Pharmalgen Himenoptera venoms

Leaflet included in the packaging: information for the user

Pharmalgen Hymenoptera venoms

Extracts of insect venom allergens (wasp, bee)

120 μg
Powder and solvent for solution for injection
You should carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you for a specific reason. 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 side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Pharmalgen Hymenoptera venoms and what is it used for
• 2. Important information before using Pharmalgen Hymenoptera venoms
• 3. How to use Pharmalgen Hymenoptera venoms
• 4. Possible side effects
• 5. How to store Pharmalgen Hymenoptera venoms
• 6. Contents of the packaging and other information

1. What is Pharmalgen Hymenoptera venoms and what is it used for

Pharmalgen Hymenoptera venoms is a medicine containing insect venom allergen extracts.
The medicine is used for the diagnosis and treatment of IgE-dependent allergy (hypersensitivity) to bee and wasp venom.

2. Important information before using Pharmalgen Hymenoptera venoms

When not to use Pharmalgen Hymenoptera venoms

• if the patient is allergic to any of the other ingredients of this medicine, except for the active substance (listed in section 6),
• if the patient has any immunological diseases,
• if the patient has severe asthma,
• if the patient has been diagnosed with chronic heart or lung disease,
• if the patient has severe hypertension,
• if the patient has acute or chronic infectious diseases,
• if the patient has a severe rash,
• if the patient is being treated with beta-adrenergic blockers (beta blockers), including eye drops,
• if the patient is being treated with ACE inhibitors,
• if the patient is being treated with tricyclic antidepressants,
• if the patient is being treated with monoamine oxidase inhibitors (MAO),
• if the patient has cancer.

Warnings and precautions

General principles
Before starting treatment with Pharmalgen Hymenoptera venoms, you should discuss it with your doctor.
On the day of injection, you should avoid strenuous physical activity, hot baths, and alcohol consumption.
If the patient has an increased level of tryptase in the blood and (or) has mastocytosis, the risk of side effects may be higher.
If the patient has mastocytosis, the effectiveness of the medicine may be lower than in the general population of patients with insect venom allergy.
Before each injection of Pharmalgen Hymenoptera venoms:

• the doctor will check the extent and date of the previous injection (the interval between doses),
• the doctor will assess the patient's lung function,
• the doctor will check the patient's health status,
• if an allergic reaction occurred after the last injection, you should inform your doctor, as this may indicate the need for a smaller dose (dose reduction),
• you should inform your doctor about taking any other anti-allergic medicines.

Injections should be postponed for the following reasons:

• if the patient's lung function has worsened,
• if the patient has any symptoms of infection (infectious disease) or disease with fever,
• if the patient has experienced any symptoms of allergy in the last 3-4 days,
• if the symptoms of atopic dermatitis have worsened. After each injection of Pharmalgen Hymenoptera venoms
• the patient must remain under observation in a medical facility for 30 minutes after the injection,
• if an allergic reaction occurs, you should inform your doctor or nurse before leaving the medical facility,
• the doctor will assess the patient's lung function,
• you should carefully observe the injection site and inform your doctor about any allergic reaction that occurred after leaving the medical facility,
• you should contact your doctor or emergency department immediately if you experience symptoms of a severe allergic reaction.

Children

Special caution is required if Pharmalgen Hymenoptera venoms is used in children under 5 years of age.
The doctor should carefully assess the risk-to-benefit ratio for each child.
Data on the clinical efficacy in children aged 5 and older are limited; any data on safety do not indicate a higher risk than in adults.

Pharmalgen Hymenoptera venoms and other medicines

You should inform your doctor about all medicines you are currently taking or plan to take.
Medicines that modify the allergic reaction, such as antihistamines, bronchodilators, cromoglycate sodium, and glucocorticosteroids administered before allergen injection, increase the tolerance of the medicine. If the patient neglects to use standard medicines before injection, serious reactions may occur.
Immunosuppressive agents that reduce the body's immunity should not be used at the same time.
No vaccinations should be performed within 7 days before or after administration of Pharmalgen Hymenoptera venoms.

Pregnancy and breastfeeding

Pregnancy
If you are pregnant or breastfeeding, or think you may be pregnant or plan to have a child, you should consult your doctor before using this medicine.
Treatment with Pharmalgen Hymenoptera venoms should not be started during pregnancy. Women who become pregnant during treatment with this medicine may continue to use the medicine after a thorough assessment by their doctor of their overall condition and reaction to previous injections of Pharmalgen Hymenoptera venoms.
Breastfeeding
There is no evidence regarding the use of Pharmalgen Hymenoptera venoms during breastfeeding.

