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בקלופן סינטטיקה 0.5 מ"ג/מ"ל BACLOFEN SINTETICA 0.5 MG/ML (BACLOFEN)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

תוך-שדרתי : INTRATHECAL

צורת מינון:

תמיסה לאינפוזיה : SOLUTION FOR INFUSION

Interactions : אינטראקציות

4.5 Interaction with other medicinal products and other forms of interaction
The co-administration of other intrathecal agents with Baclofen Sintetica is not recommended.
An attempt should be made to reduce or discontinue concomitant oral antispastic medications, preferably before initiating baclofen infusion. However, abrupt reduction or discontinuation during chronic intrathecal baclofen therapy should be avoided.
There is little experience with the use of Baclofen Sintetica in combination with systemic medications to be able to predict specific drug-drug interactions, although it is suggested that the low baclofen systemic exposure after intrathecal administration could reduce the potential for pharmacokinetic interactions (see section 5.2). Experience with oral baclofen would suggest that:
• Alcohol and other compounds affecting the CNS: There may be increased sedation where baclofen is taken concomitantly with other drugs acting on the CNS (e.g. analgesics, neuroleptics, barbiturates, benzodiazepines, anxiolytics) or with alcohol.
• Tricyclic antidepressants: During concurrent treatment with tricyclic antidepressants, the effect of baclofen may be potentiated, resulting in muscular hypotonia.
• Antihypertensives and other drugs known to lower blood pressure: Since concomitant treatment with drugs that lower blood pressure is likely to increase the fall in blood pressure, dosage of concomitant medications should be adjusted accordingly.
• Levodopa: Concomitant use of oral baclofen and levodopa/dopa-decarboxylase (DDC) inhibitor resulted in increased risk of adverse events like visual hallucinations, confusional state, headache and nausea. Worsening of the symptoms of Parkinsonism has also been reported. Thus, caution should be exercised when intrathecal baclofen is administered to patients receiving levodopa/DDC inhibitor therapy.

Morphine
The combined use of morphine and intrathecal baclofen has been responsible for hypotension in one patient; the potential for this combination to cause dyspnoea or other CNS symptoms cannot be excluded.
Anaesthetics
Concomitant use of intrathecal baclofen and general anaesthetics (e.g. fentanyl, propofol) may increase the risk of cardiac disturbances and seizures. Thus, caution should be exercised when anaesthetics are administered to patients receiving intrathecal baclofen.

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CTS LTD

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02.11.22 - עלון לרופא 07.03.23 - עלון לרופא 27.08.24 - עלון לרופא

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02.11.22 - עלון לצרכן עברית 07.03.23 - עלון לצרכן אנגלית 07.03.23 - עלון לצרכן עברית 07.03.23 - עלון לצרכן ערבית 27.08.24 - עלון לצרכן אנגלית 27.08.24 - עלון לצרכן עברית 27.08.24 - עלון לצרכן ערבית 02.11.22 - החמרה לעלון 27.08.24 - החמרה לעלון

לתרופה במאגר משרד הבריאות

בקלופן סינטטיקה 0.5 מ"ג/מ"ל

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