Riik: Iisrael
keel: inglise
Allikas: Ministry of Health
DULOXETINE AS HYDROCHLORIDE
ELI LILLY ISRAEL LTD
N06AX21
GASTRO RESISTANT CAPSULES
DULOXETINE AS HYDROCHLORIDE 60 MG
PER OS
Required
LILLY S.A., SPAIN
DULOXETINE
DULOXETINE
Cymbalta is indicated for the treatment of major depressive episodes.- Cymbalta is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy.- Cymbalta is indicated for the treatment of generalized anxiety disorder (GAD).- Cymbalta is indicated for the management of fibromyalgia.- Cymbalta is indicated for the management of chronic muscoskeletal pain when other therapies have failed or are contra-indicated. This has been established in studies in patients with chronic low back pain (CLBP) and chronic pain due to osteoarthritis.
2015-03-31
X CYMBCP A 14 1 of 28 ב הרשואש יפכ ,אתכמסאהמ (שרדנש לככ ,טמרופהו לארשיב םושירה יאנתל המאתה דבלמ) ונושלכ ץמוא ,שגומה ןולעה ןוכדע US ךיראתב 13.12.17 _ _ GASTRO RESISTANT CAPSULES CAPSULES MG 30 ® CYMBALTA GASTRO RESISTANT CAPSULES CAPSULES MG 60 ® CYMBALTA FULL PRESCRIBING INFORMATION WARNING: SUICIDAL THOUGHTS AND BEHAVIORS ANTIDEPRESSANTS INCREASED THE RISK OF SUICIDAL THOUGHTS AND BEHAVIOR IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS IN SHORT- TERM STUDIES. THESE STUDIES DID NOT SHOW AN INCREASE IN THE RISK OF SUICIDAL THOUGHTS AND BEHAVIOR WITH ANTIDEPRESSANT USE IN PATIENTS OVER AGE 25; THERE WAS A REDUCTION IN RISK WITH ANTIDEPRESSANT USE IN PATIENTS AGED 65 AND OLDER _[SEE WARNINGS _ _AND PRECAUTIONS (5.1)]_. IN PATIENTS OF ALL AGES WHO ARE STARTED ON ANTIDEPRESSANT THERAPY MONITOR CLOSELY FOR WORSENING, AND FOR EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS. ADVISE FAMILIES AND CAREGIVERS OF THE NEED FOR CLOSE OBSERVATION AND COMMUNICATION WITH THE PRESCRIBER. CYMBALTA IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS _[SEE_ _USE IN SPECIFIC POPULATIONS _ _(8.4)]_. 1 INDICATIONS AND USAGE Cymbalta is indicated for the treatment of major depressive episodes. - Cymbalta is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy. - Cymbalta is indicated for the treatment of generalized anxiety disorder (GAD). - Cymbalta is indicated for the management of fibromyalgia. - Cymbalta is indicated for the management of chronic muscoskeletal pain when other therapies have failed or are contra-indicated. This has been established is studies in patients with chronic low back pain (CLBP) and chronic pain due to Osteoarthritis. 2 DOSAGE AND ADMINISTRATION Swallow CYMBALTA whole . Do not chew or crush. Do not open the capsule and sprinkle its contents on food or mix with liquids. All of these might affect the enteric coating. Cymbalta should not be administered through a gastric tube either because t Lugege kogu dokumenti