Driving and using machines

Pharmalgen Hymenoptera venoms may have a minor or moderate effect on the ability to drive and use machines. After injection, fatigue may occur, which can affect the ability to drive and use machines.

3. How to use Pharmalgen Hymenoptera venoms

Treatment will be carried out exclusively by doctors with experience in specific immunotherapy.
Pharmalgen Hymenoptera venoms will be administered to the patient by subcutaneous injection in the upper arm or forearm.
Appropriate means for the treatment of anaphylactic shock should be available.

Diagnosis

Before starting treatment with Pharmalgen Hymenoptera venoms, allergy to bee or wasp venom should be confirmed in the patient's medical history and by diagnostic methods in vivo (skin prick test using a drop of solution or intradermal test) and (or) in vitro (determination of specific immunoglobulin E (IgE) in the patient's blood serum).
Before administering Pharmalgen Hymenoptera venoms, the medicine will be diluted by medical personnel in a diluent containing albumin. Medical personnel should familiarize themselves with the instructions for dissolving and diluting Pharmalgen Hymenoptera venoms, which can be found at the end of the leaflet.

Treatment

Treatment is divided into two phases: the initial phase (the dose is gradually increased during subsequent injections) and the maintenance phase (a constant dose is used).
Dosing in both phases is individually determined by the doctor, depending on the patient's tolerance and sensitivity to the allergen.
Initial phase
During the initial phase, the dose of Pharmalgen Hymenoptera venoms is gradually increased until the maximum dose is reached, which is suitable for the patient (maintenance treatment).
The initial phase lasts from 7 to 12 weeks, except for accelerated treatment, which requires hospitalization for about 1 week.
Maintenance phase (maintenance treatment)
The doctor will decide what maintenance dose is suitable for the patient. After reaching the maintenance dose, the interval between injections of Pharmalgen Hymenoptera venoms will be gradually increased from 1 to 2 and 4 weeks. The maintenance dose will be administered every 4 weeks for at least 3 years (3-5 years). After reaching the maintenance dose, it is possible to switch to a depot product (slow-release form) of Alutard SQ Bee Venom or Alutard SQ Wasp Venom. After switching to Alutard SQ, the interval between doses will be gradually increased from 1 to 2, 4, and 6 weeks. Then, the maintenance dose will be administered every 6 weeks ± 2 weeks for at least 3 years (3-5 years).
Dose reduction
The doctor will adjust the dose of Pharmalgen Hymenoptera venoms in the following situations:

• if the interval between two injections was longer than recommended,
• if a severe reaction occurred at the injection site,
• in the event of a generalized reaction to the medicine. If a severe reaction occurs, it should be carefully considered whether to continue treatment. In the event of continuation, the dose should be reduced to 1/10 of the last dose and gradually increased.

Treatment of more than one allergy

Patients allergic to bee and wasp venom should be treated first with one medicine (containing wasp or bee venom). When the maintenance dose is reached, treatment with the second medicine can be started. Maintenance doses of both venoms should be administered with an interval of 2-3 days.

Use of a higher dose of Pharmalgen Hymenoptera venoms than recommended

In the event of injection of a higher dose of Pharmalgen Hymenoptera venoms than recommended, the risk of an allergic reaction increases. The patient should be under observation, and if a reaction occurs, symptomatic treatment should be initiated.

Missed administration of Pharmalgen Hymenoptera venoms

If the patient suspects that they have missed an injection, they should inform their doctor.
In the event of too long an interval between two injections, the doctor will reduce the dose to avoid allergic reactions.
In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should ask your doctor how to act in case of an allergic side effect.
You should contact your doctor immediately if a severe side effect occurs.
Side effects can be an allergic response to the administered allergen, which the patient is being treated for.
Symptoms of early side effects may occur within the first 30 minutes after injection, although reactions may also occur up to 24 hours after the injection.
Most allergic side effects are mild or moderate in severity and can be treated symptomatically with antihistamines if necessary.

Very common side effects (occurring in more than 1 in 10 people)

Headache
Swelling at the injection site
Common side effects (occurring in more than 1 in 100 people but less than 1 in 10 people)

Redness of the eyes
Diarrhea, vomiting, nausea, indigestion
Itching and hives at the injection site
Feeling of discomfort and fatigue
Wheezing, coughing, and shortness of breath
Hives, itching, and rash
Feeling of heat (flushing)
Uncommon side effects (occurring in more than 1 in 1,000 people but less than 1 in 100 people)

Anaphylactic reactions (such as facial, lip, or throat swelling, difficulty breathing, and hives)
Back pain
Rare side effects (occurring in more than 1 in 10,000 people but less than 1 in 1,000 people)

Anaphylactic shock. Common symptoms of a severe anaphylactic reaction may include flushing, severe itching on the inside of the hands, feet, or other parts of the body, hives, and difficulty breathing. A feeling of heat, general discomfort, and restlessness may also occur.

