Alutard Bee Venom
ALUTARDALUTARD SQ Bee contains matter from honey bee venom (Apis mellifera) adsorbable to aluminum hydroxide, hydrated.The biological activity of ALUTARD SQ Bee is expounded to the concentration of the matter and is expressed in SQ-U/ml.
Table 1: ampoule variety and strength
Vial No.
(Colour code)
Strength (SQ-U/ml)
Aluminium content in adjuvant (mg/ml)
For a full list of excipients, see section half dozen.1.
3. Pharmaceutical kind
Suspension for injection.
The suspension is white to faintly brown or inexperienced.
4. Clinical particulars
4.1 Therapeutic indications
Allergy therapy for patients with a documented history of generalised and/or general IgE-mediated allergies because of sensitisation to honey bee venom (Apis mellifera), confirmed by skin prick check and/or {intradermal check|subcutaneous test|skin test} and/or specific immune gamma globulin test.
4.2 materia medica and methodology of administration
Treatment with ALUTARD SQ Bee ought to be administered beneath the supervising of a doctor knowledgeable in specific therapy. once every injection, the patient should be determined for a minimum of half-hour.
Posology
The treatment is split into 2 parts; associate degree up-dosing part and a maintenance phase. The aim is to step by step increase the dose till the very best tolerated maintenance dose is reached. the very best suggested maintenance dose is one cubic centimeter of a hundred 000 SQ-U/ml (vial 4). The dosing of ALUTARD SQ Bee should be adjusted in keeping with the substance anamnesis and therefore the patient's sensitivity to the precise matter (see four.4).
Up-dosing phase:
Recommendations for up-dosing area unit given in table a pair of, 3 and 4. The recommendations given within the tables area unit to be thought-about as a steering. The patient ought to learn that native and general reactions could occur throughout the up-dosing part (see section four.8). the selection of up-dosing schedule depends on the patient's sensitivity since the danger of developing allergies is reduced with a slow up-dosing.
Table 2: 7-week up-dosing (cluster) that is usually recommended in cases once there's a necessity for quicker protection.
Vial
no
Strength
SQ-U/ml
Week
no
Injection
no
Volume
ml
Dosage
SQ-U
1
100
1
1
0.1
10
2
1 000
2
0.1
100
3
10 000
3
0.1
1 000
10 000
2
4
0.2
2 000
10 000
5
0.2
2 000
10 000
3
6
0.5
5 000
10 000
7
0.5
5 000
4
100 000
4
8
0.2
20 000
100 000
5
9
0.4
40 000
100 000
6
10
0.6
60 000
100 000
7
11
1.0
100 000
Table 3: 15-week up-dosing (conventional) that is appropriate for the bulk of patients.
Vial
no
Strength
SQ-U/ml
Week
no
Injection
no
Volume
ml
Dosage
SQ-U
1
100
1
1
0.2
20
100
2
2
0.4
40
100
3
3
0.8
80
2
1 000
4
4
0.2
200
1 000
5
5
0.4
400
1 000
6
6
0.8
800
3
10 000
7
7
0.2
2 000
10 000
8
8
0.4
4 000
10 000
9
9
0.8
8 000
4
100 000
10
10
0.1
10 000
100 000
11
11
0.2
20 000
100 000
12
12
0.4
40 000
100 000
13
13
0.6
60 000
100 000
14
14
0.8
80 000
100 000
15
15
1.0
100 000
Table 4: 25-week up-dosing (extended conventional) suggested for sensitive patients.
Vial
no
Strength
SQ-U/ml
Week
no
Injection
no
Volume
ml
Dosage
SQ-U
1
100
1
1
0.2
20
100
2
2
0.4
40
100
3
3
0.8
80
2
1 000
4
4
0.2
200
1 000
5
5
0.4
400
1 000
6
6
0.8
800
3
10 000
7
7
0.1
1 000
10 000
8
8
0.2
2 000
10 000
9
9
0.3
3 000
10 000
10
10
0.4
4 000
10 000
11
11
0.5
5 000
10 000
12
12
0.6
6 000
10 000
13
13
0.7
7 000
10 000
14
14
0.8
8 000
10 000
15
15
0.9
9 000
4
100 000
16
16
0.1
10 000
100 000
17
17
0.2
20 000
100 000
18
18
0.3
30 000
100 000
19
19
0.4
40 000
100 000
20
20
0.5
50 000
100 000
21
21
0.6
60 000
100 000
22
22
0.7
70 000
100 000
23
23
0.8
80 000
100 000
24
24
0.9
90 000
100 000
25
25
1.0
100 000
Maintenance phase:
When the upkeep dose is reached, the interval between injections is step by step increased . The interval is increased from one to a pair of, four and half dozen to eight weeks. later, the injections area unit given each half dozen to eight weeks. the upkeep treatment is sustained for 3-5 years.
