Consumer medicine information

Biological Therapies Cyanocobalamin 20 mg in 2 mL Injection

Cyanocobalamin

BRAND INFORMATION

Brand name

Biological Therapies Cyanocobalamin 20 mg in 2 mL Injection

Active ingredient

Cyanocobalamin

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Biological Therapies Cyanocobalamin 20 mg in 2 mL Injection.

What is in this leaflet

This leaflet answers some common questions about Cyanocobalamin 20 mg in 2 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 Cyanocobalamin 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 Cyanocobalamin Injection is used for

Cyanocobalamin 20 mg in 2 mL Injection contains the active ingredient Cyanocobalamin (Vitamin B12).

Cyanocobalamin belongs to a group of vitamins called cobalamins. The cobalamins are various different forms of Vitamin B12.

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.

Cyanocobalamin 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 Cyanocobalamin Injection for another reason.

Ask your doctor if you have any questions about why Cyanocobalamin Injection has been prescribed for you.

Cyanocobalamin Injection is not addictive.

Cyanocobalamin Injection is only available from a medical practitioner.

Before you are given Cyanocobalamin Injection

When you must not be given it:

Do not have Cyanocobalamin Injection administered if:

  • you have a known allergy to cobalamins
    If you have had an allergic reaction to Vitamin B12 before, you may be allergic to Cyanocobalamin.
  • 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 Cyanocobalamin Injection to treat megaloblastic anaemia.
  • you do not have a confirmed diagnosis that Vitamin B12 may be useful
  • you are breastfeeding infants
    Vitamin B12 is distributed into breast milk. Therefore it is not recommended for breastfeeding mothers unless the expected benefits to the mother outweigh any potential risk to the infant.
  • 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 Cyanocobalamin Injection, talk to your doctor.

Before you have it injected:

Your doctor may test if you have an allergy to Cyanocobalamin 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 Cyanocobalamin 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

If you have not told your doctor about any of these conditions, tell them before you have Cyanocobalamin 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.

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

How Cyanocobalamin Injection is given

Cyanocobalamin Injection must only be given by a doctor or nurse.

Cyanocobalamin Injection will be injected intramuscularly (into the buttock muscle) by your doctor.

How much is given:

Your doctor will tell you how much Cyanocobalamin 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 20 mg 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 Cyanocobalamin Injection.

Your doctor will tell you know how long you should take Cyanocobalamin 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 Cyanocobalamin, so an overdose is not likely to occur.

But if you think that you or anyone else may have been given too much Cyanocobalamin 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 Cyanocobalamin Injection

Things you must do:

  • Tell all doctors, dentists and pharmacists who are treating you that you are being treated with Cyanocobalamin Injection.
  • If you are about to be started on any new medicine, remind your doctor and pharmacist that you are being treated with Cyanocobalamin Injection.
  • If you need to have any urine or blood tests tell your doctor that you are being given Cyanocobalamin Injection. Cyanocobalamin Injection may affect the results of some of these tests.
  • Tell your doctor if you become pregnant while being treated with Cyanocobalamin Injection.
  • Tell your doctor if you feel that giving Cyanocobalamin 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 Cyanocobalamin 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 Cyanocobalamin Injection.

Cyanocobalamin 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
  • Any other mild allergies

These are usually mild side effects of using Cyanocobalamin, but could be serious.

If any of the following happen, stop taking Cyanocobalamin 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, breathing tubes, 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
  • diarrhea
  • heart failure
  • vision problems
  • loss of consciousness

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 Cyanocobalamin Injection

Store below 25°C. Do NOT refrigerate or freeze. Protect from light.

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). He expiry date can be found on the packaging.

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 or used for more than one person.

Product Description

What it looks like:

Cyanocobalamin Injection is a clear red coloured solution, contained in an amber glass vial sealed with a rubber stopper and an aluminium cap.

pack sizes:

  • 6 x 2 mL vials per carton
  • 1 x 2 mL vial per carton

Ingredients per vial:

Active Ingredient:

  • Cyanocobalamin 20 mg

Other Ingredients

  • Sodium Chloride
  • Hydrochloric Acid
  • Water for Injections

Supplier

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
Tel: +61 3 9587 3948
Fax: +61 3 9587 1720
Website: www.biologicaltherapies.com.au
Email: [email protected]

Australian Registration Number:
AUST R 22407

Date this document last updated:
22 November 2018

Published by MIMS February 2018

BRAND INFORMATION

Brand name

Biological Therapies Cyanocobalamin 20 mg in 2 mL Injection

Active ingredient

Cyanocobalamin

Schedule

Unscheduled

 

1 Name of Medicine

Cyanocobalamin.

