Phostal

PATIENT INFORMATION LEAFLET: USER INFORMATION

PHOSTALPlant-based allergen extracts
PHOSTALAnimal-based allergen extracts
PHOSTALHouse dust mite allergen extracts
PHOSTALFungal allergen extracts (mold fungi, dermatophytes, yeast)
PHOSTALMixtures of allergen extracts (plant-based, animal-based, mite, fungal)
0.01 IR or IC/ml; 0.1 IR or IC/ml; 1 IR or IC/ml; 10 IR or IC/ml
Suspension for injection

You should carefully read the contents of this leaflet before using the medicine because it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist or nurse. See section 4.

Table of contents of the leaflet

• 1. What PHOSTAL is and what it is used for
• 2. Important information before using PHOSTAL
• 3. How to use PHOSTAL
• 4. Possible side effects
• 5. How to store PHOSTAL
• 6. Package contents and other information

1. What PHOSTAL is and what it is used for

PHOSTAL is an injection suspension containing allergen extracts.
PHOSTAL is a medicine that is intended to increase immunological tolerance in patients allergic to plant-based allergens (plant pollen), animal-based allergens, house dust mites, or fungi, and thus reduce allergic symptoms. A complete list of allergens is attached as Annex 1 to this leaflet.

Indications for use

PHOSTAL is used to treat seasonal or year-round allergies characterized by rhinitis (sneezing, runny nose, itchy nose, stuffy nose), conjunctivitis (itchy and watery eyes), nasal and conjunctival inflammation, or asthma (mild to moderate), in adults and children.

2. Important information before using PHOSTAL

When not to use PHOSTAL

• if the patient has been found to be hypersensitive (allergic) to any of the other ingredients of this medicine (listed in section 6.)
• if the patient has been found to have immune deficiencies or an active autoimmune disease
• if the patient has been found to have cancer
• if the patient has been found to have uncontrolled or severe asthma

Warnings and precautions

Before starting treatment, the patient's allergic symptoms should be stabilized using appropriate symptomatic treatment, if necessary.
Before starting desensitization treatment with PHOSTAL, the possibility of systemic allergic reactions that can be life-threatening and require the use of epinephrine should be considered (see "PHOSTAL and other medicines").

• the doctor should be informed immediately if the patient experiences systemic symptoms such as intense itching of the palms and soles, rash, swelling of the mouth or throat causing difficulty swallowing and breathing, or voice changes, nausea, and vomiting (see section 4 "Possible side effects"),
• if the patient experiences fever or an asthma attack confirmed clinically and/or by measuring peak expiratory flow, the doctor will consider further use of PHOSTAL,
• the doctor should be informed if the patient is taking beta-adrenergic blockers (i.e., a group of medicines often used to treat heart conditions and high blood pressure, but also present in some eye drops and ointments), as this medicine may reduce the effectiveness of adrenaline used to treat severe systemic reactions.

In order to avoid serious side effects, it is not recommended to engage in physical activity or intense sports on the day of injection.
PHOSTAL and other medicines.
The doctor should be told about all medicines taken recently, including those that are available without a prescription.
Before starting treatment, the doctor should be told:

• if the patient is taking antidepressant medicines: tricyclic or monoamine oxidase inhibitors (MAO inhibitors), as the risk of side effects increases in the event of a severe allergic reaction and the need for adrenaline,
• if the patient plans to be vaccinated. Prophylactic vaccination may be performed during maintenance treatment. It is recommended that the interval between two injections be at least 1 week, except in life-threatening situations.

Pregnancy and breastfeeding

Before using any medicine, a doctor should be consulted.
If the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before using this medicine.
If the patient is breastfeeding, she should consult a doctor before using this medicine, as there is no experience with the use of PHOSTAL during pregnancy or breastfeeding.
The decision to continue treatment during pregnancy and breastfeeding is made by the doctor.
In no case should allergen immunotherapy be started during pregnancy.

