MCR 100

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

MORPHINE SULFATE

Tilgængelig fra:

RAFA LABORATORIES LTD

ATC-kode:

N02AA01

Lægemiddelform:

TABLETS CONTROLLED RELEASE

Sammensætning:

MORPHINE SULFATE 100 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

RAFA LABORATORIES LTD, JERUSALEM

Terapeutisk gruppe:

MORPHINE

Terapeutisk område:

MORPHINE

Terapeutiske indikationer:

Prolonged relief of severe pain.

Autorisation dato:

2023-03-31

Indlægsseddel

[לוגו מדינת ישראל] [http://www.gov.il/]
[http://www.gov.il/] [לוגו משרד הבריאות] [לוגו משרד
הבריאות] [*5400]
[http://www.health.gov.il/PniyotHazibur/Pages/CallCenter.aspx]
[http://www.health.gov.il/PniyotHazibur/Pages/CallCenter.aspx]
הציבור הרחב עסקים ומוסדות עובדים
בבריאות חפש מידע
תפריט *
[סגירה]
סגור *
דף הבית [http://www.health.gov.il/] *
אודות *
אודות המשרד
[http://www.health.gov.il/About/Pages/about_us.aspx] *
תוכנית עבודה
[http://www.health.gov.il/About/Pages/Agenda.aspx] *
תקציב המשרד
[http://www.health.gov.il/About/Pages/budget.aspx] *
תרשים מבנה ארגוני
[http://www.health.gov.il/About/Pages/OrganizationalStructureDiagram.aspx] *
בעלי תפקידים
[http://www.health.gov.il/About/Phonebook/Pages/PhoneBook.aspx] *
יחידות המשרד
[http://www.health.gov.il/UnitsOffice/Pages/UnitsList.aspx] *
לשכות הבריאות
[http://www.health.gov.il/About/Phonebook/Pages/PhoneBook.aspx?tab=3] *
אמנת שירות
[http://www.health.gov.il/About/sla/Pages/default.aspx] *
אותות ופרסים
[http://www.health.gov.il/About/Awards/Pages/mifal.aspx] *
פרוייקטים תשתיתיים
[http://www.health.gov.il/About/projects/shared_medical_info/Pages/default.aspx] *
דרושים
[http://www.health.gov.il/About/Careers/Pages/default.aspx] *
מנכ"לי משרד הבריאות לדורותיהם
[http://www.health.gov.il/About/Pages/GeneralManegerHistory.aspx] *
יחידות המשרד *
יחידות המשרד
[http://www.health.gov.il/UnitsOffice/Pages/UnitsList.aspx] *
לשכות הבריאות
[http://www.health.gov.il/UnitsOffice/LB/Pages/default.aspx] *
וועדות ומועצות
[http://www.health.gov.il/Services/Committee/Pages/CommitteeList.aspx] *
נושאים *
בריאות הנפש
[http://www.health.gov.il/Subjects/mental_health/Pages/default.aspx] *
בריאות הסביבה
[http://www.health.gov.il/Subjects/Environmental_Health/

Produktets egenskaber

1
MCR-DL-April 2021-06
1.
NAME OF THE MEDICINAL PRODUCT
MCR
®
10, MCR
®
30, MCR
®
100
Controlled release tablets.
For oral use.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
MCR 10: Morphine Sulfate 10 mg
MCR 30: Morphine Sulfate 30 mg
MCR 100: Morphine Sulfate 100 mg
Excipients with known effect:
MCR 10 and MCR 30 tablets contain Lactose.
MCR 30 tablets contain sunset yellow (E110).
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Controlled-release tablets
MCR 10 tablets are brown round coated tablets.
MCR 30 tablets are purple round coated tablets.
MCR 100 tablets are grey round coated tablets.
4.
CLINICAL PARTICULARS
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 sections 4.4, 4.5].
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.
4.1
THERAPEUTIC INDICATIONS
Prolonged relief of severe pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For the correct and effective use of morphine it is critical to adjust
the dosing regimen for each patient individually. The
following dosage recommendations are, therefore, only suggested
approaches to what is actually a series of clinical
decisions in the management of the pain of an individual patient.
The dosage of morphine is individualized according to the severity of
the pain, the patient's age and metabolism, previous
history of analgesic therapy, and response to morphine.
The correct dosage for any individual patient is that which is
sufficient to control pain with no, or tolerable, side effects for a
full 12 hours.
MCR should be taken on a regular 12-hourly schedule, at the minimum
dose required to