VARIHYDRASALTS® ORANGE FLAVOUR Powder 2.6/1.5/2.9/13.5 Units

Država: Tanzanija

Jezik: engleski

Izvor: Tanzania Medicinces & Medical Devices Authority

Preuzimanje Svojstava lijeka (SPC)
06-03-2023

Aktivni sastojci:

Glucose Anhydrous BP , Sodium Chloride BP , Potassium Chloride BP , Sodium Citrate Dihydrate BP

Dostupno od:

Varichem Pharmaceuticals Private Limited, ZIMBABWE

ATC koda:

Electrolytes with carbohydrates

INN (International ime):

Glucose Anhydrous BP + Sodium Chloride BP + Potassium Chloride BP + Sodium Citrate Dihydrate BP

Doziranje:

2.6/1.5/2.9/13.5 Units

Farmaceutski oblik:

Powder

Proizveden od:

Varichem Pharmaceuticals (Pvt) Limited,, ZIMBABWE

Proizvod sažetak:

Physical description: Pale orange powder which produces a pale orange solution after reconstitution; Local technical representative: TALEMWA INVESTMENTS CONSULTING COMPANY LIMITED (2074)

Status autorizacije:

Registered/Compliant

Datum autorizacije:

2022-07-19

Svojstava lijeka

                                SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
VARIHYDRASALTS® ORANGE FLAVOUR
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Quantity per dosage unit g/l:
Sodium Chloride
2.6
Glucose Anhydrous
13.5
Potassium Chloride
1.5
Trisodium Citrate, dehydrate 2.9
.
Contains Sunset Yellow Supra (FD +C No.6)
3.
PHARMACEUTICAL FORM
Pale orange crystalline powder which produces a clear pale orange
solution after
reconstitution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Vari-Hydrasalts® is indicated for the treatment of diarrhea and fluid
loss due to
diarrhea in infants, children, and adults.
Vari-Hydrasalts® Orange is particularly recommended in the case of
too loose or
frequent stools where it enables over-loose stools to revert to
normal.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
PREPARATION
1.
Boil and cool clean water.
2.
Find and clean equipment: a 1L water bottle, cup and spoon.
3.
Wash hands.
4.
Measure the required clean boiled water, according to instructions on
sachets.
ORS (1L WATER = 20,5G VARIHYDRASALTS
®
ORANGE)
AGE
DOSAGE
WATER
FOR
SOLUTION
DURATIO
N
HOW
OFTEN
Les
s
tha
n 2
yea
rs
1.3 – 2.6g
Varihydrasalts
®
Orange powder
Between
¼ and
½ of a
2 5 0
millilitr
e cup
2 days
After
each
water
y
stool
O l d
e
r
t h a
n
2
yea
rs
2.6 – 5.1g
Varihydrasalts
®
Orange powder
Between
½ and 1
whole
250
millilitre
cup
5.
Put the contents of the Varihydrasalts
®
Orange packet in a clean container. Check
the packet for directions and add the correct amount of clean water.
Too little water
could make the diarrhoea worse. Add water only. Do not add
Varihydrasalts
®
Orange to milk, soup, fruit juice or soft drinks. Do not add sugar.
6.
Mix Varihydrasalts
®
Orange in the water.
Stir well, and feed it to the child from a clean cup. Do not use a
bottle.
Varihydrasalts
®
Orange is best given by spoon to infants or cup for older children
4.3.
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients.
Oral treatment is inappropriate in such conditions as severe
dehydration, which
requires
                                
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