MORPHINE INJECTIONS 1 MGML

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

MORPHINE SULFATE

Verfügbar ab:

RAFA LABORATORIES LTD

ATC-Code:

N02AA01

Darreichungsform:

SOLUTION FOR INJECTION

Zusammensetzung:

MORPHINE SULFATE 1 MG/ML

Verabreichungsweg:

INTRATHECAL, EPIDURAL, I.V

Verschreibungstyp:

Required

Hergestellt von:

RAFA LABORATORIES LTD, JERUSALEM

Therapiegruppe:

MORPHINE

Therapiebereich:

MORPHINE

Anwendungsgebiete:

For the relief of pain that does not respond to treatment with non-opioid analgesics. Morphine injection is a systemic opioid analgesic administered by the IV , epidural and intrathecal routes. Morphine sulphate administered epidurally or intrathecally provides pain relief for extended periods without attendant loss of motor, sensory or sympathetic function

Berechtigungsdatum:

2021-05-31

Fachinformation

1
DOCTOR LEAFLET
NAME OF THE MEDICINAL PRODUCT:
MORPHINE INJECTIONS 1 MG/ML
preservative-free
COMPOSITION:
Active ingredient: Morphine sulfate 1
mg/ml
Each ampoule of Morphine Injections 1 mg/ml contains morphine sulphate
(5H
2
O)
1 mg/ml in a 5 ml ampoule.
Each ampoule also contains sodium chloride 9 mg/ml and water for
injections.
Morphine Injections 1 mg/ml contains no preservatives.
EPIDURAL , I.V , INTRATHECAL
WARNING: RISKS WITH NEURAXIAL ADMINISTRATION; LIFE-THREATENING
RESPIRATORY DEPRESSION; RISK OF ADDICTION, ABUSE, AND MISUSE;
NEONATAL OPIOID WITHDRAWAL SYNDROME; AND RISKS FROM CONCOMITANT
USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
RISKS WITH NEURAXIAL ADMINISTRATION
SINGLE-DOSE NEURAXIAL ADMINISTRATION MAY RESULT IN ACUTE OR DELAYED
RESPIRATORY DEPRESSION UP TO
24 HOURS. BECAUSE OF THE RISK OF SEVERE ADVERSE REACTIONS WHEN
MORPHINE INJECTIONS 1 MG/ML IS
ADMINISTERED BY THE EPIDURAL OR INTRATHECAL ROUTE OF ADMINISTRATION,
PATIENTS MUST BE OBSERVED IN
A FULLY EQUIPPED AND STAFFED ENVIRONMENT FOR AT LEAST 24 HOURS AFTER
THE INITIAL DOSE _[SEE WARNINGS _
_AND PRECAUTIONS (5.1)]_.
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH USE OF MORPHINE
INJECTIONS 1 MG/ML. MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY
DURING INITIATION OF MORPHINE
INJECTIONS 1 MG/ML OR FOLLOWING A DOSE INCREASE. BECAUSE OF DELAY IN
MAXIMUM CNS EFFECT WITH
INTRAVENOUSLY ADMINISTERED DRUG (30 MIN), RAPID IV ADMINISTRATION MAY
RESULT IN OVERDOSING _[SEE _
_WARNINGS AND PRECAUTIONS (5.2)]_.
ADDICTION, ABUSE, AND MISUSE
MORPHINE INJECTIONS 1 MG/ML EXPOSES 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 MORPHINE INJECTIONS 1 MG/ML, AND MONITOR ALL PATIENTS
REGULARLY FOR THE DEVELOPMENT
OF THESE BEHAVIORS AND CONDITIONS _[SEE WARNINGS AND PRECAUTIONS
(5.3)]_.
NEONATAL OPIOID WITHDRAWAL SYNDROME
PROLONGED USE OF MORPHINE INJECTIONS 1 MG/ML DURING PREGN