VIAFLO 5% GLUCOSE 50g/1000mL injection bag

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

glucose, Quantity: 50 g/L

제공처:

Baxter Healthcare Pty Ltd

약제 형태:

Injection, solution

구성:

Excipient Ingredients: water for injections

관리 경로:

Intravenous

패키지 단위:

1000ml x 1

처방전 유형:

Not scheduled. Not considered by committee

치료 징후:

Isotonic (Glucose 5%) intravenous infusions are mainly indicated: ? Whenever non-electrolyte fluid replacement is required. ? As a vehicle for drug delivery, provided that the added components are compatible with glucose.

제품 요약:

Visual Identification: Clear colourless solution; Container Type: Bag; Container Material: Composite plastic laminate; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

승인 상태:

Registered

승인 날짜:

2018-03-13

제품 특성 요약

VIAFLO 5% GLUCOSE INTRAVENOUS INFUSION
Version 1.3
1 of 13
AUSTRALIAN PRODUCT INFORMATION –
VIAFLO 5% GLUCOSE (GLUCOSE) INTRAVENOUS
INFUSION
1
NAME OF THE MEDICINE
Glucose
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
VIAFLO
5%
Glucose
Intravenous
(IV)
Infusions
are
sterile,
non-pyrogenic
parenteral
solutions
containing
glucose
(5%)
in
Water
for
Injections.
They
do
not
contain
an
antimicrobial agent or added buffer, and have a pH of 3.5 - 6.5. The
isotonicity of this
preparation is shown in Table 1 below:
TABLE 1: VIAFLO 5% GLUCOSE INTRAVENOUS INFUSION PREPARATIONS
(ISOTONIC)
CODE NO
.
ACTIVE COMPONENTS & CONC.
% (MMOL/1000ML); ENERGY
(KJ/L)
OSMOLARITY

(MOSMOL/L)
ARTG/
AUSTR
PACK SIZE*
(ML)
BSE0086G
Glucose 5% (278); 835 kJ/L
278 (278)
298214
50
BSE0087
Glucose 5% (278); 835 kJ/L
278 (278)
298215
100
BSE0062
Glucose 5 % (278); 835 kJ/L
278 (278)
298216
250
BSE0063
Glucose 5% (278); 835 kJ/L
278 (278)
298217
500
BSE0064
Glucose 5% (278);
835 kJ/L
278 (278)
298218
1000
* Not all packs are marketed.

Osmolarity is calculated as glucose. The figures in the bracket are
Osmolality in mOsmol/kg as
printed on the VIAFLO bags.
1 gram of glucose provides 16.7 kiloJoules (kJ) of energy.
VIAFLO 5% Glucose IV Infusions are
ISOTONIC
solutions.
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Clear colourless solution for Intravenous Infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VIAFLO 5% Glucose IV infusions are mainly indicated:
•
whenever non-electrolyte fluid replacement is required
•
as a vehicle for drug delivery, provided that the added components are
compatible with
glucose.
VIAFLO 5% GLUCOSE INTRAVENOUS INFUSION
Version 1.3
2 of 13
4.2
DOSE AND METHOD OF ADMINISTRATION
To be used for intravenous administration as directed by the
physician. The infusion rate and
volume of the VIAFLO 5% Glucose IV Infusions are dependent upon the
age, weight,
concomitant therapy, clinical and metabolic conditions of the patient
as well as laboratory
determinations. Electr