Broncho-Vaxom

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LYOPHILIZED BACTERIAL, LYSATES

Available from:

OM PHARMA S.A. R. da Industria, 2, 2610-088 Amadora, Lisboa, Portugal

ATC code:

R07AX

INN (International Name):

LYOPHILIZED BACTERIAL LYSATES 7 mg

Pharmaceutical form:

CAPSULE

Composition:

LYOPHILIZED BACTERIAL LYSATES 7 mg

Prescription type:

POM

Therapeutic area:

OTHER RESPIRATORY SYSTEM PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2006-10-31

Patient Information leaflet

_ _
Page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
BRONCHO-VAXOM
® ADULTS, 7 MG, CAPSULES, HARD
BRONCHO-VAXOM
® CHILDREN, 3.5 MG, CAPSULES, HARD
LYOPHILIZED BACTERIAL LYSATES
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Broncho-Vaxom is and what it is used for
2.
What you need to know before you take Broncho-Vaxom
3.
How to take Broncho-Vaxom
4.
Possible side effects
5.
How to store Broncho-Vaxom
6.
Contents of the pack and other information
1.
WHAT BRONCHO-VAXOM IS AND WHAT IT IS USED FOR
Immunotherapy. Prevention of recurrent infections of the airways and
acute infectious exacerbations
of chronic bronchitis.
Co-medication in the treatment of acute airway infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRONCHO-VAXOM
DO NOT TAKE BRONCHO-VAXOM
-
if you are allergic to the active substance or any of the other
ingredients of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Broncho-Vaxom.
In the event of allergic reactions to Broncho-Vaxom, stop the
treatment immediately and inform
your doctor.
CHILDREN
On the basis of present knowledge, the administration of Broncho-Vaxom
to children aged less than
6 months is not recommended.
OTHER MEDICINES AND BRONCHO-VAXOM
Tell your doctor or pharmacist if you are taking/using, have recently
taken/used or might take/use
any other medicines.
No drug interaction is known up to now.
PREGNANCY, BREAST-FEEDING AND FERTILITY
If you are pregnant or breast-feeding, think you may be pregnant o

Summary of Product characteristics

_ _
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BRONCHO-VAXOM
®
Adults, 7 mg, capsules, hard
BRONCHO-VAXOM
®
Children, 3.5 mg, capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
_1 hard capsule for adults contains: _
_ _
Lyophilized bacterial lysates of Haemophilus influenzae, Streptococcus
(Diplococcus)
pneumoniae,
Klebsiella
pneumoniae
ssp.
pneumoniae
and
ssp.
ozaenae,
Staphylococcus aureus, Streptococcus pyogenes and sanguinis
(viridans), Moraxella
(Branhamella/Neisseria) catarrhalis: 7 mg.
_ _
_ _
_1 hard capsule for children contains: _
_ _
Lyophilized bacterial lysates of Haemophilus influenzae, Streptococcus
(Diplococcus)
pneumoniae,
Klebsiella
pneumoniae
ssp.
pneumoniae
and
ssp.
ozaenae,
Staphylococcus aureus, Streptococcus pyogenes and sanguinis
(viridans), Moraxella
(Branhamella/Neisseria) catarrhalis: 3.5 mg.
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Broncho-Vaxom Adults
Capsule, hard
Opaque capsules with a blue capsule body and a blue cap.
Broncho-Vaxom Children
Capsule, hard
Opaque capsules with a white capsule body and a blue cap.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Immunotherapy.
Prevention of recurrent infections of the airways and acute infectious
exacerbations of
chronic bronchitis.
Co-medication in the treatment of acute airway infections.
_ _
Page 2 of 5
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Oral route.
Adults
_ _
_Pre_v_entive treatment and/or consolidation therapy_: 1 capsule daily
on an empty
stomach during 10 consecutive days per month for 3 months.
_ _
_Treatment of acute episodes: _1 capsule daily on an empty stomach
until disappearance
of the symptoms (but for at least 10 days). In cases in which
antibiotics are needed, the
administration of Broncho-Vaxom Adults should be associated preferably
from the
start of therapy.
Children (aged from 6 months to 12 years)
The capsule can be opened and the content poured into a drink (water,
fruit juice, milk,
etc.).
_Pre_v_entive treatment