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 risks and benefits of being given zinc during pregnancy.

Tell your doctor or pharmacist if you are breast-feeding or plan to breast-feed. Your doctor or pharmacist will discuss the possible risks and benefits of being given zinc during breastfeeding.

Tell your doctor or pharmacist if you have or have had any medical conditions, especially the following:

• kidney disease.

If you have not told your doctor about any of the above, tell them before you are given DBL™ Zinc Chloride Injection.

Taking other medicines

Tell your doctor or pharmacist if you are taking or using any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

How DBL™ Zinc Chloride Injection is given

How much is given

Your doctor will decide what dose you will receive. This depends on your condition and other factors, such as your weight.

How it is given

DBL™ Zinc Chloride Injection is given as an infusion (intravenous drip) into a vein.

DBL™ Zinc Chloride Injection must only be given by a doctor or nurse.

Overdose

As DBL™ Zinc Chloride Injection is given to you under the supervision of your doctor, it is very unlikely that you will receive too much. However, if you experience severe side effects, tell your doctor or nurse immediately. Symptoms of a zinc overdose may include dizziness or light-headedness, difficulty breathing, diarrhoea, vomiting and passing less urine than normal.

Ask your doctor or pharmacist if you have any concerns.

In case of overdose, immediately contact the Poisons Information Centre for advice on management. (In Australia, call 13 11 26; in New Zealand call 0800 764 766.)

Side Effects

Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well while you are being given DBL™ Zinc Chloride Injection. DBL™ Zinc Chloride Injection helps most people with low levels of zinc in their bodies, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor, nurse or pharmacist if you notice any of the following:

• tiredness, headaches, being short of breath when exercising, dizziness, looking pale.

These side effects are rare and may occur with prolonged use of zinc. You may need medical attention.

How to store DBL™ Zinc Chloride Injection

DBL™ Zinc Chloride Injection will be stored in the pharmacy or on the ward. The injection is kept in a cool dry place where the temperature stays below 25°C.

Product description

What it looks like

DBL™ Zinc Chloride Injection is a clear, colorless solution. It is available in 2 mL ampoules in packs of 5.

Ingredients

Active ingredient:

• zinc chloride equivalent to 5.1 mg of zinc in 2 mL.

Other ingredients:

• water for injection.
• Hydrochloric acid
• Sodium hydroxide

DBL™ Zinc Chloride Injection does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Supplier

Australian Sponsor:

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizer.com.au

AUST R 16383

Date of leaflet update:
April 2019.

Published by MIMS July 2019

1 Name of 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.

Children.

Note.

4.3 Contraindications

Direct intramuscular (IM) or intravenous (IV) injection is contraindicated as the acidic pH of the injection may cause considerable tissue irritation. It is contraindicated in individuals hypersensitive to any of the ingredients in the preparation.

4.4 Special Warnings and Precautions for Use

Do not use unless solution is clear and seal is intact.
Zinc should be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment. The injection contains no preservatives, therefore any unused portion should be discarded.
The injection should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential for increased excretory loss of zinc from a bolus injection. Administration of zinc in the absence of copper may cause a decrease in serum copper levels. Periodic determinations of serum copper as well as zinc are suggested as a guideline for subsequent zinc administration.
Avoid contact of DBL Zinc Chloride Injection with the eyes and skin. Wash with copious amount of water if contamination of the skin and eyes occurs. Zinc chloride is a caustic agent and therefore should not be given orally.
Copper uptake, liver biopsy and clinical observations are all useful procedures to check the dose and compliance.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Direct IM or IV injection may cause considerable tissue irritation and is therefore not recommended.
Chronic zinc toxicity in man has not been identified with certainty. Prolonged use of zinc may lead to copper deficiency and anaemia which has responded to withdrawal of zinc and symptomatic therapy.
Increased serum levels of amylase, lipase and alkaline phosphatase, which may indicate pancreatic damage, are commonly reported during zinc therapy. However, insufficient evidence was found for pancreatic damage in either humans or rat studies.

Reporting suspected adverse effects.

4.9 Overdose

Symptoms.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Zinc is distributed widely throughout the body and is excreted in the faeces. Only traces appear in the urine since the kidneys play only a minor role in regulating the content of zinc within the body. Approximately 70% of zinc is loosely bound to albumin and other proteins.
The normal concentration of zinc in plasma and serum ranges from 0.7 to 1.5 mg/L.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Hydrochloric acid, sodium hydroxide, water for injections.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Strength.

Pack.

ARTG.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

CAS number.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes