SUMMARY CMI

Biological Therapies Thiamine Hydrochloride 100 mg in 1 mL 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 given this medicine?

This medicine contains the active ingredient thiamine hydrochloride. It is used for the prevention and treatment of vitamin B1 deficiency. For more information, see Section 1. Why am I being given this medicine? in the full CMI.

2. What should I know before I am given this medicine?

Do not use if you have ever had an allergic reaction to this medicine or any of the ingredients listed at the end of the CMI. This medicine must not be given to a child under 2 years.

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 I am given this medicine? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Thiamine Hydrochloride 100 mg in 1 mL 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 this medicine given to me?

This medicine is given as an injection into a vein or a muscle. This medicine must only be given by a doctor or nurse. The usual dose is 5 mg to 100 mg under normal circumstances or much higher amounts in critically ill patients.

More instructions can be found in Section 4. How is this medicine given to me? in the full CMI.

5. What should I know while being given this medicine?

For more information, see Section 5. What should I know while being given this medicine? in the full CMI.

6. Are there any side effects?

The more common side effects of this medicine are tenderness or a hard lump around the injection site. Serious side effects comprise of allergic reactions. Very serious side effects include severe allergic reactions, sneezing, severe rash, temporary itchiness, blue discolouration of the skin, bleeding, prolonged stomach pain, severe dizziness or drowsiness, muscular paralysis, low blood pressure, prolonged nausea or vomiting, restlessness, scaling of the facial skin and inability to focus eyes.

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

Biological Therapies Thiamine Hydrochloride 100 mg in 1 mL Injection

Active ingredient(s): Thiamine hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using Thiamine Hydrochloride 100 mg in 1 mL 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 Thiamine Hydrochloride 100 mg in 1 mL Injection.

Where to find information in this leaflet:

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

1. Why am I being given this medicine?

Thiamine Hydrochloride 100 mg in 1 mL Injection contains the active ingredient thiamine hydrochloride. Thiamine Hydrochloride 100 mg in 1 mL Injection is a form of vitamin B1.

Thiamine Hydrochloride 100 mg in 1 mL Injection is used for the prevention and treatment of vitamin B1 deficiency.

This medicine works by increasing the amount of thiamine in your body.

Vitamin B1 deficiencies:

Thiamine deficiencies may occur as a result of a diet deficient in B vitamins, malnutrition, or changes to the gastrointestinal tract which slow or prevent the absorption of B vitamins (e.g. abdominal surgery or some diseases of the gastro-intestinal tract).

A specific deficiency of vitamin B1 (thiamine) may cause the disease Beriberi and cause the condition Wernicke's encephalopathy.

Extra vitamin B1 may be needed during pregnancy, with increased carbohydrate intake, increased physical activity, infection and with some diseases relating to the liver.

Your doctor may prescribe this medicine to treat vitamin B1 deficiency, to supplement vitamin B1 missing in your diet or to raise the level of thiamine in your body.

Your doctor may decide that Thiamine Hydrochloride 100 mg in 1 mL Injection is the best way for you to take vitamin B1.

Malnutrition resulting from alcoholism:

Alcoholism can lead to a diet deficient in B vitamins. The normal metabolism of alcohol in your liver also requires B vitamins, especially thiamine.

Your doctor may have prescribed this medicine for another reason.

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

This medicine is not addictive.

This medicine is only available from a medical practitioner or from a pharmacy with a prescription from a medical practitioner.

This medicine is not expected to affect your ability to drive a car or operate machinery.

2. What should I know before I am given this medicine?

Warnings

You must not be given this medicine if:

• You are allergic to thiamine hydrochloride, or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.

Some of the symptoms of an allergic reaction include:

• Coughing or 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 must not be given this medicine if you are taking high dose B vitamins. This medicine should not be given to you if you have high levels of B vitamins in your body from other sources, such as high dose vitamin supplements.
• This medicine must not be given to a child under 2 years. This medicine should not be given to children under the age of 2 years because it contains benzyl alcohol which may be harmful.
• You must not be given this medicine if the solution in the vial is not clear or contains particles.
• You must not be given this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If you are given this medicine after the expiry date has passed, it may not work and it may be harmful to you.
  If it is expired or damaged, return it to your pharmacist for disposal.
• If you are not sure whether you should be given this medicine, talk to your doctor.

Check with your doctor if you:

• Have any other medical conditions
• Take any medicines for any other condition
• Have had an allergy to any of the ingredients listed at the end of this leaflet. Your doctor may test if you have an allergy to this medicine by injecting a small amount under your skin.
• Have any memory problems
• Have allergies to any other medicines or any other substances, such as foods, preservatives or dyes

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.

There is an increased need for some B vitamins during pregnancy. It is recommended that you and your doctor discuss your requirements during pregnancy and the possible risks and benefits of having this medicine during pregnancy.

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

There is an increased need for some B vitamins during breastfeeding. It is recommended that you and your doctor discuss your requirements during breastfeeding and the possible risks and benefits of having this medicine during breastfeeding.

If you have not told your doctor about any of the above, tell them before you are given Thiamine Hydrochloride 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 Thiamine Hydrochloride 100 mg in 1 mL Injection and affect how it works.

These include:

• Vitamin and Mineral Supplements
• Medicines used to relax muscles
• Some antibiotic drugs such as kanamycin
• Sulfate and streptomycin sulfate

These medicines may be affected by Thiamine Hydrochloride 100 mg in 1 mL Injection, or affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines. Your doctor and pharmacist have more information about medicines to be careful with, or avoid while you are being treated with 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 Thiamine Hydrochloride 100 mg in 1 mL Injection.

4. How is this medicine given to me?

Thiamine Hydrochloride 100 mg in 1 mL Injection is given as an injection, usually into a large muscle, or it may be given by infusion (slow injection) into a vein in your arm.

This medicine must only be given by a doctor or nurse.

How much is given

Your doctor will decide how much Thiamine Hydrochloride 100 mg in 1 mL Injection will need to be given and for how long it will need to be given. This is determined by many factors including your body weight and your medical condition. The usual dose of thiamine hydrochloride is 5 mg to 100 mg under normal circumstances or much higher amounts in critically ill patients.

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

How long is the treatment time with this medicine

Each person will respond differently to Thiamine Hydrochloride 100 mg in 1 mL Injection.

Treatment times will differ depending on the reason for prescribing this medicine.

Your doctor will let you know how long you will need to be treated with this medicine.

If you miss an appointment

If you miss an appointment, talk to your doctor and arrange another appointment as soon as possible.

If you are not sure what to do, contact your doctor or pharmacist as soon as possible.

If too much of this medicine is given

Your doctor or nurse should be the only person to inject Thiamine Hydrochloride 100 mg in 1 mL Injection, so an overdose is unlikely to occur.

If you think that you or anyone else may have been given too much Thiamine Hydrochloride 100 mg in 1 mL Injection you may need urgent medical attention.

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 being given this medicine?

Things you must do

• If you about to be started on any new medicine, remind your doctor and pharmacist that you are being treated with Thiamine Hydrochloride Injection.
• Tell any other doctors, dentists and pharmacists who treat you that you are being given this medicine.
• If you are going to have surgery, tell the surgeon and anaesthetist that you are being treated with this medicine. It may affect other medicines used during surgery.
• If you are about to have any urine or blood tests tell your doctor that you are being treated with this medicine. It may interfere with the results of some tests.
• If you become pregnant while being treated with Thiamine Hydrochloride Injection, tell your doctor immediately.
• Tell your doctor if you feel that giving Thiamine Hydrochloride Injection is not helping your condition.
• 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.
• Remind any other doctor, dentist or pharmacist you visit that you are being given Thiamine Hydrochloride 100 mg in 1 mL Injection.

Things you must not do

• Do not attempt to inject this medicine yourself.
• Do not take any other medicines, whether they require a prescription or not, without first telling your doctor or consulting a pharmacist.
• Do not give your medicine to anyone else, even if they have the same condition as you.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Thiamine Hydrochloride 100 mg in 1 mL Injection affects you.

Drinking alcohol

Tell your doctor if you drink alcohol.

Alcoholism can lead to a diet deficient in B vitamins. The normal metabolism of alcohol in your liver also requires B vitamins, especially thiamine.

Looking after your medicine

Thiamine Hydrochloride 100 mg in 1 mL Injection is usually stored in the doctor's surgery or clinic, or at the pharmacy.

If you need to store Thiamine Hydrochloride 100 mg in 1 mL injection keep it in the original pack until it is time for it to be given. If you take the vials out of the pack they may not keep well.

Store it in a cool dry place, where the temperature stays below 25°C, away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it. A locked cupboard at least one and a half metres above the ground is a good place to store medicines.

When to discard your medicine

Each vial is for SINGLE USE in one patient on one occasion only. It will be used once only and then it will be discarded. It must never be stored after it is opened or used for more than one person.

Getting rid of any unwanted medicine

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any vials that are left over.

Do not use this medicine after the expiry date.

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given or treated with Thiamine Hydrochloride Injection.

This medicine helps most people with vitamin B1 deficiency conditions, 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 attention if you get some of the side effects.

Do not be alarmed by the following lists. You may not experience any of them.

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

Less serious side effects

The above includes the more common side effects of this medicine. They are usually mild and short-lived.

Serious side effects

The above list includes serious side effects that may require medical attention. Serious side effects are rare.

The above list includes very serious side effects. You may need urgent medical attention or hospitalization.

These side effects are rare.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell, even if is not on this list. This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

Ask your doctor or pharmacist if you don't understand anything in this list.