6.7 Physicochemical Properties

Molecular formula: C63H88CoN14O14P. Molecular weight: 1355.39.
Cyanocobalamin appears as dark red crystals or an amorphous or crystalline red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80).

Chemical structure.


CAS number.

68-19-9.

2 Qualitative and Quantitative Composition

Biological Therapies Cyanocobalamin 20 mg in 2 mL Injection vial contains a minimum of 2 mL of solution and has cyanocobalamin 20 mg as an active ingredient. Each 1 mL contains cyanocobalamin 10 mg, sodium chloride 9 mg, hydrochloric acid for pH adjustment and water for injections.

3 Pharmaceutical Form

Biological Therapies Cyanocobalamin 20 mg in 2 mL Injection is a clear red coloured solution for injection supplied in amber glass vials. The pH of the solution is 3.8-5.5.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Several chemically related forms of vitamin B12, differing in slight modification of a side chain attached to the cobalamin nucleus have been isolated. Such variants of vitamin B12 include cyanocobalamin, hydroxocobalamin, adenosylcobalamin and methylcobalamin.
Vitamin B12 is essential for normal growth, haematopoiesis, production of all epithelial cells and maintenance of myelin throughout the nervous system. Whenever nucleic acid synthesis occurs and therefore whenever cell reproduction occurs, vitamin B12 is required.
The amounts of vitamin B12 needed to maintain normal blood forming functions are small and low doses are sufficient to correct the usual symptoms of vitamin B12 deficiency.
Vitamin B12 acts as an enzyme or co-enzyme in a number of metabolic processes and is transformed in the body to at least two compounds which possess enzymatic properties.
In humans there are two active forms of Vitamin B12.
i) Co-enzyme B12 (adenosylcobalamin) is required for conversion of propionate to succinate, thus involving vitamin B12 in both fat and carbohydrate metabolism.
ii) Co-methylcobalamin acts in a transmethylation process converting homocysteine to methionine, thus involving vitamin B12 in fat and protein metabolism.
In some cases of vitamin B12 deficiency, severe neurological symptoms develop, as vitamin B12 is necessary for the formation of protein structures required for the integrity of the nerve cell and myelin sheath.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Cyanocobalamin is quantitatively and rapidly absorbed from intramuscular and subcutaneous sites of injection; the plasma level of the compound reaches its peak within 1 hour after intramuscular injection. Absorbed vitamin B12 is transported via specific B12 binding proteins, transcobalamin I and II to the various tissues. The liver is the main organ for vitamin B12 storage.
Gastrointestinal absorption of vitamin B12 depends on the presence of sufficient intrinsic factor and calcium ions. Intrinsic factor deficiency causes pernicious anemia, which may be associated with subacute combined degeneration of the spinal cord. Prompt parenteral administration of vitamin B12 prevents progression of neurologic damage.
The average diet supplies about 5 to 15 microgram/day of vitamin B12 in a protein-bound form that is available for absorption after normal digestion. Vitamin B12 is not present in foods of plant origin, but is abundant in foods of animal origin. In people with normal absorption, deficiencies have been reported only in strict vegetarians who consume no products of animal origin (including no milk products or eggs).
Vitamin B12 is bound to intrinsic factor during transit through the stomach; separation occurs in the terminal ileum in the presence of calcium, and vitamin B12 enters the mucosal cell for absorption. It is then transported by the transcobalamin binding proteins. A small amount (approximately 1% of the total amount ingested) is absorbed by simple diffusion, but this mechanism is adequate only with very large doses. Oral absorption is considered too undependable to rely on in patients with pernicious anemia or other conditions resulting in malabsorption of vitamin B12.

Excretion.

Within 48 hours after injection of 100 or 1000 microgram of cyanocobalamin, 50 to 98% of the injected dose may appear in the urine. The major portion is excreted within the first eight hours. Intravenous administration results in even more rapid excretion with little opportunity for liver storage.
Cyanocobalamin is the most widely used form of vitamin B12, and has hematopoietic activity apparently identical to that of the antianemia factor in purified liver extract. Hydroxycobalamin is equally as effective as cyanocobalamin, and they share the cobalamin molecular structure.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

Long term studies in animals to evaluate carcinogenic potential have not been done. There is no evidence from long-term use in patients with pernicious anemia that cyanocobalamin is carcinogenic. Pernicious anemia is associated with an increased incidence of carcinoma of the stomach, but this is believed to be related to the underlying pathology and not to treatment with cyanocobalamin.

