SODIUM CHLORIDE Infusion 0.9 gm

Država: Tanzanija

Jezik: engleski

Izvor: Tanzania Medicinces & Medical Devices Authority

Aktivni sastojci:

Sodium Chloride

Dostupno od:

Aculife Healthcare Private Limited, INDIA

ATC koda:

I.V. Solutions And Additives

INN (International ime):

Sodium Chloride

Doziranje:

0.9 gm

Farmaceutski oblik:

Infusion

Proizveden od:

Aculife Healthcare Private Limited, INDIA

Proizvod sažetak:

Physical description: A clear colorless solution, free from foreign matter; Local technical representative: AFYA BORA PHARMA LIMITED (1075)

Status autorizacije:

Registered/Compliant

Datum autorizacije:

2021-03-29

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT PRODUCT NAME: Sodium Chloride Intravenous Infusion BP (0.9%w/v) STRENGTH: 0.9gm / 100ml PHARMACEUTICAL DOSAGE FORM: Intravenous Infusion
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
QUALITATIVE
COMPOSITION: Sodium Chloride BP
Water for injections BP
QUANTITATIVE COMPOSITION: Sodium Chloride BP – 0.9%w/v
Water for injections BP – q.s
3.
PHARMACEUTICAL FORM
A clear colorless solution filled in 100 ml Non – PVC bag. Sealed
the bag with HMHD Pouch
and such 60 bags packed in one corrugated box with plate partition.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS:
Sodium
Chloride
Injection
is
use
as
Pharmaceutical
aid
(tonicity
adjusting
agent), Fluid and electrolyte Replenisher.
When alkalosis is present along with fluid loss, normal saline is
indicated.
In case of severe salt depletion when rapid electrolyte restoration is
essential normal saline is
of particular value.
In the treatment of low salt syndrome which may occur in presence of
heart failure, renal
impairment, during surgery, etc. In these cases chloride loss
frequently exceeds sodium loss.
In
severe
salt
depletion
resulting
from
excessive
fluid
loss
due
to
sweating,
diarrhea,
vomiting, etc. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION: DOSE: 1 Lt / day in average adult.
RATE: Normal saline is usually given at the rate of 400 M/hr. in
adult.
In case of shock treatment 2000 ml/hr may be given.
ROUTE OF ADMINISTRATION: Intravenous 4.3 CONTRAINDICATIONS:
•
Cautious use or avoid in hypertensive and in patients with oedema due
to congestive
heart failure, renal failure, renal diseases and cirrhosis.
•
Dehydration with severe Hypokalaemia: with deficit of potassium so
infusion of isotonic
saline,
without
additional
potassium
supplementation,
will
aggravate
electrolyte
imbalance of ICF.
•
Normal
saline
solution
is
inadequate
for
repairing
electrolyte
deficit
involving
intracellular fluid because it may increase intracellular deficits
e.g. the main electrolyte of
intracellular fluid is