Medsafe: New Zealand Medicines and Medical Devices Safety Authority

MEDSAFE


New Zealand Medicines and Medical
Devices Safety Authority

Revised: 26 August 2026

Medicines

 

Medsafe Product Detail

File ref: TT50-4804
Trade Name Dose Form Strength Identifier
Ped-el sterile Solution for injection see composition
Sponsor Application date Regulatory status Classification
Pfizer New Zealand Limited
Level 3, Pfizer House
14 Normanby Road
Mt Eden
AUCKLAND
21/06/1990 Approval lapsed
Approval date:21/06/1990
Notification date: 28/11/2012
General sale

Composition

Component Ingredient Manufacturer
solution for injectionActive 
 Calcium chloride dihydrate 22.06 mg/mL
 Copper chloride dihydrate 12.8 µg/mL
 Ferric chloride hexahydrate 135 µg/mL
 Magnesium chloride hexahydrate 5.08 mg/mL
 Manganese chloride tetrahydrate 49.5 µg/mL
 Phosphoric acid 8.65 mg/mL
 Potassium iodide 1.7 µg/mL
 Sodium fluoride 31.5 µg/mL
 Zinc chloride 20.4 µg/mL

Production

Manufacturing step Manufacturer
Manufacture of Final Dose FormRecipharm Karlskoga AB
Lindhagensgatan 133
Stockholm SE-11 287
SWEDEN
PackingRecipharm Karlskoga AB
Lindhagensgatan 133
Stockholm SE-11 287
SWEDEN
NZ Site of Product ReleaseNo site specified

Packaging

Package Contents Shelf life
Vial, 20 mL24 months from date of manufacture stored at 8° to 15°C (Cool)