ADRENALINE JR VIATRIS adrenaline (epinephrine) 0.15 mg/0.3 mL injection syringe auto-injector

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

adrenaline (epinephrine), Quantity: 0.5 mg/mL

Disponible depuis:

Alphapharm Pty Ltd

forme pharmaceutique:

Injection, solution

Composition:

Excipient Ingredients: sodium metabisulfite; water for injections; sodium chloride; hydrochloric acid

Mode d'administration:

Intramuscular

Unités en paquet:

2mL X 2, 2mL X 1

Type d'ordonnance:

(S3) Pharmacist Only Medicine

indications thérapeutiques:

For the emergency treatment of anaphylactic reactions to insect stings through immediate self administration by individuals with a history of hypersensitivity to insect stings. ADRENALINE MYLAN and ADRENALINE JR MYLAN are designated as emergency supportive therapy only and are not a replacement or substitute for subsequent medical or hospital care, nor are they intended to supplant insect venom hyposensitization. INDICATIONS AS AT 17 JUNE 2003: For the emergency treatment of anaphylaxis (acute severe allergic reactions) due to insect stings, drugs or other allergens.

Descriptif du produit:

Visual Identification: clear, colourless liquid; Container Type: Syringe; Container Material: Glass; Container Life Time: 19 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statut de autorisation:

Registered

Date de l'autorisation:

2018-03-01

Notice patient

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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ADRENALINE JR VIATRIS?
ADRENALINE JR VIATRIS contains the active ingredient adrenaline
(epinephrine). In some countries, adrenaline is known as
epinephrine. ADRENALINE JR VIATRIS is only to be used for the
immediate EMERGENCY TREATMENT of a SEVERE ALLERGIC
REACTION (also known as ANAPHYLAXIS).
For more information, see Section 1. Why am I using ADRENALINE JR
VIATRIS? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ADRENALINE JR VIATRIS?
ADRENALINE JR VIATRIS is a life-saving treatment in the emergency
management of severe allergic reactions. Therefore, it should
not be withheld from anyone who is considered to need it. TALK TO YOUR
DOCTOR IF YOUR CHILD HAS ANY OTHER MEDICAL CONDITIONS, OR
TAKE ANY OTHER MEDICINES.
For more information, see Section 2. What should I know before I use
ADRENALINE JR VIATRIS? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ADRENALINE JR VIATRIS and affect how
it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ADRENALINE JR VIATRIS?
ADRENALINE JR VIATRIS delivers one measured dose of adrenaline
intended for a child who weighs 15 kg to 30 kg.
More instructions can be found in Section 4. How do I use ADRENALINE
JR VIATRIS? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ADRENALINE JR VIATRIS?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
ADRENALINE JR VIATRIS.
•
Check the expiry date on ADRENALINE JR VIATRIS and request for
replacement prior to the expiry
date.
THINGS YOU
SHOULD NOT DO
•
Do not use ADRENALINE JR VIATRIS to treat any other medical conditions
including other types of
shock unless advised by the doctor.
•
Do not use ADRENALINE JR VIATRIS if the so

Résumé des caractéristiques du produit

AUSTRALIAN PRODUCT INFORMATION
ADRENALINE JR VIATRIS
_Adrenaline (epinephrine)* _
1
NAME OF THE MEDICINE
_* In some countries, adrenaline is known as epinephrine._
Adrenaline (epinephrine)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ADRENALINE
JR
VIATRIS
adrenaline
(epinephrine)
injection
contains
adrenaline
(epinephrine)
150
micrograms in 0.3 mL as the active ingredient.
Excipients with known effect: Contains Sulfites.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Clear, colourless liquid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the emergency treatment of anaphylaxis (acute severe allergic
reactions) due to insect stings, or bites, foods,
drugs or other allergens.
4.2
DOSE AND METHOD OF ADMINISTRATION
_DOSAGE: _
Selection of the appropriate dosage strength is determined according
to patient body weight and this
_decision_
should be based on careful assessment of the individual patient and
recognition of the life-threatening nature of
reactions for which ADRENALINE JR VIATRIS is prescribed.
Adults (

30 kg): Intramuscular injection of ADRENALINE VIATRIS Auto-Injector
containing 0.3 mg
adrenaline injection (0.3 mg/0.3 mL)
Children (15 to 30 kg): Intramuscular injection of ADRENALINE JR
VIATRIS Auto-Injector containing 0.15
mg adrenaline injection (0.15 mg/0.3 mL)
The doctor or pharmacist may choose to recommend more or less than
this amount*. With severe persistent
anaphylaxis, repeat injections with an additional ADRENALINE JR
VIATRIS Auto-Injector may be necessary.
Since the dose of adrenaline delivered from an ADRENALINE JR VIATRIS
Auto-Injector is fixed, consider
using other forms of injectable adrenaline if doses lower than 0.15 mg
are deemed necessary.
To manage severe anaphylaxis, repeat ADRENALINE JR VIATRIS injections
may be necessary. Each
ADRENALINE JR VIATRIS Auto-Injector is used once only. The ADRENALINE
JR VIATRIS dose may be
repeated after 15 minutes if symptoms recur or have not subsided (see
SECTION 4.9 OVERDOSE
).
_Use of Adrenaline: