Posology : מינונים

4.2 Posology and method of administration
The 100 ml bottle is restricted to adults, adolescents and children weighing more than 33 kg.
The 50 ml bottle is restricted to toddlers and children weighing more than 10 kg and up to33 kg.
The 10 ml ampoule is restricted to term newborn infants, infants and toddlers weighing up to 10 kg.

Posology:
The dose to be administered and the bottle size to be used depend exclusively on the patient`s weight. The volume to be administered must not exceed the determined dose. If applicable, the desired volume must be diluted in a suitable solution for infusion prior to administration (see section 6.6) or a syringe driver must be used.

Dosing based on patient weight (please see the dosing table here below) 
10 ml ampoule
Patient              Dose               Volume per ad-         Maximum volume of Paraceta-        Maximum weight         per administration        ministration           mol B. Braun 10 mg/ml per        daily dose** administration based on upper weight limits of group (ml)***
 10 kg*            7.5 mg/kg               0.75 ml/kg                     7.5 ml                  30 mg/kg 
50 ml bottle
Patient weight            Dose           Volume per ad-       Maximum volume of Pa-          Maximum daily per administration    ministration         racetamol B. Braun 10            dose** mg/ml per administration based on upper weight limits of group (ml)***
> 10 kg to            15 mg/kg             1.5 ml/kg                  49.5 ml                  60 mg/kg  33 kg                                                                                   not exceeding 2 g 
100 ml bottle
Patient weight              Dose          Volume per ad-         Maximum volume of Parace-         Maximum (per admin-        ministration         tamol B. Braun 10 mg/ml per          daily istration)                            administration based on upper        dose** weight limits of group (ml)***
> 33 kg to            15 mg/kg            1.5 ml/kg                      75 ml                   60 mg/kg  50 kg                                                                                          not ex- ceeding 3 g
> 50 kg with additional risk
100 ml                       100 ml                       3g factors for               1g hepatotoxicity
> 50 kg and no additional risk
100 ml                       100 ml                       4g factors for               1g hepatotoxicity

*Preterm newborn infants:
No safety and efficacy data are available for premature newborn infants (see also section 5.2) 
** Maximum daily dose:
The maximum daily dose as presented in the table above is for patients that are not receiving other paracetamol containing products and should be adjusted accordingly taking such products into ac- count.

***Patients weighing less will require smaller volumes.
The minimum interval between each administration must be at least 4 hours.
The minimum interval between each administration in patients with severe renal insufficiency must be at least 6 hours.
No more than 4 doses to be given in 24 hours.

Severe renal insufficiency:
It is recommended, when giving paracetamol to patients with severe renal impairment (creatinine clearance ≤ 30 ml/min), to reduce the dose and increase the minimum interval between each admin- istration to 6 hours (See section 5.2).

Adults with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low reserves of hepatic glutathione), dehydration:
The maximum daily dose must not exceed 3000 mg (see section 4.4).

Method of administration

Take care when prescribing and administering Paracetamol B. Braun 10 mg/ml to avoid dosing errors due to confusion between milligram (mg) and millilitre (ml), which could result in accidental over- dose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume. Take care to ensure the dose is measured and administered accurately.
Intravenous use.
The paracetamol solution is administered as a 15-minute intravenous infusion.

Patients weighing 10 kg:
• In case of non- availability of the 10 ml ampoule, the 50 ml bottle of Paracetamol B. Braun 10 mg/ml might be used but should not be hung as an infusion due to the small volume of the medic- inal product to be administered in the population. The volume to be administered should be with- drawn from the ampoule and diluted in a sodium chloride 9 mg/ml (0.9%) solution or glucose 50 mg/ml (5%) solution or a combination of both solutions up to one tenth (one volume Paracetamol B. Braun 10 mg/ml into nine volumes diluent) and administered over 15 minutes. See also section 6.6
• A 5 or 10 ml syringe should be used to measure the dose as appropriate for the weight of the child and the desired volume. However, this should never exceed 7.5ml per dose
• The user should be referred to the product information for dosing guidelines.

Paracetamol B. Braun 10 mg/ml can be diluted in a 9 mg/ml (0.9%) sodium chloride solution or 50 mg/ml (5%) glucose solution or a combination of both solutions up to one tenth (one volume Parace- tamol B. Braun 10 mg/ml into nine volumes diluent). In this case, use the diluted solution within the hour following its preparation (infusion time included).

For instructions on dilution of the medicinal product before administration, see section 6.6.

For single use only. Any unused solution should be discarded.
Before administration, the product should be visually inspected for any particulate matter and discol- ouration. Only to be used if solution is clear, colourless or slightly pinkish-orangish (perception may vary) and the container and its closure are undamaged.

As for all solutions for infusion presented in containers with air space inside, it should be remembered that close monitoring is needed notably at the end of the infusion, regardless of administration route.
This monitoring at the end of the infusion applies particularly for central route infusions, in order to avoid air embolism.