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 Thiamine Hydrochloride 100 mg in 1 mL Injection contains

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

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

Vial stopper is not made with natural rubber latex.

What Thiamine Hydrochloride 100 mg in 1 mL Injection looks like

Thiamine Hydrochloride 100 mg in 1 mL Injection is a clear and colourless solution contained in an amber glass vial sealed with a grey chlorobutyl rubber stopper and aluminium seal with red polypropylene flip-off insert. It is packed in an outer carton.

This medicine may be available in 4 pack sizes:

1 x 1 mL vial

5 x 1 mL vials

6 x 1 mL vials

10 x 1 mL vials

Who distributes Thiamine Hydrochloride 100 mg in 1 mL Injection

Biological Therapies
A Division of Orthomolecular Medisearch Laboratories Pty Ltd
5 / 20 – 30 Malcolm Road, Braeside VIC 3195
Australia
Tel: + 61 3 9587 3948
Fax: +61 3 9587 1720
Website: www.biologicaltherapies.com.au
Email: [email protected]

This leaflet was prepared in May 2022.

Published by MIMS July 2022

1 Name of Medicine

Thiamine hydrochloride.

2 Qualitative and Quantitative Composition

Each 1 mL Injection contains 100 mg of thiamine hydrochloride.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Injection for intravenous or intramuscular use.
The injection is a clear and colourless solution.
The pH of the solution is 2.5 to 3.5.

4 Clinical Particulars

4.1 Therapeutic Indications

Biological Therapies Thiamine Hydrochloride 100 mg in 1 mL injection is used for the prevention and treatment of vitamin B₁ deficiency.

4.2 Dose and Method of Administration

Use in one patient on one occasion only and discard any residue.
Biological Therapies Thiamine Hydrochloride 100 mg in 1 mL injection is administered by IM injection or slow IV injection over a period of at least 10 minutes.
Due to the potential for serious anaphylactic reactions, parenteral administration of thiamine is only indicated when oral administration of thiamine is not acceptable or possible. Facilities for treating anaphylaxis should be available when administering thiamine injection.
If the thiamine hydrochloride solution is cloudy or contains visually detectable particles, please contact the Quality Assurance Manager at Biological Therapies.

Thiamine deficiency.

Dietary supplementation.

Use in infants and children.

4.3 Contraindications

Known hypersensitivity to any of the ingredients.
Do not use thiamine hydrochloride 100 mg in 1 mL Injection in children less than 2 years of age due to the benzyl alcohol content.

4.4 Special Warnings and Precautions for Use

Serious hypersensitivity reactions to thiamine have been reported following parenteral administration (see Section 4.8 Adverse Effects (Undesirable Effects)). These reactions include feelings of warmth, tingling, pruritus, pain, urticaria, weakness, sweating, nausea, restlessness, tightness of the throat, angioedema, respiratory distress, cyanosis, pulmonary oedema, gastrointestinal bleeding, transient vasodilatation and hypotension, vascular collapse, and death.
A sensitivity history should be obtained from the patient prior to administration of thiamine.
An intradermal diluted test dose of thiamine should be administered to patients with suspected sensitivity (e.g. a history of an allergic response such as itching, sneezing, wheezing or frank anaphylactic shock with a previous injection) before parenteral administration.
Simple thiamine deficiency is rare. Multiple vitamin deficiencies should be suspected in any case of dietary inadequacy.
Intravenous glucose loading may precipitate or worsen the condition of Wernicke's encephalopathy in thiamine deficient patients. Thiamine hydrochloride should be administered prior to glucose.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Although the clinical importance is unknown, thiamine reportedly may enhance the effect of neuromuscular blocking agents.
In vitro thiamine hydrochloride at a concentration of 0.1% significantly reduces the activity of kanamycin sulfate and streptomycin sulfate at 25°C.

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)

Anaphylactic reactions.

Metabolic and nutritional disorders.

Skin and appendages.

Reporting suspected adverse effects.

4.9 Overdose

In animals, very large parenteral doses have produced neuromuscular and ganglionic blockade. Parenteral doses of 100 mg to 500 mg, as single or repeated doses have been administered without toxic effects. In cases of overdose, withdraw thiamine and give supportive treatment for symptoms and respiratory and cardiac function.
For information on the management of overdose please contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Benzyl alcohol, disodium edetate, water for injections.

6.2 Incompatibilities

Thiamine is unstable in neutral or alkaline solutions; therefore, administration with carbonates, citrates, barbiturates, or copper ions is not recommended. In addition, stability is poor in intravenous solutions containing sodium bisulfite as an antioxidant or preservative; if these solutions must be given, they should be given separately from a thiamine hydrochloride injection.
Oxidation of thiamine hydrochloride results in the formation of the highly blue-coloured and biologically inactive compound - thiochrome.

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.
Keep out of reach of children.

6.5 Nature and Contents of Container

Container type.

Pack sizes.

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.

CAS number.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Summary Table of Changes