Label: information for the user

Alutard SQ Apis mellifera initial packaging (100 SQ-U/ml, 1 000 SQ-U/ml, 10 000 SQ-U/ml and

100 000 SQ-U/ml), injectable suspension

Alutard SQ Apis mellifera 100 000 SQ-U/ml injectable suspension

Bees venom allergen (Apis mellifera)

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• This medication has been prescribed only to you, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this label. See section 4.

Alutard SQ Apis mellifera contains the allergen (the substance that causes the allergic reaction) from bee venom. It is used as a preventive treatment for bee sting allergy.

This treatment is used in patients with a history of severe allergic reactions to bee stings. The goal of the treatment is to combat the underlying cause of the allergy. It works by gradually increasing the patient's immunological tolerance to bee venom.

Do not use Alutard SQ Apis mellifera

• if you are allergic to any of the other components of this medication (listed in section 6).
• if you have any disease that affects the immune system.
• if you have recently had an asthma attack and/or your asthma symptoms have worsened, for example, have increased your symptoms during the day, have had nighttime awakenings, have increased your need for medication and/or have had limitations in your activity.
• if you have any severe heart or vascular disease.

Warnings and precautions

Consult your doctor before starting to use Alutard SQ Apis mellifera if:

• you have experienced any adverse effect after the last administration of Alutard SQ Apis mellifera
• you have chronic heart disease
• you know that your renal function is decreased, as there may be a risk of aluminum accumulation in your body
• you have an autoimmune disease
• you have cancer
• you have a fever or show any other sign of infection
• in the last 3 or 4 days you have experienced allergic symptoms such as allergic rhinitis
• you have eczema that has worsened
• you know that you have an elevated level of the protein tryptase in your blood
• you know that you have mastocytosis or any other disease that produces an increase in the number of mast cells in your body
• you have asthma

If you present any of the above cases, it is essential to inform your doctor about it, in order to reduce the risk of allergic reactions related to treatment with Alutard SQ Apis mellifera (see section 4 "Possible adverse effects").

Children and adolescents

Children from 5 years old: The information on the effect of treatment in children is limited. Safety data have not shown a higher risk in children than in adults. It is recommended that the doctor evaluate the risks and benefits in each child.

Children under 5 years old: The doctor should carefully evaluate the risks and benefits of treatment in each child.

Use of Alutard SQ Apis mellifera with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medication.

Inform your doctor or nurse especially if

• you are taking any other medication to treat your allergy such as antihistamines or corticosteroids, as they may increase your tolerance to this treatment. The doctor may need to adjust the dose
• you are taking medications that contain large amounts of aluminum, such as some antacids (used for stomach heartburn). Since Alutard SQ Apis mellifera also contains aluminum, there may be a risk of aluminum accumulation in your body
• you have recently been vaccinated, for example, against tetanus. You should wait at least a week between the injection of Alutard SQ Apis mellifera and the other vaccine
• you are taking beta-blockers or ACE inhibitors to treat high blood pressure or heart disease, tricyclic antidepressants or MAOIs for depression, or COMT inhibitors for Parkinson's disease. These medications may increase the risk of/or influence the treatment of any allergic reaction produced when using Alutard SQ Apis mellifera

Use of Alutard SQ Apis mellifera with alcohol

You should avoid alcohol on the day of the injection as it may increase the risk of a severe allergic reaction (anaphylaxis).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The treatment should not be initiated during pregnancy. If you become pregnant during maintenance treatment, you should discuss the risks of continuing maintenance treatment with your doctor.

The excretion of Alutard SQ Apis mellifera in breast milk is unknown. You should consult your doctor before starting treatment if you are breastfeeding.

Driving and operating machinery

Alutard SQ Apis mellifera may affect your ability to drive or operate machinery in some cases, as you may feel dizzy after receiving the treatment.

Alutard SQ Apis mellifera contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free".

Alutard SQ Apis mellifera treatment is administered through an injection. The injections will normally be given in your arm, under the skin. Your doctor or nurse will always administer the injections.

You should remain in the clinic for at least 30 minutes after the injection to detect and treat any potential allergic reaction.

You should avoid: intense physical exercise, hot baths, and alcohol on the day of the injection.

The treatment is divided into two phases: initiation phase and maintenance phase.

Initiation phase:

The treatment will start according to the schedule established by your doctor. In the initiation phase, the administration of injections is usually once a week. This phase usually lasts between 7 and 25 weeks.

The goal is to gradually increase the dose until the maximum dose that you can tolerate or the recommended maximum maintenance dose is reached. If a reaction occurs at the injection site and lasts more than 6 hours after the injection, your doctor may adjust the dose based on the extent of your skin reaction. Your doctor may prescribe antihistamines before the injection.

