INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ALLPYRAL SPECIAL GRASS 100 PNU/mL
ALLPYRAL SPECIAL GRASS 1 000 PNU/mL
ALLPYRAL SPECIAL GRASS 10 000 PNU/mL
ALLPYRAL SPECIAL GRASS TREATMENT SET
ALLPYRAL SPECIAL GRASS MAINTENANCE SET 10 000 PNU/mL
ALLPYRAL PURE MITE 100 PNU/mL
ALLPYRAL PURE MITE 1 000 PNU/mL
ALLPYRAL PURE MITE 10 000 PNU/mL
ALLPYRAL PURE MITE TREATMENT SET
ALLPYRAL PURE MITE MAINTENANCE SET 10 000 PNU/mL

SCHEDULING STATUS:
S4

ALLPYRAL®

ALLERGEN EXTRACTS FOR SUBCUTANEOUS INJECTION

USAGE GUIDE

Please read this leaflet carefully before treatment commences


PROPRIETARY NAME
and registration numbers:

ALLPYRAL SPECIAL GRASS 100 PNU/mL
T/30.1/692

ALLPYRAL SPECIAL GRASS 1 000 PNU/mL
T/30.1/693

ALLPYRAL SPECIAL GRASS 10 000 PNU/mL
T/30.1/694

ALLPYRAL SPECIAL GRASS TREATMENT SET
T/30.1/734
3 Vials containing 100, 1 000 and 10 000 PNU/mL

ALLPYRAL SPECIAL GRASS MAINTENANCE SET 10 000 PNU/mL
T/30.1/694

ALLPYRAL PURE MITE 100 PNU/mL
T/30.1/722

ALLPYRAL PURE MITE 1 000 PNU/mL
T/30.1/723

ALLPYRAL PURE MITE 10 000 PNU/mL
T/30.1/724

ALLPYRAL PURE MITE TREATMENT SET
T/30.1/737
3 Vials containing 100, 1 000 and 10 000 PNU/mL

ALLPYRAL PURE MITE MAINTENANCE SET 10 000 PNU/mL
T/30.1/724

DESCRIPTIVE NAME OF MEDICINE:
Sterile Aqueous suspension of allergen extract for subcutaneous injection.

PHARMACOLOGICAL CLASSIFICATION:
A.30.1 Antigens

SCHEDULING STATUS:
S4

COMPOSITION:
ALLPYRAL SPECIAL GRASS
consists of: 50% Bermuda Grass (Cynodon dactylon) 50% Perennial Rye (Lolium perenne)

ALLPYRAL PURE MITE consists of: 100% House dust mite (D. pteronyssinus)

ALLPYRALis a sterile, pyridine-extracted, alum precipitated antigen complex suspended in 0.9% saline containing 0.4% phenol as a preservative.

ALLPYRAL is standardised on a protein nitrogen unit (PNU) basis.
The method of manufacture ensures a minimal amount of free allergen in the supernatant.

IDENTIFICATION:
The allergen extract is suspended in an aqueous medium the colour of which varies with the allergen.
The labels of the vials of different strengths are colour-coded.

PHARMACOLOGICAL ACTION OF THE MEDICINE:
Immunotherapeutic.

INDICATIONS:
The treatment of allergic rhinitis, allergic conjunctivitis, and allergic asthma due to inhalant allergens; provided the allergy to the allergen in question has been proven, the allergen causes substantial clinical symptoms, elimination of allergen from the environment is impossible, symptomatic treatment does not give adequate relief or is associated with unacceptable side effects.

CONTRA-INDICATIONS:
Do not give specific immunotherapy (SIT) to patients with serious immunological diseases.

Do not give specific immunotherapy (SIT) to patients on treatment with beta-adrenergic blockers. They may be more reactive to allergens given for treatment and unresponsive to the usual doses of adrenaline used to treat allergic reactions.

Do not give specific immunotherapy (SIT) to patients with diseases in which adrenaline is contra-indicated such as coronary artery disease, hypertension and hyperthyroidism.

It is not advisable to use during pregnancy or lactation. If a patient becomes pregnant during treatment stop injections.

Immunotherapy should be avoided in patients with a bleeding tendency.

It is uncertain whether specific immunotherapy (SIT) can exacerbate autoimmune diseases, therefore allergen injections should be given cautiously to patients with autoimmune diseases and only if the risk from allergen exposure is greater than the risk of exacerbating the autoimmune disease.

WARNINGS:
STOP SPECIFIC IMMUNOTHERAPY (SIT) IN PATIENTS WITH SEVERE REACTIONS. DO NOT INJECT INTO A BLOOD VESSEL OR INTRAMUSCULARLY.

DOSAGE AND DIRECTIONS FOR USE:
ALLPYRAL
injections must be given subcutaneously in the lower frontal upper arm.

To avoid the formation of nodules caused by frequent injections at the same site, gently massage the area immediately after administration.

