Venomenhal

Leaflet attached to the packaging: patient information

VENOMENHAL

Hymenoptera insect venom (wasp or bee),
bee venom 120 VU
or
wasp venom 120 VU,
powder and solvent for preparing a solution for skin tests and specific immunotherapy.
Kit for initial and maintenance treatment.

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor 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 side effects not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is VENOMENHAL and what is it used for

VENOMENHAL is used for diagnosis (skin tests) and specific immunotherapy (desensitization) of allergic diseases
dependent on specific immunoglobulins of class E (IgE), which are a response to Hymenoptera insect venom (wasp or bee).
The indication should be based on a detailed medical history, which confirms the occurrence of an allergic reaction
to insect venom in the patient.

2. Important information before using VENOMENHAL

When not to use VENOMENHAL

• -if the patient is hypersensitive (allergic) to any of the other components of this medicine (listed in section 6.)
• -if the patient has decreased immunity (e.g., due to taking medicines that suppress the activity of the immune system)
• -if the patient has autoimmune diseases (e.g., rheumatic disease)
• -if the patient has severe bronchial asthma, especially with an FEV (one-second forced expiratory volume) consistently below 70% of the normal value or asthma dependent on glucocorticosteroids
• -if the patient has cardiovascular failure, is being treated with beta-adrenergic blockers or ACE inhibitors (angiotensin-converting enzyme)
• -if the patient has contraindications to the use of adrenaline (e.g., hyperthyroidism)
• -if the patient has serious mental disorders, has difficulty communicating, or does not follow the doctor's recommendations
• -if the patient has active tuberculosis
• -if the patient has cancer
• -if the patient is pregnant or suspects they may be pregnant. If treatment was started before pregnancy, it may be continued according to the doctor's recommendation.

Warnings and precautions

Immunotherapy medicines should only be prescribed and administered to patients by specialist allergists
with experience in treating allergies.
If there is acute and chronic eczema (e.g., atopic dermatitis) at the test site, secondary inflammatory changes or secondary degenerative skin inflammation (e.g., fish scales, skin sclerosis), generalized urticaria or induced (dermographism) may affect skin reactivity
and significantly alter the results of skin tests.
Before and after each injection of the medicine, physical exertion (sports, heavy physical work) should be avoided.
A doctor should be consulted immediately if there is a feeling of burning pain, itching, a feeling of heat on or under the tongue, in the throat, on the hands, and soles of the feet. These symptoms precede the onset of anaphylactic shock with blue discoloration of the skin, decreased blood pressure, accelerated heart rate, difficulty breathing, and loss of consciousness.
Treatment involves life-saving measures.
Other side effects: see section 4. Possible side effects.
The doctor should be informed if the above symptoms have occurred in the past.

Children and adolescents

Special precautions should be taken when using VENOMENHAL in children under 5 years of age. The benefit-risk ratio should be considered individually for each child.
Data on the clinical efficacy in children aged 5 and older are limited, although safety data do not indicate a higher risk than in adults.

VENOMENHAL and other medicines

The doctor should be informed about all medicines currently being taken or recently taken, including those available without a prescription.
During immunotherapy, medicines that suppress the activity of the immune system should not be used. Concurrent use of medicines that lower blood pressure (beta-adrenergic blockers, ACE inhibitors) may cause a very strong reaction even at small doses of the allergen.
If the patient is taking antiallergic medicines (antihistamines, mast cell degranulation inhibitors, or corticosteroids), their sensitivity to previously well-tolerated doses of venom may change. Additionally, skin sensitivity may change, and skin tests performed during this period may be false and unreliable.
Bacterial and viral vaccines may be administered no earlier than 7 days after the last injection of VENOMENHAL (except in life-threatening situations). The next injection of the medicine may be administered only after the complete disappearance of the reaction to the vaccine, but not earlier than 7 days after vaccination.

Bee venom should never be mixed with wasp venom.

VENOMENHAL with food and drink

Food and drink do not affect the efficacy of VENOMENHAL.

Pregnancy and breastfeeding

Pregnancy

There are currently no adequately documented data on the use of immunotherapy medicines in pregnant women. The potential risk to the mother and human fetus is unknown.
Therapy with VENOMENHAL should not be started during pregnancy. If treatment was started before pregnancy, it may be continued according to the doctor's recommendation.

Breastfeeding

Therapy with VENOMENHAL should not be started during breastfeeding. If treatment was started before pregnancy, it may be continued according to the doctor's recommendation.

Driving and using machines

In very rare cases, there may be a feeling of mild fatigue. This possibility should be taken into account when driving or operating machines.

3. How to use VENOMENHAL

The medicine should always be used according to the doctor's recommendations. In case of doubts, consult a doctor.

Using a higher dose of VENOMENHAL than recommended

In case of any doubts, consult the attending doctor.

Missing a dose of VENOMENHAL

In such a case, consult the attending doctor to schedule a new appointment.

Stopping the use of VENOMENHAL

In case of any further doubts related to the use of the medicine, consult a doctor.

4. Possible side effects

Like all medicines, VENOMENHAL can cause side effects, although not everybody gets them.
There is an increased risk of side effects during dose escalation. This may occur especially when the patient is being treated with bee venom or if they have an elevated level of tryptase enzyme and (or) an increased number of mast cells in the body. The increased risk of side effects occurs more frequently in women and in patients with advanced allergy.
Within 30 minutes after injection, the following side effects may occur. Several hours after injection, delayed reactions may occur. In such cases, the doctor will individually reassess whether to continue therapy.
Possible side effects:

• anaphylactic shock
• headache
• redness of the face
• cough, shortness of breath, wheezing
• diarrhea, stomach problems, nausea, vomiting
• itching, rash, urticaria, eczema, redness of the skin
• swelling of the skin of the face, mucous membranes of the mouth and (or) throat
• swelling and pain in the joints
• swelling at the injection site, feeling of discomfort, malaise, fatigue, itching or urticaria, pain, fever
• rapid heartbeat, abnormal blood pressure

In rare cases, anaphylactic shock may occur. Typical warning symptoms are stinging, burning, itching, and a feeling of heat on and under the tongue, in the throat, especially on the hands and soles of the feet.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, consult a doctor, pharmacist, or nurse. 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 181 C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store VENOMENHAL

Store in a refrigerator (2°C - 8°C).
Do not freeze.

Solutions that have been frozen must not be used!

The medicine should be stored out of sight and reach of children.
Shelf life after reconstitution of the powder:
concentration 100 VU/ml of insect venom
6 months
Shelf life after dilution of the solution for concentrations:
10 VU/ml of insect venom
6 months
1 VU/ml of insect venom
6 months
0.1 VU/ml of insect venom
6 months
<0.1 VU/ml of insect venom
1 day
Do not use the medicine after the expiry date stated on the packaging after the words "Expiry date:" The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What VENOMENHAL contains

The active substance of the medicine is:
Lyophilized insect venom (wasp or bee)
The excipients are:
human albumin
mannitol
Solvent
Sodium chloride, phenol, human albumin, water for injections
Diluent:
sodium chloride, phenol, human albumin, water for injections

What VENOMENHAL looks like and what the packaging contains

The potency of the product is expressed in insect venom units (VU)
Kit for initial and maintenance treatment
6 vials of powder with 120 VU of lyophilized bee venom or 120 VU of lyophilized wasp venom and
6 vials of solvent with 1.2 ml of solvent.
Kit for preparing dilutions
10 vials of diluent with 4.5 ml each.

Marketing authorization holder and manufacturer

Hal Allergy B.V.
J.H. Oortweg 15, 2333 CH Leiden
P.O. Box 1204, 2302 BE Leiden, Netherlands
For more detailed information, please contact the representative of the marketing authorization holder.
Centrofarm Sp. z o.o.
Leszczynowa 1
05-092 Kiełpin, Łomianki
Tel: +48 691 810 590

Date of the last update of the leaflet: