. Allergopedia

ΠΡΟΙΟΝΤΑ - ALLER DROP SUBLINGUAL SPECIFIC HYPOSENSITIZING EXTRACT

PRODUCT CHARACTERISTICS


1.      Name of the medicinal product

Specific sublingual immunotherapy containing allergen extracts.

 

2. Composition

Specific allergenic extract:

Starting therapy: four vials containing 6 ml of the following allergen concentrations: 40-200-1000-1000 B.U. /ml

Paediatric starting therapy: five vials containing 6 ml of the following allergen concentrations: 8-40-200-1000-1000 B.U. /ml

Pre-seasonal therapy: five vials containing 6 ml of the following allergen concentrations: 40-200-1000-1000-1000 B.U. /ml

Rapid induction therapy: three vials containing 8 ml of solution at 1000 B.U./ml.

Maintenance therapy: three vials containing 6 ml of solution at 1000 B.U./ml.

Other ingredients in 1 ml: sodium chloride 9 mg, glycerine 0.5 ml, ultrapure water sufficient to reach 1 ml.

 

3. Pharmaceutical form

Oral solution that must be administered in sublingual form.

 

4. Product properties

The administration of allergens by sublingual means with regular intervals induces a persistent reduction of allergic symptomathology. The reduction degree depends on the individual sensibility and on the administered doses.

 

5. Clinical particulars

 

5.1 Therapeutic indications

Treatment therapy for allergic disease caused by inhalant agents.

 

5.2 Contra-indications

Immunotherapy is contraindicated in the acute and serious diseases that affect general conditions, and in all pathologies and therapies that depress the immune system.

Besides, it is contraindicated for patients with continuous lesions of the mouth mucosa, for patients with gastroenteric disturbances, both current and temporary, for patients with an acute allergic reaction and for patients which cannot use adrenaline.

5.3 Undesirable effects

The administration of immunotherapy may be accompanied by gastro-abdominal pain especially if the dosage has not been optimised and exceeds the patient’s maximum tolerance. Although, these effects disappear once the dosage has been readapted. No important general reactions have been advised. However, patients should inform their doctors in the event of any undesirable effect.

5.4 Special warning and special precautions for use

For the hours that follow administration it is important that the patient avoids any sporting activity, physical strain, hot baths and saunas.

5.5 Pregnancy and lactation

Normally, during pregnancy, a hyposensitizing therapy is not initiated. Should the patient become pregnant during an immunotherapy, the contraindication to the vaccine administration would be the difficulty to establish a suitable therapeutic treatment for possible undesired effects. The prescribing doctor shall decide whether or not to proceed with the therapy.

There are no contraindications for the administration of the therapy during breast feeding.

5.6 Interaction with other medicaments and other form of interaction

The patient should avoid contact with causative and cross-reacting allergens. The doctor should consider that a parallel treatment with symptomatic anti-allergic drugs (antihistamines, corticosteroids, membrane stabilizers) may alter the patient’s tolerability threshold or complicate the choice for the optimal dose.

5.7 Posology and method of administration

The doctor managing immunotherapy establishes doses and frequency of the administrations, adjusting dosage to each patient’s degree of sensitization and general conditions.

1. Method of vial preparation

      a- Remove the dropper from the wrapping

      b- Remove the flip-off ring nut and open the vial

      c- Holding the vial with the left hand, put the dropper on the vial with the right hand

      d- Finally push with the forefingers and the middle fingers, until the plastic ring nut is completely well-adjusted.

Attention: to avoid liquid leak, after the dropper application, the vial must be stored vertically.

2. Method of administration

Sublingual administration is to be taken before any food, preferably in the morning. Remove the cap from the dropper and put the vial upside down under the tongue.

By means of a pronounced pressure in the centre of the dropper, place the recommended dose under the tongue, where it is left for at least two minutes, keeping the mouth slightly open and the tongue raised.

To keep a sign of the administered doses we suggest to fill in the tables 1-2-3 “Administered doses” for the doctor.

