Lantigen B

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

BRANHAMELLA CATARRHALIS, HAEMOPHILUS INFLUENZAE, KLEBSIELLA PNEUMONIAE, STREPTOCOCCUS PYOGENES, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS PNEUMONIAE

Tilgjengelig fra:

Bruschettini S.r.L. Via Isonzo 6 - 16147 Genova, Italy

ATC-kode:

J07AX

INN (International Name):

STREPTOCOCCUS PYOGENES 126.2 AgU/ml BRANHAMELLA CATARRHALIS 39.9 AgU/ml STAPHYLOCOCCUS AUREUS 79.6 AgU/ml HAEMOPHILUS INFLUENZAE B 50.2 AgU/ml KLEBSIELLA PNEUMONIAE 39.8 AgU/ml STREPTOCOCCUS PNEUMONIAE 63.2 AgU/ml

Legemiddelform:

ORAL DROPS, SUSPENSION

Sammensetning:

STREPTOCOCCUS PYOGENES 126.2 AgU/ml BRANHAMELLA CATARRHALIS 39.9 AgU/ml STAPHYLOCOCCUS AUREUS 79.6 AgU/ml HAEMOPHILUS INFLUENZAE B 50.2 AgU/ml KLEBSIELLA PNEUMONIAE 39.8 AgU/ml STREPTOCOCCUS PNEUMONIAE 63.2 AgU/ml

Resept typen:

OTC

Terapeutisk område:

VACCINES

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2005-10-04

Informasjon til brukeren

Lantigen B
ORAL DROPS, SUSPENSION OF BACTERIAL ANTIGENS
COMPOSITION
: 1 ml of suspension contains antigenic extracts of: streptococcus
pneumoniae
type 3 63,2 A.u.; streptococcus pyogenes group A 126,2 A.u.;
Branhamella catarrhalis 39,9
A.u.; staphylococcus aureus 79,6 A.u.; Haemophilus influenzae type b
50,2 A.u.; Klebsiella
pneumoniae 39,8 A.u.
Excipients: polysorbate 80, Clorhexidine diacetate, sodium methyl
parahydroxy benzoate,
purified water.
PHARMACEUTICAL FORM AND CONTENT
: oral drops, 18 ml bottle.
PHARMACOTHERAPEUTIC CATEGORY
: Bacterial lysates
MARKETING AUTHORIZATION HOLDER AND MANUFACTURER
: Bruschettini s.r.l. - Genova (italy)
THERAPEUTIC INDICATIONS
_Adults_
: prophylaxis of recurrent upper respiratory tract infections (RTI).
_Children_
: prophylaxis of recurrent upper respiratory tract infections (RTI) in
children from 3 months
of age.
INFORMATION WHICH MUST BE KNOWN BEFORE THE PRODUCT USE
CONTRAINDICATIONS
: Hypersensitivity to the active substances or any of the excipients.
PRECAUTIONS OF USE
: it is necessary to keep drops in mouth for about 2 minutes,
preferably
sublingually, without swallowing, to allow the suspension to
distribute into the salivary secretions of
the oro-pharyngeal mucosa in order to facilitate absorption.
_Treatment length_
: two bottles (36 ml) in adults and one bottle (18 ml) in children
according to relevant
posology. Treatment should be discontinued for 2-3 weeks.
_Important information on some excipients_
: since Lantigen B contains sodium methyl parahydroxy
benzoate, it can cause allergic reaction (also delayed) and, in rare
cases, bronchospasm.
INTERACTIONS WITH OTHER MEDICAMENTS OR OTHER INTERACTION FORMS.
unknown.
SPECIAL WARNINGS
: Tell your doctor if you or your child ever experienced any unwanted
side effect
following administration of a vaccine, or if you or your child suffer
from any type of allergy.
The use of Lantigen B in the prevention of pneumonia is not
recommended, as no data from clinical
studies are available to demonstrate such effect.
_Pregnancy and l

Preparatomtale

_LANTIGEN B _
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT:
LANTIGEN B oral drops, suspensions, 1 bottle of 18 ml
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
_Each ml contains _
_Active ingredients.Antigenic extract of: _Streptococcus pneumoniae
type 3 63,2 Antigenic Units,
Streptococcus
pyogenes group A 126,2 Antigenic Units, Branhamella catarrhalis 39,9
Antigenic Units, Staphylcoccus
aureus
79,6 Antigenic Units, Haemophylus influenzae type b 50,2 Antigenic
Units, Klebsiella pneumoniae 39,8
Antigenic Units
For a full list of excipients: see section 6.1
3. PHARMACEUTICAL FORM. Oral drops, suspension.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS.
_Adults: _
Prophylaxis of recurrent upper respiratory tract infections (RTI).
_Children _:
Prophylaxis of recurrent upper respiratory tract infections (RTI) in
children from 3 months of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION.
Dose for adults and children over 10 years of age: one dose,
corresponding to the amount delivered by
pressing the dispenser twice (15 drops), is placed under the tongue
twice a day (in the morning and in the
evening).
Children from 3 months to 10 years of age: half a dose, corresponding
to the amount delivered by pressing
the dispenser once (7-8 drops) twice a day or one dose (15 drops)
administered once daily in the morning,
preferably on an empty stomach.
In very young children it is possible to administer Lantigen B when
asleep by placing drops between their
lower lip and lower gum.
SHAKE BEFORE USE. Possible presence (even after shaking) of floating
agglomerates is not prejudicial to the
safety of the product
IMPORTANT: each dose should be held in the month for about 2 minutes
without swallowing in order to
allow the suspension to disperse into the salivary secretion of the
oral-pharyngeal mucosa, thus to facilitate
product absorbance.
TREATMENT LENGTH: two bottles (36 ml) in adults and one bottle (18 ml)
in children according to relevant
posology.
Treatment should be discontinued for 2-3 weeks.
Subsequentl