MORPHINE INJECTIONS 20 MGML

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

MORPHINE SULFATE

Disponible des:

RAFA LABORATORIES LTD

Codi ATC:

N02AA01

formulario farmacéutico:

SOLUTION FOR INJECTION

Composición:

MORPHINE SULFATE 20 MG/ML

Vía de administración:

INTRATHECAL, I.V, EPIDURAL

tipo de receta:

Required

Fabricat per:

RAFA LABORATORIES LTD, JERUSALEM

Grupo terapéutico:

MORPHINE

Área terapéutica:

MORPHINE

indicaciones terapéuticas:

Morphine injection 20 mg/ml is a systemic opioid analgesic indicated only for IV, epidural and intrathecal infusion in the treatment of intractable chronic pain. It was developed for use in continuous microinfusion devices and the dosage requirements of the individual patient. Morphine injetion 20 mg/ml is primarily intended for patients who are opioid -tolerant. Morphine sulfate administered epidurally or intrathecally provides pain relief for extended periods without attendant loss of motor, sensory or sympathetic function

Data d'autorització:

2022-06-30

Fitxa tècnica

1
MORPHINE INJECTION 20MG/ML-SPC- JANUARY 2024
SUMMARY OF PRODUCT CHARACTERISTICS
HIGHLY CONCENTRATED
1.
NAME OF THE MEDICINAL PRODUCT
Morphine Injections 20 mg/ml (100mg/5 ml) (Preservative Free)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Each ml of morphine injection 20mg/ml contains 20
mg Morphine sulfate.
Excipients: each ampule also contains sodium chloride 7.43 mg/ml and
water for injection.
3.
PHARMACEUTICAL FORM
Solution for injection
EPIDURAL, INTRATHECAL, CONTINUOUS INTRAVENOUS
IMPORTANT! THIS LEAFLET REFERS TO BOTH NEURAXIAL (EPIDURAL AND
INTRATHECAL)
ADMINISTRATION AND CONTINUOUS IV ADMINISTRATION. TEXT THAT REFERS ONLY
TO NEURAXIAL
ADMINISTRATION OR ONLY TO CONTINUOUS IV ADMINISTRATION IS DELINEATED. 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
BECAUSE OF THE RISK OF SEVERE ADVERSE REACTIONS WHEN MORPHINE
INJECTIONS 20 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 (SINGLE) TEST DOSE
AND, AS
APPROPRIATE, FOR THE FIRST SEVERAL DAYS AFTER CATHETER IMPLANTATION
_[SEE _
_WARNINGS AND PRECAUTIONS (4.4)]_
.
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH
USE OF
MORPHINE INJECTIONS 20 MG/ML. MONITOR FOR RESPIRATORY DEPRESSION,
ESPECIALLY DURING
INITIATION OF MORPHINE INJECTIONS 20 MG/ML OR
FOLLOWING A DOSE INCREASE. PATIENTS MUST BE OBSERVED IN A FULLY
EQUIPPED AND
STAFFED ENVIRONMENT FOR AT LEAST 24 HOURS AFTER EACH TEST DOSE AND, AS
INDICATED, FOR THE FIRST SEVERAL DAYS AFTER SURGERY
_[SEE WARNINGS AND _
_PRECAUTIONS (4.4)]_
.
2
ADDICTION, ABUSE, AND MISUSE
MORPHINE INJECTIONS 20 MG/ML EXPOSES PATIENTS AND OTHER USERS TO
THE RISKS OF OPIOID ADDICTION, ABUS