3.      Indicative administration schedule – unless different prescribed from the doctor

Starting therapy/pre-seasonal therapy: start using the lowest dosage vial (marked No.1), with daily administration increasing from 1 to 5 drops. On the 6th day proceed with vial n°2, with daily administration increasing from 1 to 5 drops. On the 11th day proceed with vial n°3, with the administration of one drop, increasing to the best tolerated dose, but not more than  5/7 drops. If this dose is well tolerated continue with this dose on alternate days, until the vials n° 3 are empty.

Paediatric starting therapy: start using the lowest dosage vial (marked No.0), with daily administration increasing from 1 to 5 drops. On the 6th day proceed with vial n°1, with daily administration increasing from 1 to 5 drops. On the 11th day proceed with vial n°2, with daily administration increasing from 1 to 5 drops. On the 16th day proceed with vial n°3, with the administration of one drop, increasing to the best tolerated dose, but not more than  5/7 drops. If this dose is well tolerated continue with this dose on alternate days, until the vials n° 3 are empty.

Rapid induction therapy: it is performed, only under the direct control of the specialist doctor, with the allergenic extract n°3, with daily administration increasing from 1 to 5/7 drops. If this dose is well tolerated continue with this dose on alternate days, until the vials n° 3 are empty.

Maintenance therapy: use only the allergenic extract n° 3, administering from 5 to 7 drops, on alternate days, at the doctor discretion.

4. If there are two different therapies to be administered, it is better to separate these  by   taking one therapy in the morning and the other in the evening.

5. Treatment period

The treatment period shall be established by the prescribing doctor in accordance to patient’s clinical trend (approximately 3 years).

6. Omission of one or more doses

If the therapy is interrupted for more than a 7 day period, then it is wise to decrease dosage. Should the therapy be suspended for a very long period (3-4 weeks), it is advisable to resume therapy by using the concentration previously reached and interrupted.

5.8 Overdose

The administration of an excessive dose of allergen can cause either immediately or after several hours, a fresh outbreak of the allergic symptoms, as gastrointestinal pain which can easily be controlled with suitable pharmacological therapy.

5.9 Special warnings

None

5.10 Effects on ability to drive and use machines

Although none of these effects have been reported, these cannot be excluded.

 

6 Pharmaceutical particulars

 

6.1 Incompatibilities

Not reported.

 

6.2 Shelf-life

12 months; the expiry date on the pack refers to unopened and undamaged vials that have been stored correctly.

 

6.3 Special precautions for storage

Store  at +2/+8°C upon receipt.

 

6.4 Nature and contents of container

Neutral glass vials, elastomeric cap sealed with aluminium flip-off ring nut.  Dropper with polyethylene cap in single packaging.

Starting therapy: packaging of four vials containing 6 ml of the following allergen concentrations: 40-200-1000-1000 B.U. /ml

Paediatric starting therapy: packaging of five vials containing 6 ml of the following allergen concentrations: 8-40-200-1000-1000 B.U. /ml

Pre-seasonal therapy: packaging of five vials containing 6 ml of the following allergen concentrations: 40-200-1000-1000-1000 B.U. /ml

Rapid induction therapy: packaging of three vials containing 8 ml of solution at 1000 B.U./ml.

Maintenance therapy: packaging of three vials containing 6 ml of solution at 1000 B.U./ml.

 

6.5 Marketing authorization holder

BIAL - ARISTEGUI ITALIA SRL . - Via Tiburtina Km.18.300 – 00012 Guidonia (Roma) – Italy

Telephone: +39 0774 376697 - 376964

Fax: +39 0774 376868

 

6.6 Marketing  authorization

D.M. 13th December 1991 and D. Lgs. 24/04/2006 n°219

 

6.7 Drug table according to ATC – Anatomic Therapeutic Classification

Allergen extracts: V01AA

 

6.8 Delivery system

Product prepared upon medical individual request.