Adrenaline (Epinephrine) 1 mg/10 ml (1:10,000) Solution for Injection in Pre-Filled Syringe

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Adrenaline tartrate

から入手可能:

Laboratoire AGUETTANT

ATCコード:

C01CA; C01CA24

INN（国際名）:

Adrenaline tartrate

投薬量:

1 milligram/10 millilitres

医薬品形態:

Solution for injection in pre-filled syringe

処方タイプ:

Product subject to prescription which may not be renewed (A)

治療領域:

Adrenergic and dopaminergic agents; epinephrine

認証ステータス:

Marketed

承認日:

2016-03-11

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ADRENALINE (EPINEPHRINE) 1 MG/10 ML (1:10,000),
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
(Referred to as ‘Adrenaline (Epinephrine) injection’ in this
leaflet)
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 (Epinephrine) injection is and what it is used for
2. What you need to know before you are given Adrenaline (Epinephrine)
injection
3. How Adrenaline (Epinephrine) injection is given
4. Possible side effects
5. How to store Adrenaline (Epinephrine) injection
6. Contents of the pack and other information
1. WHAT ADRENALINE (EPINEPHRINE) INJECTION IS AND WHAT IT IS USED FOR
Adrenaline (Epinephrine) 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 (EPINEPHRINE)
INJECTION
YOU MUST NOT BE GIVEN ADRENALINE (EPINEPHRINE) 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
(Epinephrine)
injection
is
indicated
for
emergency
treatment.
Continuous
medical
supervision is necessary after administration.
PRECAUTIONS FOR USE
The ri

製品の特徴

Health Products Regulatory Authority
05 October 2022
CRN00D5GN
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Adrenaline (Epinephrine) 1 mg/10 ml (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
(epinephrine) (as adrenaline (epinephrine) tartrate).
Each 10 ml pre-filled syringe contains 1 mg adrenaline (epinephrine)
(as adrenaline (epinephrine) 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 10 ml 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 (1mg) 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 1 mg/10 ml (1:10,000) solution for injection in pre-filled
syringe is not recommended for intramuscular use in acute
anaphylaxis. For i