Ecocillin Vaginal Capsules

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

LACTOBACILLUS PLANTARUM

Dostępny od:

Proge Farm S.r.l. Baluardo La Marmora, 4 - 28100 - Novara, Italy

Kod ATC:

G01AX

INN (International Nazwa):

LACTOBACILLUS PLANTARUM 17630 CFU

Forma farmaceutyczna:

VAGINAL SOFT CAPSULE

Skład:

LACTOBACILLUS PLANTARUM 17630 CFU

Typ recepty:

POM

Dziedzina terapeutyczna:

GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS

Status autoryzacji:

Withdrawn

Data autoryzacji:

2006-09-18

Ulotka dla pacjenta

ECOCILLIN  
ATC G01AX49 LACTOBACILLUS PLANTARUM P 17630 

VAGINAL SOFT CAPSULES 

COMPOSITION:  
Each vaginal soft capsule contains: 
Active ingredient: 
Lactobacillus plantarum P 17630 
minimum 10
8
 CFU at origin 
Excipients: 
Triglycerides medium chain - Silica
(Aerosil 300) – Sodium ethyl p-hydroxybenzoate – Sodium 
propyl p-hydroxybenzoate - Gelatine - Glycerine
- Dimethylpolysiloxane - Titanium dioxide (E 
171). 
PHARMACEUTICAL FORM AND PACKAGING 
Vaginal soft capsules – 6 soft capsules pack. 
PHARMACO -THERAPEUTIC CATEGORY 
It restores the vaginal bacterial flora. 
MANUFACTURING AUTHORISATION OWNER 
PROGE FARM S.r.l. - Baluardo La Marmora, 4 - Novara 
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
CARDINAL HEALTH ITALY 407 S.p.A. - Via Nettunense Km 20.100 - Aprilia
(LT) - Italy 
THERAPEUTIC INDICATIONS 
ECOCILLIN vaginal soft capsules is indicated for ‘vaginitis
and vulvovaginitis’ in general as the 
lactobacilli, implanting and proliferating themselves in the vaginal
mucosa, restore the balance 
of autochthonous bacterial flora and antagonise, by competition,
the colonisation of the 
pathogenic germs. Therefore ECOCILLIN is used in the topic
treatment of vaginal infections 
related to pathogenic germs. In particular, for vaginitis
associated with ovarian insufficiency, 
hypofolliculin leukorrhea, senile vaginitis, vaginitis in children,
vulvar itching, vaginal 
dystrophy.  
ECOCILLIN is also used as an adjuvant during chemotherapy and
antibiotic treatment of 
Trichomonas vaginitis.  
CONTRA-INDICATIONS 
Hypersensitivity to any of the components (active ingredient or
excipients) or chemically related 
substances. 
PRECAUTIONS IN USE 
ECOCILLIN does not replace the antibiotic treatment or
chemotherapy. However, it is a useful 
adjuvant to restore vaginal physiological conditions,
especially upon completion of a specific 
therapy.  
Because of the presence of sodium ethyl p-hydrox

Charakterystyka produktu

 
Page 1 of 4 
SUMMARY OF PRODUCT CHARACTERISTICS 

1.  NAME OF THE MEDICINAL PRODUCT 

ECOCILLIN vaginal capsules ATC G01AX49 – Lactobacillus plantarum P
17630 

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 

EACH VAGINAL CAPSULE CONTAINS: 
Active ingredient: Lactobacillus plantarum P-17630 
nlt 10
8
 UFC originally 

For excipients see 6.1. 

3. PHARMACEUTICAL 
FORM 

Vaginal soft capsules 

4.  CLINICAL PARTICULARS  

4.1 THERAPEUTIC INDICATIONS 

ECOCILLIN vaginal capsules are indicated in
treatment of “vaginitis and vulvo-vaginitis” in 
general, since the lactic bacteria contained, establishing and
increasing themselves in the 
vaginal mocous, besides restoring the native bacteric flora
equilibrium,  they fight indirectly by 
competition the colonisation from the pathogen germs. 
ECOCILLIN is therefore used in topic therapy of vaginal infections
maintained from pathogen 
germs. In particular is used in vaginitis jointed to oophorogenous
insufficiency, hypofolliculin 
leukorrhoea, infant and senile vaginitis, vulvar itching, vaginal
dystrophy. 
ECOCILLIN is used even as co-adjuvant in antibiotic and
chemotherapeutic treatment of 
Trichomonas vaginitis.   

4.2 POSOLOY AND METHOD OF ADMINISTRATION 

•  Vaginal capsules: 1 vaginal capsule per day. 
Method of administration: deeply insert vaginal capsule in vagina,
staying in a supine 
position, in the evening before to go to bed. 

4.3 CONTRA-INDICATIONS 

Hypersensitivity towards one of the components. 

4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 

ECOCILLIN does not replace antibiotic or chemotherapy, but
it represents an useful adjuvant to 
restore vaginal physiological conditions especially at the end of
the specific treatment. 

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4.5 INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF
INTERACTION 

Unknown. 

4.6 PREGNANCY AND LACTATION 

Lactobacillus planta