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VITA-B12 INJECTION

Consumer Medicine Information

VITA-B12 INJECTION
Hydroxocobalamin acetate (vitamin B12)
Solution for injection 1 mg/mL (as Hydroxocobalamin)

What is in this leaflet

Please read this leaflet carefully before you are given VITA-B12 INJECTION.

This leaflet answers some common questions about VITA-B12 INJECTION. It does not
contain all the available information. The most up-to-date Consumer Medicine
Information can be downloaded from www.medsafe.govt.nz.

Reading this leaflet 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 you using
VITA-B12 INJECTION against the benefits this medicine is expected to have for you.

If you have any concerns about using this medicine, ask your doctor or
pharmacist.

Keep this leaflet with the medicine.

You may want to read it again.

What VITA-B12 INJECTION is used for

VITA-B12 INJECTION contains hydroxocobalamin acetate (vitamin B12).

Vitamin B12 is important for the function of several key body enzymes. It is needed for
physical growth and development and for the formation of red blood cells in the bone
marrow. This vitamin is also needed for the body to absorb folic acid and carbohydrates
in the diet and for keeping the nervous system healthy.

Only small daily amounts of vitamin B12 are required. Deficiency of vitamin B12 may take
months or years to develop, but eventually leads to anaemia, a condition in which the
amount of oxygen-carrying pigment (haemoglobin) in the blood is reduced. Symptoms of
vitamin B12 deficiency anaemia include sore mouth and tongue, numbness and tingling in
the arms and legs, memory loss and depression. The most common type of vitamin B12
deficiency anaemia is Addisonian pernicious anaemia, in which absorption of vitamin B12
from the stomach does not take place properly.

VITA-B12 INJECTION is used to replace the body’s low vitamin B12 levels caused by:
 Addisonian pernicious anaemia
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VITA-B12 INJECTION

 other vitamin B deficiency anaemias

 stomach surgery
 strict vegetarianism.

VITA-B12 INJECTION is also used to treat tobacco amblyopia (smoker’s blindness) and
another eye condition called Leber’s optic atrophy.

Your doctor may have prescribed this medicine for another reason.
Ask your doctor if you have any questions about why it has been prescribed for
you.

VITA-B12 INJECTION is not addictive.

Before you are given VITA-B12 INJECTION

VITA-B12 INJECTION is not suitable for everyone.

When you must not be given it

Do not use VITA-B12 INJECTION if you are allergic to any medicine containing
hydroxocobalamin, cobalt or any of the ingredients listed at the end of this leaflet.

Do not use it if you have a condition called megaloblastic anaemia and are
pregnant.

Do not use it after the expiry date printed on the pack.

If you are being given this medicine after the expiry date has passed, it may not work as
well.

Do not use it if the packaging is torn or shows signs of tampering, or if the

solution in the ampoule is discoloured or cloudy.

If you are not sure whether you should start using this medicine, talk to your
doctor.

Before you are given it

Tell your doctor if you have or have had any medical conditions, especially the
following:
 a disease of the spinal cord
 folate-deficient megaloblastic anaemia (a type of anaemia caused by the deficiency
of another vitamin called folic acid).
Tell your doctor or pharmacist if you:
1. have allergies to any other medicines, foods, preservatives or dyes.
2. are pregnant or plan to become pregnant.
Your doctor will discuss with you the possible risks and benefits involved.
3. are breast-feeding or plan to breast-feed.
The active ingredient in VITA-B12 INJECTION passes into breast milk. Your doctor
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VITA-B12 INJECTION

will discuss the risks and benefits of using hydroxocobalamin if you are breast-
feeding.

If you have not told your doctor or pharmacist about any of the above, tell them
before being given VITA-B12 INJECTION.

Taking other medicines

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

Tell any health professional who is prescribing a new medicine for you that you
are using VITA-B12 INJECTION.

Some medicines and VITA-B12 INJECTION may interfere with each other. These
include:
 chloramphenicol
 antibiotics (antibacterials) for any type of infection
 antimetabolites (medicines used to treat cancer)
 the contraceptive pill (birth control pill)
 folic acid.

The above medicines may be affected by VITA-B12 INJECTION, or may affect how well
it works. You may need different amounts of VITA-B12 INJECTION or you may need to
take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or
avoid while using VITA-B12 INJECTION.

How VITA-B12 INJECTION is given

How it is given
VITA-B12 INJECTION is given as an injection into a muscle by a doctor or nurse.

Do not leave your doctor’s surgery after a VITA-B12 INJECTION injection until your
doctor tells you to.
Very occasionally, VITA-B12 INJECTION can cause a sudden severe allergic reaction
(anaphylaxis) soon after the injection.

How much you will be given

Your doctor will decide how many injections you need, and how often you should receive
them.

