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ארטיקאין 4% ואפינפרין 1:100,000 ARTICAINE HCL 4 % AND EPINEPHRINE 1 : 100,000 (ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
חסם עצב דנטלי, הזרקה שינית מוחדרת : DENTAL NERVE BLOCK, DENTAL INFILTRATION INJ.
צורת מינון:
תמיסה להזרקה : SOLUTION FOR INJECTION
עלון לרופא
מינוניםPosology התוויות
Indications תופעות לוואי
Adverse reactions התוויות נגד
Contraindications אינטראקציות
Interactions מינון יתר
Overdose הריון/הנקה
Pregnancy & Lactation אוכלוסיות מיוחדות
Special populations תכונות פרמקולוגיות
Pharmacological properties מידע רוקחי
Pharmaceutical particulars אזהרת שימוש
Special Warning עלון לרופא
Physicians Leaflet
Posology : מינונים
4.2 Posology and method of administration The following dosage instructions apply: The smallest possible volume of solution which will lead to an effective anaesthesia should be used. For extraction of maxillary teeth, 1.7 ml Articaine HCl 4% and Epinephrine 1:100,000 per tooth suffices in most cases; painful palatal injections can thus be avoided. In the case of serial extractions of neighbouring teeth, a reduction of the injection volume is often possible. If a cut or suture is required in the palate, a palatal injection of approx 0.1 ml per puncture is indicated. For smooth extractions of mandibular premolar teeth, infiltration anaesthesia of 1.7 ml Articaine HCl 4% and Epinephrine 1:100,000 per tooth is mostly sufficient; in single cases a buccal re-injection of 1 to 1.7 ml is required. An injection into the mandibular foramen can be indicated in rare cases. Vestibular injections of 0.5 - 1.7 ml Articaine HCl 4% and Epinephrine 1:100,000 per tooth enable cavity and crown-stump preparations. Nerve-block anaesthesia should be used in the treatment of mandibular molar teeth. In surgical procedures Articaine HCl 4% and Epinephrine 1:100,000 should be dosed individually depending on the extent and duration of the operation and factors relating to the patient Generally, in children weighing about 20 - 30 kg, doses of 0.25 - 1 ml are sufficient; in children weighing 30 - 45 kg, 0.5 - 2 ml. Articaine HCl 4% and Epinephrine 1:100,000 must not be used with children aged under 4 years (see section 4.3). Increased plasma levels of Articaine HCl 4% and Epinephrine 1:100,000 can occur in older patients due to diminished metabolic processes and lower distribution volume. The risk of accumulation of Articaine HCl 4% and Epinephrine 1:100,000 is increased in particular after repeated application (e.g. re-injection). A similar effect can ensue from the reduced general condition of the patient, as well as severely impaired hepatic and renal function (see also section 4.4). A lower dosage range is thus recommended in all such cases (minimum quantity for sufficient anaesthetic depth). The dose has to be likewise reduced in patients with certain pre-existing diseases (angina pectoris, arteriosclerosis) (see also section 4.4). Maximum Recommended Dosage: Adults: For healthy adults, the maximum dose is 7 mg/kg body weight articaine (500 mg for a 70 kg patient), equivalent to 12.5 ml Articaine HCl 4% and Epinephrine 1:100,000. The maximum dose represents 0.175 ml of solution per kg. Children: The quantity to be injected should be determined by the age and weight of the child and the magnitude of the operation. Do not exceed the equivalent of 7 mg articaine/kg (0.175 ml Articaine HCl 4% and Epinephrine 1:100,000 /kg) of body weight. Articaine HCl 4% and Epinephrine 1:200,000 is also available and may be more appropriate for short procedures and/or where control of bleeding in the operative field is not relevant (see section 5.1 for more information on duration of analgesia). Method of administration For injection/oromucosal use FOR USE IN DENTAL ANAESTHESIA ONLY To avoid intravascular injection, aspiration control at least in two planes (rotation of the needle by 180°) must always be carefully undertaken, although a negative aspiration result does not safely rule out an unintentional and unnoticed intravascular injection. The injection rate should not exceed 0.5 ml in 15 seconds, i.e. 1 cartridge per minute. Major systemic reactions as a result of accidental intravascular injection can be avoided in most cases by an injection technique – after aspiration slow injection of 0.1 – 0.2 ml and slow application of the rest – not earlier than 20 – 30 seconds later. Opened cartridges must not be used in other patients. Residues must be discarded.
שימוש לפי פנקס קופ''ח כללית 1994
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