If the patient responds with severe allergies throughout the up-dosing part, it's doable that the very best suggested dose of a hundred 000 SQ-U isn't reached. A lower dose ought to then be thought-about because the largest tolerated dose for the patient, and this may be the upkeep dose.
Exceeded interval between 2 visits
If the suggested interval between visits has been exceeded, the dosing of the subsequent injection is handled in keeping with the subsequent recommendation:
Table 5: Exceeded interval between 2 visits throughout the up-dosing part
Weeks between visits
Dosage
Up to a pair of weeks
Continue up-dosing in keeping with table a pair of, 3 or 4
2 - three weeks
Repeat previous dose
3 - four weeks
Reduce to fifty you look after previous dose
4 weeks or additional
Restart up-dosing in keeping with table a pair of, 3 or 4
Table 6: Exceeded interval between 2 visits throughout the upkeep part
Weeks between visits
Dosage
Up to eight weeks
Continue with the upkeep dose
8 - ten weeks
Reduce to seventy five you look after previous dose
10 - twelve weeks
Reduce to fifty you look after previous dose
12 – fourteen weeks
Reduce to twenty five you look after previous dose
14 - sixteen weeks
Reduce to ten you look after previous dose
16 weeks or additional
Restart up-dosing in keeping with table a pair of, 3 or 4
In case of a dose reduction within the maintenance part, the patient should be fastidiously determined once the injection. later, up-dose in keeping with the recommendations in table a pair of, three or four till the largest maintenance dose is reached.
Concomitant treatment with quite one matter
In case of treatment with quite one matter concomitantly, the injections ought to be in several locations on the arm. so as to judge doable allergies caused by the precise matter it's suggested to grant the injections with a thirty minute interval.
Dose reduction just in case of allergies
Dose reductions just in case of native reactions
If associate degree injection web site reaction persists for quite half dozen hours once the injection, the subsequent dose reduction is usually recommended counting on the dimensions of the swelling:
Table 7: suggested dose-reduction just in case of native adverse events
Maximum diameter of swelling
Recommended dose reduction
Children
Adults
< 5 cm
< 8 cm
Continue up-ward volumetric analysis in keeping with schedule (table a pair of, 3 or 4)
5-7 cm
8-12 cm
Repeat dose last given
7-12 cm
12-20 cm
Reduce dose to dose given the time before last
12-17 cm
>20 cm
Reduce dose to dose given a pair of times before last
>17 cm
-
Reduce dose to dose given three times before last
Dose reduction just in case of general reactions
If a significant general reaction (see section four.8) happens once injection, the treatment ought to solely be continuing once careful thought. If the treatment is sustained, the subsequent dose ought to be reduced to 100% of the dose agitating the reaction.
The chosen reduced dose is split into 2 injections given with a thirty minute interval. The patient ought to be determined once the injections. later, up-dose in keeping with recommendations in table a pair of, three or four till the largest tolerated dose or a hundred 000 SQ-U is reached.
Elderly population
No further dose adjustment is needed within the old population.
Paediatric population
No further dose adjustment is needed within the medicine population. See section four.4.
Method of administration
After every injection, the patient should be determined for a minimum of half-hour. On the day of injection the patient should avoid exercise, hot baths associate degreed alcohol as these co-factors could probably amplify an hypersensitivity reaction reaction.
ALUTARD SQ Bee is run subcutaneously. The vials should be inverted up and down ten - twenty times before use. The injection is given either laterally within the distal a {part of} the higher arm or dorsally within the proximal part of the forearm.
Avoid intravascular injection by careful aspiration before injection. Aspiration should be continual for each zero.2 cubic centimeter throughout the injection and therefore the injection should be slowly. associate degree hypersensitivity reaction emergency kit should be accessible whereas victimisation ALUTARD SQ Bee. Please talk to section four.4 for warnings and precaution in respect to treatment.