1. SHAKE VIAL GENTLY BEFORE WITHDRAWING DOSE.
2. Proper aseptic precautions should be taken during withdrawal of dose including swabbing of bungs with suitable antiseptic.
3. Inject slowly in the lower frontal upper arm using deep subcutaneous route. Always pull back syringe plunger before injecting to ensure needle is not in a blood vessel.

Seasonal allergens
Initial Treatment
Treatment should commence with an initial Treatment Set. A course of twelve subcutaneous injections at weekly intervals should ideally be administered pre-seasonally. If more than ten days have elapsed since the previous injection, repeat the same dose. If more than three weeks have elapsed since the last injection, reduce the dose proportionately.

The course should be completed not less than three weeks before the particular allergen becomes airborne. Best results are obtained if the pre-seasonal course is timed to end as close as possible to a date three weeks before pollination.

Special diluent vials are available from the manufacturer for extremely sensitive patients.

Note: The patient should avoid strenuous exercise on the day of the injection.

Maintenance Treatment
Maintenance treatment is advisable in all cases. Maintenance treatment is intended to maintain the protection afforded by the initial treatment course and should only be given where an initial treatment course has recently been completed.

Treatment with a Maintenance Set involves repeat injections of the top dose achieved on the preceding initial course. These injections should be administered at monthly intervals.

No more than six weeks should elapse between the end of the initial course and the first maintenance injection or between subsequent maintenance injections. If more than six weeks have elapsed the dosage should be reduced proportionately depending on the time interval.

When changing to a new bottle either at the initiation of, or during Maintenance therapy, it is advisable to reduce the dose by 50%, then administer the full dose 7 - 14 days later, and thereafter continue normal Maintenance therapy.

Note: No strenuous exercise on day of injection.

Perennial Allergens
Initial Treatment
Treatment should commence with an Initial Treatment Set and consists of a course of twelve subcutaneous injections administered at weekly intervals. If more than ten days have elapsed since the last injection, repeat the same dose. If more than three weeks have elapsed since the last injection, reduce the dose proportionately. Where only perennial (non-seasonal) allergens are involved, treatment may commence at any time of year.

Special diluent vials are available from the manufacturer for extremely sensitive patients.

Maintenance Treatment
Treatment with a Maintenance Set involves repeat injections of the top dose achieved on the preceding initial course, administered at intervals of four to six weeks.

No more than six weeks should elapse between the end of the initial course and the first maintenance injection or between subsequent maintenance injections. If more than six weeks have elapsed, the dosage should be reduced proportionately depending on the time interval.

Whenever changing to a new bottle either at the initiation of, or during, Maintenance therapy, it is advisable to reduce the dose by 50%, then administer the full dose 7 - 14 days later, and thereafter continue normal Maintenance therapy.
Standard Dosage Schedule

Vial Label Colour & Strength Dose Number Dose (PNU) Volume Injected (mL)
GREEN
        100 PNU/mL
1
2
3
10
20
50
0.10
0.20
0.50
BLUE
        1000 PNU/mL
4
5
6
7
100
200
400
800
0.10
0.20
0.40
0.80
BLACK
        10000 PNU/mL
8
9
10
11
12
1500
2500
4000
8000
10000
0.15
0.25
0.40
0.80
1.00


NB: For maintenance therapy please order the 10 mL Maintenance Set of 10 000 PNU/mL (black label) at the 10th week. Continue to administer the highest dose achieved with initial therapy, at 4 to 6 week intervals.

For Extremely sensitive patients
Once the special dilution injections have been completed, treatment should continue with the Standard Dosage Schedule.

SIDE EFFECTS:
Local and/or systemic reactions may occur. Injections of ALLPYRAL may be associated with some itching and redness at the injection site. Prolonged pain, or pain radiating up the arm is usually the result of intramuscular injection.

Management of adverse reactions
Small local reactions
If a small local reaction occurs at the injection site consisting of a swelling less than 5 cm in diameter, proceed to the next dose on the dosage schedule.

Large local reactions
If a large local reaction occurs at the injection site consisting of a swelling greater than 5 cm in diameter, treat with oral antihistamine. An ice pack may lessen discomfort. Reduce the next dose to that previously tolerated. If necessary increase subsequent doses by smaller increments.

DISCONTINUE INJECTIONS IF EXTENT OF REACTION INCREASES.

A repeat dose should NEVER be given until all local reaction resulting from the previous dose has disappeared.

Mild systemic reactions.
If a mild systemic side-effect occurs such as mild itching of the eyes, nose, throat or skin, or localised urticaria, treat with oral antihistamine. Reduce the next dose to that previously tolerated. If necessary increase subsequent doses by smaller increments.

Patients may complain of drowsiness after an injection. This should be regarded as a mild systemic reaction.

DO NOT CONTINUE TO INCREASE DOSE IF REPEATED REACTIONS OCCUR but continue treatment with the dose previously tolerated.

