One-Alpha 2 micrograms/ml oral drops

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Alfacalcidol

Sẵn có từ:

Leo Laboratories Limited

Mã ATC:

A11CC; A11CC03

INN (Tên quốc tế):

Alfacalcidol

Liều dùng:

2 microgram(s)/millilitre

Dạng dược phẩm:

Oral drops, solution

Loại thuốc theo toa:

Product subject to prescription which may be renewed (B)

Khu trị liệu:

Vitamin D and analogues; alfacalcidol

Tình trạng ủy quyền:

Marketed

Ngày ủy quyền:

1999-07-26

Tờ rơi thông tin

PACKAGE LEAFLET: INFORMATION FOR THE USER
ONE-ALPHA
®
2 MICROGRAMS/ML ORAL DROPS
alfacalcidol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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
oral drops will be called One-Alpha.
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 to be changed.
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
(hypopar

Đặc tính sản phẩm

Health Products Regulatory Authority
11 December 2020
CRN009VYR
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
One-Alpha 2 micrograms/ml oral drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Alfacalcidol 2 micrograms/ml. Each drop (0.05 millilitre) contains 0.1
micrograms (100 nanograms) alfacalcidol.
Excipients with known effect:
Ethanol equivalent to 14 vol%, methylparahydroxybenzoate (E218) 1.5
mg/ml, macrogolglycerol hydroxystearate 22.6 mg/ml,
sorbitol (E420) 452 mg/ml.
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 a-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
To administer this medicine hold the dropper in a vertical position,
upside down. The drops should flow immediately but if they
do not, tap the bottle gently. Do not shake the bottle.
Half-drop doses should be rounded up to the next whole number of
drops.
Health Products Regulatory Authority
11 December 2020
CRN009VYR
Page 2 of 7
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