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ONE-ALPHA INJECTION

Active substance(s): ALFACALCIDOL / ALFACALCIDOL / ALFACALCIDOL

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Scale

Please return to:
LEO Pharma A/S
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Subject

Material No.

GB

Rev. No.

Sent by e-mail

N/A

055514
Date

INS 148 x 315 mm

Date

Date

Sign.

Sign.

03/08/11

Colour

Sign.

JUG

Black

Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength

Get-up

100%



ARTWORK

Supplier / Place of production

One-Alpha® injection

Cenexi

Comments:

Page 1 of 2 Cenexi code: 28049221

Pointsize: 9 pt. Pointsize headings: 3,4 mm

Page 1

What is in this leaflet:
1. What One-Alpha® is and what it is used for
2. What you need to know before you have One-Alpha®
3. How to use One-Alpha®
4. Possible side effects
5. How to store One-Alpha®
6. Contents of the pack and other information

1. What One-Alpha® is and what it is used for
One-Alpha contains the active substance alfacalcidol.
One-Alpha belongs to a group of medicines called vitamin D
analogues. It is a type of vitamin D.
Vitamin D controls the levels of two substances in your
body. These substances are called calcium and phosphate.
Your body needs both of these substances for healthy
bones and teeth.
One-Alpha works by increasing the amount of vitamin D in
your body. This means the levels of calcium and phosphate
in your body will increase too.
One-Alpha is used to treat diseases where the amount of
calcium in your body needs changing.
It is used to treat:
• Changes in bone caused by kidney failure (osteodystrophy).
• Changes to your parathyroid glands. These are small
glands found in your neck. They make a substance
called the parathyroid hormone. This changes the
amount of calcium in your body.
° The glands may make the amount of calcium in your
blood too high (hyperparathyroidism).
° The glands may make the amount of calcium in your
blood too low (hypoparathyroidism).
• Low levels of calcium in the blood of newborn babies
(hypocalcaemia).
• Softening and deformity of the bones due to lack of
calcium (rickets or osteomalacia).

2. What you need to know before you have
One-Alpha®
Do not have One-Alpha
• If you are allergic (hypersensitive) to alfacalcidol or
any of the other ingredients. You can find a list of these
ingredients in section 6 of this leaflet.
• If you know you have a condition called hypercalcaemia.
This means you have high levels of calcium in your blood.
• If you know that you have a condition called calcification.
This means you have high levels of calcium in your body
tissues.
If you are unsure if any of the above apply to you, talk to
your doctor before having One-Alpha.
Warnings and precautions
Talk to your doctor or nurse before having One-Alpha
• If you are taking any of the medicines in the
“Taking other medicines” section below.
• If you have any problems with your kidneys.
This includes if you have kidney stones.
• If you have granulomas or sarcoidosis. You may be more
sensitive to alfacalcidol.
This medicine contains small amounts of alcohol.
This may be harmful to some patients such as patients with
liver disease, epilepsy and those suffering from alcoholism.
You may get too much calcium or phosphate in your blood
when you have this medicine. Please read section 4 of this
leaflet so you can spot any signs this may be happening to
you. Your doctor may need to change your dose.
While you are having One-Alpha your doctor will take
regular blood tests. This is very important in children,
patients with kidney problems, or patients on a high dose of
medicine. This is to check the level of calcium and
phosphate in your blood while you have your medicine.

