Krajina: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
MORPHINE SULFATE
RAFA LABORATORIES LTD
N02AA01
SOLUTION FOR INJECTION
MORPHINE SULFATE 20 MG/ML
INTRATHECAL, I.V, EPIDURAL
Required
RAFA LABORATORIES LTD, JERUSALEM
MORPHINE
MORPHINE
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
2022-06-30
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 Prečítajte si celý dokument