Precautions in respect to administrations
The injection ought to be postponed:
- If the patient includes a fever or shows different clinical signs of a chronic or acute infection.
- If the patient has associate degree dermatitis that has exacerbated.
- If the patient has had associate degree allergy among the last 3-4 days before the injection.
- If other forms of vaccinations are given, wait a minimum of per week before treatment with ALUTARD SQ is sustained. different vaccinations shouldn't be ahead of per week once associate degree ALUTARD SQ injection.
Before injection:
- check the matter, concentration, volume and former injection date (dosing interval), before every injection.
- ALUTARD SQ Bee is meant for shot. blood vessel administration should be avoided because of the increased risk of allergies.
- allergies (both native and systemic) that occurred throughout the previous injections ought to be recorded and therefore the dose ought to be assessed on the idea of this.
- Pre-treatment with H1 antihistamines ought to be thought-about within the up-dosing part for patients WHO expertise massive native reactions or general allergies.
- The patient's state of health and hypersensitivity reaction standing should be evaluated yet as any changes of different medication since the last administered injection (see section four.4 and 4.5).
- The respiratory illness standing, in patients with a case history of respiratory illness, should be evaluated before injection (see section four.4).
After injection:
- The patient should be suggested to consult a doctor or ER right away just in case of severe general delayed reactions.
- The patient should be suggested to look at any native or general reactions which will occur later, and to tell the attending doctor at succeeding visit.
- Any allergies (both native and systemic) ought to be recorded before the patient leaves the clinic.
4.3 Contraindications
- Hypersensitivity to any of the excipients listed in section half dozen.1.
- Patients with active or poorly controlled general response diseases and immunological disorder disorders.
- Patients with disorders or conditions wherever associate degree induced hypersensitivity reaction reaction imply associate degree unacceptable risk like severe upset.
- respiratory illness patients in danger of exacerbation and/or with inadequate symptom management outlined because the presence of:
loss of symptom management among the last four weeks (e.g. increase in daytime symptoms, nightly waking up, increased would like of medication, activity limitations).
4.4 Special warnings and precautions to be used
Severe general allergies
Due to the danger of significant allergies, immediate access to full revitalization instrumentation and medicines should be accessible, as well as Adrenalin for injection and employees trained within the use thence. If symptoms of a general reaction, like urtication, angioedema or severe respiratory illness occur, symptomatic treatment ought to be initiated right away (see section four.2 and 4.8).
Cardiovascular diseases
Patients with viscus diseases could also be at increased risk just in case of general allergies. Patients with vessel diseases should be sufficiently treated for the underlying condition before the initiation of ALUTARD SQ Bee treatment. In reference to the treatment with ALUTARD SQ Bee special attention ought to be. See section four.3. Clinical expertise in treatment with ALUTARD SQ Bee of patients with viscus diseases is proscribed.
Autoimmune diseases
There aren't any controlled studies on the influence of response disorders on the effectivity of hypersensitivity reaction therapy (AIT), or on response disorders as a predisposing issue for severe facet effects throughout AIT. AIT could solely be initiated in patients with response maladys just in case of disease remission or well-balanced medical aid. ALUTARD SQ Bee ought to so be prescribed with caution in these patients.
Malignant growth diseases
There aren't any controlled studies on the influence of malignant growth diseases on the effectivity of AIT, or on malignant growth diseases as a predisposing issue for severe facet effects throughout ALUTARD SQ Bee therapy. AIT could solely be initiated once the malignant malady is stable. just in case of aggravation treatment with ALUTARD SQ Bee ought to be out of print. ALUTARD SQ Bee ought to so be prescribed with caution in these patients.
Mastocytosis
Patients with increased baseline body fluid tryptase associate degreed/or mastocytosis could also be at an increased risk of developing general allergies and therefore the severity of those could also be increased . Patients with mastocytosis ought to so be monitored fastidiously throughout treatment with ALUTARD SQ Bee. Patients with mastocytosis could expect less effectivity of treatment compared with the overall insect venom allergic population.
Treatment with ACE-inhibitors
Patients at the same time treated with ACE inhibitors could also be at higher risk of developing additional severe hypersensitivity reaction reactions and will so be fastidiously monitored throughout the up-dosing part. quickly interrupting the antihypertensive treatment (based on the half-life of the ACE inhibitor) ought to be thought-about fastidiously in respect to the benefits of therapy within the individual patient. ACE inhibitors would possibly scale back the result of ALUTARD SQ Bee.