Your doctor may prescribe another medicine called a
phosphate binding agent to take as well as One-Alpha.
This will help to keep the right amount of phosphate in your
blood. Your doctor may also prescribe a calcium
supplement to take as well as One-Alpha. This is to maintain
the right amount of calcium in your blood.
Other medicines and One-Alpha
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
This includes any medicines which you have bought
without a prescription.
You must tell your doctor or pharmacist if you are taking any
of the following medicines:
• Anticonvulsants (for example, barbiturates, phenytoin,
carbamazepine or primidone): for epilepsy or fits.
You may need a larger dose of One-Alpha.
• Cardiac glycosides, such as digoxin: for heart problems.
You may get too much calcium in your blood.
This may cause an abnormal heart beat.
• Thiazide diuretics, often called “water pills”: for
increasing the amount of water (urine) that your body
makes. You may get too much calcium in your blood.
• Calcium-containing medicines. You may get too much
calcium in your blood.
• Other medicines that contain vitamin D. You may get
too much calcium in your blood.
• Antacids containing magnesium: for heartburn or
indigestion. You may get too much magnesium in your blood.
• Medicines containing aluminium. Too much aluminium
is toxic.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before having this medicine.
Driving and using machines
Usually your medicine may have very little effect on your
ability to drive or use machines. Check with your doctor if
you feel any side effect, for example dizziness, that may
stop you from driving or using machines.
Important information about some of the ingredients of
One-Alpha
One-Alpha contains:
• Ethanol. This is an alcohol. This medicinal product
contains 10 vol % ethanol i.e.up to 160 mg per dose
(corresponding to 4 micrograms of alfacalcidol),
equivalent to 4 ml beer or 1.7 ml wine. The alcohol content
may be harmful for those suffering from alcoholism.
The alcohol content must be taken into account in
pregnant or breast-feeding women, children and high-risk
groups such as patients with liver disease or epilepsy.
• Sodium. This medicine is essentially “sodium free”.
Your medicine contains 0.14 mmol sodium per dose
(corresponding to 4 micrograms of alfacalcidol).
Please ask your doctor if you are worried about any of the
ingredients in this medicine.

3. How to use One-Alpha®
One-Alpha will be given to you by a doctor or nurse.
How much One-Alpha to have
Your doctor or nurse will give you One-Alpha because it is
an injection.
This injection goes into your vein. This may be called IV
(intravenous) by your doctor or nurse.
At first you will have weekly blood tests to check the levels
of some substances in your blood. These tests are to check
the levels of calcium, an enzyme called alkaline phosphatase
or the parathyroid hormone. This is so your doctor knows
that you are having the dose that is right for you. When you
are getting the correct dose you will not need blood tests so
often.

RBE

Read all of this leaflet carefully before you start having this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
• In this leaflet One-Alpha Injection will be called One-Alpha.

24/04/17

alfacalcidol

30.

One-Alpha Injection

28049221

28049221
00000000

®

Value: Cenexi number

Package leaflet: Information for the user

128 BARCODE

055514

Scale

Please return to:
LEO Pharma A/S
Internal Market Access

Subject

Material No.

GB

Rev. No.

Sent by e-mail

N/A

055514
Date

INS 148 x 315 mm

Date

Date

Sign.

Sign.

03/08/11

Colour

Sign.

JUG

Black

Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength

Get-up

100%



ARTWORK

Supplier / Place of production

One-Alpha® injection

Cenexi

Comments:

Page 2 of 2 Cenexi code: 28049221

Pointsize: 9 pt. Pointsize headings: 3,4 mm

Page 2

055514

You may get too much calcium or phosphate in your blood
when you have this medicine. Please read section 4 of this
leaflet so you can spot any signs this may be happening to
you. Your doctor will tell you not to have any more medicine.
You will need to have some blood tests. When the blood
tests are normal you can start your medicine again. It is
important that you only have half the dose you had before.
Adults and children weighing more than
20 kilograms:
The usual starting dose is 1 microgram each day.
People usually have between 1 and 3 micrograms each day.
Most people have between 0.25 and 1 microgram each day
once the blood test results show the medicine is working.
If you have very low levels of calcium in your blood, the
doctor may prescribe between 3 and
5 micrograms each day. Your doctor may prescribe another
medicine called a calcium supplement to take as well as
One-Alpha. This will help to keep the right amount of
calcium in your blood.
Elderly:
The usual starting dose is 0.5 microgram each day.
Children:
The dose depends on the weight of the child
(called bodyweight).
Newborn and premature babies:
The usual starting dose is 0.05 to 0.1 microgram per
kilogram of bodyweight each day.
If the level of calcium in their blood is very low, up to
2 micrograms per kilogram of bodyweight may be needed
each day.
A dose of 0.1 microgram per kilogram bodyweight each day
is used to stop low blood calcium levels in premature babies.
Children weighing less than 20 kilograms:
The usual starting dose is 0.05 microgram per kilogram
bodyweight each day.
If you have more One-Alpha than you should
Your doctor or nurse will give you this medicine. If you think
you may have been given too much, tell your doctor or
nurse straight away. You may need to stop having this
medicine.

Other possible side effects which may affect
up to 1 in 10 people are:
• Abdominal/stomach pain or discomfort
• Rash
• Itch.
Uncommon possible side effects which may affect
up to 1 in 100 people are:
• Headache
• Diarrhoea, vomiting, constipation, nausea
• Muscle pain
• Fatigue
• Calcinosis (deposits of calcium in the body)
• Feeling weak or unwell.
Rare possible side effects which may affect
up to 1 in 1,000 people are:
• Dizziness.
Side effects with unknown frequency (cannot be estimated
from the available data):
• Confusion
• Hives (urticaria).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store One-Alpha®
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is
stated on the ampoule. The expiry date refers to the last
day of that month.
• Store at 2 to 8°C (in a refrigerator).
• Keep the ampoule in the outer carton in order to protect it
from light.
Do not throw away any medicines via waste water or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

6. Contents of the pack and other information
You may get too much calcium or phosphate in your blood.
Please read section 4 of this leaflet so you can spot any
signs this may be happening to you.
If you forget to have One-Alpha
Your doctor or nurse will give you this medicine.
If you think that you have missed a dose then tell your
doctor or nurse.
If you have any further questions on the use of this
medicine, please ask your doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Important side effects to look out for:
You should tell your doctor straight away if you spot any of
the following signs which may be due to too much calcium
or phosphate in your blood. These side effects may affect
up to 1 in 10 people:
• You feel weak or have pain in your muscles or bones
• You need to pass water (urine) more often
• You feel thirsty
• You feel fatigue
• You feel sick, vomit, have constipation or have lost
your appetite
• You are sweating a lot
• You are having headaches
• You feel confused
• You feel drowsy.

What One-Alpha contains
• The active ingredient is alfacalcidol.
• One-Alpha contains 2 micrograms of alfacalcidol in each
millilitre (ml).
• The other ingredients are citric acid, ethanol, propylene
glycol, sodium citrate, sorbitol and water for injection.
You can find important information about some of the
ingredients in your medicine near the end of section 2 of
this leaflet.
What One-Alpha looks like and contents of the pack
One-Alpha is a clear colourless solution for injection.
One-Alpha comes in one-point-cut amber glass ampoules
containing 0.5 or 1 ml.
There are 10 ampoules in a carton. Not all pack sizes may
be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
LEO Laboratories Limited,
Hurley, Berkshire SL6 6RJ, UK.
Manufacturer:
CENEXI SAS, 52 rue Marcel et Jacques Gaucher,
94120 Fontenay-sous-Bois, France.
This leaflet was last revised in March 2017.
® Registered Trade Mark

28049221

Value: Cenexi number

Your doctor may adjust your dose. Your doctor may ask you
to have more or less medicine depending on your test
results.

28049221
00000000

You should tell your doctor as soon as possible if you spot
any of the following signs which may be due to problems
developing with your kidneys. The frequency of these side
effects is not known (cannot be estimated from the
available data):
• Kidney problems:
• Needing to pass water (urine) less often
• Swelling of any parts of your body
• Fever with a pain in your side.
Kidney stones may be forming. Kidney stones may cause a
sharp spasm in one side of your lower back.

128 BARCODE

You may also have other tests such as X-rays. This is also
so your doctor knows that the dose is right for you.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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