4 Clinical Particulars

4.1 Therapeutic Indications

Cobalamin deficiency may exist that is unable to be corrected by oral intake and in these cases parenteral administration may be preferable. Oral administration of vitamin B12 may be insufficient in pernicious anaemia, malabsorption disorders, gastrectomy and gastrointestinal pathologies.
Biological Therapies Cyanocobalamin 20 mg in 2 mL Injection is indicated for pernicious anaemia as a result of in situ B12 deficiency.

4.3 Contraindications

Known hypersensitivity to B12, or pre-existing hypervitaminosis. Known sensitivity to cyanocobalamin or any other ingredient in the preparation. Known sensitivity to cobalt.
Cyanocobalamin should not, if possible, be given to patients or used to treat megaloblastic anaemia of pregnancy without first confirming the diagnosis (see Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy).

4.4 Special Warnings and Precautions for Use

The therapeutic response to vitamin B12 may be impaired by concurrent infection, uraemia, folic acid or iron deficiency or by drugs with bone marrow suppressing effects such as chloramphenicol.

Allergy.

A sensitivity history should be obtained from the patient prior to administration of vitamin B12. An intradermal test dose is recommended before vitamin B12 is administered to patients who may be sensitive to cobalamins.
Anaphylactic shock and death have been reported after parenteral vitamin B12 administration. Should anaphylactic shock occur, immediately stop administration of the product and administer the appropriate dose of adrenaline 1:1000 (1 mg/1 mL) intramuscularly. This may be repeated at five minute intervals, if clinically indicated. Additionally, intravenous administration of corticosteroids and antihistamines may be considered.

Hypokalaemia.

Hypokalaemia and cardiac arrest have been reported when megaloblastic anaemia is treated intensively.
Serum potassium is to be carefully monitored during the initial phase of treatment in pernicious anaemia.

Degenerative lesions of the spinal cord.

Vitamin B12 deficiency that is allowed to progress for longer than 3 months may produce permanent degenerative lesions of the spinal cord.
Do not use vitamin B12 until diagnosis is fully established, as it may mask symptoms of subacute degeneration of the spinal cord, or of the true diagnosis of pernicious anaemia.

Folic acid.

Folic acid may potentiate the neurological complications of vitamin B12 deficiency, so should not be administered to patients with pernicious anaemia (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Doses of folic acid greater than 0.1 mg per day may result in hematologic remission in patients with vitamin B12 deficiency.
Neurologic manifestations will not be prevented with folic acid, and if not treated with vitamin B12, irreversible damage will result.

Folate deficiency.

Doses in excess of 10 microgram daily may produce a haematological response in patients with folate deficiency: indiscriminate administration may mask the true diagnosis of folate deficiency.

Diet.

A vegetarian diet which contains no animal products (including milk products or eggs) does not supply any vitamin B12. Patients following such a diet, should be advised to take oral vitamin B12 regularly.

Other warnings.

Treatment with vitamin B12 may unmask polycythaemia vera, because vitamin B12 deficiency may suppress the symptoms of this condition.

Early Leber's disease (hereditary optic nerve neuropathy involving impaired cyanide detoxification).

Severe optic nerve atrophy has occurred rapidly after administration of cyanocobalamin.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

Most antibiotics, methotrexate and pyrimethamine invalidate folic acid and vitamin B12 blood assays.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Colchicine para-aminosalicylic acid and heavy alcohol intake for longer than two weeks may produce malabsorption of vitamin B12.
Serum concentrations of cyanocobalamin may be lowered by oral contraceptives.
Vitamin B12 concentrations in the blood may be reduced following administration of large and continuous doses of folic acid. Folic acid administration may impair the therapeutic response to cyanocobalamin.
The therapeutic response to vitamin B12 may be impaired by drugs with bone marrow suppressing effects such as chloramphenicol.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
Exempt from classification in the Australian categorisation system for prescribing medicines in pregnancy.
The need for vitamin B12 is increased by pregnancy and lactation.
Problems in humans have not been documented with intake of normal daily amounts. Vitamin B12 crosses the placental barrier. There are no studies establishing the safety of this drug during pregnancy. It is not recommended for pregnancy unless the expected benefits outweigh any potential risk to the infant.
Megaloblastic anaemia occurring during pregnancy is usually due to folic acid deficiency rather than vitamin B12 deficiency.
Cyanocobalamin should not be used for the treatment of megaloblastic anaemia of pregnancy caused by folic acid deficiency.
Cyanocobalamin is distributed into breast milk. Therefore it is not recommended for breastfeeding mothers unless the expected benefits to the mother outweigh any potential risk to the infant.
Deficiency has been recognized in infants of vegetarian mothers who were breast fed, even though the mothers had no symptoms of deficiency at the time.

