D5 500 Intravenous Infusion 5%

Страна: Танзанія

мова: англійська

Джерело: Tanzania Medicinces & Medical Devices Authority

Активний інгредієнт:

Glucose Anhydrous

Доступна з:

Alfa Pharmaceuticals Limited, TANZANIA

Код атс:

Carbohydrates

ІПН (Міжнародна Ім'я):

Glucose Anhydrous

Дозування:

5%

Фармацевтична форма:

Intravenous Infusion

Виробник:

Alfa Pharmaceuticals Limited, TANZANIA

Огляд продуктів:

Physical description: clear and colorless solution; Local technical representative: Alfa Pharmaceuticals Limited (25919)

Статус Авторизація:

Registered/Compliant

Дата Авторизація:

2022-10-31

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
Glucose Intravenous Infusion 5% w/v
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100ml contains 5g Glucose (as anhydrous)
Water for injections q.s to 100ml
For the full list of excipients: see section 6.1
3.
PHARMACEUTICAL FORM
Solution for infusion
Clear solution, free from visible particles.
4.
CLINICAL PARTICULARS
4.1.THERAPEUTIC INDICATIONS
Glucose 5% intravenous infusion is indicated for:
•
Treatment of carbohydrate and fluid depletion
•
as a vehicle and diluent for compatible medicinal products for
parenteral administration.
4.2.POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_ADULTS, OLDER PEOPLE AND CHILDREN: _
The concentration and dosage of Glucose 5% intravenous infusion is
determined by several
factors
including
the
age,
weight
and
clinical
condition
of
the
patient.
Serum-glucose
concentrations may need to be carefully monitored.
Fluid balance, serum glucose, serum sodium and other electrolytes
should be monitored
before
and
during
administration,
especially
in
patients
with
increased
non-osmotic
vasopressin release (syndrome of inappropriate antidiuretic hormone
secretion, SIADH) and in
patients co-medicated with vasopressin agonist drugs due to the risk
of hyponatraemia.
Monitoring of serum sodium is particularly important for
physiologically hypotonic fluids;
Some
products
may
become
extremely
hypotonic
after
administration
due
to
glucose
metabolization in the body (see sections 4.4, 4.5 and 4.8).
The recommended dosage for treatment of carbohydrate and fluid
depletion is:
-
for adults: 500 ml to 3 litres / 24h
-
for babies and children:
0-10 kg body
weight: 10-20 kg
body weight:
> 20 kg body weight:
00 ml/kg/24h.
000 ml + 50 ml /kg over 10 kg /
24h. 500 ml + 20 ml / kg over 20
kg / 24h.
1
The infusion rate depends on the patient's clinical condition.
Infusion rate should not exceed the patient's glucose oxidation
capacities in order to avoid
hyperglycaemia. Therefore, the maximum dose ranges from 5mg/kg/min for
adults to 10-18