QUININE DIHYDROCHLORIDE 6% sterile concentrate (600 mg/10 mL) injection vial

Country: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

quinine dihydrochloride, Quantity: 60 mg/mL

থেকে পাওয়া:

Phebra Pty Ltd

ফার্মাসিউটিকাল ফর্ম:

Injection, solution

রচনা:

Excipient Ingredients: water for injections

প্রশাসন রুট:

Intravenous

প্যাকেজ ইউনিট:

10 mL x 5, 10 mL x 10

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

INDICATIONS AS AT 1 JANUARY 1991 : Acute treatment of Malaria. It may also be used in the treatment of Babesiosis in conjunction with clindamycin.

পণ্য সারাংশ:

Visual Identification: Faint straw coloured solution; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

1991-10-14

তথ্য লিফলেট

Quinine Dihydrochloride 6%
Page 1 of 3
_ _
_Version 07 _
QUININE DIHYDROCHLORIDE 6%
(QUININE DIHYDROCHLORIDE) SOLUTION FOR INJECTION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Quinine
Dihydrochloride 6%. It does not
contain all the available information. It
does not take the place of talking to
your doctor.
All medicines have risks and benefits
.
Your doctor has weighed the risks of
you being given Quinine
Dihydrochloride 6% against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET
.
You may need to read it again.
WHAT
QUININE
DIHYDROCHLORIDE 6%
IS
USED FOR
QUININE DIHYDROCHLORIDE 6% IS A
CONCENTRATED SOLUTION AND MUST BE
DILUTED BEFORE USE.
This medicine is used for the treatment
of severe malaria or when the patient is
unable to take medication by mouth.
It is also used in the treatment of
Babesiosis, a rare disease caused by an
infection carried by ticks.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY QUININE
DIHYDROCHLORIDE 6% HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
BEFORE YOU ARE GIVEN
QUININE
DIHYDROCHLORIDE 6%
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU MUST NOT BE GIVEN QUININE
DIHYDROCHLORIDE 6% IF YOU HAVE AN
ALLERGY TO QUININE OR QUINIDINE.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath.
•
wheezing or difficulty breathing.
•
swelling of the face, lips, tongue,
or other parts of the body.
•
rash, intense itching, flushing or
hives on the skin.
•
ringing in the ears.
•
changes in vision.
•
fever.
•
stomach pain or upset.
YOU MUST NOT BE GIVEN QUININE
DIHYDROCHLORIDE 6% IF YOU HAVE ANY
OF THE FOLLOWING MEDICAL CONDITIONS:
•
glucose-6-phosphate-
dehydrogenase deficiency (an
inherited condition)
•
a history of blackwater fever
•
haemolysis (destruction of red
blood cells)
•
tinnitus (buzzing, whistling,
ringing or other persistent noises
in the ear)
•
inflam

পণ্য বৈশিষ্ট্য

PRODUCT INFORMATION
Australian Product Information - Quinine Dihydrochloride 6%
Page 1 of 8
Version 10
QUININE DIHYDROCHLORIDE 6%
(QUININE DIHYDROCHLORIDE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Quinine dihydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Quinine Dihydrochloride 6% contains 600 mg quinine dihydrochloride in
10 mL of water for injections.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Quinine Dihydrochloride 6% is a sterile concentrated solution for
injection which has a faint straw coloured
appearance. Dilute before administration.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Quinine Dihydrochloride 6% Sterile Concentrate 600 mg in 10 mL
solution for injection is indicated for the acute
treatment of malaria. It may also be used in the treatment of
Babesiosis in conjunction with clindamycin.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The solution should be diluted before administration and contains no
antimicrobial preservative. Quinine
Dihydrochloride 6% should be used in one patient on one occasion only
and unused solution should be discarded.
WHEREVER POSSIBLE, PATIENTS SHOULD BE TRANSFERRED TO ORAL THERAPY AS
SOON AS POSSIBLE.
FOR INTRAVENOUS INJECTION
ADULTS - The following doses may be used as a guide, Quinine
Dihydrochloride 6% must be diluted in 500 mL of
glucose 5% preferably, or sodium chloride 0.9% (usually 600 mg in 500
mL) and infused slowly over 4 hours.
Loading dose: 20 mg/kg up to a MAXIMUM of 1400 mg given slowly by
infusion over 4 hours. Commence the
maintenance doses 8 to 12 hours after loading dose.
Maintenance dose: 10 mg per kg up to a MAXIMUM of 700 mg over 4 hours
given slowly by infusion. Repeat every
8-12 hours if necessary.
A LOADING DOSE IS NOT REQUIRED IF ANTI-MALARIALS HAVE BEEN GIVEN
DURING THE PREVIOUS 24 HOURS.
PRODUCT INFORMATION
QUININE DIHYDROCHLORIDE 6%
Australian Product Information - Quinine Dihydrochloride 6%
Page 2 of 8
Version 10
If parenteral therapy is required for more than 48 hours, the
mainte