MINERALI

Riik: Iisrael

keel: inglise

Allikas: Ministry of Health

Osta kohe

Infovoldik Infovoldik (PIL)
11-01-2023
Toote omadused Toote omadused (SPC)
11-01-2023
Avaliku hindamisaruande Avaliku hindamisaruande (PAR)
02-12-2020

Toimeaine:

GLUCOSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM CITRATE

Saadav alates:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

ATC kood:

B05XA30

Ravimvorm:

SOLUTION (ORAL)

Koostis:

GLUCOSE MONOHYDRATE 14.85 MG / 1 ML; SODIUM CITRATE 2.20 MG / 1 ML; POTASSIUM CHLORIDE 1.50 MG / 1 ML; SODIUM CHLORIDE 2.70 MG / 1 ML

Manustamisviis:

PER OS

Retsepti tüüp:

Not required

Valmistatud:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

Terapeutiline ala:

COMBINATIONS OF ELECTROLYTES

Näidustused:

For the prevention of dehydration by replacing fluids and electrolytes loss associated with conditions such as acute diarrhoea.

Loa andmise kuupäev:

2019-06-24

Infovoldik

                                PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
This medicine is dispensed without a doctor’s prescription
MINERALI ORAL SOLUTION
EACH 1 ML CONTAINS:
GLUCOSE MONOHYDRATE 14.85 MG
SODIUM CHLORIDE 2.70 MG
POTASSIUM CHLORIDE 1.50 MG
SODIUM CITRATE 2.20 MG
For inactive ingredients in the preparation see section 6 -
“Additional information” and the section “Important information
about some ingredients of the medicine”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine.
If you have additional questions, refer to the doctor or the
pharmacist.
Take the product according to the instructions in the dosage
section of this leaflet. Consult the pharmacist if you have
further questions. Refer to the doctor if signs of the ailment
(symptoms) worsen or do not improve after 24-48 hours.
1. WHAT IS THE MEDICINE INTENDED FOR?
Minerali is intended for the prevention of dehydration by
replacing fluids and electrolytes loss associated with conditions
such as acute diarrhea.
Minerali contains glucose and various salts that belong to a
group of medicines called oral electrolyte solutions, which are
used to restore fluids and salts lost from the body.
THERAPEUTIC CLASS: Oral electrolytes.
2. BEFORE USING THE MEDICINE:
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredients or to
any of the other ingredients this medicine contains (see
section 6 – “Additional information”). Signs of an allergic
reaction include: rash, swallowing or breathing problems,
swelling of the lips, face, throat or tongue.
•
You are suffering from a partial or complete obstruction of
the intestines.
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE: BEFORE TREATMENT WITH MINERALI, INFORM THE DOCTOR IF:
•
You are suffering from liver problems.
•
You are suffering from kidney problems.
•
You have diabetes.
•
You are on a low salt (sodium) diet (see “Important
information about some ingredients o
                                
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Toote omadused

                                1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Minerali
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Glucose monohydrate
14.85 mg
Sodium Chloride
2.70 mg
Potassium Chloride
1.50 mg
Sodium Citrate
2.20 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral Solution
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prevention of dehydration by replacing fluids and electrolytes
loss associated
with conditions such as acute diarrhoea.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
IT IS ADVISABLE THAT SMALL AMOUNTS OF MINERALI BE TAKEN FREQUENTLY
EVERY FEW
MINUTES.
During the first 2-4 hours the following dosage is recommended:
FLUID LOSS WITHOUT DEHYDRATION SYMPTOMS (patient is alert, drinks
normally, non-
sunken eyes, tears present when crying, normal or reduced urine
output, warm
extremities, moist lips and tongue, pinched skin recoil instantly): 10
ml/kg body after
each loose motion and 2 ml/kg after each vomiting episode.
In case the child weight is unknown:
Below 10 kg (below 2 years of age): 50 -100 ml after each loose motion
or vomiting
episode
10 kg and above (age 2-10 years): 100-200 ml after each loose motion
or vomiting
episode.
The patient should be encouraged to drink as much as wanted until
condition is
resolved.
MILD TO MODERATE FLUID LOSS: (patient is restless, irritable or
fatigued, thirsty, slightly
sunken eyes [in babies, anterior fontanel is slightly sunken],
decreased tears when
crying, decreased urine output, cool extremities, sticky or dry lips
and tongue, pinched
skin recoil slowly (<2 seconds): 50-100 ml/kg body weight.
2
IN ADDITION, 10 ml/kg body weight should be added after each loose
motion
and 2 ml/kg
body weight after each vomiting episode.
In case the child weight is unknown:
Below 10 kg (below 2 years of age): add 50 -100 ml after each loose
motion or vomiting
episode
10 kg and above (age 2-10 years): add 100-200 ml after each loose
motion or vomiting
episode.
SEVER FLUID LOSS OR SEVER ILLNESS CONDITION (blood in 
                                
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