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.

SUMMARY CMI

Zinc Chloride

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why is Zinc Chloride being used?

Zinc Chloride Injection contains the active ingredient zinc chloride. Zinc Chloride is used to prevent or treat a deficiency of zinc in the blood.

For more information, see Section 1. Why is Zinc Chloride being used? in the full CMI.

2. What should I know before Zinc Chloride is used?

Do not use if you have ever had an allergic reaction to zinc or zinc chloride or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before Zinc Chloride is used? in the full CMI.

3. What if I am using other medicines?

Some medicines may interfere with Zinc Chloride and affect how it works.

A list of these medicines is in Section 3. What if I am using other medicines? in the full CMI.

4. How is Zinc Chloride given?

  • Your doctor will decide what dose of Zinc Chloride you will receive and for how long you will receive it.
  • Zinc Chloride Injection must only be given by a doctor or nurse.

More instructions can be found in Section 4. How is Zinc Chloride given? in the full CMI.

5. What should I know while Zinc Chloride is being used?

Things you should do
  • Remind any doctor, surgeon, anesthetist, dentist, pharmacist or nurse you visit that you have been given Zinc Chloride.
  • Tell your doctor or nurse if you feel unwell during the administration of Zinc Chloride.
Things you should not do
  • Do not contact the Zinc Chloride with the skin.
Driving or using machines
  • The effects of Zinc Chloride on a person's ability to drive and use machines were not studied.
Drinking alcohol
  • The effects of alcohol with Zinc Chloride use were not studied. Your doctor will decide what you need to do.
Looking after your medicine
  • Zinc Chloride will be stored in the surgery, pharmacy or ward of a hospital.
  • The injection is stored below 25°C in a cool dry place.

For more information, see Section 5. What should I know while Zinc Chloride is being used? in the full CMI.

6. Are there any side effects?

Zinc Chloride can cause tiredness, headaches, shortness of breath during exercise, dizziness, and pale skin. Other side effects may include anemia, low blood pressure or low levels of copper in the blood, which can only be identified through periodic tests performed by your doctor to monitor your progress.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

Zinc Chloride

Active ingredient: 10.6 mg in 2 mL Zinc Chloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using Zinc Chloride. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Zinc Chloride.

Where to find information in this leaflet:

1. Why is this Zinc Chloride being used?
2. What should I know before Zinc Chloride is used?
3. What if I am taking other medicines?
4. How is Zinc Chloride given?
5. What should I know while Zinc Chloride is being used?
6. Are there any side effects?
7. Product details

1. Why is Zinc Chloride being used?

Zinc Chloride Injection contains the active ingredient zinc chloride. Zinc Chloride is an essential trace mineral, and it is administered intravenously to maintain adequate levels of zinc in the body, ensuring proper body functioning.

Zinc Chloride is used to prevent or treat a deficiency of zinc in the blood.

2. What should I know before Zinc Chloride is used?

Warnings

You should not be given Zinc Chloride if:

  • you are allergic to zinc, or zinc chloride, or any of the ingredients listed at the end of this leaflet.
  • always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

  • have any other medical conditions:
    - kidney disease
    - low levels of cooper in the blood
  • you have allergies to any other medicines, foods, preservatives, or dyes.
  • take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed. Your doctor can discuss with you the risks and benefits involved.

Avoid skin contact with Zinc Chloride solution

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

3. What if I am taking other medicines?

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

Some medicines may interfere with Zinc Chloride and affect how it works.

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

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Zinc Chloride.

4. How is Zinc Chloride given?

How much is given

  • The suggested dosage is 2.5 to 4 mg zinc per day. Your doctor will decide the exact dosage Zinc Chloride you will receive.

When Zinc Chloride is given

  • Your doctor will decide when and for how long you will receive Zinc Chloride.

How Zinc Chloride is given

  • Zinc Chloride injection must only be given by a doctor or nurse.
  • Zinc Chloride should be mixed with another solution before it is given to you. Your doctor or nurse will make sure it is prepared correctly.
  • Zinc Chloride is usually given by infusion (drip) into a vein.

If Zinc Chloride is missed

Zinc Chloride should be given by your doctor or nurse. If you miss the appointment for your dose, speak with your doctor or nurse.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If too much Zinc Chloride is given

As Zinc Chloride is given to you in a hospital under the supervision of a doctor or nurse, it is unlikely that you will receive an overdose.

Symptoms of an overdose are the same as side effects but may be more severe. The symptoms of a side effect are listed under section 6. Are there any side effects?

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while Zinc Chloride is being used?

Things you should do

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

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.

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.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Zinc Chloride affects you.

The effects of Zinc Chloride on a person's ability to drive and use machines were not studied.

Drinking alcohol

Tell your doctor if you drink alcohol.

The effects of alcohol with Zinc Chloride use were not studied. Your doctor will decide what you need to do.

Looking after your medicine

  • Zinc Chloride will be stored in the surgery, pharmacy or ward of a hospital. The injection is stored below 25°C in a cool dry place.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

No known undesirable effects have been reported with the use of Zinc Chloride according to recommendation. The below common and serious side effects were reported during post-market monitoring. If you get any adverse effects, talk to your doctor or nurse as soon as possible.

Common side effects

Common side effectsWhat to do
  • Tiredness
  • Headache
  • Shortness of breath during exercise
  • Dizziness
  • Pale skin
  • Skin irritation
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • 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
Call your doctor straight away or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Some side effects such as anaemia, low blood pressure 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.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Zinc Chloride contains

Active ingredient
(main ingredient)		10.6 mg of zinc chloride
Other ingredients
(inactive ingredients)		Water for injections
Hydrochloric acid
Potential allergensNot applicable

Do not take this medicine if you are allergic to any of these ingredients.

What Zinc Chloride looks like

Zinc Chloride 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. It is supplied in a 2 mL vial.

(AUST R 22876)

Who distributes Zinc Chloride

Zinc Chloride is made and supplied in Australia by:

Phebra Pty Ltd
19 Orion Road
Lane Cove West, NSW 2066
Australia
Ph 1800 720 020

This leaflet was updated in August 2023.

Phebra and the Phi symbol are trademarks of Phebra Pty Ltd, 19 Orion Road, Lane Cove West, NSW 2066, Australia.

Published by MIMS October 2023

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