Jak stosować ISMIJEN
Treść ulotki
ISMIGEN 50 mg sublingual tablets
Lyophilized bacterial lysate
Read this leaflet carefully before taking this medicine as it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist
- This medicine has been prescribed for you only. Do not pass it on to others, evenif their symptoms are the same as yours, as it could be harmful.
- If any side effects occur, including those not listed in thisleaflet, tell your doctor or pharmacist
Contents of this leaflet:
- 1. What Ismigen is and what it is used for
- 2. What you need to know before you take Ismigen
- 3. How to take Ismigen
- 4. Possible side effects
- 5. How to store Ismigen
- 6. Contents of the pack and other information
1. WHAT ISMIGEN IS AND WHAT IT IS USED FOR
Pharmacotherapeutic category: Bacterial vaccines
ISMIGEN contains as its active ingredient a mixture of lyophilized bacterial lysates (bacterial antigens), belonging to the group of bacterial vaccines, which locally stimulate the activity of the body's defense system (immune system).
IN ADULTS
Prophylaxis of recurrent respiratory tract infections in adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ISMIGEN
Do not take Ismigen
If you are allergic to the active ingredient or any of the excipients of this medicine
(Listed in section 6)
In case of autoimmune diseases
In case of acute intestinal infections
Warnings and precautions
Talk to your doctor or pharmacist before taking ISMIGEN
Stop treatment and consult your doctor, who will assess whether to discontinue ISMIGEN therapy permanently, if you experience the following conditions:
allergic reactions (hypersensitivity reactions);
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asthma attacks in predisposed patients;
fever, especially if it occurs at the beginning of treatment;
The type of high fever above 39°C that may occur as a rare, isolated and of unknown cause adverse event, must be differentiated from the fever that occurs following the original pathology, based on the conditions of the larynx, nose or ears.
The medicine should only be administered if absolutely necessary under the direct
control of the doctor.
The use of ISMIGEN for the prevention of pneumonia is not recommended because there are
no data from clinical studies demonstrating this effect.
Other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including over-the-counter medicines.
Avoid taking ISMIGEN together with other medicines that stimulate the activity of the immune system (immunostimulants)
ISMIGEN may be less effective if you suffer from disorders of the immune system (with congenital or acquired immunodeficiency), if you are undergoing therapy with medicines that
reduce the activity of the immune system (immunosuppressive therapy) or if you are taking
medicines used for the treatment of allergies and inflammation (corticosteroids).
Interaction studies with other drugs or vaccines have not been conducted.
Pregnancy and breastfeeding
Do not take ISMIGEN if you are pregnant,
do not take ISMIGEN if you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and operating machinery
To date, no effects on the ability to drive or operate machines have been reported.
However, no specific studies have been conducted.
Ismigen containsSilicon dioxide, Microcrystalline cellulose, Dicalcium phosphate, Magnesium stearate, Ammonium glycyrrhizinate, Powdered mint essence.
3. HOW TO TAKE ISMIGEN
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Route of administration: sublingual (to be allowed to dissolve under the tongue)
The recommended dose is one 50mg tablet per day, to be allowed to dissolve under the
tongue, for 10 consecutive days per month, for the duration of three consecutive months.
If you take more Ismigen than you should
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To date, no cases of overdose have been reported.
If you have taken more ISMIGEN than you should, immediately inform your doctor or go to the
nearest hospital.
If you forget to take Ismigen
Do not take a double dose to make up for a missed dose and continue
normally until the end of the treatment.
If you stop taking Ismigen
If you have any doubts about the use of this medicine, consult your doctor or pharmacist
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare cases of the following side effects have been reported:
- Respiratory, thoracic and mediastinal disorders: oropharyngeal pain
- Skin and subcutaneous tissue disorders: allergic reactions such as urticaria, rash, itching and edema
- Systemic disorders and conditions related to the site of administration: fever and headache
- Gastrointestinal disorders: stomach pain and vomiting
- Infections and infestations: rhinitis
If any disturbance occurs, treatment should be discontinued.
If you notice a worsening of symptoms or if any side effect not listed in this leaflet occurs, contact your doctor or pharmacist.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
contact your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE ISMIGEN
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The
expiry date refers to the last day of that month.
Do not store at a temperature above 25°C. Store in the original packaging.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
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What Ismigen contains:
- The active ingredient is Lyophilized bacterial lysate:
Staphylococcus aureus6 billion, Streptococcus pyogenes6 billion, Streptococcus oralis6
billion, Klebsiella pneumoniae6 billion, Klebsiella ozaenae6 billion, Haemophilus
influenzae6 billion, Neisseria catarrhalis6 billion, Streptococcus pneumoniae6 billion
(of which type 1, 1 billion - type 2, 1 billion - type 3, 1 billion - type 5, 1 billion - type 8, 1
billion type 47, 1 billion)
and glycocolla as a lyophilization support.
- The other ingredients are Silicon dioxide, Microcrystalline cellulose, Dibasic calcium phosphate, Magnesium stearate, Ammonium glycyrrhizinate, Powdered mint essence.
Description of the appearance of Ismigen and package contents
Ismigen sublingual tablets are whitish, have brownish dots and
are packaged in aluminum/PVC blisters of 10 tablets. The notch on the
tablet is to facilitate breaking it if necessary and not to divide it into
equal doses.
3 blisters inserted in a lithographed cardboard box.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
LALLEMAND PHARMA EUROPE
Toftebakken 9B
3460 Birkerød
DENMARK
Manufacturer:
Bruschettini S.r.l
Via Isonzo, 6
16147 Genova
Italy
Sales Representative:
Zambon Italia S.r.l.
Via Lillo del Duca 10
20091 Bresso (MI)
Italy
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- Kraj rejestracji
- Postać farmaceutycznaTablet, 50 MG
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki ISMIJENPostać farmaceutyczna: Powder and solvent for injectable solution, 0,5 MLSubstancja czynna: haemophilus influenzae B, combinations with toxoidsProducent: SANOFI WINTHROP INDUSTRIEWymaga receptyPostać farmaceutyczna: Injectable suspension in pre-filled syringe, 0.5MLSubstancja czynna: meningococcus B, multicomponent vaccineProducent: GLAXOSMITHKLINE VACCINES S.R.L.Bez receptyPostać farmaceutyczna: Injectable suspension, 0.5 MLSubstancja czynna: pertussis, purified antigen, combinations with toxoidsProducent: GLAXOSMITHKLINE S.P.A.Bez recepty
Odpowiedniki ISMIJEN w innych krajach
Leki z tą samą substancją czynną dostępne w innych krajach.
Odpowiednik ISMIJEN w Polska
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ISMIJEN wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
ISMIJEN jest produkowany przez LALLEMAND PHARMA EUROPE. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie ISMIJEN jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić ISMIJEN w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną () to m.in. AKTIB, BEXSERO, BOOSTRIX. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
















