strength series (100 SQ-E / ml, 1,000 SQ-E / ml, 10,000 SQ-E / ml and 100,000 SQ-E / ml) and 100,000 SQ-E / ml injection , suspension 
Dermatophagoides pteronyssinus, 2 ‑ Dermatophagoides mites (Dermatophagoides pteronyssinus, Dermatophagoides farinae)

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 can harm them, even if they show signs of illness 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 Alutard SQ is and what it is used for 
2. What you need to know before you use Alutard SQ 
3. How to use Alutard SQ 
4. Possible side effects 
5. How to store Alutard SQ 
6. Contents of the packaging and other information 

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

Alutard SQ is used to treat allergic diseases caused by allergens. The purpose of treatment is to influence the root cause of the allergic disease. The drug works by gradually increasing your immune tolerance to the allergen that causes the allergy. Alutard SQ is not normally recommended for the treatment of allergies in children under five years of age.

2. What you need to know before using Alutard SQ

Your doctor will examine you and guide you before starting treatment.

Do not use Alutard SQ

  • if you are allergic to any of the other ingredients of this medicine (listed in section 6)
  • 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 limitations of physical activity
  • if you have a disease that affects your immune system
  • if you suffer from severe cardiovascular disease

Warnings and cautions

Talk to your doctor before using Alutard SQ:

  • if you experience any side effects after the last treatment with Alutard SQ
  • if you have chronic heart disease or kidney disease
  • if you have an autoimmune disease
  • if you have cancer
  • if you have a fever or show signs of infection
  • if you have had allergic symptoms such as hay fever in the last 3 to 4 days
  • if you have eczema that has worsened
  • if 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 Alutard SQ (see section 4 “Possible side effects”).

Other medicines and Alutard SQ

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

Tell your doctor or nurse in particular if you:

  • using other drugs for allergy, such as antihistamine s or corticosteroid s, because this may increase your tolerance for this treatment. Your doctor may need to adjust dose one. 
  • use medicines that contain large amounts of aluminum, such as certain antacids (used against heartburn).
  • recently received another vaccination, such as tetanus vaccination. There should be at least one week between injection one with Alutard SQ and other vaccination.
  • use beta-blockers to treat high blood pressure, tricyclic antidepressants, or monoamine oxidase inhibitors ( MAOIs ) to treat depression, or COMT inhibitors to treat Parkinson’s disease. These medicines may increase the risk of / or affect the treatment of any allergic reactions while you are using Alutard SQ.

Alutard SQ with alcohol

Alcohol intake should be avoided on the day of injection as this 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 Alutard 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 Alutard SQ passes into breast milk. If you are breast-feeding, talk to your doctor before starting treatment.

Driving and using machines

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. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Alutard SQ contains sodium

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

3. How to use Alutard SQ

Treatment with Alutard SQ is given in the form of injections. 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.


Dosage phase:

The treatment is started according to a schedule drawn up by your doctor. During the dosing phase, the injections are usually given once a week. The dosing phase usually takes 7–25 weeks. The aim is to increase the dose one step at a time until your highest tolerable dose or maximum recommended maintenance dose is reached. If a reaction occurs at the injection site and persists for more than six hours after injection, your doctor may adjust the dose depending on the size of your skin reaction. Your doctor may give you a dose of antihistamine before injecting one.


Maintenance phase:

Once the maintenance dose has been reached, the time interval between injections is gradually increased. Thereafter, the injections are given every 6 weeks – 8 weeks for 3-5 years.

Concomitant treatment with more than one allergen

It is possible to treat several allergens at the same time.

If you miss a dose of Alutard SQ

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

If you stop using Alutard SQ

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

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

4. Possible side effects

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

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. However, delayed reactions may occur up to 24 hours after injection.

Mild to moderate allergic reactions can be treated with anti-allergy medicines, such as antihistamines, if needed.

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 an anaphylactic reaction:

  • sudden swelling of the face, mouth, or throat
  • difficulty swallowing
  • difficulty breathing
  • hives
  • changes in voice
  • worsening of existing asthma
  • nausea, stomach pain and stomach cramps, vomiting, and diarrhea
  • severe discomfort

Very common (may affect more than 1 user in 10):

  • injection site reactions: swelling, hives, discoloration, lumps, pain, bruising, hematoma, calluses, inflammation, rash, fever , papules (blisters), redness and/or itching

Common (may affect up to 1 in 10 people):

  • dizziness
  • eye inflammation
  • itching in the eyes
  • asthma symptoms, shortness of breath, cough or sneezing
  • nasal discomfort, stuffy or runny nose
  • stomach pain, nausea
  • hives, itching, reddening of the skin
  • fatigue
  • the feeling of foreign objects in the throat

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

  • anaphylactic shock
  • severe allergic reaction
  • stinging sensation in the skin
  • swollen eyelids
  • itching in the ears
  • the feeling of fast, strong, or irregular heartbeat
  • abnormally high heart rate
  • bluish discoloration of the skin
  • low blood pressure
  • pallor
  • sudden reddening of the skin
  • contraction of the lower respiratory tract
  • the feeling of tightness in the throat
  • hissing breathing
  • irritation in the throat
  • itchy nose
  • diarrhea, vomiting, heartburn
  • swelling of the face or neck
  • rash
  • eczema
  • swollen joints, joint pain
  • chest discomfort
  • hair growth at the injection site
  • feeling uncomfortable
  • overindulge
  • feeling of warmth

Eczema can worsen during treatment.

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 Alutard 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. Shelf life for broken packaging is 6 months.

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

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 substances are: 
    Alutard SQ Dermatophagoides pteronyssinus – Dermatophagoides pteronyssinusAlutard SQ 2-Dermatophagoides mites – Dermatophagoides pteronyssinus, Dermatophagoides farinae
  • The other ingredients are aluminum hydroxide, sodium chloride, sodium bicarbonate, phenol, sodium hydroxide, water for injections.

What the medicine looks like and the contents of the pack

Alutard SQ is a suspension for injection.

The product is available in two types of packaging. A strength series with four strengths and a maintenance package with a strength of 100,000 SQ-E / ml. The numbers of the bottles are color-coded so that they can be distinguished. Not all types of packaging may be marketed.

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

The activity in 1 ml solution for injection is:

Bottle no./ 
color code
Bottle 4RED Bottle 3orange Bottle 2Green Bottle 1gray
Allergen extract /the activity 100,000 SQ-E 10,000 SQ-E 1,000 SQ-E 100 SQ-E

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

ALK-Abelló A / S

Bøge Allé 6-8

2970 Hørsholm

Denmark

Manufacturer:

ALK-Abelló SA

Miguel Fleta 19

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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