ROCALTROL CAPSULE 0.25MCG

Pays: Malaisie

Langue: anglais

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingrédients actifs:

CALCITRIOL

Disponible depuis:

DKSH MALAYSIA SDN BHD

DCI (Dénomination commune internationale):

CALCITRIOL

Unités en paquet:

30 Capsules; 100 Capsules

Fabriqué par:

Catalent Germany Eberbach GmbH

Notice patient

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ROCALTROL

_calcitriol 0.25 micrograms _
1
WHAT IS IN THIS LEAFLET
1.
What Rocaltrol is used for
2.
How Rocaltrol works
3.
Before you take Rocaltrol
4.
How to take Rocaltrol
5.
While you are taking Rocaltrol
6.
Side effects
7.
After taking Rocaltrol
8.
Product Description
9.
Manufacturer
&
Product
Registration Holder
1. WHAT ROCALTROL IS USED FOR
Rocaltrol
is
used
to
treat
the
following:
•
Bone disease in people with
kidney
problems
(renal
osteodystrophy),
•
Hypoparathyroidism (reduced
function
of
the
parathyroid
glands)
•
Rickets.
•
Weakening
of
the
bones
in
women
after
the
menopause
(When mensuration stops). This
is
also
known
as
post-
menopausal osteoporosis.
•
Predialysis patients
2. HOW ROCALTROL WORKS
Rocaltrol
works
by
enabling
your
body to absorb more calcium from
your diet. This helps to form healthy
bones and reduce bone damage.
3. BEFORE YOU TAKE ROCALTROL
_WHEN YOU MUST NOT TAKE IT _
Do not take Rocaltrol if:
•
you have had an allergic reaction
to
Rocaltrol,
calcitriol,
other
Vitamin
D
compounds,
or
any
ingredients listed at the end of this
leaflet (Under Inactive ingredient)
•
you have high levels of calcium in
your
blood
(called
hypercalcaemia)
•
you have vitamin D toxicity
•
you are breast-feeding or intend to
breast-feed
Rocaltrol
may
pass
into
breast
milk and have unwanted effects on
the baby.
Do not take Rocaltrol if the package is
torn or shows signs of tampering.
Do not take Rocaltrol if the expiry
date (EXP) printed on the pack has
passed.
If you take this medicine after the
expiry date has passed, it may not
work as well.
If you are not sure if you should be
taking Rocaltrol, talk to your doctor.
_BEFORE YOU START TO TAKE IT _
You must tell your doctor if:
•
you
are
allergic
to
any
other
medicines,
foods,
dyes
or
preservatives
•
you
have
any
other
health
problems
including:
kidney
problems
•
you
are
pregnant
or
intend
to
become pregnant
Your doctor will discuss the risks and
benefits
of
taking
Rocaltrol
when
pregna

Résumé des caractéristiques du produit

MY
766-2521 NP 01
PAGE 1 OF 2
MY 766-2521 NP 01
Date 23-02-23 Previous 703-0695
ROCALTROL 0.25MCG 100 CAPS
Size
148 X 594 MM
Printable Colours
Black
Non Printable Colours
Guides
Text free
area
Notes
PACK INSERT FOR MALAYSIA
ROCALTROL
®
Calcitriol
BIOLOGICALLY ACTIVE FORM OF VITAMIN D
3
1.
DESCRIPTION
1.1
THERAPEUTIC/ PHARMACOLOGIC
CLASS OF DRUG
ATC Code: A11CC04
1.2
TYPE OF DOSAGE FORM
Capsules containing 0.25 µg calcitriol
1.3
ROUTE OF ADMINISTRATION
Orally
1.4
QUALITATIVE AND QUANTITATIVE
COMPOSITION
_Active ingredient: _
synthetic calcitriol
(biologically active form of
vitamin D
3
).
_Chemical names: _
1α, 25 -
dihydroxycholecalciferol;
(5Z-/E)- 9, 10-secocholesta -
5, 7, 10 (19) - triene - 1α, 3β,
25 - triol.
Capsules: 0.25µg
_Excipients_
:
Butylhydroxyanisole,butylhydroxytoluene,
medium-chain triglycerides, gelatin,glycerol
85%, hydrogenated products of partially
hydrolysed starch, titanium dioxide E171, red
and yellow iron oxide (E172)
2.
CLINICAL
PARTICULARS
2.1
THERAPEUTIC INDICATIONS
Established postmenopausal osteoporosis.
Renal osteodystrophy in patients with chronic
renal failure, particularly those undergoing
hemodialysis.
Postsurgical hypoparathyroidism.
Idiopathic hypoparathyroidism.
Pseudohypoparathyroidism.
Vitamin D-dependent rickets.
Hypophosphatemic vitamin D-resistant rickets.
Predialysis patients: Rocaltrol is indicated for
the treatment of predialysis patients, i.e. for the
treatment of secondary hyperparathyroidism
and resultant metabolic bone disease in
patients with moderate to severe chronic renal
failure (Ccr 15 to 55 ml/min); in children, the
creatinine clearance value must be corrected for
a surface area of 1.73 square meters. A serum
iPTH level of ≥ 100pg/ml is strongly suggestive
of secondary hyperparathyroidism.
2.2
DOSAGE AND ADMINISTRATION
The optimal daily dose of Rocaltrol must be
carefully determined for each patient on the
basis of the serum calcium level. Rocaltrol
therapy should always be started at the lowest
possible dose and should not be increased
without care