Země: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Zinc chloride 5.3 mg/mL equivalent to 5.1 mg Zn/2mL
Pfizer New Zealand Limited
Zinc chloride 5.3 mg/mL (Equiv to 5.1 mg Zn/2mL)
10.6 mg/2mL
Solution for injection
Active: Zinc chloride 5.3 mg/mL equivalent to 5.1 mg Zn/2mL Excipient: Water for injection
Ampoule, glass, 2mL, 5 dose units
Pharmacy only
BDH Chemicals (Australia) Ltd
Package - Contents - Shelf Life: Ampoule, glass, 2mL - 5 dose units - 60 months from date of manufacture stored at or below 25°C
1984-12-13
Version: pfdzinci10219 Supersedes: Hospira 3.0 Page 1 of 6 NEW ZEALAND DATA SHEET 1. PRODUCT NAME _ _ DBL™ Zinc Chloride Injection 10.6 mg/ 2 mL Solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DBL™ Zinc Chloride Injection contains 10.6 mg Zinc Chloride equivalent to 5.1 mg Zinc in 2 mL. (The zinc component of each ampoule is 0.078 mmol (5.1 mg) and the chloride component of each ampoule is 0.156 mmol (5.5 mg). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection DBL™ Zinc Chloride Injection is a clear, colourless solution. The pH of the solution ranges between 4.0 and 5.5. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DBL™ Zinc Chloride Injection is intended for use as an additive to compatible intravenous fluids or total parenteral nutrition solutions. It is indicated for the prevention and treatment of zinc deficiency, which may be characterised by growth deterioration, skin lesions, alopecia, impaired reproductive development and function, and delayed or inhibited wound healing. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE ADULTS The suggested IV dosage is 2.5 to 4 mg zinc per day. An additional 2 mg zinc/day is suggested for acute catabolic states. If there is fluid loss from the small intestines, an additional 12.2 mg of zinc per litre of small intestinal fluid lost, or an additional 17.1 mg of zinc per kg of stool or ileostomy output is suggested. Blood levels of zinc should be frequently monitored to ensure proper dosage. DOSE ADJUSTMENTS PAEDIATRIC POPULATION For premature infants (up to 3kg in body weight) 300 microgram of zinc/kg/day is suggested. Version: pfdzinci10219 Supersedes: Hospira 3.0 Page 2 of 6 For full-term infants and children up to 5 years of age, 100 microgram of zinc/kg/day is recommended. For children over 5 years of age, the dose is the same as that recommended for adults; up to a maximum of 4 mg/day. METHOD OF ADMINISTRATION DBL™ Zinc Chloride Injection should be given via intravenous infusion by diluting each Přečtěte si celý dokument