For Addisonian pernicious anaemia and most other types of vitamin B12 deficiency
anaemia, provided your nervous system is not affected, the usual dose is 250
micrograms to 1000 micrograms every second day for up to two weeks, then 250
micrograms once a week until your vitamin B12 levels are normal. A 1000 microgram
injection is often given every two to three months to keep your vitamin B12 levels in the
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VITA-B12 INJECTION

normal range. If your nervous system has been affected, the starting dose is 1000
micrograms every second day, then 1000 micrograms every two months, provided your
condition is improving.

For vitamin B12 deficiency anaemia caused by stomach surgery, stomach disorders in
which vitamin B12 is not absorbed normally and strict vegetarianism, the usual dose is
1000 micrograms every two to three months.

If you have smoker’s blindness or Leber’s optic atrophy, the usual starting dose is at
least 1000 micrograms given every day for two weeks, then twice weekly, provided you
are responding well. Your doctor may then give you a 1000 microgram injection once a
month.

Ask your doctor or pharmacist if you are unsure of the correct dose for you.
This depends on your condition and whether or not you are taking any other medicines.

If you receive the wrong dose, VITA-B12 INJECTION may not work as well and your
problem may not improve.

How long you will be given it

Depending on the disorder you are being given VITA-B12 INJECTION for, you may need
regular injections long-term.

While you are using VITA-B12 INJECTION

Things you must do

If you are about to be started on any new medicine, tell your doctor and
pharmacist that you are using VITA-B12 INJECTION. Likewise, tell any other
doctors, dentists and pharmacists who are treating you that you are being given
this medicine.

If you become pregnant while using this medicine, tell your doctor immediately.
Keep all of your doctor’s appointments so that your progress can be checked.
Your doctor may do regular blood tests to make sure VITA-B12 INJECTION is working
effectively for you.

See your doctor if you feel that your condition is not improving or getting worse.

Things you must not do

Do not give your medicine to anyone else, even if they have the same condition as
you.
This medicine is only intended for the use of the patient it has been prescribed for.

Do not use VITA-B12 INJECTION to treat any other complaints unless your doctor
tells you to.

Things to be careful of
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VITA-B12 INJECTION

Be careful driving or operating machinery until you know how VITA-B12

INJECTION affects you.

In case of overdose

If you are given too much

Immediately telephone your doctor, or the Poisons Information Centre (telephone
0800 POISON or 0800 764 766), or go to Accident and Emergency at your nearest
hospital, if you think that you or anyone else may have been given too much VITA-
B12 INJECTION.

Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while
you are using VITA-B12 INJECTION.

Like all medicines, VITA-B12 INJECTION may occasionally cause side effects in some
people. Sometimes they are serious, most of the time they are not. You may need
medical attention if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry
you:
 diarrhoea
 red colour faeces
 pink or reddish tinge urine
 nausea
 headache
 vomiting
 dizziness
 acne
 skin rash
 pain or redness at the injection site
 generalised itching
 redding of skin
 loss of pigmentation of skin and mucosa
 feeling hot or cold.

These side effects are usually mild.

Tell your doctor immediately, or go to Accident and Emergency at your nearest

hospital if you notice any of the following:
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VITA-B12 INJECTION

 serious allergic (hypersensitivity) reaction. Symptoms include swelling of the face,

lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing,
severe skin rash, itching or hives, nausea, dizziness, fever, chills, hot flushes, feeling
faint or dizzy (low blood pressure)
 breathlessness, which may be very severe and usually worsens on lying down (due
to a build-up of fluid in the lungs)
 changes in heart rate (fast, slow or irregular)
 chest tightness or pain.
These are very serious side effects; you may need urgent medical attention or
hospitalisation.

Tell your doctor if you notice any unusual acne-like eruptions on your skin.

Tell your doctor if you notice anything else that is making you feel unwell, even if
it is not mentioned in this leaflet.
Other side effects not listed above may also occur in some patients.

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

You may not experience any of them.

After using VITA-B12 INJECTION

Storage
If you are keeping a supply of VITA-B12 INJECTION at home:

Keep VITA-B12 INJECTION in a cool dry place where the temperature stays below
25°C. Protect from light.

Do not store it or any other medicine in the bathroom, near a sink, or on a window
sill.
Do not leave it in the car.
Heat and damp can destroy some medicines.

Keep it and any other medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to
store medicines.
Do not keep VITA-B12 INJECTION past its expiry date.

Disposal
Return any unused medicine, and any medicine past its expiry date (as shown on
the dispensing label or on the packaging) to your pharmacy.

Product description
What it looks like
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VITA-B12 INJECTION

VITA-B12 INJECTION is a clear, red solution supplied in single dose ampoules. It is

available in packs of 3 ampoules.

Ingredients
Active ingredient:
 hydroxocobalamin acetate

Inactive ingredients:
 sodium chloride
 glacial acetic acid
 water for injections

Sponsor details
BNM Group
39 Anzac Road
Browns Bay
Auckland 0753

Ph: 0800 565 633

Date of preparation
This leaflet was prepared on 20 April 2023