Երկիր: Իսրայել
Լեզու: անգլերեն
Աղբյուրը: Ministry of Health
METHADONE HYDROCHLORIDE
RAFA LABORATORIES LTD
N02AC52
SOLUTION
METHADONE HYDROCHLORIDE 50 MG/ML
PER OS
Required
RAFA LABORATORIES LTD, JERUSALEM
METHADONE, COMB. EXCL. PSYCHOLEPTICS
METHADONE, COMB. EXCL. PSYCHOLEPTICS
Relief of severe pain. Detoxification and withdrawal treatment in narcotic addiction.
2022-05-31
ראוני 2019 ,ה/דבכנ ת/חקורו ה/אפור METHADONE ORAL SOLUTION – אפורל ןולע ןוכדע רישכתה לש אפורל ןולעה ןכדוע יכ םכתעידיל איבהל תשקבמ אפר תודבעמ ליעפה ביכרמה : Methadone HCl היוותה : Relief of severe pain. Detoxification and withdrawal treatment in narcotic addiction. םידיאויפואה תצובקמ םירישכתה לכל ףיסוהל תואירבה דרשמ תשירדל םאתהב Black box יבגל :אבה עדימה היוותהה ינפל ןולעב ףסוה ,םיניפזאידוזנב םע היצקארטניא WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see section 'Interactions']. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. אפורל ןולעל רושיק ב"צמ – .עבצב ןמוסמ יונישה תואירבה דרשמ רתאבש תופורתה רגאמב םוסרפל חלשנ אפורל ןולעה ) www.health.gov.il ( , מ תרבחל הינפ י"ע ספדומ ולבקל םג ןתינו :'לטב מ"עב אפר תודבע 5893939 - 02 ל"אודב וא ותבותכש RA@rafa.co.il . ,בר דובכב ץיבוקיוו לכימ 'רגמ הנוממ תחקור 325005- I Doctor Leaflet Methadone *Narcotic prescription required. COMPOSITION Active ingredient: Methadone HCl Concentrated Solution 50 mg/ml To be diluted before administration. The solution should be diluted by the pharmacist to the requested concentration and volume into a new bottle, according to the physician’s instructions. Inactive Ingredients: Methyl paraben, propyl paraben, purified water Կարդացեք ամբողջական փաստաթուղթը
1 Doctor Leaflet METHADONE Concentrated oral solution *Narcotic prescription required. COMPOSITION Active ingredient: Methadone HCl 50 mg/ml To be diluted before administration. The solution should be diluted by the pharmacist to the requested concentration and volume into a new bottle, according to the physician’s instructions. Inactive Ingredients: methylhydroxybenzoate (methyl paraben), propylhydroxybenzoate (propyl paraben), purified water. Methylhydroxybenzoate and propylhydroxybenzoate may cause allergic reactions (possibly delayed). WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; LIFE- THREATENING QT PROLONGATION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; AND TREATMENT FOR OPIOID ADDICTION ADDICTION, ABUSE, AND MISUSE METHADONE EXPOSE PATIENTS AND OTHER USERS TO THE RISKS OF OPIOID ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS EACH PATIENT'S RISK PRIOR TO PRESCRIBING METHADONE, AND MONITOR ALL PATIENTS REGULARLY FOR THE DEVELOPMENT OF THESE BEHAVIORS AND CONDITIONS [SEE WARNINGS AND PRECAUTIONS (5.1)]. LIFE-THREATENING RESPIRATORY DEPRESSION SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR WITH USE OF METHADONE. THE PEAK RESPIRATORY DEPRESSANT EFFECT OF METHADONE OCCURS LATER, AND PERSISTS LONGER THAN THE PEAK ANALGESIC EFFECT, ESPECIALLY DURING THE INITIAL DOSING PERIOD. MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF METHADONE OR FOLLOWING A DOSE INCREASE [SEE WARNINGS AND PRECAUTIONS (5.3)]. ACCIDENTAL INGESTION ACCIDENTAL INGESTION OF EVEN ONE DOSE OF METHADONE, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF METHADONE [SEE WARNINGS AND PRECAUTIONS (5.3)]. LIFE-THREATENING QT PROLONGATION QT INTERVAL PROLONGATION AND SERIOUS ARRHYTHMIA (TORSADES DE POINTES) 2 HAVE OCCURRED DURING TREATMENT WITH METHADONE. MOST CASES INVOLVE PATIENTS BEING TR Կարդացեք ամբողջական փաստաթուղթը