Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Biological Therapies B-Dose Forte 2.5 mL Injection. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of administering B-Dose Forte Injection against the benefits they expect it will have for you.

If you have any concerns about the administration of this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Biological Therapies B-Dose Forte Injection is used for

B-Dose Forte 2.5 mL Injection contains the Vitamins B1, B2, B3, B5, B6 and B12 as the following active ingredients:

B1 - Thiamine hydrochloride,
B2 - Riboflavine sodium phosphate,
B3 - Nicotinamide,
B5 - Dexpanthenol,
B6 - Pyridoxine hydrochloride,
B12 - Cyanocobalamin.

These B vitamins are required by the body for normal metabolic processes in your cells, including the production of energy. Different metabolic processes need several of these B vitamins at the same time. Deficiencies of one, some or all of these vitamins in your cells can have serious consequences for your health.

Vitamin B deficiencies:
Vitamin B 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 gastrointestinal tract).

A specific deficiency of vitamin B1 (thiamine) may cause the disease beriberi.

A specific deficiency of vitamin B3 (niacin) may cause the disease pellagra.

A specific deficiency of vitamin B12 (cobalamin) may cause the disease pernicious anaemia.

Some of the B vitamins need other B vitamins to work properly.

Your doctor may prescribe B-Dose Forte Injection to treat specific vitamin B deficiencies, or to raise the levels of B vitamins in your body.

When administration by mouth is not feasible or appropriate:
Your doctor may decide that B-Dose Forte Injection is the best way for you to take B vitamins.

Debilitated or elderly patients where the diet is inadequate:
Confinement to bed, debility or old age may lead to an inadequate diet. In these cases, vitamin B deficiencies may occur.

Your doctor may prescribe B-Dose Forte to supplement B vitamins missing in your diet.

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. Thiamine may be prescribed to treat Wernicke’s encephalopathy, a disorder caused by thiamine deficiency in alcoholism.

B-Dose Forte Injection contains a high dose of thiamine and may be prescribed by your doctor to help the effects of alcoholism.

Peripheral neuritis and Carpal tunnel syndrome:
This means nerve pain, usually in the arms or hands, legs or feet (the peripheral parts). Many of the B vitamins are important for the normal functioning of the nervous system. Long-term alcoholism, beriberi, pellagra or long-term gastrointestinal disease may lead to B vitamin deficiencies and peripheral nerve pain.

Carpal tunnel syndrome and its symptoms may be relieved by the administration of vitamin B6 (pyridoxine). Carpal tunnel syndrome symptoms include pain in the hands and wrists, weakness of the hands and loss of grip strength, and coldness of the hands and fingers.

Your doctor may prescribe B-Dose Forte Injection to treat peripheral nerve pain or carpal tunnel syndrome.

Pernicious anaemia:
Anaemia occurs when red blood cells cannot carry sufficient oxygen to meet the requirements of the body’s cells. This may be due to a deficiency of oxygen, lack of ability of red blood cells to bind oxygen, or some defect of red blood cells. Vitamin B12 is needed to make red blood cells grow correctly, without it the red blood cells become large and less effective. This is a type of anaemia called megaloblastic (large cells) anaemia. Megaloblastic anaemia may also be caused by a folate (folic acid) deficiency. The “pernicious” part is because prolonged Vitamin B12 deficit can also lead to damage to the nervous system. The combination of nervous system damage and anaemia is called Pernicious Anaemia.

Symptoms of pernicious anaemia include tiredness, breathlessness, lack of energy and different sensations of the nervous system, such as pins and needles and loss of strength.

B-Dose Forte may be prescribed to help with the symptoms of pernicious anaemia, or for megaloblastic anaemia if Vitamin B12 deficiency is the diagnosed cause.

Your doctor may have prescribed B-Dose Forte Injection for another reason.

Ask your doctor if you have any questions about why B-Dose Forte Injection has been prescribed for you.

B-Dose Forte Injection is not addictive.

B-Dose Forte Injection is only available from a medical practitioner.

