CALCIJEX INJECTION 1 mcgml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CALCITRIOL

Available from:

ABBVIE PTE. LTD.

ATC code:

A11CC04

Dosage:

1 mcg/ml

Pharmaceutical form:

INJECTION

Composition:

CALCITRIOL 1 mcg/ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Avara Liscate Pharmaceutical Services SpA

Authorization status:

ACTIVE

Authorization date:

1992-10-08

Patient Information leaflet

CALCIJEX
®

CALCITRIOL INJECTION 
1 MCG/ML AND 2 MCG/ML 

_DESCRIPTION_  
Calcijex
®
 (calcitriol injection) is synthetically manufactured calcitriol and is available as a sterile, 
isotonic,  clear,  aqueous  solution  for  intravenous  injection.  Calcijex
®
  is  available  in  1  ml 
ampoules. Each 1 mL contains calcitriol, 1 or 2 mcg; Polysorbate 20, 4 mg; sodium chloride 1.5 
mg; sodium ascorbate 10 mg added; dibasic sodium phosphate, anhydrous 7.6 mg; monobasic 
sodium  phosphate,  monohydrate  1.8  mg;  edetate  disodium,  dihydrate  1.1  mg  added,  pH  7.2 
(6.5 to 8.0). It does not contain a preservative. 

Calcitriol is a colorless, crystalline compound which occurs naturally in humans. It is soluble in 
organic solvents but relatively insoluble in water. 

Calcitriol is chemically designated (5Z, 7E)-9, 10-secocholesta-5, 7,10(19)-triene-1
α, 3β, 25-triol 
and has the following structural formula: 

Molecular Formula: C
27
H
44
O
3

The  other  names  freque
ntly  used  for  calcitriol  are  1α,  25-dihydroxycholecalciferol,  1α,  25-
dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)
2
D3 and 1,25-diOHC. 

_CLINICAL PHARMACOLOGY_ 
Calcitriol is the active form of vitamin D
3
 (cholecalciferol). The natural or endogenous supply of 
vitamin  D  in  man  mainly  depends  on  ultraviolet  light  for  conversion  of  7-dehydrocholesterol  to 
vitamin  D3  in  the  skin.  Vitamin  D
3
  must  be  metabolically  activated  in  the  liver  and  the  kidney 
before it is fully active on its target tissues. The initial transformation is catalyzed by a  vitamin 
D
3
-25-  hydroxylase  enzyme  present  in  the  liver,  and  the  product  of  this  reaction  is  25-(OH)D
3

(calcifediol). �

Summary of Product characteristics

CALCIJEX
®
CALCITRIOL INJECTION
1 MCG/ML AND 2 MCG/ML
Calcijex
®
(calcitriol injection) is synthetically manufactured calcitriol and is
available as a sterile,
i s o t o n i c ,
c l e a r ,
c o l o r l e s s
t o
y e l l o w,
a q u e o u s
so l u t i o n
f o r
i n tr a ve n o u s
injection. Calcijex
®
is
available
in
1
ml
ampoules. Each
1
mL
contains
calcitriol,
1
or
2
mcg;
Polysorbate
20,
4
mg;
sodium chloride 1.5 mg; sodium ascorbate 10 mg added; dibasic sodium
phosphate, anhydrous
7.6
mg;
monobasic
sodium
phosphate,
monohydrate
1.8
mg;
edetate
disodium, dihydrate
1.1
mg added, pH 7.2 (6.5 to 8.0). It does not contain a preservative.
Calcitriol is a white or almost white crystalline compound which
occurs naturally in humans. It is
soluble in organic solvents but relatively insoluble in water.
Calcitriol is chemically designated (5Z, 7E)-9, 10-secocholesta-5,
7,10(19)-triene-1α, 3β, 25-triol
and has the following structural formula:
Molecular Formula: C
27
H
44
O
3
T h e
o t h er
n a m e s
frequently used for calcitriol are 1α,
25-dihydroxycholecalciferol, 1α, 25-
dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)
2
D3 and 1,25-diOHC.
_CLINICAL PHARMACOLOGY_
Calcitriol is the active form of vitamin D
3
(cholecalciferol). The natural or endogenous supply of
vitamin
D
in
man
mainly
depends
on
ultraviolet
light
for
conversion
of
7-dehydrocholesterol to
vitamin
D3
in
the
skin.
Vitamin
D
3
must
be
metabolically
activated
in
the
liver
and
the
kidney
before it is fully active on its target tissues. The initial
transformation is catalyzed by a vitamin
D
3
-25- hydroxylase
enzyme
present
in
the
liver,
and
the
product
of
this
reaction
is
25-(OH)D
3
(calcifediol).
The
latter
undergoes
hydroxylation
in
the
mitochondria
of
kidney
tissue,
and
this
r e a c t i o n
i s
a ct i va t e d
b y
t h e
r e n a l
2 5 - h yd r o xy vi t a m i n
D
3
- 1 - α- h yd r o xyl a s e
t o
pr o d u c e
1,
25-
(OH)
2
D
3
(calcitriol), the active form of vitamin D
3
.
T h e
k n o w n
s i t e s
o f
a c t i o n
o f
c a l c i t r i o l
a r e
i n t e s t i