ALUTARD SQ Bee Initial Pack (100 SQ-U/ml, 1 000 SQ-U/ml, 10 000 SQ-U/ml and 100 000 SQ-U/ml) suspension for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Apis mellifera; Apis mellifera; Apis mellifera; Apis mellifera

Available from:

ALK-Abello A/S

ATC code:

V01AA07

INN (International Name):

Apis mellifera; Apis mellifera; Apis mellifera; Apis mellifera

Dosage:

100,000

Pharmaceutical form:

Suspension for injection

Therapeutic area:

insects

Authorization status:

Marketed

Authorization date:

2019-04-12

Patient Information leaflet

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1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALUTARD SQ BEE 100 000 SQ-U/ML
ALUTARD SQ BEE INITIAL PACK
(100 SQ-U/ML, 1 000 SQ-U/ML, 10 000 SQ-U/ML AND 100 000 SQ-U/ML)
SUSPENSION FOR INJECTION
ALLERGEN FROM HONEY BEE VENOM (_APIS MELLIFERA_)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. 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 pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What ALUTARD SQ Bee is and what it is used for
2.
What you need to know before you are given ALUTARD SQ Bee
3.
How to use ALUTARD SQ Bee
4.
Possible side effects
5.
How to store ALUTARD SQ Bee
6.
Contents of the pack and other information
1.
WHAT ALUTARD SQ BEE IS AND WHAT IT IS USED FOR
ALUTARD SQ Bee contains allergen (the substance that cause the
allergic reaction) from honey bee
venom and is used as preventive treatment for allergy against honey
bee stings.
This treatment is used for patients who are known to have serious
allergic reactions to honey bee
stings. The aim of the treatment is to address the underlying cause of
the allergy. It works by gradually
increasing the immune system’s tolerance to honey bee venom.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ALUTARD SQ BEE
DO NOT USE ALUTARD SQ BEE
-
if you are allergic to any of the other ingredients of this medicine
(listed in section 6)
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if you have a disease which affects the immune system
-
if you have recently had an asthma attack and/or have recently
_ _
experienced worsening of your
asthma symptoms e.g. increase in daytime symptoms, nightly wakening,
increased need for
medication and/or activity limitations
-
if you suffer from severe heart or blood vessel d

Summary of Product characteristics

Health Products Regulatory Authority
19 January 2022
CRN00C7F2
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ALUTARD SQ Bee Initial Pack (100 SQ-U/ml, 1 000 SQ-U/ml, 10 000
SQ-U/ml and 100 000 SQ-U/ml) suspension for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ALUTARD SQ Bee contains allergen from honey bee venom (_Apis
mellifera_) adsorbed to aluminium hydroxide, hydrated.
The biological activity of ALUTARD SQ Bee is related to the
concentration of the allergen and is expressed in SQ-U/ml. The vials
are distinguished by differently coloured vial numbers.
Table 1: Vial number and strength
Vial No.
(Colour code)
Strength (SQ-U/ml)
Aluminium content in adjuvant (mg/ml)
1 (Grey)
100
0.00113
2 (Green)
1000
0.0113
3 (Orange)
10 000
0.113
4 (Red)
100 000
1.13
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
Clear liquid with or without a precipitate. The precipitate might be
white to faintly brown or green.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Allergy immunotherapy for patients with a documented history of
generalised and/or systemic IgE-mediated allergic reactions
due to sensitisation to honey bee venom (_Apis mellifera_), confirmed
by skin prick test and/or intradermal test and/or specific
IgE test.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with ALUTARD SQ Bee should be carried out under the
supervision of a doctor experienced in specific
immunotherapy. After each injection, the patient must be observed for
at least 30 minutes.
_Posology_
The treatment is divided into two phases; an up-dosing phase and a
maintenance phase. The aim is to gradually increase the
dose until the highest tolerated maintenance dose is reached. The
highest recommended maintenance dose is 1 ml of 100 000
SQ-U/ml (vial 4). The dosing of ALUTARD SQ Bee must always be adjusted
according to the allergenic anamnesis and the
patient's sensitivity to the specific allergen (see 4.4).
Up-dosing phase:
Recommendations for up-dosing are give