Panadol Baby suppositories rectal

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

paracetamol

Available from:

Farmaclair

ATC code:

N02BE01 օրիգինալ դեղի առաջին դեղաձև, դեղաչափ

INN (International Name):

paracetamol

Dosage:

125mg (10/2x5/)

Pharmaceutical form:

suppositories rectal

Units in package:

125mg (10/2x5/)

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2021-05-16

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Panadol Baby 125 mg Rectal Suppositories
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains Paracetamol 125 mg.
Complete list of excipients is given in section 6.1.
3.
PHARMACEUTICAL FORM
Rectal Suppository
White or almost white homogeneous fatty-looking suppositories of a
conical
shape, without physical defects and visible impurities.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Symptomatic treatment of pain from mild to moderate intensity and / or
fever.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_Dosage regimen _
Panadol
Baby
suppositories
125
mg
are
for
children
aged
6
to
18
months
(with body weight of 7 to 10 kg).
Use the lowest recommended doses to achieve effect within the shortest
possible
time.
If necessary, repeat after 6 hours. Do not use more than 4
suppositories per day.
When used in children, it is necessary to observe the dosages
determined in
accordance with the body weight of the child and choose the required
dosage
form.
Maximum daily doses should not exceed 60 mg / kg body weight of the
child,
which should be divided into 4 applications, that is, 15 mg / kg body
weight every
6 hours.
Due to potential toxicity of such medicine rectal administration of
paracetamol
should be as short as possible. Not more than four doses in any 24
hour period.
Maximum duration of continued use without medical advice: 3 days.
In case of diarrhea, do not use this medicine.
Systematic use of this medicine allows to avoid sharp jumps in
temperature and
fluctuations in the intensity of pain.
_Special Patient groups _
_Patients with impaired renal function _
Patients with renal insufficiency should consult their doctor before
taking this
medicine. In adults in case of renal insufficiency, while using this
medicine
without consulting a doctor, it is recommended to reduce the dose and
increase the
minimal interval between 2 doses according to the following table:
Creatinine clearance
Interval between doses
Creatinine clearance >