DBL ZINC CHLORIDE INJECTION 5mg Zn/2mL (as zinc chloride 10.6mg/2mL) Injection

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

zinc chloride, Quantity: 5.3 mg/mL

Beschikbaar vanaf:

Pfizer Australia Pty Ltd

farmaceutische vorm:

Injection, concentrated

Samenstelling:

Excipient Ingredients: water for injections; hydrochloric acid; sodium hydroxide

Toedieningsweg:

Intravenous

Eenheden in pakket:

5x5mgZn/2mL

Prescription-type:

Not scheduled. Not considered by committee

therapeutische indicaties:

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 samenvatting:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius

Autorisatie-status:

Registered

Autorisatie datum:

1991-10-08

Bijsluiter

Page 1
DBL™ ZINC CHLORIDE INJECTION
Zinc Chloride _(Zink KLOR-ide)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about DBL™
Zinc Chloride Injection.
It does not contain all the
available information.
It does not take the place of
talking to your doctor and
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you being
given DBL™
Zinc Chloride
Injection against the benefits this
medicine is expected to have for
you.
IF YOU HAVE ANY CONCERNS
ABOUT BEING GIVEN THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET IN A SAFE
PLACE.
You may need to read it again.
WHAT DBL™
ZINC
CHLORIDE INJECTION IS
USED FOR
Zinc chloride is a zinc salt, used
to increase the amount of zinc in
your body.
DBL™
Zinc Chloride Injection
works by providing a source of
zinc for your body to use.
Your doctor may have
prescribed zinc for another
reason.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
DBL™
ZINC CHLORIDE INJECTION
HAS BEEN PRESCRIBED FOR YOU.
Zinc is not addictive._ _
BEFORE YOU ARE GIVEN
DBL™
ZINC CHLORIDE
INJECTION
_ _
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU SHOULD NOT BE GIVEN
DBL™
ZINC CHLORIDE INJECTION
IF YOU HAVE AN ALLERGY TO ZINC
OR ANY OF THE INGREDIENTS LISTED
AT THE END OF THIS LEAFLET.
Symptoms of an allergic reaction
may include:
•
shortness of breath,
wheezing or difficulty
breathing
•
swelling of the face, lips,
tongue or other parts of the
body
•
rash, itching or hives on the
skin.
YOU SHOULD NOT BE GIVEN ZINC
CHLORIDE AS A DIRECT INJECTION
INTO THE MUSCLE OR VEIN.
A direct injection may cause
irritation of the tissues, therefore
zinc chloride must be diluted
before it is given to you.
_ _
_BEFORE YOU ARE GIVEN IT _
TELL YOUR DOCTOR OR PHARMACIST
IF YOU HAVE ALLERGIES TO:
•
any other medicines
•
any other substances, such
as foods, preservatives or
dyes.
TELL YOUR DOCTOR OR PHARMACIST
IF YOU ARE PREGNANT OR INTEND
TO BECOME PREGNANT.
Your doctor or pharmacist will
discuss the possible ris

Productkenmerken

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Supersedes: Version 4.0
Page 1 of 6
AUSTRALIAN PRODUCT INFORMATION –
DBL
™ ZINC CHLORIDE INJECTION (ZINC
CHLORIDE)
1.
NAME OF THE MEDICINE
Zinc chloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL
™
Zinc Chloride Injection is equivalent to Zinc 5.1 mg in 2 mL, and is a
clear, colourless
solution containing 10.6 mg of zinc chloride and water for injection
in each 2 mL ampoule.
(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). The pH of the solution ranges
between 4.0 and 5.5.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Zinc chloride injection is a colourless solution, concentrated
injection.
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
DOSAGE
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.
DBL
™
Zinc Chloride Injection should be given via intravenous infusion by
diluting each 2
mL ampoule in 1 litre infusion solution (glucose 5% injection or
sodium chloride 0.9%
injection) and administering over 8 to 24 hours.
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Supersedes: Version 4.0
Page 2 of 6
CHILDREN
For premature infants (up to 3kg in body weight) 300 microgram of
zinc/kg/day is suggested.
For full-term infants and children up to 5 yea