Consumer medicine information

Zinc Chloride Concentrated Injection for Infusion

Zinc chloride

BRAND INFORMATION

Brand name

Zinc Chloride Concentrated Injection (Phebra)

Active ingredient

Zinc chloride

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Zinc Chloride Concentrated Injection for Infusion.

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 normally a clear, colourless solution.

You should not be given this medicine if, when added to another IV solution, it causes the IV solution to precipitate, become cloudy, turbid, discolour, or particles are visible.

You should not be given this medicine if the packaging is torn or shows signs of tampering or if the expiry date on the pack has passed. If you are given this medicine after the expiry date has passed, it may not work as well.

If you are not sure whether you should be given this medicine, talk to your doctor.

Before you are given it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical condition:

  • kidney disease
  • low levels of copper in the blood.

Tell your doctor if you are pregnant, or plan to become pregnant, or are breastfeeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you are given Zinc Chloride Concentrated Injection.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket, health food shop, naturopath or herbalist. Some medicines may interfere with Zinc Chloride Concentrated Injection.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while being given this medicine.

How Zinc Chloride Concentrated Injection is given

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

This medicine is a concentrated solution and must be diluted before use.

This medicine should not be given by mouth. It is caustic and could burn the mouth.

This medicine is usually given by mixing it with an IV solution and then infusing it into a vein.

Your doctor will decide what dose of this medicine you will receive and for how long you will receive it. This depends on your medical condition and other factors, such as your weight.

Care should be taken so that no Zinc Chloride Concentrated Injection solution is accidentally spilt onto the skin or into the eye, as it is caustic. In this case the Zinc Chloride Concentrated Injection solution should be thoroughly washed away.

If you are given too much (overdose)

Zinc Chloride Concentrated Injection must only be given by a doctor or nurse, so an overdose is not likely to occur.

Immediately contact your doctor or nurse or go to the Accident and Emergency Department at your nearest hospital if you have the following symptoms of an overdose:

  • dizziness or light headedness
  • vomiting and diarrhoea
  • breathlessness which may be worse on lying down
  • yellowing of the skin and or eyes
  • passing less urine than normal.

While you are being given Zinc Chloride Concentrated Injection

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you have been given Zinc Chloride Concentrated Injection.

Tell any other doctors, dentists, and pharmacists who treat you that you have been given this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you have been given this medicine. It may affect other medicines used during surgery.

If you are about to have any blood tests, tell your doctor that you have been given this medicine. It may interfere with the results of some tests.

Things to be careful of

If you feel light headed or faint when getting out of bed or standing up, get up slowly. Standing up slowly, especially when you get up from beds or chairs, will help your body get used to the change in position and blood pressure. If this problem continues to get worse talk to your doctor.

Avoid contact of Zinc Chloride Concentrated Injection with the skin or eyes. This medicine can burn the skin. Wash with plenty of water if it comes into contact with the eyes or skin.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Zinc Chloride Concentrated Injection. Zinc Chloride 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 to answer any questions you may have.

Tell your doctor or nurse as soon as possible if you notice any of the following:

  • tiredness
  • headache
  • shortness of breath when exercising
  • dizziness
  • pale skin.

Tell your doctor or nurse if you notice anything that is making you feel unwell. Other side effects not listed above may occur in some people.

Some side effects such as anaemia or low levels of copper in the blood can only be found when your doctor does tests from time to time to check your progress.

After being given Zinc Chloride Concentrated Injection

Storage

Zinc Chloride Concentrated Injection will be stored in the surgery, pharmacy or ward of a hospital. The injection is kept in a cool dry place where the temperature stays below 25°C.

Zinc Chloride Concentrated Injection will be opened for use on you. It will be used only once and then it will be discarded.

It will never be stored after it is opened or used for more than one person.

Product description

What it looks like

Zinc Chloride Concentrated Injection is a clear, colourless to faint straw coloured solution in a clear glass vial sealed with a grey rubber stopper and aluminium seal with a white plastic flip off cap.

Zinc Chloride Concentrated Injection is supplied in a 2 mL vial.