Maintenance phase:

Once the maintenance dose is reached, the time between injections will be gradually increased until they are administered every 6-8 weeks for 3-5 years.

Treatment with more than one allergen at the same time:

If you are being treated with more than one allergen at the same time, the time between injections should be at least 30 minutes.

If you use more Alutard SQ Apis mellifera than you should:

A doctor will administer the Alutard SQ Apis mellifera treatment. In case of an overdose, you will be monitored and treated by a doctor.

If you forget to use Alutard SQ Apis mellifera:

Contact your doctor if you think you have forgotten to administer a dose. If the time interval between two injections has been too long, your doctor will reduce the dose to avoid an allergic reaction.

If you interrupt the treatment with Alutard SQ Apis mellifera:

To get the best results from your treatment, you will need to receive injections for 3 to 5 years.

If you have any other questions about the use of this medication, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Side effects can be an allergic reaction to the allergen being treated. Local reactions such as itching, redness, and swelling can occur at the injection site after each injection. Side effects usually occur within 30 minutes after injection. However, late reactions can occur up to 24 hours after injection.

Seek immediate medical attentionif your asthma suddenly worsens or if you experience any of the following symptoms, which may be a sign of anaphylactic reaction (frequency cannot be estimated with available data):

• Quick swelling of the face or throat
• Difficulty swallowing
• Difficulty breathing
• Hives
• Flush
• Worsening of existing asthma
• Nausea, abdominal pain, vomiting, and diarrhea
• Severe discomfort

Other possible side effects (frequency cannot be estimated with available data):

• Injection site reactions: swelling, nodules, pain, itching, redness, hair growth
• Headache
• Dizziness
• Itchy skin sensation
• Swelling of the eyelids
• Inflammation or itching in the eyes
• Accelerated heart rate
• Sensation of rapid and strong or irregular heartbeats
• Low blood pressure
• Pallor
• Conjunctivitis
• Throat constriction or sensation of irritation
• Whistling breathing
• Asthmatic symptoms, shortness of breath, or cough
• Rash
• Joint pain or swelling
• Sensation of heat
• Sensation of something stuck in the throat
• Swelling of tissues (usually in lower limbs)
• Chest discomfort
• Fatigue
• Sensation of discomfort

In the event of any allergic reaction, you must contact your doctor immediately to receive proper treatment.

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Usewww.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label after CAD. The expiration date is the last day of the month indicated. The vial must be used within 6 months after opening when used for a specific patient and stored in a refrigerator (between 2°C and 8°C).

Store in a refrigerator (between 2°C and 8°C). Do not freeze. Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or trash. Dispose of containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Alutard SQ Apis mellifera

• The active principle is the allergen of bee venom (Apis mellifera).
• The other components are aluminium hydroxide (hydrated), sodium chloride, sodium hydrogen carbonate, phenol, sodium hydroxide, and water for injection.

Aspect of the product and content of the container

Alutard SQ Apis mellifera is an injectable suspension. The suspension is white to slightly brown or green in color.

The product is available in two presentations:A starter pack with four concentrations and a maintenance pack with a concentration of 100,000 SQ-U/ml. The vial numbers are of different colors to distinguish the different concentrations. Not all container sizes may be commercially available.

The activity is expressed in SQ-U/ml units.

The activity in 1 ml of injectable suspension is:

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

ALK-Abelló A/S

Bøge Allé 6-8

2970 Hørsholm

Denmark

Responsible for manufacturing

ALK-Abelló S.A.

Miguel Fleta 19

28037 Madrid

Spain

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

ALK-Abelló. S.A.

C/ Miguel Fleta, 19

28037 – Madrid

This medication is authorized in the Member States of the European Economic Area with the following names:

Date of the last review of this leaflet:11/2021

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

This information is intended solely for healthcare professionals:

The treatment with Alutard SQ Apis mellifera should be performed under the supervision of a doctor with experience in specific immunotherapy. After each injection, the patient should remain under observation for at least 30 minutes.

During storage, a precipitate and a transparent liquid may be observed. This is something normal in a suspension and does not constitute a sign of deterioration of the product's quality. The precipitate may be white to slightly brown or green in color. The vials should be slowly turned upside down and back 10-20 times to form a homogeneous suspension before use. Visually inspect the suspension to detect fine particles before administration. Discard the product if there are visible particles in it.

Alutard SQ Apis mellifera is administered subcutaneously. The injection is administered or laterally in the distal part of the upper arm, or dorsally in the proximal part of the forearm.

Avoid intravascular injection by carefully aspirating before injection. The aspiration should be repeated every 0.2 ml during the injection, and the injection should be administered slowly. During the use of Alutard SQ Apis mellifera, an emergency kit for treating anaphylaxis should be available.

Due to the absence of compatibility studies, this medication should not be mixed with other medications.