Emerade 150micrograms/0.15ml (1 in 1,000) solution for injection auto-injectors

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Adrenaline acid tartrate

Available from:

1 in 1,000) solution for injection auto-injectors (Bausch & Lomb UK Ltd

ATC code:

C01CA24

INN (International Name):

Adrenaline acid tartrate

Dosage:

1mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 03040300; GTIN: 7046265359388

Patient Information leaflet

Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.
ULOTKA PIL
Nazwa produktu
Product Name
EMERADE
150ΜG/300ΜG/500ΜG
_/adrenaline/_
Kolor nadruku Colours
Cyan
Black
-
-
Kraj
Country (ISO)
UK/IE
Nr wykrojnika
Spec No
-
Opracowane przez
Designed by
5599
Kod Wytwórcy
Manufacturer code
620314
Nr korekty
Proof No
1
Data
Date
23-09-2016
Kod farmaceutyczny
Pharmacode
-
Kod wersji
Valeant version code
P9UKIE03
Inny kod
Other code
-
Rozmiar czcionki
Font size
MINIMUM 9 PT
Wymiar ulotki
PIL size
170 X 320 MM
Krój czcionki
Font used
TIMES NEW ROMAN FONT
FAMILY
Gramatura papieru
Paper weight
-
Komentarze Comments (Reason for the change)
- CHANGES IN THE TEXT
- PACKING SITE: RECHON LIFE SCIENCE AB
- PMR_ICN-16-1025
Akceptacja Techniczna Technical Approval
Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval
PACKAGE LEAFLET: INFORMATION FOR THE USER
EMERADE
® 150 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED PEN
EMERADE
® 300 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED PEN
EMERADE
® 500 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED PEN
Adrenaline
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
pharmacist.
-
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
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Emerade is and what it is used for
2.
What you need to know before you use Emerade
3.
How to use Emerade
4.
Possible side effects
5.
How to store Emerade
6.
Contents of the pack and other information
1. WHAT EMERADE IS AND WHAT IT IS USED FOR
Emerade is an auto-injector that contains adrenaline
in a solution for injection.
Adrenaline counteracts the fall of blood pressure
in anaphy

Summary of Product characteristics

OBJECT 1
EMERADE, 150 MICROGRAMS, SOLUTION FOR INJECTION
IN PRE-FILLED PEN
Summary of Product Characteristics Updated 20-Jan-2017 | Bausch & Lomb
U.K Limited
1. Name of the medicinal product
Emerade 150 micrograms solution for injection in pre-filled pen
2. Qualitative and quantitative composition
The pre-filled pen contains 0.5 ml of adrenaline solution 1 mg/ml.
Emerade 150 micrograms delivers a single dose of 0.15 ml containing
150 micrograms of adrenaline (as
tartrate).
Each 0.15 ml (150 micrograms) dose contains 0.075 mg sodium
meta-bisulphite (E223).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection in a pre-filled pen (auto-injector).
Clear and colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Emerade is indicated for the emergency treatment of severe acute
allergic reactions (anaphylaxis)
triggered by allergens in foods, medicines, insect stings or bites,
and other allergens as well as for
exercise-induced or idiopathic anaphylaxis.
4.2 Posology and method of administration
Posology
The effective dose is usually within the range 5- 10 micrograms per kg
bodyweight but higher doses may
be necessary in some cases.
_Paediatric population _
Use in children: Emerade 500 micrograms is not recommended for use in
children.
_Children below 15 kg bodyweight_
A dosage below 150 micrograms cannot be administered with sufficient
accuracy in children weighing
less than 15 kg and use is therefore not recommended unless during a
life-threatening situation and under
medical advice.
_Children between 15 kg and 30 kg bodyweight_
The usual dose is 150 micrograms.
_Children over 30 kg bodyweight_
The usual dose is 300 micrograms.
_Adolescent patients over 30 kg bodyweight_
The dosage recommendations for adult patients should be followed.
_Adults _
The recommended dose is 300 micrograms for individuals under 60 kg
bodyweight. The recommended
dose is 300 to 500 micrograms for individuals over 60 kg bodyweight,
depending on clinical judgement.
An initial dose sho