Driving and operating machinery

PHOSTAL has no effect on driving and operating machinery.
The medicinePHOSTAL contains sodium chloride
In the case of patients on a low-sodium diet, the presence of sodium chloride in the medicine should be taken into account, as one vial of PHOSTAL, i.e., 5 ml of suspension, contains 45 mg of sodium chloride.

3. How to use PHOSTAL

PHOSTAL is administered subcutaneously by a doctor or nurse.
Instructions for using PHOSTAL are found in the "Information intended exclusively for medical personnel" section at the end of the leaflet.
The patient should follow the doctor's recommendations.

Dosage

The dose is determined by the doctor. Treatment is divided into two stages:

• basic treatment - with gradual dose increase until a well-tolerated dose is achieved;
• maintenance treatment - using a constant dose injected regularly at intervals determined by the attending doctor.

Duration of treatment

Usually, desensitization treatment is used for 3 to 5 years.

Use in children

Allergen immunotherapy is not indicated for use in children under 5 years of age.

Missing a dose of PHOSTAL

The patient should go to the doctor as soon as possible to receive the missed dose and determine the further treatment schedule.

Stopping PHOSTAL treatment

PHOSTAL treatment should not be stopped unless the doctor recommends it.
In case of any further doubts related to the use of this medicine, the patient should consult a doctor.

4. Possible side effects

Like all medicines, PHOSTAL can cause side effects, although not everybody gets them.
During treatment, patients are exposed to allergens that can cause reactions at the injection site and/or systemic reactions.
Such reactions can occur at the beginning of therapy or later, during treatment.

In case of occurrence or observation of the following symptoms, the doctor should be contacted immediately:

severe itching or rash, difficulty breathing, abdominal pain or symptoms related to low blood pressure, such as dizziness and malaise.
During treatment, the patient's tolerance to the medicine may change depending on their health condition and environment.
The doctor may recommend that the patient receive preliminary treatment with antihistamines to reduce the frequency and severity of unwanted reactions.
Possible side effects include:

• Very common (occurring in more than 1 in 10 patients)
• Nasal rhinitis (stuffy nose, runny nose, sneezing, itchy nose)

Common (occurring in less than 1 in 10 patients)

• Severe allergic reactions
• Headache
• Conjunctivitis (redness and irritation of the eyes)
• Asthma
• Cough
• Difficulty breathing and/or shortness of breath
• Rash
• Itching
• Eczema
• Redness of the skin
• Reactions at the injection site (swelling, itching, redness)

Uncommon (occurring in less than 1 in 100 patients)

• Dizziness
• Abnormal skin sensations (burning, tingling, numbness)
• Eye disorders (irritation, swelling, itching, and redness)
• Ear pain
• Irregular heartbeat (palpitations)
• Low blood pressure
• Hot flashes
• Throat pain (irritation, pain, redness)
• Sinusitis
• Bronchitis
• Tongue swelling
• Difficulty swallowing
• Abdominal pain
• Nausea
• Diarrhea
• Facial swelling
• Disorders at the injection site (pain, nodule)
• Swelling of the limbs
• Weakness
• Feeling of pressure in the chest

Most reactions at the injection site do not require a change in the treatment schedule.
Additionally, after the marketing of the medicine, the following side effects have been reported spontaneously without frequency: sudden swelling of the skin and mucous membranes (Quincke's edema), throat swelling, wheezing, vomiting, malaise, nodules at the injection site (injection site granuloma), redness of the whole body (generalized erythema), joint pain, muscle pain, allergic reaction with fever, lymph node swelling, joint pain, skin redness, and gastrointestinal disorders (serum sickness), lymph node enlargement, fever, and severe allergic reaction (anaphylactic shock).

Reporting side effects

If any side effects occur, including any not listed in the leaflet, the doctor or pharmacist should be told. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected]. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store PHOSTAL

Store in a refrigerator (2°C - 8°C).
Do not freeze!
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the carton.
The expiry date refers to the last day of the given month.