Ingredients

Zinc Chloride Concentrated Injection contains 10.6 mg of zinc chloride in Water for Injection.

Hydrochloric acid is added for pH adjustment when required.

This medicine does not contain lactose, sucrose, gluten, tartrazine, dyes or any preservatives.

Manufacturer

Zinc Chloride Concentrated Injection is made in Australia by:

Phebra Pty Ltd
19 Orion Road
Lane Cove West, NSW 2066
Australia

Zinc Chloride Concentrated Injection
10.6 mg in 2 mL vial
AUST R 22876
Phebra Product Code - INJ062

This leaflet was last amended in Dec 2019.

Published by MIMS March 2020

BRAND INFORMATION

Brand name

Zinc Chloride Concentrated Injection (Phebra)

Active ingredient

Zinc chloride

Schedule

Unscheduled

 

1 Name of 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, 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 Therapeutic 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 Dose 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 bodyweight), 300 microgram of zinc/kg/day is suggested.
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.

Note:

Zinc Chloride Concentrated Injection for Infusion should be filtered through asbestos or sintered glass, since they dissolve paper and cotton wool. Zinc Chloride Concentrated Injection for Infusion should be diluted before use. It contains no preservatives; therefore, any unused portions should be discarded.

Compatibilities.

Zinc Chloride Concentrated Injection for Infusion is reported to be compatible with glucose 5% injection or sodium chloride 0.9% injection.

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

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 Zinc Chloride Concentrated Injection for Infusion 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.

Warnings.

Do not use unless solution is clear and seal is intact. Single use injection; do not multidose. Discard after use and discard any unused portion. Do not store or resterilise.

Use in renal impairment.

There is a possible risk of zinc accumulation in patients with renal failure.

Use in the elderly.

No data available.

Paediatric use.

See Section 4.2 Dose and Method of Administration.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
Animal reproduction studies have not been conducted with zinc chloride. It is not known whether zinc can cause fetal harm when administered to a pregnant woman, or whether it can affect reproductive capacity. Therefore, Zinc Chloride Concentrated Injection for Infusion should be administered to pregnant women only if clearly indicated.
 Zinc is excreted in breast milk. The baby may be at risk of zinc induced copper deficiency. However, the amount of zinc in the milk may not be sufficient to induce copper deficiency in infants. Therefore, the potential hazards of zinc to the infant must be weighed against the potential benefits to the mother before zinc is administered to mothers who are breastfeeding.

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 humans 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 on either humans or rat studies.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Symptoms of zinc poisoning include hypotension, pulmonary oedema, diarrhoea, vomiting, jaundice and oliguria.

Treatment of overdosage.

Symptomatic and supportive measures should be given as required in the event of overdosage.
Administration of sodium calcium edetate by mouth and intravenously has been suggested. To relieve pain, analgesics may be given. The electrolyte imbalance should be corrected.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Zinc is an essential trace element in nutrition. It is a constituent of many enzymatic systems, including alkaline phosphatase, carbonic anhydrase, carboxypeptidase and alcohol dehydrogenase. It is also present with insulin in the pancreas. Zinc is involved in DNA and protein synthesis and facilitates wound healing, helping to maintain normal growth rates. It is essential for immune function and development of the reproductive organs and normal functioning of the prostate gland. It is also involved in certain enzymatic reactions necessary for the normal functioning of the skin's oil glands. Zinc is required for the mobilisation of vitamin A from the liver into plasma. It also helps to maintain the senses of taste and smell.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

No data available.

Distribution.

Zinc is distributed widely throughout 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.

Metabolism.

No data available.

Excretion.

Zinc 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.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Zinc Chloride Concentrated Injection for Infusion contains water for injections. The solution also contains hydrochloric acid for pH adjustment. It contains no preservatives.

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)1. The expiry date can be found on the packaging.
1 AUST R 22876.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Zinc Chloride Concentrated Injection for Infusion is presented as:
2 mL in a 2 mL glass vial as a pack of 10 vials.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

The chemical formula for zinc chloride is: ZnCl2.
The molecular weight of the compound is 136.3.

CAS number.

7646-85-7.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Summary Table of Changes