TIGECYCLINE JUNO tigecycline 50 mg Powder for injection Glass vial

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

tigecycline, Quantity: 50 mg

Prieinama:

Juno Pharmaceuticals Pty Ltd

INN (Tarptautinis Pavadinimas):

Tigecycline

Vaisto forma:

Injection, powder for

Sudėtis:

Excipient Ingredients: arginine; hydrochloric acid; sodium hydroxide

Vartojimo būdas:

Intravenous

Vienetai pakuotėje:

10 vials per carton

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

TIGECYCLINE JUNO is indicated for the treatment of the following infections in adults:,? Complicated skin and skin structure infections, including those with methicillin resistant Staphylococcus aureus (MRSA), where there is suspected or proven resistance to, intolerance of, or there are co- morbidities preventing the use of, other available agents.,? Complicated intra-abdominal infections, where there is suspected or proven resistance to, intolerance of, or there are co-morbidities preventing the use of, other available agents.

Produkto santrauka:

Visual Identification: Lyophilised orange to orange-red cake or powder. The reconstituted solution is orange to orange-red and essentially free of particulate matter.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Autorizacija statusas:

Licence status A

Leidimo data:

2017-04-11

Pakuotės lapelis

1
TIGECYCLINE JUNO
_Tigecycline_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TIGECYCLINE
JUNO. It does not contain all the
available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking TIGECYCLINE JUNO
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TIGECYCLINE
JUNO IS USED FOR
TIGECYCLINE JUNO is an antibiotic
of the tetracycline class in the
glycylcycline subcategory that works
by stopping the growth of bacteria that
cause infections.
Your doctor has prescribed
TIGECYCLINE JUNO because you
have one of the following types of
serious infections:
•
Infection of the skin, including
those with resistant bacteria
•
Infection in the abdomen.
TIGECYCLINE JUNO is for use in
adults aged 18 and over. There is no
experience with the use of
TIGECYCLINE JUNO in children
under 18 years of age. TIGECYCLINE
JUNO, like other tetracyclines, may
cause enamel loss and staining in
developing teeth.
TIGECYCLINE JUNO will not work
against viral infections such as colds or
flu.
There is no evidence that
TIGECYCLINE JUNO is addictive.
TIGECYCLINE JUNO is available
only with a doctor's prescription.
BEFORE YOU ARE GIVEN
TIGECYCLINE JUNO
_WHEN YOU MUST NOT BE GIVEN IT_
DO NOT HAVE TIGECYCLINE JUNO
IF YOU ARE ALLERGIC TO TIGECYCLINE.
Some of the symptoms of an allergic
reaction may include rash, itching or
hives on the skin, swelling of the face,
lips, tongue or other parts of the body,
shortness of breath, wheezing or
troubled breathing.
DO NOT HAVE TIGECYCLINE JUNO
AFTER THE EXPIRY DATE (EXP. DATE)
PRINTED ON THE PACK HAS PASSED.
If you take this medicine after the
expiry date it may not work.
TALK TO YOUR DOCTOR IF YOU ARE NOT
SURE WHETHER YOU SHOULD BE GIVEN
TIGECYCLINE JUNO.
_BEFORE YO

Prekės savybės

Australian Product Information
Page | 1
AUSTRALIAN PRODUCT INFORMATION
_TIGECYCLINE JUNO _
_ _
_(TIGECYCLINE) _
_ _
1 NAME OF THE MEDICINE
Tigecycline
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 50 mg tigecycline.
Each vial contains 50 mg of Arginine. The pH is adjusted with
hydrochloric acid, and if
necessary sodium hydroxide. The reconstituted solution has a pH of 4.5
to 5.5.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Tigecycline is an orange to orange-red lyophilised powder or cake. The
reconstituted
solution is orange to orange-red, essentially free of particulate
matter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TIGECYCLINE JUNO is indicated for the treatment of the following
infections in adults:
•
Complicated skin and skin structure infections, including those with
methicillin-resistant
_Staphylococcus aureus _ (MRSA), where there is suspected or proven
resistance to,
intolerance of, or there are co-morbidities preventing the use of,
other available agents.
•
Complicated intra-abdominal infections, where there is suspected or
proven resistance
to, intolerance of, or there are co-morbidities preventing the use of,
other available
agents.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The recommended dosage regimen for tigecycline is an initial dose of
100 mg, followed by
50 mg every 12 hours. Intravenous (IV) infusions of tigecycline should
be administered over
approximately 30 to 60 minutes every 12 hours.
The recommended duration of treatment with tigecycline for complicated
skin and skin
structure infections or for complicated intra-abdominal infections is
5 to 14 days. The
duration of therapy should be guided by the severity and site of the
infection and the
patient’s clinical and bacteriological progress.
Australian Product Information
Page | 2
DOSAGE ADJUSTMENT
_PATIENTS WITH RENAL IMPAIRMENT _
No dosage adjustment of tigecycline is necessary in patients with
renal impairment or in
patients
undergoing
haemodialysis
(see
SEC