CERNEVIT

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

ASCORBIC ACID; BIOTIN; COCARBOXYLASE TETRAHYDRATE; COLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NICOTINAMIDE; PYRIDOXINE (VIT B6) HYDROCHLORIDE; RETINOL PALMITATE; RIBOFLAVINE; TOCOPHEROL

可用日期:

REMEDIX CARE LTD

ATC代码:

B05CB10

药物剂型:

POWDER FOR SOLUTION FOR INJECTION

组成:

RETINOL PALMITATE 3500 IU/VIAL; COLECALCIFEROL 220 IU/VIAL; TOCOPHEROL 10.2 MG/VIAL; ASCORBIC ACID 125 MG/VIAL; RIBOFLAVINE 5.67 MG/VIAL; PYRIDOXINE (VIT B6) HYDROCHLORIDE 5.5 MG/VIAL; CYANOCOBALAMIN 0.006 MG/VIAL; FOLIC ACID 0.414 MG/VIAL; DEXPANTHENOL 16.15 MG/VIAL; BIOTIN 0.069 MG/VIAL; NICOTINAMIDE 46 MG/VIAL; COCARBOXYLASE TETRAHYDRATE 5.8 MG/VIAL

给药途径:

I.V

处方类型:

Required

厂商:

BAXTER S.A., BELGIUM

治疗组:

COMBINATIONS

治疗领域:

COMBINATIONS

疗效迹象:

Vitamin supplementation in patients receiving parenteral nutrition. Only for adults and children over 11 years of age.

授权日期:

2013-11-30

资料单张

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
_____
JUNE 2, 2013
__
םש
רישכת
תילגנאב
רפסמו
םושירה
_____________
CERNEVIT
POWDER FOR SOLUTION FOR INJECTION :םושיר 'סמ
139
72
30602
11
םש
לעב
םושירה
עבט
לקידמ
קוויש
םיגרואה ,מ"עב
8
דודשא
77100
__
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
INDICATION
This formulation is indicated as a daily
multivitamin maintenance dosage for adults
and
children
aged
11 years
and
above
receiving parenteral nutrition.
It is also indicated in other situations where
administration by the intravenous route is
required. Such situations include surgery,
extensive burns, fractures and other trauma,
severe
infectious diseases,
and
comatose
states, which may provoke a "stress" situation
with
profound
alterations
in
the
body's
metabolic demands and consequent tissue
depletion of nutrients.
The physician should not await the
development of clinical signs of vitamin
deficiency before initiating vitamin therapy.
This product (administered in intravenous
fluids under proper dilution) contributes intake
of these necessary vitamins, except Vitamin
K, toward maintaining the body's normal
resistance and repair processes.
Patients with multiple vitamin deficiencies
or with markedly increased requirements may
be given multiples of the daily dosage for two
or more days as indicated by the clinical
status.
This product does not contain Vitamin K,
which may have to be administered separately.
Clinical testing indicates that some patients
do not maintain adequate levels of certain
vitamins
when
this
formulation
in
recommended amounts is the sole source of
vitamins. Although there was no clinical
evidence of vitamin deficiency or toxicity,
blood levels of Vitamin E and 1,25-OH

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
CERNEVIT
1.
NAME OF THE MEDICINAL PRODUCT
Cernevit
Powder for solution for injection.
Intravenous administration.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder contains:
Retinol palmitate
3500 IU
Cholecalciferol
220 IU
DL-

-tocopherol
10.20 mg
Ascorbic acid
125 mg
Cocarboxylase tetrahydrate
5.80 mg
Riboflavin dihydrated sodium phosphate
5.67 mg
Pyridoxine hydrochloride
5.50 mg
Cyanocobalamin
6 µg
Folic acid
414 µg
Dexpanthenol
16.15 mg
Biotin
69 µg
Nicotinamide
46 mg
equivalent to:
Vitamin A (Retinol)
3500 IU
Vitamin D3
220 IU
Vitamin E (

tocopherol)
11.20 IU
Vitamin C
125 mg
Vitamin B1 (Thiamine)
3.51 mg
Vitamin B2 (Riboflavin)
4.14 mg
Vitamin B6 (pyridoxine)
4.53 mg
Vitamin B12
6 µg
Folic Acid
414 µg
Pantothenic acid
17.25 mg
Biotin
69 µg
Vitamin PP (Niacine)
46 mg
Excipient with known effect:
Each vial contains 112.5 mg soybean lecithin.
Each vial contains 24 mg sodium (main component of cooking/table
salt). This is
equivalent to 1.2% of the WHO recommended maximum daily intake of 2 g
sodium
for an adult.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
Orange yellow freeze-dried cake.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Vitamin supplementation in patients receiving parenteral nutrition.
Only for adults and children aged over 11 years of age.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
1 vial per day
Intravenous route exclusively.
_Method of Reconstitution: _
The single-dose vial of CERNEVIT is reconstituted by adding 5 ml of
Sterile Water
for Injection into the vial and gently mixing to dissolve the
lyophilized powder. The
obtained solution is yellow-orange in colour. The resultant solution
should be
administered by intravenous infusion. After reconstitution, CERNEVIT
should be
used immediately or stored under refrigeration (2-8

C) for no more than 24 hours. To
minimize vitamin losses in parenteral nutrition admixtures, add the
vitamins
immediat