DBL™ Zinc Chloride

देश: न्यूज़ीलैंड

भाषा: अंग्रेज़ी

स्रोत: Medsafe (Medicines Safety Authority)

सक्रिय संघटक:

Zinc chloride 5.3 mg/mL equivalent to 5.1 mg Zn/2mL

थमां उपलब्ध:

Pfizer New Zealand Limited

INN (इंटरनेशनल नाम):

Zinc chloride 5.3 mg/mL (Equiv to 5.1 mg Zn/2mL)

डोज़:

10.6 mg/2mL

फार्मास्यूटिकल फॉर्म:

Solution for injection

रचना:

Active: Zinc chloride 5.3 mg/mL equivalent to 5.1 mg Zn/2mL Excipient: Water for injection

पैकेज में यूनिट:

Ampoule, glass, 2mL, 5 dose units

प्रिस्क्रिप्शन प्रकार:

Pharmacy only

द्वारा बनाया गया:

BDH Chemicals (Australia) Ltd

उत्पाद समीक्षा:

Package - Contents - Shelf Life: Ampoule, glass, 2mL - 5 dose units - 60 months from date of manufacture stored at or below 25°C

प्राधिकरण की तारीख:

1984-12-13

उत्पाद विशेषताएं

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