DNS 500 Intravenous Infusion 0.9% & 5%

Ország: Tanzánia

Nyelv: angol

Forrás: Tanzania Medicinces & Medical Devices Authority

Aktív összetevők:

Sodium Chloride & Glucose Intravenous Infusion BP (0.9% w/v & 5% w/v)

Beszerezhető a:

Alfa Pharmaceuticals Limited, TANZANIA

ATC-kód:

Electrolytes with Carbohydrates

INN (nemzetközi neve):

Sodium Chloride & Glucose Intravenous Infusion BP (0.9% w/v & 5% w/v)

Adagolás:

0.9% & 5%

Gyógyszerészeti forma:

Intravenous Infusion

Gyártó:

Alfa Pharmaceuticals Limited, TANZANIA

Termék összefoglaló:

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

Engedélyezési státusz:

Registered/Compliant

Engedély dátuma:

2022-10-31

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
Sodium Chloride 0.9 % w/v and Glucose 5% w/v Solution for Infusion BP
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100ml contains Glucose (as anhydrous) 5g
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
Sodium Chloride 0.9 % w/v and Glucose 5% w/v solution is indicated
for:
Treatment of sodium depletion, extracellular dehydration or
hypovolaemia in cases where
supply of water and carbohydrates is required due to restriction of
the intake of fluids and
electrolytes by normal routes of carbohydrate and fluid depletion
4.2.POSOLOGY AND METHOD OF ADMINISTRATION
The choice of the specific sodium chloride and glucose concentration,
dosage, volume, rate
and duration of administration depends on the age, weight, clinical
condition of the patient and
concomitant therapy. It should be determined by a physician. For
patients with electrolyte and
glucose abnormalities and for pediatric patients, consult a physician
experienced in intravenous
fluid therapy.
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. Sodium
Chloride 0.9 % w/v and Glucose 5% w/v solution may become extremely
hypotonic after
administration due to glucose metabolization in the body (see sections
4.4, 4.5 and 4.8).
S o
d
i
u
m
chloride:
0.9g
mmol/l:
N a + :
154
Cl-: 154.
MEq/l:
N a + :
154
Cl-: 154.
pH: 3.5 – 6.5
1
Rapid correction of hyponatraemia and hypernatraemia is potentially
dangerous (risk of
serious neurologic complications);
Electrolyte supplementation m