4.8 Adverse Effects (Undesirable Effects)

Generalized.

Anaphylactic shock and death have been reported with administration of parenteral vitamin B12 (see Section 4.4 Special Warnings and Precautions for Use). Allergic hypersensitivity reactions have rarely occurred.

Cardiovascular.

Pulmonary oedema and congestive heart failure early in treatment; peripheral vascular thrombosis. Cardiac arrest, low blood pressure.

Nervous system.

Severe dizziness, drowsiness, muscular paralysis, vision problems, loss of consciousness.

Hematological.

Polycythemia vera. Hypokalaemia.

Gastrointestinal.

Mild transient diarrhea, prolonged abdominal pain, prolonged nausea or vomiting.

Dermatological.

Itching; transitory exanthema.

Miscellaneous.

Feeling of swelling of entire body bleeding.

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 http://www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

Warnings.

A sensitivity history should be obtained from the patient prior to administration of vitamin B12. An intradermal test dose is recommended before vitamin B12 is administered to patients who may be sensitive to cobalamins.
Anaphylactic shock and death have been reported after parenteral vitamin B12 administration. Should anaphylactic shock occur, immediately stop administration of the product and administer the appropriate dose of adrenaline 1:1000 (1 mg/1 mL) intramuscularly. This may be repeated at five minute intervals, if clinically indicated. Additionally, intravenous administration of corticosteroids and antihistamines may be considered.
Diagnosis of vitamin B12 deficiency should be confirmed by laboratory investigation before institution of vitamin B12 therapy. Do not use vitamin B12 until diagnosis is fully established, as it may mask symptoms of subacute degeneration of the spinal cord, or of the true diagnosis of pernicious anaemia.
Hematocrit, reticulocyte count, vitamin B12, folate and iron levels should be obtained prior to treatment.
If folate levels are low, folic acid should also be administered.
Patients with pernicious anemia should be informed that they will require monthly injections of vitamin B12 for the remainder of their lives. Failure to do so will result in return of the anemia and in development of incapacitating and irreversible damage to the nerves of the spinal cord. Also, patients should be warned about the danger of taking folic acid in place of vitamin B12, because the former may prevent anemia but allow progression of subacute combined degeneration.
If the solution is cloudy or contains visually detectable particles, please contact the Quality Assurance Manager at Biological Therapies.

Single use only.

Biological Therapies Cyanocobalamin 20 mg in 2 mL Injection contains no antimicrobial agent. Use in one patient on one occasion only and discard any residue.
It is recommended to administer Biological Therapies Cyanocobalamin 20 mg in 2 mL Injection by slow intramuscular (deep intragluteal) injection or as determined by the physician.
For patient comfort, warm solution to body temperature before administration.
For short periods, daily doses of 5 mg in adults and 1 mg in neonates have been given for other disorders.

Patient monitoring.

During the initial treatment of patients with pernicious anemia, serum potassium must be observed closely during the first 48 hours and potassium replaced if necessary.
Hematocrit and reticulocyte counts should be repeated daily from the fifth to seventh days of therapy and then frequently until the hematocrit is normal.
If reticulocytes have not increased after treatment or if reticulocyte counts do not continue at least twice normal while the hematocrit is less than 35%, diagnosis or treatment should be re-evaluated. Repeat determinations of iron and folic acid may reveal a complicating illness that might inhibit the response of the marrow.
Regular blood tests to determine vitamin B12 levels are advisable during treatment.

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.

4.9 Overdose

No overdosage has been reported with this medicine.
For information on the management of overdose please contact the Poisons Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

Unscheduled.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

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 below 25°C (Do not refrigerate or freeze). Protect from light.

6.5 Nature and Contents of Container

Container type.

Amber glass vial sealed with a rubber stopper and an aluminium seal with a tear-away centre.

Pack sizes.

1 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.

Summary Table of Changes