PHARMA-Q ADRENALINE INJECTION 1 mg/ml

البلد: جنوب أفريقيا

اللغة: الإنجليزية

المصدر: South African Health Products Regulatory Authority (SAHPRA)

متاح من:

Pharma-Q Holdings (Pty) Ltd

جرعة:

See ingredients

الشكل الصيدلاني:

INJECTION

تركيب:

EACH 1 ml LIQUID CONTAINS EPINEPHRINE BITARTRATE 1,80 mg EQUIVALENT TO EPINEPHRINE 1 mg

الوضع إذن:

Registered

تاريخ الترخيص:

1996-11-11

نشرة المعلومات

Pharma-Q Holdings (Pty) Ltd
PHARMA-Q ADRENALINE 1 mg/ml INJECTION
Injection
1 mg/ml
Page 1 of 11
SCHEDULING STATUS
S4
PHARMA-Q ADRENALINE INJECTION 1 MG/ML SOLUTION FOR INJECTION ADRENALINE (EPINEPHRINE) BASE AS TARTRATE
SUGAR FREE
_ _
READ THIS FULL LEAFLET CAREFULLY BEFORE YOUR MEDICAL PRACTITIONER
ADMINISTERS
PHARMA-Q ADRENALINE INJECTION 1 MG/ML.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist, nurse
or other
health care provider.
•
PHARMA-Q ADRENALINE INJECTION 1 mg/ml has been prescribed for you
personally and you should not share your medicine with other people.
It may
harm them, even if their symptoms are the same as yours._ _
WHAT IS IN THIS LEAFLET
1. What PHARMA-Q ADRENALINE INJECTION 1 mg/ml is and what it is used
for.
2. What you need to know before your doctor administers Pharma-Q
Adrenaline
Injection 1 mg/ml.
3. How PHARMA-Q ADRENALINE INJECTION 1 mg/ml will be given to you.
4. Possible side effects that you may experience.
5. How to store PHARMA-Q ADRENALINE INJECTION 1 mg/ml.
6. Contents of the pack and other information.
Pharma-Q Holdings (Pty) Ltd
PHARMA-Q ADRENALINE 1 mg/ml INJECTION
Injection
1 mg/ml
Page 2 of 11
1. WHAT PHARMA-Q ADRENALINE INJECTION 1 MG/ML IS AND WHAT IT IS USED
FOR.
The active substance of PHARMA-Q ADRENALINE INJECTION 1 mg/ml is:
Adrenaline (epinephrine) belongs to a group of medicines called
sympathomimetic
substances.
Each 1 ml contains 1 mg adrenaline (epinephrine) as the acid tartrate.
PHARMA-Q
ADRENALINE
INJECTION
1
mg/ml
is
used
in
life-threatening
emergencies, such as acute allergic reactions
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PHARMA-Q ADRENALINE
INJECTION 1 MG/ML.
PHARMA-Q ADRENALINE INJECTION 1 mg/ml should not be administered to
you:
•
if you are hypersensitive (allergic) to adrenaline (epinephrine) or
any of the other
ingredients of PHARMA-Q ADRENALINE INJECTION 1 mg/ml
(listed in section
6). _ _
•
If you are receiving mono-amine oxidase inhibitors as adrenaline
(epinephri

خصائص المنتج

Pharma-Q Holdings (Pty) Ltd
PHARMA-Q ADRENALINE 1 mg/ml INJECTION
Injection
1 mg/ml
Page 1 of 16
PROFESSIONAL INFORMATION
SCHEDULING STATUS
S4
1
NAME OF THE MEDICINE
PHARMA-Q ADRENALINE INJECTION 1 MG/ML solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains 1 mg adrenaline (epinephrine) base as tartrate
_Excipients with known effect: _
Antioxidant: sodium metabisulphite 0,1 % _m/v_._ _
For full list of excipients, see section 6.1
Sugar free.
3
PHARMACEUTICAL FORM
Solution for injection
A clear, practically colourless, slightly acid liquid. Gradually turns
dark on
exposure to light and air.
The pH of the solution is between 2,2 to 5,0.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PHARMA-Q ADRENALINE INJECTION 1 mg/ml may be used in the treatment of
acute allergy and anaphylactic shock.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Discard contents if discoloured.
Pharma-Q Holdings (Pty) Ltd
PHARMA-Q ADRENALINE 1 mg/ml INJECTION
Injection
1 mg/ml
Page 2 of 16
The dosage of PHARMA-Q ADRENALINE INJECTION 1 mg/ml is:
By subcutaneous or intramuscular injection.
Adults: 0,2 to 0,5 ml
Children: 0,1 to 0,3 ml
ADULTS
_Bronchodilator_: Subcutaneous injection: 0,2 to 0,5 mg every 20
minutes to 4 hours
if necessary (maximum of 1 mg per dose).
_Anaphylactic reaction_: Intramuscular or subcutaneous injection: 0,2
to 0,5 mg
repeated every 10 to 15 min if necessary (maximum 1 mg per dose).
CHILDREN
_Bronchodilator or anaphylactic reactions_: Subcutaneous 0,01 mg per
kg body
weight (maximum of 0,5 mg per dose) every 15 min for 2 doses and then
every 4
hours as needed.
The patient must be continuously monitored.
ADULTS
_Vasopressor (anaphylactic shock): _0,1 mg to 0,25 mg (base)
administered slowly.
May be repeated every five to fifteen minutes as needed.
CHILDREN
_Vasopressor (anaphylactic shock): _0,01 mg (base) per kg of body
weight every
five to fifteen minutes as needed, if an inadequate response to IM or
SC
administration.
METHOD OF ADMINISTRATION
By subcutaneous or intramuscular inje