Patient Medication Information: uses, side effects, how to take - Pollinex R
Serious Warnings and Precautions
- Treatment should only be carried out by, or under supervision of physicians experienced in specific immunotherapy.
- Severe systemic reactions, including life-threatening anaphylactic shock, can occur with the use of POLLINEX-R.
Patients with asthma may be more susceptible to severe adverse reactions. • The patient must be under observation for at least 30 minutes (longer in high risk patients)
after having received an injection with POLLINEX-R.
- All patients receiving immunotherapy should be instructed in the procedure for emergency self-injection of epinephrine.
What is POLLINEX-R used for?
- Treatment of seasonal ragweed allergic rhinitis (hayfever) caused by ragweed pollen in patients over the age of 8 years.
How does POLLINEX-R work?
POLLINEX-R is a seasonal specific immunotherapy (sometimes known as allergy vaccination or hyposensitisation) that contains extracts of ragweed pollen.
The exact mode of action of POLLINEX-R is not known, as is the case with other seasonal immunotherapies. It has been suggested that the treatment modifies the levels of the patients’ antibodies and this changes a patient’s reaction when they are exposed to ragweed pollen.
Before you have this treatment you will have tested positive to a skin prick test and/or an IgE antibody blood test completed by your doctor.
Your treatment will begin and will be completed before the start of the ragweed pollen season.
POLLINEX-R is not expected to completely eliminate your various allergic symptoms but should reduce their severity after one course of treatment. POLLINEX-R may also reduce your dependence on other medications that relieve your allergic symptoms such as anti-histamines, nasal and oral steroids.
For long-term improvement in allergic symptoms it is recommended that the treatment takes place for 3-5 consecutive years.
What are the ingredients in POLLINEX-R?
Medicinal ingredient: Modified Ragweed Pollen Allergen Tyrosine Adsorbate
Non-medicinal ingredients: Disodium phosphate dodecahydrate. Glycerol. L-tyrosine, Phenol, Sodium Chloride, Sodium dihydrogen phosphate dihydrate, Water for injections.
POLLINEX-R comes in the following dosage forms:
Suspension for injection 105 PNU/0.5 ml, 250 PNU/0.5 ml, 700 PNU/0.5 ml, 2150 PNU/0.5 ml
Do not use POLLINEX-R if:
- You have previously had a severe anaphylactic reaction to a ragweed immunotherapy; • You are hypersensitive to any of the excipients;
- You have not tested positive to a ragweed skin prick test or show no signs of seasonal allergic hayfever to ragweed;
- You have a condition which causes you to bleed heavily;
- You have a condition which prevents treatment of possible anaphylactic reactions for example chronic heart and lung disease;
- You have unstable or severe chronic or seasonal asthma;
- You have problems with your immune system.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you receive POLLINEX-R. Talk about any health conditions or problems you may have, including if you:
- Are suffering from an infection or fever;
- Are taking Beta-blockers or Angiotensin – Converting Enzyme (ACE) inhibitors to treat high blood pressure and heart problems;
- Are taking Tricyclic anti-depressants and monoamine oxidase inhibitors (MAOIs); • Have cardiovascular disease;
- Have unstable or steroid dependent asthma.
Other warnings you should know about:
Anaphylactic Shock
Severe, immediate reactions including life-threatening anaphylactic shock can occur with the use of POLLINEX-R.
Warning symptoms:
Tingling, itching and burning sensations on and under the tongue, in the mouth, in the throat and particularly on the palms and soles. This may be immediately followed by shock with bluish grey skin colour, decreased blood pressure, increased heart rate, cramp like tightness of the respiratory tract and unconsciousness. Further clinical signs are: hives/nettle rash, anxiety, restlessness, dizziness, swelling of the throat with difficult or laboured breathing, feeling or being sick, respiratory and cardiac arrest.
If you show signs of a severe allergic reaction or anaphylactic shock, you must seek medical help immediately.
The product should be administered under the supervision of physicians experienced in specific immunotherapy. An emergency kit will be available. You must wait in the surgery or clinic for at least 30 minutes after each injection. This may be longer if you are a high risk patient or experience mild symptoms or signs of an allergic reaction.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.
The following may interact with POLLINEX-R:
- Beta-blockers;
- Immunosuppressant regimes;
- Hyposensitisation therapy;
- Symptomatic anti-allergic agents;
- Viral or bacterial pathogen vaccines;
- ACE inhibitors;
- MAOIs or Tricyclic anti-depressants.
How POLLINEX-R is administered:
POLLINEX-R will be given to you by a healthcare professional who is experienced in the use of specific immunotherapy.
Usual dose:
The following is a suggested schedule for average patients; however, some patients may be more sensitive and would require lower doses. Your doctor should monitor you and adjust your treatment as needed. POLLINEX-R should be administered as a course of four 0.5 ml subcutaneous injections. One 105 PNU/0.5 ml injection, one 250 PNU/0.5 ml injection, one 700 PNU/0.5 ml injection and one 2150 PNU/0.5 ml injection must be administered prior to the pollen season with a recommended interval of 7 days between injections.
At each strength, the maximum injection of 0.5 ml must not be exceeded.
Overdose:
The likelihood of severe allergic reactions is increased if an overdose is administered. In the case of an allergic reaction, contact your doctor immediately.
Missed Dose:
If the recommended interval between injections is exceeded by more than seven days, the treatment should be recommenced from vial or syringe No. 1 for safety reasons.
What are possible side effects from using POLLINEX-R?
These are not all the possible side effects you may feel when POLLINEX-R is used. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.
Like all medicines, POLLINEX-R can cause side effects. These include local reactions at the injection site (e.g. swelling, itching, pain, redness, discolouration). Further side effects to occur are respiratory disorders (e.g. shortness of breath, throat tightness, throat irritation, blocked sinuses, stuffy/blocked nose, runny nose), gastrointestinal disorders (e.g. diarrhoea, sickness/feeling of vomiting, abdominal discomfort), skin disorders (itching, hives/nettle rash), eye disorders (e.g. eye swelling) and general disorders (e.g. chest discomfort, chills, body temperature increased).
You should contact your doctor immediately in the event of any serious side effects which develops while in your doctor’s office or at any time following the injection.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Get immediate medical help | |
| Only if severe | In all cases | ||
VERY RARE Severe shortness of breath, hives/nettle rash, drop in blood pressure, cramp-like tightness of respiratory tract, collapse, allergic/anaphylactic shock. | ✓ | ✓ | |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional. Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect;
- By calling 1-866-234-2345 (toll-free);
By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
POLLINEX-R should be stored in a refrigerator at 2 – 8 °C. Do not freeze.
Keep out of the reach and sight of children.
If you want more information about POLLINEX-R:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; or by calling the distributor, Paladin Labs Inc., at: 1-888-867-7426.
Distributed by Paladin Labs Inc., 100 Alexis Nihon Blvd, Suite 600, St-Laurent, Québec, H4M
2P2.