Tigecycline Juno

Land: Nya Zeeland

Språk: engelska

Källa: Medsafe (Medicines Safety Authority)

Aktiva substanser:

Tigecycline 50mg

Tillgänglig från:

Juno Pharmaceuticals NZ Limited

Dos:

50 mg

Läkemedelsform:

Powder for injection

Sammansättning:

Active: Tigecycline 50mg Excipient: Arginine Hydrochloric acid Nitrogen Sodium hydroxide

Receptbelagda typ:

Prescription

Terapeutiska indikationer:

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.

Produktsammanfattning:

Package - Contents - Shelf Life: Combination pack, 10 vials (50 mg/ 5mL) per cardboard carton. - 10 dose units - 24 months from date of manufacture stored at or below 25°C - Vial, glass, Type I glass vial, 5 mL - 50 mg - 24 months from date of manufacture stored at or below 25°C

Tillstånd datum:

2017-09-28

Produktens egenskaper

TIGECYCLINE JUNO Datasheet v1.1
Page 1 of 21
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Tigecycline Juno 50 mg Powder for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOISTION
Each 5 mL glass vials of Tigecycline contains 50 mg tigecycline
lyophilised powder for
intravenous infusion.
For the full list of excipients, see
SECTION 6.1
.
3.
PHARMACEUTICAL FORM
Powder for intravenous infusion. Orange to orange-red lyophillised
cake or powder.
The reconstituted solution is orange-red, essentially free of
particulate matter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tigecycline 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
_ADULT_
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.
_CHILDREN AND ADOLESCENT_
Safety and effectiveness in patients under 18 years of age have not
been established.
Therefore, use in patients under 18 years of age is not recommended.
TIGECYCLINE JUNO Datasheet v1.1
Page 2 of 21
_ELDERLY_
No dosage adjustment is necessary in elderly patients.
_HEPATIC IMPAIRMENT_
No dosage adjustment is necessary in patients