Adrenaline (base) 1mg/10ml (1 in 10,000) dilute solution for injection pre-filled syringes

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Adrenaline

から入手可能:

base) 1mg/10ml (1 in 10,000) dilute solution for injection pre-filled syringes (Aguettant Ltd

ATCコード:

C01CA24

INN（国際名）:

Adrenaline

投薬量:

100microgram/1ml

医薬品形態:

Solution for injection

投与経路:

Intraosseous; Endotracheopulmonary; Intravenous

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 02070300; GTIN: 5060238380294 5060238380287

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ADRENALINE 1 MG/10 ML (1:10,000),
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
(Referred to as ‘Adrenaline injection’ in this leaflet)
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, pharmacist 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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Adrenaline injection is and what it is used for
2. What you need to know before you are given Adrenaline injection
3. How Adrenaline injection is given
4. Possible side effects
5. How to store Adrenaline injection
6. Contents of the pack and other information
1. WHAT ADRENALINE INJECTION IS AND WHAT IT IS USED FOR
Adrenaline Injection belongs to a group of medicines called adrenergic
and dopaminergic
agents.
THIS MEDICINE IS USED FOR:
-
Treatment of cardiac arrest (unexpected loss of heart function,
breathing and
consciousness),
-
Treatment of acute anaphylaxis in adults (serious shock or collapse
produced by a severe
allergic reaction).
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ADRENALINE INJECTION
YOU MUST NOT BE GIVEN ADRENALINE INJECTION
If you are allergic (hypersensitive) to any ingredients of this
medicine (listed in section 6)
where an alternative presentation of Adrenaline or alternative
vasopressor is available.
WARNINGS AND PRECAUTIONS
Adrenaline injection is indicated for emergency treatment. Continuous
medical supervision is
necessary after administration.
PRECAUTIONS FOR USE
The risk of side effects is increased if you:
-
have medical history of hyperthyroidism (disease of the thyroid
gland), _ _
-
have severe renal insuffici

製品の特徴

OBJECT 1
ADRENALINE 1 MG/10 ML (1:10,000), SOLUTION FOR
INJECTION IN PRE-FILLED SYRINGE
Summary of Product Characteristics Updated 30-Jan-2018 | Aguettant Ltd
1. Name of the medicinal product
Adrenaline 1mg/10ml (1:10,000), solution for injection in pre-filled
syringe
2. Qualitative and quantitative composition
Each ml of solution for injection contains 0.1 mg of adrenaline (as
adrenaline tartrate)
Each 10 ml pre-filled syringe contains 1 mg adrenaline (as adrenaline
tartrate)
Excipient with known effect: sodium
Each ml of solution for injection contains 3.54 mg equivalent to 0.154
mmol of sodium.
Each 10 ml pre-filled syringe contains 35.4 mg equivalent to 1.54 mmol
of sodium.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection in pre-filled syringe
Clear and colourless solution in a 10ml pre-filled syringe
pH = 3.0 to 3.4
Osmolarity: 270 – 300 mOsm/l
4. Clinical particulars
4.1 Therapeutic indications
Cardiopulmonary resuscitation
Acute anaphylaxis in adults
4.2 Posology and method of administration
Intravenous adrenaline should only be administered by those
experienced in the use and titration of
vasopressors in their normal clinical practice.
CARDIOPULMONARY RESUSCITATION:
10 ml of the 1:10,000 solution (1 mg) by the intravenous or
intraosseous route, repeated every 3-5
minutes until return of spontaneous circulation.
Endotracheal use should only be considered as a last resort if no
other route of administration is
accessible, at a dose of 20 to 25 ml of the 1:10,000 solution (2 to
2.5 mg).
In cardiac arrest following cardiac surgery, Adrenaline should be
administered intravenously in doses of
0.5 ml or 1ml of 1:10,000 solution (50 or 100 micrograms) very
cautiously and titrated to effect.
ACUTE ANAPHYLAXIS
Titrate using intravenous boluses of 0.5 ml 1:10,000 solution (0.05
mg) according to response.
Adrenaline 1mg/10ml (1:10,000) solution for injection in pre-filled
syringe is not recommended for
intramuscular use in acute anaphylaxis. For intramuscular
administrat