Other side effects with unknown frequency

Feeling of rapid or irregular heartbeat and bluish discoloration of the skin
Fainting (dizziness)
Lid swelling
Abdominal pain
Itching, feeling of discomfort in the chest, chills, flushing at the injection site, pain at the injection site, feeling of a foreign body
Redness of the skin
Swelling and pain in the joints
Dizziness, feeling of spinning, and feeling of pinching and tingling of the skin
Asthma, feeling of a stuffy nose or cold, sneezing, bronchospasm, throat irritation, and feeling of pressure in the throat
Swelling of the face, lips, and throat (vascular swelling)
Low blood pressure and paleness

You should contact your doctor immediately if you experience any of the following symptoms:

Sudden feeling of discomfort with flushing and difficulty breathing
Swelling of the face, lips, and throat
Difficulty swallowing
Difficulty breathing
Worsening of existing asthma
Rash

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Thanks to the reporting of side effects, more information can be collected on the safety of the medicine.

5. How to store Pharmalgen Hymenoptera venoms

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging after "Expiry date". The expiry date refers to the last day of the given month.
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Store the vials in the original packaging to protect them from light.
Shelf life after reconstitution and dilution with albumin diluent:

• 100 micrograms/ml – 6 months.
• 0.1 microgram/ml – 1 week.
• 1 microgram/ml – 1 week.
• 10 micrograms/ml – 2 weeks.

After dilution to a concentration below 0.1 microgram/ml, the solution should be used on the same day.
After reconstitution and dilution of Pharmalgen Hymenoptera venoms, a new expiry date should be written on the vial. The expiry date after reconstitution and dilution cannot exceed the expiry date of the lyophilized Pharmalgen Hymenoptera venoms and cannot exceed the expiry date of the albumin diluent.
Only the albumin diluent should be used for reconstitution and dilution of this medicine.

6. Contents of the packaging and other information

What does Pharmalgen Hymenoptera venoms contain?

The active substance of the medicine is:
Insect venom allergen extracts:
801 bee venom
802 wasp venom
One vial of powder contains 120 micrograms of insect venom allergen extracts.
The other ingredients are: powder: mannitol and human albumin. Diluent: human albumin, phenol, and sodium chloride, hydrochloric acid (for pH adjustment), and water for injections.

What does Pharmalgen Hymenoptera venoms look like?

Vials made of type I glass with a chlorobutyl rubber stopper and an aluminum cap.
Pharmalgen Hymenoptera venoms (wasp or bee) is supplied in packaging containing 4 vials of powder with 120 micrograms + 4 vials of albumin diluent with 5 ml each.
Dilution set:

• 10 vials of 5 ml albumin diluent.

Marketing authorization holder and manufacturer:

ALK-Abelló A/S
Bøge Allé 6-8
DK-2970 Hørsholm, Denmark

Date of last revision of the leaflet: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Information intended exclusively for healthcare professionals:
Before administration, the product should be reconstituted in the albumin diluent, in accordance with the instructions below.
Reconstitution of the powder:

• 1. 1.2 ml of albumin diluent should be drawn into a single-dose syringe.
• 2. 1.2 ml of albumin diluent should be slowly injected into the vial with the lyophilized venom.
• 3. Before withdrawing the needle, 1.2 ml of air should be drawn to remove the pressure.
• 4. The vial should be gently rotated 10-20 times, and then checked to see if the powder has been reconstituted.

After reconstitution, the solution contains 100 micrograms/ml of insect venom allergen extracts. The date of reconstitution and the expiry date should be noted on the vial label.
Serial dilution
Smaller concentrations should be prepared by diluting the solution. The albumin diluent should be used for dilution. To avoid confusion, the concentrations should be labeled on the vial labels [minimum information: allergen, concentration, date of dilution, and expiry date (see section 5)].

• 1. 10 micrograms/ml (1:10):0.55 ml of the solution with a concentration of 100 micrograms/ml of venom + 5 ml of albumin diluent.
• 2. 1 microgram/ml (1:100):0.55 ml of the solution with a concentration of 10 micrograms/ml of venom + 5 ml of albumin diluent.
• 3. 0.1 microgram/ml (1:1000):0.55 ml of the solution with a concentration of 1 microgram/ml of venom + 5 ml of albumin diluent.

In the same way, further dilutions can be prepared (see the diagram below).
WARNING:the same sterile syringe should not be used to transfer solutions with different concentrations. A new sterile syringe should be used for each concentration. To avoid confusion, the concentrations should be labeled on the vial labels [minimum information: allergen, concentration, date of dilution, and expiry date (see section 5)].