6. Package contents and other information

What PHOSTAL contains

The active substanceis allergen extracts or their mixtures in combination with mannitol. The amount of mannitol does not exceed 40 mg/ml.
1 vial (5 ml) of suspension contains allergen extracts (according to Annex 1) at a concentration of:
0.01; 0.1; 1; 10 IR*/ml (standardized allergen extract)
or
0.01; 0.1; 1; 10 IC**/ml (non-standardized allergen extract)
The qualitative composition of the active substance can be individually selected for the patient within the range of allergens listed in Annex 1.
(*/**) The activity of the respective allergen expressed in IR/ml or IC/ml is given on the label.
Other ingredients are: calcium phosphate, sodium chloride, phenol, glycerol, water for injections.

What PHOSTAL looks like and what the package contains

PHOSTAL is a suspension with a white or slightly yellow-brown color, depending on the type of allergen and its concentration.
The basic treatment kit contains:
4 vials of 5 ml (concentration from 0.01 IR/ml to 10 IR/ml or from 0.01 IC/ml to 10 IC/ml)
gray cap
concentration: 0.01 IR/ml or 0.01 IC/ml
yellow cap
concentration: 0.1 IR/ml or 0.1 IC/ml
green cap
concentration: 1 IR/ml or 1 IC/ml
blue cap
concentration: 10 IR/ml or 10 IC/ml
The maintenance treatment kit contains:
1 vial of 5 ml (concentration 10 IR/ml or 10 IC/ml) - blue cap.

Marketing authorization holder

STALLERGENES
6 rue Alexis de Tocqueville
92160 Antony, France

Manufacturer

STALLERGENES S.A.
6 rue Alexis de Tocqueville
92183 Antony Cedex, France
To obtain more detailed information, you should contact the representative of the marketing authorization holder:
STALLERGENES Sp. z o.o.
tel. 22 620 29 98

Date of last update of the leaflet:

INFORMATION INTENDED EXCLUSIVELY FOR MEDICAL PERSONNEL

Dosage and administration

Before each administration of this medicine, the following should be done:

• carefully check the information on the vial (patient's name, composition, concentration, expiration date);
• shake the vial before withdrawing the suspension;
• follow the rules of asepsis during the injection;
• use single-use tuberculin syringes with a capacity of 1 ml, scaled in 1/100;
• measure the dose very accurately.

The patient should remain under close medical supervision for 30 minutes after the injection.
On the day of injection, the patient should avoid physical exertion.
Dosage, duration of treatment, and treatment schedule

• 1. Duration of treatmentUsually, desensitization treatment is used for 3 to 5 years. If there is no significant improvement in symptoms after 1 year (year-round allergy) or after the first pollen season (seasonal allergy), the treatment schedule should be re-evaluated.
• 2. Basic treatment with dose increaseThis medicine is injected subcutaneously once a week. The dose should be gradually increased until the maintenance dose (maximum tolerated dose) is achieved, according to the following scheme:

The above dosage scheme should be considered as a guideline and example of treatment. The treatment may be modified by the doctor depending on the patient's condition and their reaction to the treatment.

• 3. Maintenance treatment - constant doseThe maximum tolerated dose should be repeated every 15 days, then at monthly intervals or less frequently. The interval between injections should not exceed 6 weeks. If the interval between injections is longer than 6 weeks, the dose should be reduced.

It is recommended to reduce the dose by half when starting a new vial and possibly during the pollen season.
Stopping treatment
In case of stopping treatment or extending the interval between two injections (not related to an adverse reaction), according to clinical experience after the marketing of this medicine, the following scheme should be followed:

Break in treatment from

Treatment stage Last injection dose

2 weeks
continue basic treatment with the last used dose
2 weeks to 1 month
resume treatment from 0.1 ml of the vial with the same concentration and continue basic treatment

Basic treatment

longer than 1 month
resume basic treatment using 10 times lower concentration (if possible*), and then continue basic treatment
less than 6 weeks
continue treatment with the last dose (at the same concentration

Maintenance treatment

restart basic treatment from 0.1 ml of the 1 IR/ml (or 1 IC/ml) vial until the maximum tolerated dose is achieved. Then, continue maintenance treatment.
6 weeks to 6 months
* For patients treated with the suspension with the lowest concentration, basic treatment should be restarted with the suspension of the same concentration.

PHOSTAL ANNEX 1

I. Plant-based allergen extracts

Weeds

641 Alfalfa (Medicago sativa)
IC/ml
664 Dandelion (Taraxacum vulgare)
IC/ml
623 Fat hen (Chenopodium album)
IC/ml
673 Goldenrod (Solidago canadensis)
IC/ml
636 Hop (Humulus lupulus)
IC/ml
605 Mugwort (Artemisia vulgaris)
IR/ml
646 Black mustard (Brassica nigra)
IC/ml
654 Nettle (Urtica dioica)
IC/ml
643 Ox-eye daisy (Chrysanthemum leucanthemum)
IC/ml
665 Plantain (Plantago)
IC/ml
604 Ragweed (Ambrosia elatior)
IR/ml
625 Oilseed rape (Brassica oleifera)
IC/ml
710 Russian thistle (Salsola kali)
IC/ml
655 Sorrel (Rumex acetosa)
IC/ml
678 Sunflower (Helianthus annus)
IC/ml
657 Parietaria (Parietaria officinalis)
IR/ml

Grasses

601 Red fescue (Agrostis vulgaris)
IC/ml
705 Bermuda grass (Cynodon dactylon)
IR/ml
627 Orchard grass (Dactylis glomerata)
IR/ml
624 Quackgrass (Agropyron repens)
IC/ml
630 Meadow fescue (Festuca elatior)
IC/ml
658 Meadow grass (Poa pratensis)
IR/ml
638 Perennial ryegrass (Lolium perenne)
IR/ml
631 Sweet vernal grass (Anthoxantum odoratum)
IR/ml
661 Timothy grass (Phleum pratense)
IR/ml
637 Yorkshire fog (Holcus lanatus)
IC/ml

Cereals

652 Barley (Hordeum vulgare)
IC/ml
642 Maize (Zea mays)
IC/ml
610 Oat (Avena sativa)
IC/ml
671 Rye (Secale cereale)
IR/ml
614 Wheat (Triticum vulgare)
IC/ml
106 Wheat flour
IC/ml

Trees

609 Alder (Alnus glutinosa)
IR/ml
632 Ash (Fraxinus excelsior)
IC/ml
635 Beech (Fagus sylvatica)
IC/ml
615 Birch (Betula alba)
IR/ml
620 Chestnut (Castanea vulgaris)
IC/ml
626 Cypress (Cupressus sempervirens)
IC/ml
675 Elder (Sambucus nigra)
IC/ml
653 Elm (Ulmus campestris)
IC/ml
667 Black locust (Robinia pseudoacacia)
IC/ml
649 Hazel (Corylus avellana)
IR/ml
619 Hornbeam (Carpinus betulus)
IR/ml
644 Horse chestnut (Aesculus hippocastanum)
IC/ml
634 Juniper (Juniperus communis)
IC/ml
677 Lime (Tilia platyphyllos)
IC/ml
629 Sycamore (Acer pseudoplatanus)
IC/ml
645 Silver fir (Abies alba)
IC/ml
647 White mulberry (Morus alba)
IC/ml
621 English oak (Quercus robur)
IC/ml
651 Olive (Olea europea)
IR/ml
662 Scots pine (Pinus sylvestris)
IC/ml
666 Plane tree (Platanus vulgaris)
IC/ml
659 White poplar (Populus alba)
IC/ml
680 Privet (Ligustrum vulgare)
IC/ml
650 Walnut (Juglans regia)
IC/ml
669 Goat willow (Salix caprea)
IC/ml

Tobacco

904 Tobacco (leaves)
IC/ml
II. Animal-based allergen extracts(dander, epithelia, insects)

Animals

507 Cat
IR/ml
509 Dog
IC/ml
508 Goat
IC/ml
510 Guinea pig
IC/ml
511 Hamster
IC/ml
516 Horse
IC/ml
512 Rabbit
IC/ml
505 Sheep's wool
IC/ml

Insects

301 Cockroach
IC/ml
303 Grain weevil
IC/ml
310 Horsefly
IC/ml
307 Mosquito
IC/ml

III. House dust mite allergen extracts

325 Acarus siro
IC/ml
314 Dermatophagoides farinae
IR/ml
315 Dermatophagoides pteronyssinus
IR/ml
326 Euroglyphus maynei
IC/ml
324 Glycyphagus domesticus
IC/ml
317 Lepidoglyphus destructor
IC/ml
318 Tyrophagus putrescentiae
IC/ml
IV. Fungal allergen extracts(mold fungi, yeast, dermatophytes)
402 Botrytis cinerea
IC/ml
403 Candida albicans
IC/ml
407 Chaetomium globosum
IC/ml
409 Epicoccum
IC/ml
410 Epidermophyton
IC/ml
411 Fusarium
IC/ml
413 Helminthosporium
IC/ml
447 Merulius lacrymans
IC/ml
417 Mucor racemosus
IC/ml
425 Pullularia pullulans
IC/ml
426 Rhizopus nigricans
IC/ml
432 Stemphylium botryosum
IC/ml
435 Trichophyton
IC/ml
405 Trichothecium roseum (Cephalothecium)
IC/ml

V. Mixtures of allergen extracts * of animal origin

506 Feather mixture (duck, goose, chicken)
IC/ml
* of plant origin
a) weeds
719 Mixture I - Compositae (Goldenrod, Dandelion, Lampourde, Ox-eye-daisy) IC/ml
714 Mixture II - Chenopodiaceae (Fat hen, Rough pigweed)
IC/ml
706 Mixture III - Weed mixtures (Alfalfa, Red clover, Mustard, Nettle, Sorrel) IC/ml
b) grasses
701 3 grasses- (Orchard grass, Perennial ryegrass, Timothy grass)
IR/ml
688 5 grasses- (Orchard grass, Meadow grass, Perennial ryegrass, Sweet vernal grass, Timothy grass)
IR/ml
689 12 grasses- (Red fescue, Bermuda grass, Bromus, Orchard grass, Meadow fescue, Meadow grass, Oat grass, Perennial ryegrass, Sweet vernal grass, Timothy grass, Wild oat, Yorkshire fog)
IR/ml
690 5 grasses/4 cereals- (Orchard grass, Meadow grass, Perennial ryegrass, Sweet vernal grass, Timothy grass)/(Barley, Maize, Oat, Wheat)
IR/ml
687 4 cereals- (Barley, Maize, Oat, Wheat)
IR/ml
c) trees
702 Betulaceae (Alder, Birch, Hazel, Hornbeam)
IR/ml
696 Fagaceae (Beech, Chestnut, Oak)
IC/ml
716 Cupressaceae (Cypress, Juniper)
IC/ml
715 Oleaceae (Ash, Olive, Privet)
IC/ml
717 Salicaceae (Poplar, Willow)
IC/ml
718 Mixture of trees (Maple, Horse chestnut, Plane tree, Black locust, Lime)
IC/ml
917 Wood dust (Oak, Beech, Cherry, Pine)
IC/ml
* mites
350 D. pteronyssinus + D. farinae
IR/ml
330 Storage mites (Acarus siro, Glycyphagus domesticus, Lepidoglyphus destructor, Tyrophagus putrescentiae)
IC/ml
* fungi
400 Alternaria (alternata, longipes)
IC/ml
414 Cladosporium (cladosporoides, herbarum)
IC/ml
401 Aspergillus (fumigatus, nidulans, niger)
IC/ml
422 Penicillium (digitatum, expansum, notatum)
IC/ml
445 Yeast mixture (Saccharomyces cerevisiae, minor)
IC/ml
446 Smut mixture (Ustilago avenae, tritici, holci, zeae)
IC/ml