One-Alpha 1micrograms/0.5ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Alfacalcidol

Available from:

Neon Healthcare Ltd

ATC code:

A11CC03

INN (International Name):

Alfacalcidol

Dosage:

2microgram/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09060400; GTIN: 5702191003673

Patient Information leaflet

Page 1
128 BARCODE
Value: Cenexi number
00000000
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 a

Summary of Product characteristics

OBJECT 1
ONE-ALPHA INJECTION
Summary of Product Characteristics Updated 02-May-2017 | Leo
Laboratories Limited
1. Name of the medicinal product
One-Alpha 2 microgram/ml injection
2. Qualitative and quantitative composition
Alfacalcidol 2 micrograms/ml
Excipients with known effect:
Ethanol, sodium citrate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
Clear, colourless liquid in 1 ml one-point-cut amber glass ampoule.
4. Clinical particulars
4.1 Therapeutic indications
One-Alpha is indicated in all conditions where there is a disturbance
of calcium metabolism due to
impaired 1 α-hydroxylation such as when there is reduced renal
function.
The main indications are:
a) Renal osteodystrophy
b) Hyperparathyroidism (with bone disease)
c) Hypoparathyroidism
d) Neonatal hypocalcaemia
e) Nutritional and malabsorptive rickets and osteomalacia
f) Pseudo-deficiency (D-dependent) rickets and osteomalacia
g) Hypophosphataemic vitamin D resistant rickets and osteomalacia
4.2 Posology and method of administration
Posology
The dosage of One-Alpha Injection is the same as for One-Alpha in its
oral presentations.
Initial dosage for all indications:
Adults and children over 20 kg bodyweight:
Elderly:
Neonates and premature infants:
Children under 20 kg bodyweight:
1 microgram/day
0.5 microgram/day
0.05 - 0.1 microgram/kg/day
0.05 microgram/kg/day
The dose of One-Alpha should be adjusted thereafter to avoid
hypercalcaemia according to the
biochemical response.
Indices of response include plasma levels of calcium (ideally
corrected for protein binding), alkaline
phosphatase, parathyroid hormone, as well as radiographic and
histological investigations.
Maintenance doses are generally in the range of 0.25 - 1 microgram per
day.
When administered as intravenous injection to patients undergoing
haemodialysis the initial dosage for
adults is 1 microgram per dialysis. The maximum dose recommended is 6
micrograms per dialysis and
not more than 12 micrograms per week. The injection should be
a