100,000 SQ-E / ml Powder and solvent for solution for injection 
Bee venom, Wasp venom

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or nurse.

– This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Aquagen SQ is and what it is used for 
2. What you need to know before you use Aquagen SQ 
3. How to use Aquagen SQ 
4. Possible side effects 
5. How to store Aquagen SQ 
6. Package contents and other information 

1. What Aquagen SQ is and what it is used for

Aquagen SQ contains allergen (the substance that causes the allergic reaction) from bee and/or wasp venom. Aquagen SQ can be used as a preventive treatment for allergies to bee and/or wasp stings.

The treatment is given to patients who get severe allergic reactions to bee and/or wasp stings. The purpose of the treatment is to influence the root cause of the allergy. This is done by gradually increasing the immune system’s tolerance to bee and/or wasp venom.

Skin test ( intracutaneous test ):

Aquagen SQ can be used in skin tests to check if you are allergic to bee and/or wasp venom.

2. What you need to know before using Aquagen SQ

Do not use Aquagen SQ

Treatment:

  • if you are allergic to any of the other ingredients of this medicine (listed in section 6)
  • if you have a disease that affects your immune system
  • if you have recently had an asthma attack and/or have recently experienced a worsening of your asthma symptoms, e.g. increased symptoms during the day, nocturnal awakenings, increased need for medication, and/or limitation of physical activities.
  • if you suffer from severe cardiovascular disease.

Skin test:

  • if you are allergic to any of the other ingredients of this medicine (see section 6)
  • if you have skin problems such as hives, eczema including allergic eczema, the test must be performed on normal healthy skin.
  • if you have the lesion’s (damages) in the area where the test is performed
  • if you have hives all over your body or dermographism (a form of hives ) as this may impair the test result.
  • if you can not stop treatment with antihistamines and/or other medicines that may affect the test result.

Warnings and cautions

Treatment:

Talk to your doctor before receiving Aquagen SQ about:

  • you experienced any side effects after the last treatment with Aquagen SQ
  • you have cardiovascular disease
  • you have an autoimmune disease
  • you have cancer
  • you have a fever or show some other signs of infection
  • you have had allergic symptoms such as hay fever in the last 3-4 days
  • you have eczema that has worsened
  • you know you have an elevated level of protein et tryptase in your blood
  • you know that you are suffering from mastocytosis or some other condition that causes you to have an increased number of mast cells in your body
  • you have asthma

Skin test:

Talk to your doctor before receiving Aquagen SQ about:

  • you have previously had a severe allergic reaction
  • you have a cardiovascular disease
  • you have asthma

If any of the above applies to you, it is important that you tell your doctor. This is to minimize the risk of allergic reactions associated with treatment with Aquagen SQ (see section 4 “Possible side effects”)

Children and Adolescents

Children from five years of age: information on the treatment effect in children is limited. Safety data show no higher risk in children than in adults. It is recommended that the doctor evaluate the risks and benefits for each individual child.

Children under five years of age: the doctor should carefully consider the risks and benefits of treatment for each individual child.

Other medicines and Aquagen SQ

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Be especially careful to tell your doctor or nurse if you:

  • other medications for treating allergies, such as antihistamine s or cortisone these may increase your tolerance for this treatment. Your doctor may need to adjust dose one.
  • recently received another vaccination, such as tetanus vaccination. There should be at least one week between injection one with Aquagen SQ and other vaccination.
  • uses beta-blockers to lower blood pressure, ACE inhibitors for the treatment of high blood pressure, tricyclic antidepressants or monoamine oxidase inhibitors ( MAOIs ) for the treatment of depression, or COMT inhibitors for the treatment of Parkinson’s disease. These medicines may increase the risk of / or affect the treatment of any allergic reactions when you use Aquagen SQ.

Skin test:

Be especially careful to tell your doctor or nurse if you:

  • take other medicines to treat allergies such as antihistamines or cortisone, as these may affect the test result and give a false negative result.
  • take tricyclic antidepressants as these may affect the test result.

Aquagen SQ with alcohol

Alcohol intake should be avoided on the day of injection as it may increase the risk of a severe allergic reaction ( anaphylaxis ).

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Dosage therapy with Aquagen SQ should not be initiated during pregnancy. If you become pregnant during maintenance treatment, talk to your doctor about the risks of continuing maintenance treatment.

It is not known if Aquagen SQ passes into breast milk. Therefore, consult a physician before regular use during breast-feeding.

Driving and using machines

Aquagen SQ can in some cases affect the ability to drive and use machines as you may feel dizzy after the treatment.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Therefore, read all the information in this leaflet

Aquagen SQ contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’.

3. How to use Aquagen SQ

Treatment of your allergy

Aquagen SQ is an injection treatment. The injections are usually given in your arm, just under the skin. The injections are always given by a doctor or nurse.

You must stay at the reception for at least 30 minutes after injection to allow any allergic reactions to be detected and treated.

On the day of the injection, avoid strenuous physical exercise, hot baths, and alcohol.

The treatment takes place in two phases: the dosing phase and the maintenance phase.

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Treatment is started according to a schedule prepared by your doctor.

The injections are usually given once a week during the dosing phase.

The dosing phase usually takes 8-12 weeks. The purpose is to increase the dose one step at a time to your highest tolerable dose, or the highest recommended maintenance dose. If your doctor deems it appropriate, so-called rapid dosing can be done. If a reaction occurs at the injection site and persists for more than six hours after injection, your doctor may adjust the dose according to the size of your skin reaction. Your doctor may give you an antihistamine before your injection.

Maintenance phase:

The maximum recommended maintenance dose is 1 ml of 100,000 SQ-E / ml. The maintenance dose can also be adjusted individually according to your sensitivity to the allergen.

If there is an increased risk of repeated stings, the doctor may, in consultation with the patient, choose to increase the maintenance dose to 200,000 SQ-E.

When the maintenance dose is reached, the time interval between injections gradually increased. Thereafter, the injections are given every 4 weeks +/- 1 week for 3-5 years.

Simultaneous treatment with more than one allergen

It is possible to receive treatment with several allergens at the same time.

If you use more Aquagen SQ than you should  

Treatment with Aquagen SQ is given by a doctor. In the event of an overdose, you will be monitored and treated by a doctor.

If you miss a dose of Aquagen SQ

Ask your doctor if you think you have not been given a dose. If the interval between 2 injections is too long, the doctor will lower the dose so that you do not get an allergic reaction.

If you stop using Aquagen SQ

To achieve the best treatment results, you need to be injected for 3-5 years.

Talk to your doctor if you have any questions about your treatment.

Skin test:

Skin tests are performed to check if you are allergic to bee and/or wasp venom. The test is done by repeatedly injecting you with an increasing amount of allergen until you react to the allergen. The injection is given into the skin (intracutaneously).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Treatment:

The side effects can be an allergic reaction to the allergen you are being treated with. Local reactions such as itching, redness, and swelling may occur at the injection site after each injection. The side effects usually occur within 30 minutes after injection. Late reactions may occur up to 24 hours after injection.

Call for immediate medical attention if your asthma suddenly worsens or if you experience any of the following symptoms, which may be a sign of a severe allergic reaction (occurs in an unknown number of users):

  • Rapid swelling of the face or neck
  • Difficulty swallowing
  • Difficulty breathing
  • Hives
  • Sudden reddening of the skin
  • Nausea, stomach pain, vomiting and diarrhea
  • Severe discomfort

Other possible side effects (affects an unknown number of users):

  • Injection site reactions: swelling, hives, pain, discoloration, itching, redness
  • Headache
  • Dizziness
  • Stinging sensation in the skin
  • Swollen eyelids
  • Inflammation or itching of the eyes
  • Abnormally fast, strong, or irregular heartbeat
  • Low blood pressure
  • Pallor
  • Nasal discomfort, stuffy or runny nose
  • Sneezing
  • Tightness or irritation in the throat
  • The feeling of foreign objects in the throat
  • Asthma symptoms, wheezing, shortness of breath, lowering of the airways, or coughing
  • Rash, redness of the skin, itching
  • Joint pain or swelling
  • Feeling of warmth
  • Swelling of tissue (usually in the arm where the injection was given)
  • Discomfort in the chest
  • Fatigue
  • Feeling sick

Reactions during skin tests

A slightly increased swelling of the skin, redness, and itching at the injection site are positive reactions to the skin test and can be expected. Major swelling of the skin may occur within the first 15-20 minutes after the test. In some cases, swelling may occur later. In rare cases, severe allergic reactions (for symptoms, see above) may occur after skin tests. The risk of severe allergic reactions during a skin test is possible, but very small.

In the event of any allergic reactions, contact your doctor immediately for adequate treatment.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Aquagen SQ

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

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiration date is the last day of the specified month. 

Store in a refrigerator (2 ° C – 8 ° C). Do not freeze. Store in the outer carton. Sensitive to light.

The shelf life for broken packaging and after preparation/dilution with ALK-Diluent, when stored in a refrigerator, is:

Aquagen SQ Bigift

  • 100,000 SQ-E / ml: 6 months
  • 100, 1000 and 10,000 SQ-E / ml: 2 weeks
  • 10 SQ-E / ml: 1 day

Aquagen SQ Wasp venom 

  • 100,000 SQ-E / ml: 2 months
  • 100, 1000 and 10,000 SQ-E / ml: 1 week
  • 10 SQ-E / ml: 1 day

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

– The active substance is:

Aquagen SQ Bigift – Bigift

Aquagen SQ Wasp venom – Wasp venom

– The other ingredient is mannitol.

ALK-Diluent: Human serum albumin, sodium chloride, sodium bicarbonate, phenol, water for injections.

What the medicine looks like and contents of the pack

Aquagen SQ is a freeze-dried allergen extract that must be dissolved with ALK-Diluent before use.

Aquagen SQ is available as a maintenance package with a strength of 100,000 SQ-E / ml. In addition, there is a separate package with ALK-Diluent. Not all packaging may be marketed.

The activity is expressed in the unit SQ-E / ml.

After reconstitution with ALK-Diluent, the activity per 1 ml is 100,000 SQ-E.

Marketing Authorisation Holder

ALK-Abelló A / S

Bøge Allé 6-8

2970 Hørsholm

Denmark

Manufacturer

ALK-Abelló SA

Miguel Fleta 19 
E-28037 Madrid 
Spain

Information provided by:

ALK Nordic A / S, Denmark Branch

Box 10073

434 21 Kungsbacka

tel: 0300-185 45

email: infose@alk.net

Muhammad Nadeem

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