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עמוד הבית / אביטרן טבע ® 75מ"ג/3 מ"ל / מידע מעלון לרופא

אביטרן טבע ® 75מ"ג/3 מ"ל ABITREN TEVA ® 75 MG/3 ML (DICLOFENAC SODIUM)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

תוך-שרירי : I.M

צורת מינון:

תמיסה להזרקה : SOLUTION FOR INJECTION

Posology : מינונים

4.2 Posology and method of administration
As a general recommendation, the dose should be individually adjusted and the lowest effective dose given for the shortest possible duration.

Adults
Abitren Teva 75mg/3 ml solution for injection should not be given for more than 2 days; if necessary, treatment can be continued with the tablets or suppositories.

Intramuscular Injection
The following directions for intramuscular injection must be followed in order to avoid damage to a nerve or other tissue at the injection site.

The dose is generally one 75 mg ampoule daily, given by deep intragluteal injection into the upper outer quadrant. In severe cases (e.g., colic), the daily dose can exceptionally be increased to two injections of 75 mg, separated by an interval of a few hours (one into each buttock). Alternatively, one ampoule of 75 mg can be combined with other pharmaceutical forms of Abitren (e.g. tablets, suppositories) up to a total maximum daily dose of 150 mg.

In migraine attacks, clinical experience is limited to initial use of one ampoule of 75 mg administered as soon as possible, followed by suppositories up to 100 mg on the same day if required. The total dose should not exceed 175 mg on the first day.

Special populations
Elderly
Although the pharmacokinetics of Abitren is not impaired to any clinically relevant extent in elderly patients, nonsteroidal anti-inflammatory drugs should be used with particular caution in such patients who generally are more prone to adverse reactions. In particular it is recommended that the lowest effective dosage be used in frail elderly patients or those with a low body weight (see also Precautions) and the patient should be monitored for GI bleeding during NSAID therapy.
Cardiovascular and significant cardiovascular risk factors
Diclofenac is contraindicated in patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease (see section 4.3 Contraindications).
Patients with congestive heart failure (NYHA-I) or significant risk factors for cardiovascular disease should be treated with diclofenac only after careful consideration. Since cardiovascular risks with diclofenac may increase with dose and duration of exposure, the lowest effective daily dose should be used and for the shortest duration possible (see section 4.4 Special warnings and precautions for use).
Renal impairment
Diclofenac is contraindicated in patients with renal failure (see section 4.3     Contraindications).
No specific studies have been carried out in patients with renal impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering diclofenac to patients with mild to moderate renal impairment (see section 4.4 Special warnings and precautions for use).
Hepatic impairment
Diclofenac is contraindicated in patients with hepatic failure (see section 4.3     Contraindications).
No specific studies have been carried out in patients with hepatic impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering diclofenac to patients with mild to moderate hepatic impairment (see section     4.4 Special warnings and precautions for use).


Children and adolescents
Because of the dosage strength, Abitren Teva 75mg/3 ml solution for injection is not suitable for children and adolescents.

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בעל רישום

TEVA ISRAEL LTD

רישום

159 38 34860 00

מחיר

0 ₪

מידע נוסף

עלון מידע לרופא

22.05.22 - עלון לרופא 11.05.23 - עלון לרופא

עלון מידע לצרכן

27.02.20 - החמרה לעלון 21.02.22 - החמרה לעלון 11.05.23 - החמרה לעלון

לתרופה במאגר משרד הבריאות

אביטרן טבע ® 75מ"ג/3 מ"ל

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