Before you are given Biological Therapies B-Dose Forte Injection

When you must not be given it:

Do not have B-Dose Forte Injection administered if:

• you have a known allergy to B vitamins or any of the ingredients listed at the end of this leaflet
  Symptoms of an allergic reaction may include skin rash; itchiness; shortness of breath; swelling of the face, lips, mouth or throat.
• you are taking high dose B vitamins
  B-Dose Forte Injection should not be administered if you have high levels of B vitamins in your body from other sources, such as high dose vitamin supplements.
• you are a haemophiliac
  Dexpanthenol, the form of vitamin B5 used in B-Dose Forte Injection should not be used if you have haemophilia.
• you have mechanical intestinal obstruction (ileus)
  Dexpanthenol, the form of vitamin B5 used in B-Dose Forte Injection is often used to treat ileus (lack of forward movement of intestinal contents), but should not be used if you have ileus due to a mechanical intestinal obstruction (something stuck in there).
• you are pregnant and are diagnosed with megaloblastic anaemia
  Cobalamins can mask the effects of megaloblastic anaemia caused by folate deficiency. Folate deficiency in pregnancy is a risk for birth defects in your baby. You must have Vitamin B12 deficiency confirmed by blood tests before using B-Dose Forte Injection to treat megaloblastic anaemia.
• the solution in the bottle is not clear or contains particles.
• the packaging is torn or shows signs of tampering
• the expiry date on the pack has passed
  If you take this medicine after the expiry date has passed, it may not work.

If you are not sure whether you should be given B-Dose Forte Injection, talk to your doctor.

Before you have it injected:

Your doctor may test if you have an allergy to B-Dose Forte by injecting a small amount under your skin

If you have any of the following medical illnesses or conditions, you must tell your doctor. Your doctor will discuss the risks and benefits of using B-Dose Forte Injection if you have any of these illnesses or conditions.

• Tell your doctor if you have had an allergy to any of the ingredients listed at the end of this leaflet
• Tell your doctor if you have had an allergy to any other medicines or any other substances, such as foods, preservatives or dyes
• Tell your doctor if you are pregnant or intending 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 using B-Dose Forte Injection during pregnancy.
• Tell your doctor if you are breastfeeding or are intending 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 using B-Dose Forte Injection during breastfeeding.

If you have not told your doctor about any of these conditions, tell them before you have B-Dose Forte Injected.

If 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 or health food shop.

Some medicines and B-Dose Forte Injection may interfere with each other. These include:

• Other Vitamin and Mineral Supplements
• Levodopa
• oestrogen containing medicines, including oral contraceptives (the pill)
• immunosuppressants, such as azathioprine
• some antiepileptic drugs such as phenobarbitone and phenytoin
• hydralazine
• some drugs used to treat infections, such as isoniazid, penicillamine, cycloserine and pyrazinamide.

These medicines may be affected by B-Dose Forte Injection, or affect how well it works. You may need to take different amounts of your medicine, or you may need to take different medicines.

Your doctor or pharmacist has more information about medicines to be careful with, use correctly or to avoid while you are being treated with B-Dose Forte.

How Biological Therapies B-Dose Forte Injection is given

B-Dose Forte Injection must only be given by a doctor or nurse.

B-Dose Forte Injection will be injected intramuscularly (into the buttock muscle) by your doctor.

How much is given:

Your doctor will tell you how much B-Dose Forte Injection will need to be given and for how long it is to be given. This is determined by many factors including your body weight and your medical condition. The usual dose is 2.5mL by slow intramuscular injection.

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

How long to use it:

Each person will respond differently to B-Dose Forte Injection.

Treatment times will differ depending on the reason for prescribing B-Dose Forte Injection.

Typically, treatment will be once each week for 2-6 weeks. Your doctor will tell you know how long you should take B-Dose Forte Injection for.

If you forget an appointment or need to change an appointment:

You will need to make 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 is given (overdose):

Your doctor should be the only person to inject B-Dose Forte, so an overdose is not likely to occur.

But if you think that you or anyone else may have been given too much B-Dose Forte Injection immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) or go to accident and emergency at your nearest hospital. Do this even if there are no signs of discomfort or poisoning.

While you are being given Biological Therapies B-Dose Forte Injection

Things you must do:

• Tell all doctors, dentists and pharmacists who are treating you that you are being treated with B-Dose Forte Injection.
• If you are about to be started on any new medicine, remind your doctor and pharmacist that you are being treated with B-Dose Forte Injection.
• If you need to have any urine or blood tests tell your doctor that you are being given B-Dose Forte Injection. B-Dose Forte Injection may affect the results of some of these tests.
• Tell your doctor if you become pregnant while being treated with B-Dose Forte Injection.
• Tell your doctor if you feel that giving B-Dose Forte Injection is not helping your condition.

