ALUSTAL HT 690 5 ml. 4 vials

S.A.
ALUSTAL HT 690 5 ml. 4 vials
€ 149.00
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What is Alustal and what it is used
Alustal represents 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, mildew and allergens of animal origin that occur rhinitis, conjunctivitis, rhinoconjunctivitis or asthma.
Regular use of progressive and then constant doses allows to prevent the clinical consequences of meeting your body with the allergen.

2. What you need to know before you take Alustal
Alustal be taken only on prescription from your alerogolog.

Warnings and Precautions
Alustal should not be taken in the event of:
severe immune deficiency;
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 assess the need for concomitant symptomatic treatment during therapy Alustal.
After each injection you should remain under medical supervision for 30 minutes; you should avoid loading the rest of the day. Injections are given only by qualified medical personnel, equipped with a 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 started when the significant symptoms in a child or young patient require.

Other medicines and Alustal
Not observed interactions 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 inform the doctor in case of pregnancy or lactation.
When pregnancy during specific immunotherapy in active phase (with increasing doses) is preferred course of treatment interruption.
When pregnancy coincides with the maintenance phase (continuous dose) of specific immunotherapy with Alustal, treatment can be continued, if not establish deterioration tolerance.

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

Special warnings and special precautions for use:
The presence of sodium chloride should be considered for those of low sodium diet (one 5 ml vial contains 45 mg of sodium chloride).
Prescribing specific immunotherapy and monitoring of the patient during the implementation has been done by a physician Allergy training and experience in this area.
Patients subject to specific immunotherapy must be pre-symptomatic management, if necessary, with appropriate treatment.
Injections should be discontinued in feverish conditions.
In the case of symptomatic asthma attack, treatment should be discontinued. In these cases, treatment is resumed after the improvement of the patient's condition or the advice of an allergist.

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

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

Treatment is carried out in two stages, as determined by your doctor regimen:
first stage: active treatment with progressive increases in the dose. 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 two injections should not be more than 6 weeks) at the maximum tolerated dose.
Duration of treatment:
In general, specific immunotherapy should be continued for 3 to 5 years. In cases of seasonal allergies, may be used only during certain times 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 adverse reactions:
generalized reactions, asthma attacks, difficulty breathing,
anaphylactic shock;
Delayed reactions: arthralgia (joint pain), fatigue and fever.
These reactions require immediate treatment in a specialized environment.

If any of the side effects gets serious, or if 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 (when stored between + 2 ° C to + 8 ° C).
Keep out of the reach and sight of children.
Store in the refrigerator between + 2 ° C to + 8 ° C.
Do not swallow. Do not freeze.
Shake well 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 Alustal
1 vial containing 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 allergenic extracts)
of a group of medicines presented in the attached table / Appendix № 1 /.

Active substances: Allergen extract / Appendix № 1 /.
The drug substance is a combination of allergen extract and mannitol.
Other ingredients (in a vial of 5 ml 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 has an index of reactivity 100 IR / ml, when administered through skin PRICK test (prick test) standard Spatula Stallerpoint at 30 sensitive individuals allergen causes wheal size average of 7 mm in diameter . Skin reactions to these individuals demonstrate a 9% solution of codeine phosphate which is used as a positive control.

The unit IC (concentration index): An allergen extract has a concentration index 100 IC / ml, where its production parameters show 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 the family does not contain allergens standardized reference extract, the value 100 IC / ml corresponds to an extract whose ratio of dilution is determined by the medical practice.

Alustal looks like and contents of the pack
Primary packaging:
Each vial contains 5 ml suspension for injection.
The suspension was 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:
Colourless 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.
Secondary packaging: Polypropylene box.

CONTENTS:
Each vial contains 5 ml suspension for injection.
Active treatment: Box of 4 vials with increasing concentrations.
Maintenance treatment: Box of 1 vial at 10 IR / ml or IC / ml.
€ 149.00
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