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Broncho-Vaxom ® Infant Sachets

Broncho-Vaxom is an immunostimulant for prevention and prophylaxis of upper and lower respiratory tract infections available as sachets.

Ingredient: Lyophilized Bacterial Lysates
Multinational Partner: OM Pharma
Launch Date: January 1, 2008
Pack: Box of 1 strip each of 10 sachets

Product General

Disease Area

Otitis Media:

•Otitis media is inflammation of the middle ear, or a middle ear infection.

•It occurs in the area between the tympanic membrane and the inner ear, including a duct known as the eustachian tube. It is one of the two most common causes of an earache - the other being otitis externa. Diseases other than ear infections can also cause ear pain, including cancers of any structure that shares nerve supply with the ear and shingles which can lead to herpes zoster oticus. Though painful, otitis media is not threatening and usually heals on its own within 2–6 weeks.

-Classical complications of rhinopharyngitis

-pneumococcus (30-40%)

-Haemophilus Influenzae (20-30%)

-Moraxella catarrhalis (12-20%)

•Clinical signs

-fever - earache

-diarrhea - vomiting (infant)

-Irritability, reduction in hearing

-congestive to suppurated otitis media with bulging & yellowish tympanic membrane

Pharyngitis:

-Pharyngitis is caused by swelling (inflammation) of the pharynx, which is in the back of the throat, between the tonsils and the voicebox (larynx).

-Germs (initial)

-Virus (40 – 50%, adeno / rhinovirus)

-Bacteria that can cause pharyngitis (till 50%)

-Streptococcus A (30%)

-Haemophilus influenzae

-Moraxella catarrhalis

-Staphylococcus aureus

-Clinical signs

-fever (39° - 40°) - dysphagia

-submaxillary lymph glands (firm & sore)

-tonsil inflammation with whitish exsudates

-erythematous - pultaceous tonsillitis (Soft & Moist)

Rhinopharyngitis:

-Common cold : acute viral nasopharyngitis (rhinovirus)

-Most frequent infection in children from 6th month to 8 y old

-Benign evolution (10 days) but risk of recurrence

-Between 1 & 3 years of age à till 12 colds a year

-> 3 years à 4-8 colds – Adults à 3-5 colds

-Clinical signs

-fever

-nasal obstruction with purulent rhinorrhea

-diarrhea - vomiting

-cervical bilateral lymph glands (firm and sore)

-Red throat

Sinusitis:

1.Acute ethmoïdal sinusitis (infant from 6th month)

-clinical signs

-fever (39° - 40°)

-purulent nose blowing

-unilateral palpebral edema

-bacteriology

-before 5 years of age haemophilus influenzae

-after 5 years of age pneumococcus - streptococcus (A)

2.Acute maxillary sinusitis

-clinical signs

-fever (39° - 40°)

-purulent rhinorrhea

-Facial pain exacerbated at pressure or spontaneous pain

-X-Rays ð diagnosis

-bacteriology

-pneumococcus (30-40%)

-haemophilus (20-30%)

-moraxella catarrhalis (12-20%)

-streptococcus (A) (up to 3%)

Insert leaflet

Qualitative and quantitative composition

1 capsule for adults contains: Lyophilized bacterial lysates of Haemophilus influenzae, Diplococcus pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Neisseria catarrhalis: 7 mg.

1 capsule for children contains: Lyophilized bacterial lysates of Haemophilus influenzae, Diplococcus pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Neisseria catarrhalis: 3,5 mg.

Therapeutic indications

Prevention of recurrent infections of the airways and acute infectious exacerbations of chronic bronchitis. Comedication in the treatment of acute airway infections.

Posology and method of administration

Oral route.

Adults

Preventive 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 should be associated preferably from the start of therapy.

Children

The capsule can be opened and the content poured into a drink (water, fruit juice, milk, etc.). Preventive 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 should be associated preferably from the start of therapy.

