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

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

adrenaline (epinephrine), Quantity: 1 mg/mL

Dostupné s:

Alphapharm Pty Ltd

Léková forma:

Injection, solution

Složení:

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

Podání:

Intramuscular

Jednotky v balení:

2mL X 2, 2mL X 1

Druh předpisu:

(S3) Pharmacist Only Medicine

Terapeutické indikace:

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.

Přehled produktů:

Visual Identification: Lacks precipitate and/or pink discolouration; degree of yellow colour development does not exceed standard.; Container Type: Syringe; Container Material: Glass; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizace:

Registered

Datum autorizace:

2018-03-01

Informace pro uživatele

ADRENALINE VIATRIS
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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 VIATRIS?
ADRENALINE VIATRIS contains the active ingredient adrenaline
(epinephrine). In some countries, adrenaline is known as
epinephrine. ADRENALINE 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
VIATRIS? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ADRENALINE VIATRIS?
ADRENALINE 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 YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE
ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE
BREASTFEEDING.
For more information, see Section 2. What should I know before I use
ADRENALINE VIATRIS? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ADRENALINE 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 VIATRIS?
•
ADRENALINE VIATRIS delivers one measured dose of adrenaline intended
for a person who weighs more than 30 kg. It may
be prescribed for a child who weighs from 15 kg up to 30 kg.
More instructions can be found in Section 4. How do I use ADRENALINE
VIATRIS? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ADRENALINE VIATRIS?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
ADRENALINE VIATRIS.
•
Check the expiry date on ADRENALINE VIATRIS and request for
replacement prior to the expiry date.
THINGS YOU
SHOULD NOT DO
•
Do not use ADRENALINE VIATRIS to treat any other medical conditions
including other types of shoc

Charakteristika produktu

AUSTRALIAN PRODUCT INFORMATION
ADRENALINE VIATRIS
_Adrenaline (epinephrine)* _
1
NAME OF THE MEDICINE
_* In some countries, adrenaline is known as epinephrine. _
Adrenaline (epinephrine)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ADRENALINE VIATRIS adrenaline (epinephrine) injection contains
adrenaline (epinephrine) 300 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 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 VIATRIS
Auto-Injector may be necessary.
To
manage
severe
anaphylaxis,
repeat
ADRENALINE
VIATRIS
injections
may
be
necessary.
Each
ADRENALINE VIATRIS Auto-Injector is used once only. The ADRENALINE
VIATRIS dose may be repeated
every 5 to 15 minutes if symptoms recur or have not subsided (see
SECTION 4.9 OVERDOSE
).
_Use of Adrenaline: _
1.
Before using, check to make sure the solution in the Auto-Injector is
not brown in colour. If it is
discoloured or contains a precipitate, do not use, since these changes
indicate that the effectiveness of t