CHILDREN'S ADVIL GRAPE FLAVOR

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

IBUPROFEN

Tillgänglig från:

GSK CONSUMER HEALTHCARE, ISRAEL LTD

ATC-kod:

M01AE01

Läkemedelsform:

SUSPENSION

Sammansättning:

IBUPROFEN 100 MG / 5 ML

Administreringssätt:

PER OS

Receptbelagda typ:

Not required

Tillverkad av:

FAREVA RICHMOND INC, USA

Terapeutisk grupp:

IBUPROFEN

Terapiområde:

IBUPROFEN

Terapeutiska indikationer:

For the reduction of fever and relief of mild to moderate pain. For infants and children aged 3 months to 12 years .

Tillstånd datum:

2021-05-31

Bipacksedel

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
Under the age of 6 months use according to a doctor’s prescription
only.
Over the age of 6 months this medicine is dispensed without a doctor's
prescription.
CHILDREN'S ADVIL GRAPE FLAVOR SUSPENSION
100 mg/5 mL
CHILDREN'S ADVIL FRUIT FLAVOR SUSPENSION
100 mg/5 mL
ACTIVE INGREDIENT AND ITS CONCENTRATION:
Each 5 mL contains: Ibuprofen 100mg
For the list of inactive ingredients and allergens: see section 6
“Additional
information” and section 2 “Before using the medicine" – under
subsection "Important
information about some of the ingredients of the medicine”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains
concise information about the medicine. If you have any other
questions, refer to the
doctor or the pharmacist.
Use the preparation according to the instructions in section 3 –
“How should you use
the medicine?” in this leaflet. Consult the pharmacist if you need
more information.
Refer to the doctor if signs of the ailment (symptoms) worsen or do
not improve after
24 hours in infants aged 3-6 months or after 3 days in children aged 6
months and
older.
THIS MEDICINE IS SUITABLE FOR MOST INFANTS OVER 3 MONTHS OF AGE,
CHILDREN AND
ADULTS.
IN INFANTS AGED 3-6 MONTHS USE ACCORDING TO A DOCTOR’S PRESCRIPTION.
REFER TO THE DOCTOR IF YOUR CHILD IS TAKING ASPIRIN AT A DOSAGE ABOVE
75 MG PER
DAY, OR IF YOUR CHILD DEVELOPS A RASH, DIFFICULTY BREATHING, DIARRHEA
OR INCREASED
FATIGUE.
1. WHAT IS THE MEDICINE INTENDED FOR?
For the reduction of fever and relief of mild to moderate pain, in
infants and children
from 3 months to 12 years of age.
THERAPEUTIC CLASS: Non-steroidal anti-inflammatory drugs (NSAIDs).
2. BEFORE USING THE MEDICINE
This medicine is suitable for most people, but some people should
avoid using it.
Consult the pharmacist or the doctor if you are uncertain.
DO NOT USE THIS MEDICINE IF:
•
You or your child are sensitive (allergic) to ibuprofen, or to any of
the
add

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Advil Children's Grape Flavor
Advil Children's Fruit Flavor
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 100mg/5ml.
Excipients with known effect:
Sucrose
Sodium
Sorbitol
Sodium Benzoate
Propylene Glycol (Grape Flavor only)
Benzyl Alcohol (Fruit Flavor only)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the reduction of fever and relief of mild to moderate pain.
For infants and children aged 3 months to 12 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The lowest effective dose should be used for the shortest duration
necessary to relieve
symptoms (see section 4.4).
For pain and fever: The daily dosage of Children's Advil aged 6 months
to 12 years
old is 5 to 10 mg/kg ORALLY every 6 to 8 hours as needed MAX 4
doses/day.
Infants and children aged 3 -6 months: dosage according to
physician’s prescription
only. Children with identical ages can have significantly different
weights. Therefore,
try to obtain the weight of the child and determine the dosage by
weight. Only if you
cannot find the child's weight determine the dosage according to age.
Using the measuring cup or syringe dosing device provided this can be
achieved as
follows:
DOSING CHART
WEIGHT
AGE
DOSAGE
NUMBER OF TIMES
IN 24 HOURS
Under 5 kg
3 – 6 months
According to physician's prescription only
5 – 5.4 kg
2 ml
3 – 4 times
5.5 – 8.1 kg
6 – 11 months
2.5 ml
8.2 – 10.9 kg
12 – 23 months
3.75 ml
11 – 15 kg
2 – 3 years
5 ml
16 – 21 kg
4 – 5 years
7.5 ml
22 – 26 kg
6 – 8 years
10 ml
27 – 32 kg
9 – 10 years
12.5 ml
33 – 43 kg
11 – 12 years
15 ml
Doses should be given approximately every 6 to 8 hours, (or with a
minimum of 4
hours between each dose if required).
For short term use only.
If the child's (aged over 6 months) symptoms persist for more than 3
days, consult
your doctor.
For children aged 3-6 months, medical advice should be sought after 24