DEXTROSE VIOSER SOLUTION FOR INFUSION 5 %

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

DEXTROSE ANHYDROUS

Fáanlegur frá:

ELDAN ELECTRONIC INSTRUMENTS CO LTD, ISRAEL

Lyfjaform:

SOLUTION FOR INFUSION

Samsetning:

DEXTROSE ANHYDROUS 5 %

Stjórnsýsluleið:

I.V

Gerð lyfseðils:

Required

Framleitt af:

VIOSER S.A. PARENTERAL SOLUTIONS INDUSTRY, GREECE

Ábendingar:

Vehicle solution for supplementary medication. Energy supply, hypertonic dehydration

Leyfisdagur:

2022-02-01

Upplýsingar fylgiseðill

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
DEXTROSE VIOSER SOLUTION FOR INFUSION 5%
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 55 mg glucose as glucose monohydrate
(Equivalent to 50 mg glucose anhydrous)
For a full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless aqueous solution
Osmolarity:
278 mOsm/l
pH:
3.5 – 5.5
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Energy supply, hypertonic dehydration. Vehicle solution for
supplementary medication.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
A volume that yields the desired concentration of the medicinal
product for which Dextrose
5% is to be used as vehicle solution should be chosen, having regard
to the maximum
dose stated below.
_Maximum daily dose _
Up to 40 ml per kg body weight per day, corresponding to 2 g of
glucose per kg body
weight per day. For a 70 kg person this corresponds to a maximum
infusion of 140.0 g/d
of glucose, respectively 560 kcal. The maximum daily dose is in
accordance with usual
limitations of the daily fluid intake.
_Maximum infusion and drip rate _
The maximum infusion rate is 5 ml per kg body weight per hour,
corresponding to 0.25 g
(250 mg) of glucose per kg body weight per hour.
The maximum drip rate is 1.7 drops per kg body weight per minute.
METHOD OF ADMINISTRATION
Intravenous use. The solution must not be used if container or closure
are damaged.
Solutions containing visible solid particles musts not be
administered.
For single use only.
Partially used containers must not be reconnected.
After first use, the container and any unused contents should be
discarded.
4.3
CONTRAINDICATIONS
−
Hypersensitivity to the active substance.
−
Solutions containing dextrose may be contraindicated in patients with
hypersensitivity
to corn products.
−
Hyperglycaemia,
−
Hypokalaemia,
−
Acidosis.
If it should be necessary to administer large volumes further
contra-indications can arise
on account of the glucose and/ or fluid load:
− Hyperhydration,

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
DEXTROSE VIOSER SOLUTION FOR INFUSION 5%
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains 55 mg glucose as glucose monohydrate
(Equivalent to 50 mg glucose anhydrous)
For a full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless aqueous solution
Osmolarity:
278 mOsm/l
pH:
3.5
–
5.5
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Energy supply, hypertonic dehydration. Vehicle solution for
supplementary medication.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
A volume that yields the desired concentration of the medicinal
product for which Dextrose
Vioser Solution for Infusion 5% is to be used as vehicle solution
should be chosen, having
regard to the maximum dose stated below.
_Maximum daily dose _
Up to 40 ml per kg body weight per day, corresponding to 2 g of
glucose per kg body
weight per day. For a 70 kg person this corresponds to a maximum
infusion of 140.0 g/d
of glucose, respectively 560 kcal. The maximum daily dose is in
accordance with usual
limitations of the daily fluid intake.
_Maximum infusion and drip rate _
The maximum infusion rate is 5 ml per kg body weight per hour,
corresponding to 0.25 g
(250 mg) of glucose per kg body weight per hour.
The maximum drip rate is 1.7 drops per kg body weight per minute.
METHOD OF ADMINISTRATION
Intravenous use. The solution must not be used if container or closure
are damaged.
Solutions containing visible solid particles must not be administered.
For single use only.
Partially used containers must not be reconnected.
After first use, the container and any unused contents should be
discarded.
4.3
CONTRAINDICATIONS
−
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
−
Solutions containing dextrose may be contraindicated in patients with
hypersensitivity
to corn products,
−
Hyperglycaemia,
−
Hypokalaemia,
−
Acidosis.
If it should be necessary to administer large volumes, further
contra-ind