SUMMARY CMI

DBL™ Magnesium Chloride Concentrated Injection

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 am I being treated with DBL Magnesium Chloride Concentrated Injection?

DBL Magnesium Chloride Concentrated Injection contains the active ingredient magnesium chloride hexahydrate. This medicine works by providing a source of magnesium for the body to use. DBL Magnesium Chloride Concentrated Injection is used to: treat very low levels of magnesium in the body; prevent low levels of magnesium in patients receiving total parenteral nutrition.

For more information, see Section 1. Why am I being treated with DBL Magnesium Chloride Concentrated Injection? in the full CMI.

2. What should I know before treatment with DBL Magnesium Chloride Concentrated Injection?

Talk to your doctor if you have any heart conditions or kidney problems.

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 treatment with DBL Magnesium Chloride Concentrated Injection? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with DBL Magnesium Chloride Concentrated Injection and affect how it works.

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

4. How is DBL Magnesium Chloride Concentrated Injection given?

DBL Magnesium Chloride Concentrated Injection is given as a slow infusion “drip” into a vein by a doctor or nurse.Your doctor will decide how much DBL Magnesium Chloride Concentrated Injection is needed.

More instructions can be found in Section 4. How is DBL Magnesium Chloride Concentrated Injection given? in the full CMI.

5. What should I know during treatment with DBL Magnesium Chloride Concentrated Injection?

For more information, see Section 5. What should I know during treatment with DBL Magnesium Chloride Concentrated Injection? in the full CMI.

6. Are there any side effects?

Tell your doctor if you experience nausea or vomiting, flushing, dizziness or fainting due to low blood pressure, muscle weakness, blurred or double vision, loss of reflexes, muscle paralysis, difficulty breathing, changes in heart rate or if you are passing little or no urine.

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

DBL™ Magnesium Chloride Concentrated Injection

Active ingredient(s): magnesium chloride hexahydrate

Consumer Medicine Information (CMI)

This leaflet provides important information about using DBL Magnesium Chloride Concentrated Injection. 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 this medicine.

Where to find information in this leaflet:

1. Why am I being treated with DBL Magnesium Chloride Concentrated Injection?
2. What should I know before treatment with DBL Magnesium Chloride Concentrated Injection?
3. What if I am taking other medicines?
4. How is DBL Magnesium Chloride Concentrated Injection given?
5. What should I know during treatment with DBL Magnesium Chloride Concentrated Injection?
6. Are there any side effects?
7. Product details

1. Why am I being treated with DBL Magnesium Chloride Concentrated Injection?

DBL Magnesium Chloride Concentrated Injection contains the active ingredient magnesium chloride hexahydrate.
This medicine works by providing a source of magnesium for your body to use.

DBL Magnesium Chloride Concentrated Injection is used to:

• treat very low levels of magnesium in the body,
• prevent low levels of magnesium in patients receiving total parenteral nutrition.

Your doctor, however, may have prescribed DBL Magnesium Chloride Concentrated Injection for another purpose.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

2. What should I know before treatment with DBL Magnesium Chloride Concentrated Injection?

Warnings

Do not use DBL Magnesium Chloride Concentrated Injection if:

• you are allergic to any medicine containing magnesium,
• you have heart block (a slow or irregular heart beat)severe kidney disease.

Check with your doctor if you:

• have or have had any other medical conditions including kidney problems,
• take any medicines for any other condition.

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

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?

This medicine is not addictive.

Pregnancy and breastfeeding

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

This medicine must not be given to pregnant women in the 2 hours prior to delivery.

Use of this medicine in pregnancy for prolonged periods of time (4-13 weeks duration) should be avoided unless indicated by your doctor.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Use of this medicine in lactating women should be avoided unless indicated by your doctor. Your doctor can discuss with you the risks and benefits involved.