Be sure to keep all appointments with your doctor so that your progress can be checked.

Things you must not do:

• Do not attempt to inject B-Dose Forte Injection yourself.
• Do not take any other medicines, whether they require a prescription or not, without first telling your doctor or consulting a pharmacist.

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 B-Dose Forte Injection.

B-Dose Forte Injection helps most people 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 or nurse as soon as possible if you notice any of the following and they worry you:

• Skin irritation and/or pain around the area of injection
• Bruising around the area of injection
• Mild nausea, vomiting, abdominal pain or loss of appetite
• Headache or sleepiness
• Numbness in the hands or feet, clumsiness or difficulty walking
• Hives
• Heartburn
• Fatigue
• Sore throat

These are usually mild side effects of using B-Dose Forte, but may be serious.

If any of the following happen, stop taking B-Dose Forte and tell your doctor immediately, or go to accident and emergency at your nearest hospital:

• severe allergic reaction which may include skin rash, itching, nausea, sweating, a feeling of warmth, tingling, weakness, tightness of the throat, pain in the chest, fast heart beat, difficulty breathing, faintness or swelling of the lips, face, tongue, throat, hands or feet. Severe pain or inflammation of the feet, knees, hands, or elbows
• 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
• Inability to focus eyes

These are serious side effects. You may need urgent medical attention or hospitalisation.

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.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

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

Do not be alarmed by this list of possible side effects.

You should not experience any of them.

How to Store Biological Therapies B-Dose Forte Injection

Store at 2°C to 8°C. (Refrigerate. Do not freeze). Protect from light.

Keep out of reach of children.

This product 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, nor used for more than one person.

Product Description

What it looks like:

Biological Therapies B-Dose Forte Injection is a clear amber colour, contained in an amber glass vial sealed with a rubber stopper and an aluminium cap.

This medicine may be available in 4 pack sizes:

1 x 2.5 mL vial.

3 x 2.5 mL vials.

5 x 2.5 mL vials.

6 x 2.5mL vials.

Ingredients per vial:

Active Ingredient:

B1 Thiamine hydrochloride 250 mg
B2 Riboflavine sodium phosphate 5 mg
B3 Nicotinamide 50 mg
B5 Dexpanthenol 50 mg
B6 Pyridoxine hydrochloride 100 mg
B12 Cyanocobalamin 1 mg

Other Ingredients

Disodium Edetate
Benzyl alcohol
Water for Injections.

Supplier

Biological Therapies B-Dose Forte 2.5 mL Injection is supplied and manufactured in Australia by:

Biological Therapies
A Division of Orthomolecular Medisearch Laboratories Pty Ltd.
Suite 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]

Australian Registration Number:

AUST R 22408

Date this document last updated: 16 October 2019

Published by MIMS December 2019

1 Name of Medicine

Thiamine hydrochloride, riboflavine sodium phosphate, nicotinamide, dexpanthenol, pyridoxine hydrochloride, cyanocobalamin.

2 Qualitative and Quantitative Composition

Biological Therapies B-Dose Forte 2.5 mL Injection is a B complex mixture of B1, B2, B3, B5, B6 and B12.
Each vial contains a minimum of 2.5 mL of solution.
2.5 mL of this formulation contains:
(B1) Thiamine hydrochloride 250 mg.
(B2) Riboflavine sodium phosphate 5 mg.
(B3) Nicotinamide 50 mg.
(B5) Dexpanthenol 50 mg.
(B6) Pyridoxine hydrochloride 100 mg.
(B12) Cyanocobalamin 1 mg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Biological Therapies B-Dose Forte 2.5 mL Injection is a clear, amber colour.

4 Clinical Particulars

4.1 Therapeutic Indications

B vitamin deficiencies may exist that are unable to be corrected by oral intake and in these cases parenteral administration may be preferable. Oral administration of B vitamins may be insufficient in: alcoholism, pernicious anaemia, malabsorption disorders, gastrectomy, gastrointestinal pathologies and debilitated and elderly patients.
Specific indications include:
1. Rapid saturation of the B group vitamins.
2. When oral administration is not feasible or appropriate.
3. For alcoholic, debilitated and elderly patients when their diet is inadequate.
4. Beriberi and Wernicke's syndrome as a result of Vitamin B1 deficiency.
5. Pellagra as a result of Vitamin B3 deficiency. Patients with pellagra may have a concurrent deficiency of B1, B2, B6 and B12.
6. Peripheral neuritis caused by various B group deficiencies.
7. Carpal tunnel syndrome.
8. Pernicious anaemia as a result of in situ B12 deficiency.
General indications include:
1. Angular stomatitis and glossitis have been shown in some instances to respond to the administration of either riboflavine or pyridoxine.
2. For general energy depletion.

