Pharmalgen Bee Venom 120nanogram powder and solvent for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bee venom

Available from:

ALK-Abello Ltd

ATC code:

V01AA07

INN (International Name):

Bee venom

Dosage:

120nanogram

Pharmaceutical form:

Powder and solvent for solution for injection

Administration route:

Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Invalid to prescribe in NHS primary care

Product summary:

BNF:

Patient Information leaflet

1
PL10085/0003, PL10085/0004-1313-v1-uk
PACKAGE LEAFLET: INFORMATION FOR THE USER
PHARMALGEN® BEE VENOM
PHARMALGEN® WASP VENOM
100μg/ml
powder and solvent for solution for injection
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.
-
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 Pharmalgen is and what it is used for
2.
What you need to know before you use Pharmalgen
3.
How to use Pharmalgen
4.
Possible side effects
5.
How to store Pharmalgen
6.
Contents of the pack and other information
1. WHAT PHARMALGEN IS AND WHAT IT IS USED FOR
Pharmalgen Bee Venom and Pharmalgen Wasp Venom can be used in two
ways:
FOR TREATMENT
•
Pharmalgen Bee Venom and Pharmalgen Wasp Venom are treatments to
reduce your
body’s reaction to bee or wasp stings. In the rest of this leaflet,
these medicines will be
called Pharmalgen.
FOR DIAGNOSIS
•
Pharmalgen is also used to test if a person will react too strongly to
bee or wasp stings.
•
No specific indication for children can be made.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE PHARMALGEN
DO NOT USE PHARMALGEN IF:
•
If you are allergic to any of the ingredients of this medicine apart
from the active
substance (listed in section 6)
•
You have a disease of, or a problem with, your immune system
•
You have a chronic heart or lung disease or severe arterial
hypertension or are being
treated with β-blockers
•
You are being treated with tricyclic antidepressants or monoamine
oxidase inhibitors
(MAOIs)
•
You currently have cancer
•
You have severe asthma (seasonal or chronic)
•
You are being treated with ACE inhibitors (medicines for heart or
blood pressure)
2
PL10085/0003, PL10085/0004-1313-v1-uk
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before using P

Summary of Product characteristics

OBJECT 1
PHARMALGEN BEE VENOM
Summary of Product Characteristics Updated 10-May-2017 | ALK-Abello
Ltd
1. Name of the medicinal product
Pharmalgen Bee Venom powder and solvent for solution for injection
2. Qualitative and quantitative composition
The active ingredient is freeze-dried _Apis mellifera_ (Honey Bee)
venom.
Content of active ingredient in Pharmalgen Bee Venom is 120 μg.
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Powder and solvent for solution for injection.
4. Clinical particulars
4.1 Therapeutic indications
Diagnosis and treatment of IgE-mediated allergy to bee venom.
4.2 Posology and method of administration
DIAGNOSIS
Diagnosing allergy to bee venom using Pharmalgen Bee Venom should be
carried out using either a skin
prick test or an intracutaneous test.
Skin prick test:
A concentration of 100 μg venom/ml is recommended for use in a skin
prick test. However, for extremely
sensitive patients, testing with a lower concentration (e.g. 1 or 10
μg venom/ml) is advisable. For
instructions on reconstitution and dilution of the product before
administration, see section 6.6.
Alternatively, an end-point titration test can be used to determine
individual starting concentrations for
specific immunotherapy. The end-point titration test is performed
using concentrations of venom from
0.01 μg venom/ml. If a positive reaction is observed at 0.01 μg
venom/ml, retesting must be performed
using a lower concentration. The lowest concentration resulting in a
positive reaction is used as the end-
point.
The reaction is read after 15-20 minutes. A reaction is considered
positive when a weal with a diameter of
more than 3 mm is observed.
Albumin Diluent should be used for dilution and as control.
Intracutaneous test:
The intracutaneous test is 100-1000 times more sensitive than the skin
prick test.
The intracutaneous test should always be performed as an end-point
titration test. It is recommended to
start with a concentration of 0.0001 μg venom/ml and increase the
concentration stepwise b