ALUSTAL HT. 350 mg. 5 ml. 4 flacons

SANDOZ
ALUSTAL HT. 350 mg. 5 ml. 4 flacons
€ 169.00
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Allergen extracts
The drug substance is a combination of allergen extract and mannitol.
Excipients (one vial of 5 ml suspension for injection):
Aluminium hydroxide 4 mg, sodium chloride 45 mg, phenol 20 mg, water for injection 5 ml.

ALUSTAL HT. 350 mg. 5 ml. 4 flacons

 
 
Ingredients:

1 vial contains 5 ml suspension for injection :
0,01-0,1-1 or 10 IR/sh1 ( standardized allergenic extracts ) or
0,01-0,1-1 10 or IC / ml ( non-standardized allergen extracts )


Drugs :
Allergen extracts
The drug substance is a combination of allergen extract and mannitol.
Excipients ( one vial of 5 ml suspension for injection ):
Aluminium hydroxide 4 mg, sodium chloride 45 mg, phenol 20 mg, water for injection 5 ml.

Unit IR ( index of reactivity ):
An allergenic 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 .

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 extract standardized reference value 100 IC / ml corresponds to an extract whose ratio of dilution is determined by the medical practice.

Pharmaceutical form:
suspension for injection

Pharmacotherapeutic group:
Allergens specific hiposenzibilizatsiya .



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, asthma or rinokonyuktivit .
Regular use of Progressively increasing and then constant doses allows to prevent the clinical consequences of the meeting of your body with the allergen .

What you should know before using Alustal ®?

Alustal only be taken as prescribed by your allergist .
Alustal not to be taken in case of :
• Severe immunodeficiency ;
• Malignancies ;
• Unstable asthma ;
• autoimmune diseases;
• Concomitant 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 .

Pregnancy and lactation

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.

Effects on ability to drive and use machines

Driving and operating machinery are compatible with specific immunotherapy .

Interactions :

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.

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 .

How to use 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 : active treatment with a progressive increase in dosage. Doses are administered every week using slurries with different concentrations .
• Second stage : supportive 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.

What side effects to expect?

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

If you notice any side effects not listed in this leaflet, tell your doctor.

Shelf life :
18 months.
Shelf life after opening:
6 months ( storage at +2 ° C of up to +8 ° C ) .

How to store Alustal ®?
Store in a refrigerator at +2 ° C to +8 ° C.
Keep out of reach of children.
Do not swallow .
Do not freeze .
Shake before use.
Do not use after the expiry date stated on the label.

Packaging information:
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 Golden-plover/Pluvialis 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 suspension for injection .

Active treatment : Box of 4 vials with increasing concentrations ;
Maintenance: Box of 1 vial at 10 IR / ml or IC / ml
 
 
€ 169.00
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