Severe systemic reactions:
Generalised urticaria
Give antihistamine by mouth. If the reaction becomes more severe treat as anaphylaxis.

Asthma.
Severe asthma requires treatment with inhaled bronchodilators with or without steroids according to severity. If the reaction becomes more severe treat as anaphylaxis.

Anaphylaxis
Anaphylactic shock includes some of the following symptoms: widespread urticaria, angio-oedema of the face and glottis, pallor, cough, wheezing, bronchospasm, faintness and hypotension, bradycardia, hyperemesis and shock.

Treatment
Should an anaphylactic reaction occur immunotherapy should be discontinued. The patient should be treated with adrenaline, corticosteroids and antihistamines.

Severe delayed reactions. Serum sickness type reactions with fever, joint pain, urticaria and lymphadenopathy may occur after several days.

SPECIAL PRECAUTIONS:
1. Emergency equipment including Adrenaline injection 1:1000 and personnel trained in its use should always be available.
2. PATIENTS SHOULD BE KEPT UNDER MEDICAL OBSERVATION FOR AT LEAST 30 MINUTES AFTER TREATMENT. The majority of serious reactions will begin within 30 minutes after an injection. Patients should be instructed to seek immediate medical assistance if symptoms of an allergic reaction or shock begin after leaving the clinic. Patients must be instructed to avoid, for the remainder of the day, any activity which may increase blood flow through the injection site, such as alcoholic drinks, strenuous exercise, hot baths, sauna, application of local heat or rubbing. Patients should be instructed to seek medical advice immediately if symptoms develop after leaving the clinic. The sooner symptoms begin, the more severe they are likely to be and the sooner treatment measures should begin.
3. Special care should be taken in the treatment of patients with asthma as they may be more susceptible to severe adverse reactions. Before considering immunotherapy for patients with asthma establish serial baseline lung function values. Measure lung function (e.g. peak flow) before giving each injection to asthma patients. If limited respiratory reserve compared to previous readings, postpone the injection. After giving an injection to a patient with asthma repeat the lung function test before the patient is allowed to leave. If lung function has decreased compared to pre-injection value detain patient longer and if necessary treat the bronchospasm. Do not allow the patient to leave the clinic until lung function is satisfactory.
  In many patients with asthma, lung function is worse in the morning and therefore in such patients it may be preferable to give injections in the late afternoon.
4. Always ask the patient and record whether any local or systemic reaction occurred after leaving the clinic after the previous injection. If necessary adjust the dose of the next injection appropriately depending on the severity of the reaction.
5. Absolute accuracy of dosage is essential. Double-check both the bottle strength and amount drawn up every time. Injections must be deep subcutaneous.
6. Before each injection ask if the patient has a cold, influenza, or febrile illness; if so the injection should be postponed.
7. When changing vials for a patient on maintenance treatment the first dose from the new vial should be not more than 50% of the last dose from the previous vial.
8. If a patient is receiving 2 different allergen extracts concurrently, try to avoid giving injections of both on the same day. If this is unavoidable give the injections in different arms and allow at least 30 minutes between injections.
9. If possible avoid all other immunisation procedures (e.g. for poliomyelitis) during treatment with allergen extracts. If they are essential, give immunisation one week after allergen injection. The next allergen injection should be 2 weeks after immunisation and the dose reduced by 50%.
10. Never change a patient directly from treatment with any other type of allergen extract to treatment with ALLPYRAL or vice versa. If a change is mandatory, start with the new extract as though the patient is being treated for the first time.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF TREATMENT:
See under 'Management of adverse reactions.'

PRESENTATION:
ALLPYRAL SPECIAL GRASS Concentration
PNU/mL
Volume in mL Reg.No. 
  100
1 000
10000
5
5
5
T/30.1/692
T/30.1/693
T/30.1/694
 
MAINTENANCE SET 10 000 10 T/30.1/694
TREATMENT SET 100, 1 000 and 10 000 3 x 4,5 T/30.1/734

ALLPYRAL PURE MITE Concentration PNU/mL Volume in mL Reg.No.
  100
1 000
10 000
5
5
5
T/30.1/722
T/30.1/723
T/30.1/724
MAINTENANCE SET 10 000 10 T/30.1/724
TREATMENT SET 100, 1 000 and
10 000
3 x 5 T/30.1/737
A special diluent vial is available on request, to prepare a 1 in 10 dilution of the 100 PNU/mL vial.

STORAGE DIRECTIONS:
Store in a refrigerator between 2° and 8°C.
DO NOT FREEZE
Do not mix with any other type of allergen extract.
Do not use after expiry date on vial label.
Keep out of reach of children

NAME AND BUSINESS ADDRESS OF APPLICANT:
BAYER (PTY) LTD
Wrench Road Isando 1600
68/11192/07

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
July 1993

ALLPYRALbibliography, reprints, and additional information available on request.

Allpyral is a registered Trade Mark

Code SA.3.6                C9216/0596
Davbar Dbn.

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