METHADONE

Država: Izrael

Jezik: engleski

Izvor: Ministry of Health

Aktivni sastojci:

METHADONE HYDROCHLORIDE

Dostupno od:

RAFA LABORATORIES LTD

ATC koda:

N02AC52

Farmaceutski oblik:

SOLUTION

Sastav:

METHADONE HYDROCHLORIDE 50 MG/ML

Administracija rute:

PER OS

Tip recepta:

Required

Proizveden od:

RAFA LABORATORIES LTD, JERUSALEM

Terapijska grupa:

METHADONE, COMB. EXCL. PSYCHOLEPTICS

Područje terapije:

METHADONE, COMB. EXCL. PSYCHOLEPTICS

Terapijske indikacije:

Relief of severe pain. Detoxification and withdrawal treatment in narcotic addiction.

Datum autorizacije:

2022-05-31

Uputa o lijeku

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
[e-mail]
.
,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

Svojstava lijeka

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