Enterogermina 2 Billions5 ml oral suspension

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Δραστική ουσία:

BACILLUS CLAUSII

Διαθέσιμο από:

DKSH MALAYSIA SDN BHD

INN (Διεθνής Όνομα):

BACILLUS CLAUSII

Μονάδες σε πακέτο:

10units Units; 20units Units

Κατασκευάζεται από:

Opella Healthcare Italy S.r.l.

Φύλλο οδηγιών χρήσης

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
_ _
ENTEROGERMINA
® ORAL SUSPENSION
_ _
SPORES OF POLY-ANTIBIOTIC RESISTANT BACILLUS CLAUSII (2 BILLION/ 5 ML)
WHAT IS IN THIS LEAFLET
1. What Enterogermina is used for
2. How Enterogermina works
3. Before you use Enterogermina
4. How to use Enterogermina
5. While you are using Enterogermina
6. Side effects
7. Storage and Disposal of
Entergermina
8. Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
WHAT ENTEROGERMINA IS USED FOR
Enterogermina is a medicine consisting
of spore of poly-antibiotic resistant
Bacillus clausii, normally present in the
intestine, without disease-causing
capacity (without pathogenic ability).
Enterogermina is used for:
•
the prevention and treatment of
intestinal disorders related to the
alteration in intestinal flora, that
manifest themselves as diarrhea,
abdominal pain and increase of air in
the bowel (intestinal dismicrobism),
and vitamin deficiencies in the body
resulting from the imbalance of
intestinal flora (endogenous
avitaminosis);
•
coadjuvant treatment to restore
intestinal microbial flora altered during
treatment with antibiotics or
chemotherapy;
•
the treatment of acute and chronic
gastro-intestinal diseases of infants
caused by poisoning or alteration of the
normal balance of intestinal bacterial
flora, that manifest themselves as
diarrhea, abdominal pain and increase
of air in the bowel (intestinal
dismicrobism), or vitamin deficiencies
in the organism (avitaminosis).
HOW ENTEROGERMINA WORKS
Enterogermina re-establishes the
balance of the intestinal flora that has
undergone alterations during treatment
with antibiotics or chemotherapeutic
agents, contributing to correcting the
subsequent dysvitaminosis (that is,
disorders in the production and
assimilation of vitamins).
“Poly-antibiotic resistant” means
resistant to a certain number of
antibiotics.
This is an extremely important
characteristic of ENTEROGERMINA,
which makes it possible to take it even
during treatment with

Αρχείο Π.Χ.Π.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Oral suspension: 2 billion (strains SIN, O/C, T, N/R) For a full list
see list of Excipients.
PRODUCT DESCRIPTION
Oral suspension: Whitish, opalescent, liquid.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of intestinal dysmicrobism and subsequent
endogenous dysvitaminosis. Therapy for aiding the recovery of the
intestinal microbial flora, altered during the course of
treatment with antibiotics or chemotherapeutic agents. Acute and
chronic gastrointestinal disorders in breastfeeding infants,
attributable to intoxication or intestinal dysmicrobism and
dysvitamino-
sis.
POSOLOGY AND METHOD OF ADMINISTRATION
Adults: 2-3 minibottles per day; children: 1-2 minibottles per day;
breastfeeding infants: 1-2 minibottles per day.
Minibottles: administration at regular intervals (3-4 hours), taking
the contents of the minibottles as it is or diluting it in water or
other drinks (e.g. milk, tea, orange juice).
This medicine is for ORAL use only. DO NOT inject or administer in any
other way.
CONTRAINDICATIONS
Hypersensitivity to the active ingredient or any of the excipients.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Special warnings:
Bacteraemia/sepsis
Post-marketing cases of bacteraemia, septicaemia and sepsis have been
reported in patients being immunocompromised or severely ill, and in
preterm infants. In some critically-ill patients, the
outcome was fatal. ENTEROGERMINA should be avoided in these patient
groups (see section Undesired effects)
This medicinal product is for oral use only. Do not inject or
administer in any other way. Incorrect use of the medicinal product
has caused severe anaphylactic reactions such as anaphylactic
shock.
Precautions for use:
During antibiotic therapy, the product should be administered in the
interval between one dose of antibiotic and the next.
Any presence of visible corpuscles in the minibottles of ENTEROGERMINA
is due to aggregates of Bacillus clausii spores and does not,
therefore, suggest that the product has been late