Posology : מינונים

4.2. Posology and method of Administration
ATTENTION! APOTEL is to be administered by intravenous infusion. It is usually dissolved in 100 ml Sodium Chloride 0.9% Sterile Solution (or alternative solutions) or according to doctor’s decision.
ALTERNATIVE SOLUTIONS: 0.9% sodium chloride, Lactated Ringer's, 3.33% Dextrose/0.3% NaCl, 5.0% Dextrose.
APOTEL is stable for 4 hours in intravenous admixtures with these alternative solutions.

Α) Adolescents and adults who weigh more than 50 kg:
1 g of paracetamol per dose up to four times a day. The ampoule content is dissolved in Sodium Chloride 0.9% Sterile Solution (or alternative solutions), usually in a 100 ml vial, and is administered immediately.
The minimum interval between each administration must be at least 4 hours.
The maximum daily dose must not exceed 4 g.
Β) Pediatric dosing

Age group          Children,          Children                  Full-term       newborns, adolescents and weighing 10 to               infants and children adults weighing 33 kg (approx 1-             weighing up to 10 kg.
33 to 50 kg        11 years old)             (approx. up to 1 year old).
Dose (mg per kg of 15 mg/kg up to four times a day.               7.5 mg/kg up to four body weight)       The minimum interval between each              times a day. The administration must be at least 4              minimum          interval hours.                                         between             each administration must be at least 4 hours.

Instructions           For a dose of 15mg/kg:                   0.05 ml of APOTEL 0.1 ml of APOTEL dissolved in 1.5       dissolved in 0.75 ml ml of Sodium Chloride 0.9% Sterile       Sodium Chloride 0.9%
Solution (or alternative solutions)      Sterile Solution (or per Kg of body weight.                   alternative solutions) per Kg of body weight.
Another way is to dissolve the           Another way is to ampoule content into a 100 ml of         dissolve the ampoule
Sodium Chloride 0.9% Sterile             content into a 100 ml
Solution (or alternative solutions)      Sodium Chloride 0.9% and administer 1.5 ml of the resulting   Sterile Solution (or solution per Kg of body weight           alternative solutions) and administer 0.75 ml of the resulting solution per Kg of body weight.

Maximum        daily   60 mg/Kg of         60 mg/Kg of            30 mg/Kg of body dose                   body weight         body weight            weight.
Maximum 3 g.        Maximum 2 g


There is no information available concerning safety and effectiveness for premature infants (See 5.2 Pharmacokinetic Properties).

C. Serious renal insufficiency: When paracetamol is administered in patients with severe renal insufficiency (creatinine clearance ≤30 ml/min), the minimum interval between each administration must be at least 6 hours and a reduced total daily dose of paracetamol may be warranted.
In adults with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low reserves of hepatic glutathione) and dehydration: The maximum daily dose must not exceed 3g.

Solution preparation for intravenous infusion - Way of administration: The ampoule content is dissolved into a 100 ml of Sodium Chloride 0.9% Sterile Solution (or alternative solutions) or according to doctor’s decision. The 100 ml produced solution is administered by intravenous infusion, in a time interval of 15 min.