Peditrace

Nazione: Nuova Zelanda

Lingua: inglese

Fonte: Medsafe (Medicines Safety Authority)

Principio attivo:

Copper chloride dihydrate 53.7 µg/mL equivalent to 20 µg/0.315 µmol Cu/mL; Manganese chloride tetrahydrate 3.6 µg/mL (Tetrahydrate, =1µg/18.2nmol Mn/mL); Potassium iodide 1.31 µg/mL equivalent to 1 µg/7.88 nmol I/mL; Sodium fluoride 126 µg/mL equivalent to 57 µg/3.0 µmol F/mL; Sodium selenite 4.38 µg/mL (Anhydrous =2µg/25.3nmol Se/mL); Zinc chloride 521 µg/mL equivalent to 250 µg/3.82 µmol Zn/mL

Commercializzato da:

Fresenius Kabi New Zealand Limited

INN (Nome Internazionale):

Copper chloride dihydrate 53.7 µg/mL (=20 µg/0.315 µmol Cu/mL)

Forma farmaceutica:

Solution for infusion

Composizione:

Active: Copper chloride dihydrate 53.7 µg/mL equivalent to 20 µg/0.315 µmol Cu/mL Manganese chloride tetrahydrate 3.6 µg/mL (Tetrahydrate, =1µg/18.2nmol Mn/mL) Potassium iodide 1.31 µg/mL equivalent to 1 µg/7.88 nmol I/mL Sodium fluoride 126 µg/mL equivalent to 57 µg/3.0 µmol F/mL Sodium selenite 4.38 µg/mL (Anhydrous =2µg/25.3nmol Se/mL) Zinc chloride 521 µg/mL equivalent to 250 µg/3.82 µmol Zn/mL Excipient: Hydrochloric acid Water for injection

Confezione:

Vial, plastic, 10 x 10mL, 100 mL

Classe:

General sale

Tipo di ricetta:

General sale

Prodotto da:

Merck KGaA

Indicazioni terapeutiche:

Peditrace is indicated in premature and full-term infants and children needing intravenous nutrition to supply the basal requirements of trace elements.

Dettagli prodotto:

Package - Contents - Shelf Life: Vial, plastic, 10 x 10mL - 100 mL - 36 months from date of manufacture stored at or below 25°C

Data dell'autorizzazione:

1995-05-12

Scheda tecnica

Filename:PedDS310310-clean 
Page 1 of 3 
        Changes: New NZ name and address 
DATA SHEET 

NAME OF MEDICINE 
PEDITRACE


Concentrate for solution for infusion  

PRESENTATION 
Peditrace  is  a  clear,  colourless  solution  with  a  pH  of  2.0  and  an  osmolality  of  38 
mOsm/kg water. 

Each mL contains: 

Copper chloride (dihydrate) 53.7 
µ
g  

= 20 
µ
g/0.315 
µ
mol Cu 
Manganese chloride (tetrahydrate) 3.6 
µ
g  
= 1 
µ
g/18.2 nmol Mn  
Potassium iodide 1.31 
µ
g    

= 1 
µ
g/7.88 nmol I 
Sodium fluoride 126 
µ
g  

= 57 
µ
g/3.0 
µ
mol F 
Sodium selenate (anhydrous) 4.38 
µ
g    
= 2 
µ
g/25.3 nmol Se  
Zinc chloride 521 
µ
g  

= 250 
µ
g/3.82 
µ
mol Zn 

It also contains: 

Sodium 70 
µ
g/mL    
= 3.05 
µ
mol/mL  
Potassium 0.31
µ
g/mL  
= 7.88 nmol/mL 

USES 
ACTIONS 
Peditrace is a mixture of trace elements in amounts normally absorbed from the oral 
diet  and  should  have  no  pharmacodynamic  effect  besides  maintaining  or  repleting 
nutritional status. 

PHARMACOKINETICS 
When infused intravenously the trace elements in Peditrace are handled in a similar 
way to trace elements from an oral diet.  Individual trace elements will be taken up 
by  tissues  to  different  extents,  depending  on  the  requirement  within  each  tissue  to 
maintain or restore the concentration of each element for the metabolic requirement 
of that tissue. 

Copper  and  manganese  are  normally  excreted  via  the  bile,  whereas  selenium  and 
zinc  (especially  in  patients  receiving  intravenous  nutrition)  are  mainly  excreted  via 
the urine. 

INDICATIONS 
Peditrace  is  indicated  in  premature  and  full-term  i