Publications

1-Documents Section


BV in ARTIs in Children, Ahrens 1984


BV in recurrent acute tonsillitis, Bitar 2013


BV in Children, Collet 1993


RRTIs in Children, Gsell 1980


BV in Children, Gutierrez 2001


BV in Children, Jara Perez 2000


BV in Children, Maestroni 1984


BV in URTIs in Children, Martin du Pan, 1982


BV in children, Paupe 1990


BV in Children, Paupe 1991


Bv in Children, Schaad 2002


BV in sinusitis in Children, Zagar 1988


Cost effective Children, Zaniolo 2005


BV in Preschool wheezy children, Razi 2010


BV meta analysis, Schaad 2010

Guidelines
GLOBAL INITIATIVE FOR CHRONIC OBSTRUCTIVE LUNG DISEASE

Attached Files

GOLD Updated 2013.pdf
GOLD 2011.pdf
GOLD 2009.pdf
GOLD 2008.pdf
Q & A
Does Broncho-Vaxom® interact with corticosteroids or antihistamines?

No

Immunodepressed patients: Can Broncho-Vaxom® be given to AIDS patients?

No

Auto-immune disease: Can Broncho-Vaxom® be given to such patients

No And hepatitis is a contraindication

Time of dose: When should Broncho-Vaxom® be taken?

Ideally, in the morning on an empty stomach

Anti-viral action: Does Broncho-Vaxom® have an anti-viral action?

Indirectly, because it stimulates cell-mediated immunity

Mechanism: How can oral Broncho-Vaxom® have an effect on the general immune response?

Because its absorption through the Peyer’s patches activates the mucosal and then the general immune response

Vaccination interaction: Can Broncho-Vaxom® be given during vaccination?

No. Although there is no interaction, there should be an interval of 1 week between them

Non-specific or specific: Which action does Broncho-Vaxom® have?

Because it stimulates macrophage activity = non-specific. It may also have some specific effect against the micro-organisms in its composition

Period of effective protection: After taking Broncho-Vaxom® over a 3-month period, how long can protection be expected to last?

Generally speaking, a 3-month course offer 6 months protection. For this reason, many doctors prescribe two courses of Broncho-Vaxom® per annum for their severe bronchitic patients, thus providing the needed protection for a 12-month period

Children: In view of the fact that the child’s immune system requires time to mature, from what age should Broncho-Vaxom® be given?

The newborn benefits from inherited maternal antibody protection. This has weakened by the age of about 6 months but by now the child’s own immune defences are maturing. So Broncho-Vaxom® can be given from 6 months of age

Cost: If a patient is already (and necessarily) taking antibiotics for a serious acute infection, isn’t a prescription for Broncho-Vaxom® simply adding to the costs of treatment?

These have solved the immediate problem but have not prevented infection recurrence. Broncho-Vaxom® will reduce the recurrence rate and so, over time, that patient will have fewer infections thus eliminating the need for antibiotics and hence reducing the costs of treatment.

There is no syrup form

The formulation is unstable in liquid form. None of the competitors have this formulation either

The dose seems to be complicated.

30 days (10+10+10) administration over a 3-month period provides 6 months coverage

At what time of the day is it best to take the Broncho-Vaxom capsules/sachets ?

The capsule/sachets should be taken in the morning on an empty stomach; it is the best moment for an optimal effect of the product.

My baby is 13 months old. I breastfeed her in the morning at 7 a.m. but she is very sleepy then and I don't think I could give her the capsule first thing in the morning. She "officially" wakes up around 9.30 and eats between 10 and 10.30, a meal that consists mostly in fruits & cereals/biscuits. Is it ok to give her the capsule before this meal, or should I try to give it in the morning before breastfeeding?

Effectively, Broncho-Vaxom is recommended to be intaken before breakfeast. But in the case you describe, Broncho-Vaxom can be given to your baby before the fruits/cereals at 10h/10h30 with preservation of the properties of the product.

My daughter is 7 years old. Is it a problem if she has breakfast after taking BV? Is there any strict rules regarding having breakfast after taking BV? The instruction says there must be a one hour interval between taking BV and breakfast but I would prefer having breakfast before she goes to school. Is 15-20 minutes interval enough?

No, there is no problem that your daughter takes the Broncho-Vaxom capsule/sachets with a 15-20 minutes interval. The instruction of taking the medication on an empty stomach is a general one to avoid interference with a fatty diet which is generally not the case of a breakfast for children. Moreover it is recommended for children who have difficulties in swallowing the whole capsule/sachets to open it and mix its content with some food at breakfast, and this has not been shown to have a negative impact on Broncho-Vaxom's efficacy

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