KALOBA SYRUP

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

PELARGONIUM SIDOIDES ROOTS (1: 8- 10) (EPS® 7630) DRIED LIQUID EXTRACT; EXTRACTING AGENT : ETHANOL 11% (W/W)

MAH:

DR.SAMUELOV IMPORTING & MARKETING LTD, ISRAEL

ATC_code:

R05FB01

pharmaceutical_form:

SYRUP

composition:

PELARGONIUM SIDOIDES ROOTS (1: 8- 10) (EPS® 7630) DRIED LIQUID EXTRACT; EXTRACTING AGENT : ETHANOL 11% (W/W) 20 MG / 7.5 ML

administration_route:

PER OS

prescription_type:

Not required

manufactured_by:

DR. WILLMAR SCHWABE GMBH &CO. KG, GERMANY

therapeutic_area:

COUGH SUPPRESSANTS AND MUCOLYTICS

therapeutic_indication:

Symptomatic treatment of acute bronchitis for adults and children form age of 1 years. Traditional herbal medicinal product for use in the common cold for adults and children form age of 1 years

authorization_date:

2019-05-29

SPC

1
1.
NAME OF THE MEDICINAL PRODUCT
Kaloba® Syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Pelargonium sidoides roots (1:8-10) (EPs 7630®) dried liquid extract
20mg / 7.5ml
Extracting agent:
ethanol 11% (W/W)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Kaloba® Syrup is an orange to light brown, viscous syrup.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Symptomatic treatment of acute bronchitis for adults and children from
age of 1 years.
•
Traditional herbal medicinal product for use in the common cold for
adults and children from
age of 1 years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and adolescents over the age of 12:
7.5 ml syrup three times per day.
Children aged between 6-11 years:
5 ml syrup three times per day.
Children aged between 1 - 5 years:
2.5 ml syrup three times per day.
Use in children under the age of one is not recommended as there are
no adequate data.
Method of administration
Oral administration.
Kaloba® Syrup is to be taken mornings, at midday and evenings.
A measuring cup with various markings is enclosed for dosing Kaloba®
Syrup.
The cup should be cleaned appropriately after use.
_ _
Continuation of treatment is recommended for several days after relief
of symptoms, in order to
prevent a relapse.
If the symptoms become worse or no improvement occurs after 7 days, a
doctor must be consulted.
Treatment should not exceed 3 weeks.
2
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
Kaloba® syrup should not be taken in cases of severe hepatic
diseases, as no sufficient experience is
available in this area.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
A doctor must be consulted if the condition does not improve within
one week, with liver dysfunctions
of different origin, or if fever, shortness of breath or bloody sputum
occur.
Cases of liver damage and hepatitis have been reported in connection
with the use of medicinal
products containing Pelargonium,
Paediatr