Treatment with MAO-inhibitors, COMT- inhibitors or beta-blockers
One choice for treating severe general allergies is Adrenalin. the consequences of Adrenalin could also be potentiated in patients treated with antidepressant drug antidepressants, MAO inhibitors (MAOIs) and/or COMT inhibitors with doable fatal consequences. the consequences of Adrenalin could also be reduced in patients treated with beta-blockers. additionally, the consequences of Adrenalin could exacerbate upset, e.g .cause arrhythmia. Patients in treatment with beta-blockers ought to be fastidiously monitored throughout the up-dosing part.
Asthma
Asthma may be a known risk issue for severe general allergies. In patients with respiratory illness, the respiratory illness symptoms ought to be adequately controlled before the initiation of ALUTARD SQ Bee treatment. In reference to the treatment with ALUTARD SQ Bee special attention ought to be. The patient´s respiratory illness condition should be assessed before every injection (see section four.3).
Patients should learn of the requirement to hunt medical attention right away if their respiratory illness suddenly deteriorates. Clinical expertise in treatment with ALUTARD SQ Bee of patients with respiratory illness is proscribed.
Other populations (including patients with nephritic dysfunction)
As ALUTARD SQ Bee contains atomic number 13, there's a theoretical risk of atomic number 13 accumulation in patients at high risk (e.g. patients with nephritic disfunction and patients concomitantly treated with different atomic number 13 containing medicine (e.g. antacids)). this could be thought-about once initiating medical aid with ALUTARD SQ Bee.
Paediatric population
Special care ought to be to the risk-benefit assessment with relation to the treatment of youngsters younger than five years ancient. for kids ≥ five years ancient clinical information of effectivity area unit distributed, but information on safety don't reveal a better risk as for adults. A risk-benefit assessment with relation to the treatment of youngsters ≥ five years ancient is additionally suggested.
Co-administration with different AIT
No clinical expertise on co-administration with different kinds of hypersensitivity reaction therapy is accessible.
This healthful product contains but one mmol Na (23mg) per dose, i.e primarily 'sodium-free'.
4.5 Interaction with different healthful merchandise and different sorts of interaction
No interaction studies are conducted in humans and no potential drug interactions are known from any supply. Concomitant treatment with symptomatic anti-allergy medications, e. g. antihistamines, corticosteroids and somatic cell stabilisers could increase the patient's tolerance level towards the matter injections. this could be thought-about at conclusion of such medications.
For info considering concomitant use of ACE inhibitors, MAOIs, COMT inhibitors, beta-blockers and antacids see section four.4.
4.6 Fertility, gestation and lactation
Pregnancy
There is no clinical expertise of the utilization of ALUTARD SQ Bee throughout gestation. Up-dosing treatment shouldn't be initiated throughout gestation. If gestation happens throughout maintenance treatment, the upkeep treatment could continue once a careful analysis of the patient's general condition and reactions to previous injections with ALUTARD SQ Bee.
Breastfeeding
No clinical information is accessible on the utilization of ALUTARD SQ Bee throughout breastfeeding. No effects on the breastfed infants area unit anticipated.
Fertility
There aren't any clinical information accessible associated with the result of ALUTARD SQ Bee on fertility.
4.7 Effects on ability to drive and use machines
ALUTARD SQ Bee could in some cases influence the flexibility to drive or use machines because of the facet result giddiness.
4.8 Undesirable effects
Summary of the security profile
Generally, reactions showing in reference to ALUTARD SQ Bee treatment occur because of associate degree immunologic reaction (local and /or systemic) to honey bee venom. Symptoms of a direct reaction seem among the primary half-hour once the injection. Symptoms of a delayed reaction seem among the primary twenty four hours once the injection.
Commonly according adverse reactions in patients treated with ALUTARD SQ Bee area unit native reactions at the injection web site.
The most serious adverse drug reaction occurring in patients treated with ALUTARD SQ Bee is anaphylaxis. because it may be a life threatening condition, it demands immediate treatment.
Tabulated list of adverse reactions
Data from clinical trials with ALUTARD SQ Bee area unit restricted. Therefore, the subsequent table relies on adverse drug reactions for the merchandise according impromptu from the market. The frequency isn't known (cannot be calculable from the accessible data).
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