia and hypertension occurring in the perioperative phase and non-compensatory sinus tachycardia in adult patients where, in the physician’s judgement the rapid heart rate requires specific intervention.esmolol amomed 100 mg/10 ml is not intended for use in chronic settings.

האיחוד האירופי - אנגלית - EMA (European Medicines Agency)

aop orphan pharmaceuticals gmbh - ropeginterferon alfa-2b - polycythemia vera - immunostimulants, - besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.