4.2 Dose and Method of Administration

Biological Therapies B-Dose Forte 2.5 mL Injection is suitable for patients with acute symptoms of the indications listed (see Section 4.1).
The B vitamins tend to act synergistically in the body and are, in general, best injected as a complex.
Biological Therapies B-Dose Forte 2.5 mL Injection is administered by slow intramuscular (deep intragluteal) injection weekly for 2 to 6 weeks or as determined by the physician. In severe cases, one vial daily until the acute symptoms subside. This product is for single use only. Use once only and discard any residue. For patient comfort, warm solution to body temperature before administration. If glucose is used to treat hypoglycaemia associated with Wernicke's syndrome, it is preferable to give B-Dose Forte 2.5 mL Injection before the glucose administration to prevent further reduction of thiamine levels by the glucose. In general, high dose B complex injections are best delivered IM, however IV thiamine doses as high as 250 mg daily have been given in the successful treatment of Wernicke's encephalopathy (Martindale). If the product is to be used IV care should be taken to only slowly infuse diluted solutions such as those typically given in TPN, always being on the alert for any sign of anaphylaxis.
If the solution is cloudy or contains visually detectable particles, please contact the Quality Control Officer at Biological Therapies.

Note.

4.3 Contraindications

Known hypersensitivity to any of the ingredients, or pre-existing B hyper-vitaminosis. Dexpanthenol is contraindicated in haemophiliacs and in patients with ileus due to mechanical obstruction.
Cyanocobalamin should not be administered for megaloblastic anaemia caused by folate deficiency. Do not use Biological Therapies B-Dose Forte 2.5 mL Injection with neonates due to the benzyl alcohol content.

4.4 Special Warnings and Precautions for Use

This product contains pyridoxine hydrochloride which may be dangerous when used in large amounts or for a long time. Rare cases of anaphylactic shock have been known to occur after parenteral administration of thiamine. A few unconfirmed allergic reactions have been noted from dexpanthenol and a rare number of allergic hypersensitivity reactions from administration of cyanocobalamin.

Note.

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)

Thiamine hydrochloride.

Nicotinamide.

Pyridoxine hydrochloride.

Riboflavine sodium phosphate.

Dexpanthenol.

Cyanocobalamin.

Reporting suspected adverse effects.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

The B vitamins are critically tied to the metabolism of carbohydrates, amino acids and fats and are essential for the production of energy in cells, as well as carrying out many other functions. Deficiencies of one or more B vitamins may occur in debilitated states, with inadequate diet, with gastrointestinal pathologies, in alcoholism and the elderly. Deficiencies of several of the B vitamins are associated with severe neurological and skin disorders. The same disease condition in the body may result from the decreased level of just one of the B vitamins, or indeed from a simultaneous decrease in several of the B vitamins.
Except in rare cases of metabolic disorders affecting a single vitamin, it is unusual for a person to have a deficiency of one B vitamin without a deficiency of others. The B vitamins are synergistic in metabolism and as such it is recommended that they are administered together.

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

The pharmacokinetics of combinations of B vitamins administered parenterally have not been studied, however it is expected that each individual vitamin would behave as if administered separately.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

2.5 mL of this formation contains: disodium edetate 2 mg, benzyl alcohol 52.3 mg, water for injections to 2.5 mL.

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 at 2°C to 8°C (Refrigerate. Do not freeze). Protect from Light.
Keep out of reach of children.

6.5 Nature and Contents of Container

Container type: Amber glass vial with rubber stopper and aluminium seal.
Pack sizes: 1, 3, 5 or 6 vials per carton.

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

Thiamine hydrochloride.

Chemical structure.

CAS number.

Riboflavine sodium phosphate.

Chemical structure.

CAS number.

Nicotinamide.

Chemical structure.

CAS number.

Dexpanthenol.

Chemical structure.

CAS number.

Pyridoxine hydrochloride.

Chemical structure.

CAS number.

Cyanocobalamin.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes