Alutard SQ 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)
1. What Is Alutard SQ and Alutard SQ Used For?
Alutard SQ is used to treat allergic diseases caused by allergens. Treatment aims 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 treating allergies in children under five.
2. What Do 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 experienced a worsening of your asthma symptoms, e.g., increased symptoms during the day, nocturnal awakenings, increased need for medication, and physical activity limitations.
- 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
You must tell your doctor if any of the above applies to you. 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 other medicines. Tell your doctor or nurse in particular if you:
- Using other drugs for allergies, such as antihistamines or corticosteroids, 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 the tetanus vaccination. There should be at least one week between injection with Alutard SQ and other vaccinations.
- Use beta-blockers to treat high blood pressure, tricyclic antidepressants, 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 allergic reactions while 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 breastfeeding, think you may be pregnant, or plan 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 breastfeeding, talk to your doctor before starting treatment.
Driving And Using Machines:
You are responsible for assessing whether you can drive a motor vehicle or perform work requiring sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects 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, i.e., 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. A doctor or nurse always gives the injections.
- 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, 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 interval between injections gradually increases. After that, the injections are given every 6 – 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 you do not have an allergic reaction.
If You Stop Using Alutard SQ:
You need to get the injections for 3-5 years to achieve the best treatment results. Talk to your doctor if you have any questions about your treatment.
4. Possible Alutard SQ Side Effects:
This medicine can cause side effects like all medicines, 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
- Swelling
It 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.
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
- 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
- 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 a 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
- Eeczema
- Swollen joints
- Joint pain
- Chest discomfort
- Hair growth at the injection site
- Feeling uncomfortable
- Overindulge
- Feeling of warmth
Eczema can worsen during treatment. Contact your doctor immediately for adequate treatment if you have any allergic reactions.
Reporting of side effects
Talk to your doctor, pharmacist, or nurse if you get any side effects. 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 sight and reach of children.
- Do not use this medicine after the expiry date stated on the label after EXP. The expiration date is the last day of the specified month. The 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 that are 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, and injection water.
What Does The Medicine Look 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