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

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 DBL Magnesium Chloride Concentrated Injection and affect how it works. These include:

• digoxin, a medicine used to treat heart failure
• central nervous system depressants (medicines that cause drowsiness or sedation)
• neuromuscular blocking agents (medicines used to relax muscles during surgery)
• antacids to help with heartburn or reflux
• laxatives
• medicines used to treat high blood pressure or angina, including nifedipine.

These medicines may be affected by magnesium chloride or may affect how well it works. You may need different amounts of your medicines or you may need to take different medicines.

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

4. How is DBL Magnesium Chloride Concentrated Injection given?

How much is given

• Your doctor will decide what dose of DBL Magnesium Chloride Concentrated Injection you will receive and how long you will receive it for.

How is DBL Magnesium Chloride Concentrated Injection given

• DBL Magnesium Chloride Concentrated Injection is given as a slow infusion “drip” into the vein.
• This medicine must only be given by a doctor or nurse.

If too much DBL Magnesium Chloride Concentrated Injection is given

As DBL Magnesium Chloride Concentrated Injection is given to you under the supervision of your doctor, it is very unlikely that you will receive too much.

Symptoms of an overdose may include the side effects listed under Section 6. Are there any side effects?, and early signs may include nausea, vomiting, flushing, dizziness, fainting, muscle weakness or paralysis and problems with your vision.

If you think that you have been given too much DBL Magnesium Chloride Concentrated Injection, you may need urgent medical attention.

You should immediately:

• Alert your doctor or nurse if in a hospital or clinic,
• 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 during treatment with DBL Magnesium Chloride Concentrated Injection?

Things you should do

Tell any doctor or nurse giving you this medicine if you:

• are about to be started on any new medicine
• are planning to become pregnant. Tell your doctor immediately if you become pregnant during treatment with this medicine
• are breastfeeding or planning to breastfeed

Remind any doctor, dentist or pharmacist you see that you are being given DBL Magnesium Chloride Concentrated Injection.

Keep all of your doctor's appointments so that your progress can be checked. Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how DBL Magnesium Chloride Concentrated Injection affects you.

DBL Magnesium Chloride Concentrated Injection may cause dizziness or fainting, blurred or double vision in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Drinking alcohol

Tell your doctor if you drink alcohol.

How is DBL Magnesium Chloride Concentrated Injection stored

• DBL Magnesium Chloride Concentrated Injection is stored in the pharmacy or on the ward.
• Store below 25°C. Keep in a cool dry place, protected from light.

Keep it where young children cannot reach it.

DBL Magnesium Chloride Concentrated Injection diluted solutions should be prepared and used immediately. Any remaining contents should be discarded.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. DBL Magnesium Chloride Concentrated Injection helps most people with low magnesium levels, but may have unwanted side effects in a few people. If you do experience any side effects, they 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.

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.

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 treatment with any of your medicines.

7. Product details

What DBL Magnesium Chloride Concentrated Injection contains

What DBL Magnesium Chloride Concentrated Injection looks like

DBL Magnesium Chloride Concentrated Injection is a clear, colourless solution packaged in glass ampoules.

480 milligrams in 5 mL ampoule

Australian Registration Number: AUST R 16310

Who distributes DBL Magnesium Chloride Concentrated Injection

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

This leaflet was prepared in May 2024.

Published by MIMS July 2024

1 Name of Medicine

Magnesium chloride hexahydrate.

2 Qualitative and Quantitative Composition

The molecular formula of magnesium chloride hexahydrate is MgCl₂.6H₂O. It has a molecular weight of 203.3.
Each 5 mL solution contains magnesium chloride hexahydrate equivalent to 480 milligrams of magnesium chloride anhydrous and water for injection. Each mL of injection contains 1 mmol (2 mEq) of magnesium ions and 2 mmol (2 mEq) of chloride ions.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Magnesium chloride hexahydrate exists as colourless, odourless, deliquescent or hygroscopic crystals or flakes. It is very soluble in water and freely soluble in alcohol.
DBL Magnesium Chloride Concentrated Injection is a clear, colourless, sterile solution. The product contains no preservative. The pH of the solution ranges between 5.0 and 8.0.

4 Clinical Particulars

4.1 Therapeutic Indications

Parenteral administration of magnesium is indicated in the treatment of acute hypomagnesaemia.
Magnesium salts are also indicated to prevent hypomagnesaemia in patients receiving total parenteral nutrition.

4.2 Dose and Method of Administration

Dosage.

Adults.

Adults.

Infants.

Method of administration.

Maximum dose.

4.3 Contraindications

Magnesium may form precipitates if mixed with other electrolyte solutions (see Section 6.2 Incompatibilities).
Magnesium is contraindicated in patients with heart block, since magnesium may exacerbate this condition.
Magnesium is also contraindicated in patients with renal failure (creatinine clearance < 20 mL/min), since there is an increased risk of hypermagnesaemia in these patients.
Magnesium chloride should not be given to a pregnant woman within two hours preceding delivery as there is a risk of respiratory depression due to hypermagnesaemia in the neonate.

4.4 Special Warnings and Precautions for Use

Magnesium may precipitate an acute myasthenic crisis. Sensitivity to parenteral magnesium has been reported. An intravenous preparation of a calcium salt (e.g. calcium gluconate) should be readily available when magnesium chloride is given.
The patellar reflex should be tested prior to administering repeat doses of magnesium chloride. Suppression of the reflex is an indication of magnesium intoxication. Respiration rate should be determined and should be at least 16 per minute prior to each dose of magnesium as respiratory depression is the most critical side effect of the medication. Urine output should be monitored and should be at least 100 mL during the four hours preceding dosing to ensure adequate excretion of magnesium.

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

Cardiac glycosides/ digitalis.

CNS depressants.

Magnesium containing preparations (including antacids, laxatives).

Neuromuscular blocking agents.

Antihypertensive agents.

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)

Excessive administration of magnesium chloride may result in hypermagnesaemia. The signs of hypermagnesaemia may include nausea, vomiting, flushing, hypotension, muscle weakness, muscle paralysis, blurred or double vision, CNS depression and loss of reflexes. More severe hypermagnesaemia may result in respiratory depression, respiratory paralysis, renal failure, coma, cardiac arrhythmias and cardiac arrest. Hypocalcaemia with tetany, secondary to hypermagnesaemia, has been reported.

Reporting suspected adverse effects.

4.9 Overdose

Clinical features.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

The 95% confidence intervals for magnesium levels in healthy Australian subjects are: neonate 0.6 to 0.9 mmol/L and adult 0.8 to 1.0 mmol/L.
Approximately 50% of magnesium in the body is found in bone, with the majority of the remainder stored in muscle and soft tissue. 1% or less is contained in the extracellular compartment, of which approximately 33% is protein bound, with a further 12% bound to anions.
After intravenous infusion the duration of action of magnesium is approximately 30 minutes. Magnesium is primarily excreted in the urine, with small amounts excreted in faeces, saliva and breast milk. Over 90% of magnesium filtered by the kidneys is reabsorbed, mainly in the ascending limb of the Loop of Henle, with significant amounts also absorbed in the proximal and distal tubules. The clearance is proportional to the plasma magnesium concentration and the glomerular filtration rate.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Water for injections.

6.2 Incompatibilities

As mixtures of the following products with DBL Magnesium Chloride Concentrated Injection may cause precipitates to form, products containing these anions should not be mixed or co-administered with DBL Magnesium Chloride Concentrated Injection.
Magnesium salts have been reported to be incompatible with alkali carbonates, bicarbonates and soluble phosphates. Magnesium salts may also react with arsenates, phosphates and tartrates.

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. Protect from light.

6.5 Nature and Contents of Container

DBL Magnesium Chloride Concentrated Injection is supplied in glass ampoules.

Strength.

Pack.

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

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes