One-Alpha 2micrograms/ml oral drops

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:

Oral drops

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09060400; GTIN: 5702191004984

Patient Information leaflet

WHAT IS IN THIS LEAFLET:
1. What One-Alpha
®
is and what it is used for
2. What you need to know before you take One-Alpha
®
3. How to take 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 TAKE ONE-ALPHA
®
DO NOT TAKE 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

Summary of Product characteristics

OBJECT 1
ONE-ALPHA DROPS
Summary of Product Characteristics Updated 17-Jul-2017 | Leo
Laboratories Limited
1. Name of the medicinal product
One-Alpha 2 microgram/ml oral drops
2. Qualitative and quantitative composition
Alfacalcidol 2 micrograms/ml
Excipients with known effect:
Ethanol, methylparahydroxybenzoate, polyoxyl 40 hydrogenated castor
oil, sorbitol
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral drops, solution.
Slightly turbid to clear, colourless solution.
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
Initial dose for all indications:
Adults and children over 20 kg bodyweight:
1 microgram/day
Elderly:
0.5 microgram/day
Neonates and premature infants:
0.05 - 0.1 microgram/kg/day
Children under 20 kg bodyweight:
0.05 microgram/kg/day
Half-drop doses should be rounded up to the next whole number of
drops.
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.
Plasma levels should initially be measured at weekly intervals. The
daily dose of One-Alpha may be
increased by increments of 0.25-0.5 microgram. When the dose is
stabilised, measurements may be taken
every 2-4 weeks.
Most adult patients respond to doses between 1 and 3 micrograms per
day. When there is biochemical or
radiogr