ZINC CHLORIDE 10.6mg/2mL concentrated injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

zinc chloride, Quantity: 5.3 mg/mL

Available from:

Phebra Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; hydrochloric acid

Administration route:

Intravenous

Units in package:

2mL x 10

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

INDICATIONS AS AT 01 JAN 1991 : 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. INDICATIONS AS AT 01 JAN 1991 : 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.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

1991-10-14

Patient Information leaflet

Zinc Chloride Concentrated Injection for Infusion
Version 07 Page 1 of 3
ZINC CHLORIDE CONCENTRATED
_ _
INJECTION FOR INFUSION
CONTAINS 10.6 MG IN 2 ML ZINC CHLORIDE
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Zinc Chloride
Concentrated Injection. It does not
contain all the available information. It
does not take the place of talking to
your doctor.
All medicines have risks and benefits
.
Your doctor has weighed the risks of
you being given Zinc Chloride
Concentrated Injection against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET
.
You may need to read it again.
WHAT ZINC CHLORIDE
CONCENTRATED INJECTION
IS USED FOR
ZINC CHLORIDE CONCENTRATED
INJECTION MUST BE DILUTED BEFORE IT IS
USED.
Zinc is an essential trace mineral. Zinc
Chloride Concentrated Injection is
added to:
•
compatible intravenous fluids
•
intravenous solutions (IV) that are
given as a source of nutrition
(Total Parenteral Nutrition-TPN)
for a patient unable to ingest food.
This medicine prevents a deficiency of
zinc by maintaining the levels of this
trace element in the blood.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
BEFORE YOU ARE GIVEN
ZINC CHLORIDE
CONCENTRATED INJECTION
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU SHOULD NOT BE GIVEN ZINC
CHLORIDE CONCENTRATED INJECTION IF
YOU HAVE AN ALLERGY TO ZINC, OR ZINC
CHLORIDE
.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongues
or other parts of the body
•
rash, itching or hives on the skin.
ZINC CHLORIDE CONCENTRATED
INJECTION MUST BE DILUTED BEFORE IT IS
INJECTED INTO A MUSCLE OR VEIN.
YOU SHOULD NOT BE GIVEN THIS
MEDICINE IF
THE SOLUTION IS
DISCOLOURED, CLOUDY, TURBID, OR A
PRECIPITATE OR PARTICLES ARE PRESENT.
_ _
The solution is nor

Summary of Product characteristics

PRODUCT INFORMATION
Australian
Product Information – Zinc Chloride Concentrated Injection for
Infusion
Page 1 of 6
Version 06
ZINC CHLORIDE
(ZINC CHLORIDE) 10.6 MG IN 2 ML CONCENTRATED INJECTION FOR INFUSION
1
NAME OF THE MEDICINE
Zinc chloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 mL of Zinc Chloride Concentrated Injection for Infusion
contains:
•
10.6 mg zinc chloride.
•
Equivalent to 5.1 mg of Zinc and 5.5 mg of Chloride.
•
Equivalent to 0.078 mmoles of Zinc and 0.156 mmoles of Chloride.
•
Equivalent to 0.156 mEq of Zinc and 0.156 mEq of Chloride.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Zinc Chloride Concentrated Injection for Infusion is a clear,
colourless to faint straw coloured, sterile solution for
injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Zinc Chloride Concentrated Injection for Infusion 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
D
OSE AND METHOD OF ADMINISTRATION
ADULTS: The suggested IV dosage is 2.5 to 4 mg zinc per day. An
additional 2 mg zinc per 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.
Zinc Chloride Concentrated Injection for Infusion should be given via
intravenous infusion by diluting each 2 mL
vial in 1 litre infusion solution (glucose 5% injection or sodium
chloride 0.9% injection) and administering over 8 to
24 hours.
CHILDREN: For premature infants (up to 3 kg in body weight) 300
microgram of zinc/kg/day is suggested. For