ALUSTAL 400mg. 5 ml. 4 flacons

ALUSTAL 400mg. 5 ml. 4 flacons
€ 119.00
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Alustal is a suspension of allergenic extracts for desensitization prepared individually for each patient. This medicinal product is presented in vials containing 5 ml suspension for injection for subcutaneous use. 

ALUSTAL 400mg. 5 ml. 4 flacons 

 
 
What Alustal and what it is used
Alustal is a suspension of allergenic extracts for desensitization prepared individually for each patient. This medicinal product is presented in vials containing 5 ml suspension for injection for subcutaneous use.
Alustal used for specific immunotherapy ( hiposenzibilizatsiya ) for allergies caused by pollen, mites , mold or allergens of animal origin that occur with rhinitis , conjunctivitis, rhinoconjunctivitis or asthma.
Regular use of progressive and then stable doses allows to prevent the clinical consequences of the meeting of your body with the allergen .

2 . What you should know before taking Alustal
Alustal taken only on prescription from your alerogolog .

Warnings and Precautions
Alustal not to be taken in case of :
severe immune deficiency ;
malignancies ;
unstable asthma ;
autoimmune diseases;
concurrent treatment with beta-blockers , including eye drops .
Please tell your doctor if you suffer from any other disease. When the patients' symptoms are too severe or febrile illness , the physician must postpone hiposenzibilizatsiyata .
Your doctor will evaluate the need for concomitant symptomatic treatment during therapy Alustal.
After each injection, you need to remain under medical supervision for 30 minutes; you should avoid loading the rest of the day. Injections are made only by qualified medical personnel , equipped with means to prevent anaphylactic shock .

Children and adolescents
SIT can be applied in children 3-4 years of age , but the initiation of treatment is recommended over 5 years. Initial treatment should be initiated when significant symptoms in a child or young patient requires.

Other medicines and Alustal
Not observed interaction or incompatibility.
Please tell your doctor if you are taking or have recently taken any other medicines , even those not prescribed for you.

Pregnancy and lactation
Ask your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
If you are pregnant or breast-feeding , ask your doctor for advice before taking any medicine.
Patients should notify their physician if pregnant or breastfeeding.
If pregnancy is detected during specific immunotherapy in active phase ( with increasing doses) preferred course of treatment interruption .
When pregnancy coincides with the maintenance phase ( constant dose) of specific immunotherapy with Alustal, treatment can be continued , if not found a deterioration of tolerability.

Driving and using machines
Driving and operating machinery are compatible with specific immunotherapy .

Special warnings and special precautions for use:
The presence of sodium chloride should be considered for patients on low-salt diet ( one 5 ml vial contains 45 mg of sodium chloride ) .
Prescribing specific immunotherapy and the patient during the course it is performed by a physician with Allergy training and experience in this field.
The patients who are subject to the specific immunotherapy must be pre- symptomatic management , if necessary, by the appropriate treatment.
Injections should be discontinued in feverish conditions .
In case of symptomatic asthma attack treatment should be discontinued. In these cases, treatment is resumed after the improvement of the condition of the patient or the advice of an allergist .

3 . How to take Alustal
Dosage and method of administration
Specific immunotherapy should be administered as soon as possible after diagnosis . It is much more effective when started early . In children, the specific immunotherapy can be administered from 3-4 years of age , but it is preferable to start treatment at the age of about 5 .

dosage
The dosage is adjusted to the reactivity of the individual and is consistent with the patient's clinical condition .

Treatment takes place in two phases, as determined by your doctor regimen :
First stage: the active treatment with a progressive increase of the doses . Doses are administered every week using slurries with different concentrations ;
second stage: maintenance treatment applied regularly ( every 15 days every month or more, but the interval between the two injections should not be more than 6 weeks) of the maximum tolerated dose.
Duration of treatment :
Generally specific immunotherapy should be continued for from 3 to 5 years . In cases of seasonal allergies, may be applied only in certain seasons for 3 to 5 years.

4 . Possible side effects
Like all medicines, Alustal can cause side effects, although not everybody gets them .

Common adverse local reactions : rash , swelling and itching.
Less commonly observed side effects:
generalized effects: asthma attack , difficulty breathing,
anaphylactic shock ;
late effects: arthralgia (joint pain ), fatigue and fever.
These reactions require immediate treatment in a specialized environment .

If any of the side effects gets serious , or you notice other effects not listed in this leaflet , please tell your doctor or pharmacist.

5 . How to store Alustal
Shelf life : 18 months .
Shelf life after opening: 6 months ( storage of +2 ° C to +8 ° C).
Keep out of reach of children.
Store in a refrigerator at +2 ° C to +8 ° C.
Do not swallow . Do not freeze .
Shake before use.
Do not use after the expiry date stated on the label .
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These will help to protect the environment.

6 . Contents of the pack and other information
What does Alustal
1 vial contains 5 ml suspension for injection :
0.01 - 0.1-1 or 10 IR / ml ( standardized allergenic extracts ) or
0.01 - 0.1-1 or 10 IC / ml ( non-standardized allergen extracts )
of a group of medicines presented on the table / Annex ? 1 / .

Active Ingredients: Allergen extract / Annex ? 1 / .
The drug substance is a combination of allergen extract and mannitol.
Other ingredients ( in a vial of 5 ml of suspension for injection ): aluminum hydroxide 4 mg, sodium chloride 45 mg, phenol 20 mg, water for injection 5 ml.

Unit IR ( Index of Reactivity ): An allergen extract an index of reactivity 100 IR / ml, when administered through a skin prick test ( prick test ) Standard Spatula Stallerpoint at 30 persons sensitive to the allergen causes wheal size average of 7 mm diameter . Skin reactions to these individuals demonstrate a 9% solution of codeine phosphate which was used as a positive control .

The unit IC ( concentration index ): An allergenic extract having an index of a concentration of 100 IC / ml, where its production parameters indicate the same average ratio of dilution as a standard 100 extracts IR / ml of the same family of allergens , which serve as a reference. When atopy contains standardized extract reference value 100 IC / ml corresponds to an extract whose dilution ratio is determined by the medical practice.

Alustal looks like and contents of pack
Primary packaging :
Each vial contains 5 ml of an injectable suspension.
The suspension is packaged in a vial 11 ml of white glass type I, closed with a penicillin-type stopper and sealed with an aluminum cap with a different color depending on the concentration :
Colorless aluminum cap : 0,01 IR / ml or 0,01 IC / ml;
Gold cap : 0,1 IR / ml or 0,1 IC / ml;
Green cap : 1 IR / ml or 1 IC / ml;
Blue cap : 10 IR / ml or 10 IC / ml.
Outer packing: PP box.

CONTENTS :
Each vial contains 5 ml of an injectable suspension.

Active treatment : Box of 4 vials with increasing concentrations ;
Maintenance: Box of 1 vial at 10 IR / ml or IC / ml.

Marketing Authorisation Holder and Manufacturer
Stallergenes S.A., France.
 
 
€ 119.00
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