Tigecycline Anfarm 50 mg powder for solution for infusion

Страна: Мальта

Язык: английский

Источник: Medicines Authority

Доступна с:

Anfarm Hellas S.A. 4 Achaias Str. & Trizinias 14564 Kifissia, Attiki, Greece

код АТС:

J01AA12

ИНН (Международная Имя):

TIGECYCLINE 10 mg

Фармацевтическая форма:

POWDER FOR SOLUTION FOR INFUSION

состав:

TIGECYCLINE 10 mg

Тип рецепта:

POM

Терапевтические области:

ANTIBACTERIALS FOR SYSTEMIC USE

Обзор продуктов:

Licence number in the source country: NOT APPLICAPABLE

Статус Авторизация:

Authorised

Дата Авторизация:

2022-03-15

тонкая брошюра

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PACKAGE LEAFLET: INFORMATION FOR THE USER
TIGECYCLINE ANFARM 50 MG POWDER FOR SOLUTION FOR INFUSION
tigecycline
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU OR YOUR CHILD.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tigecycline Anfarm is and what it is used for
2.
What you need to know before you receive Tigecycline Anfarm
3.
How Tigecycline Anfarm is given
4.
Possible side effects
5.
How to store Tigecycline Anfarm
6.
Contents of the pack and other information
1.
WHAT TIGECYCLINE ANFARM IS AND WHAT IT IS USED FOR
Tigecycline Anfarm is an antibiotic of the glycylcycline group that
works by stopping the growth of
bacteria that cause infections.
Your doctor has prescribed Tigecycline Anfarm because you or your
child at least 8 years old has one
of the following types of serious infections:
•
Complicated infection of the skin and soft tissues (the tissue below
the skin), excluding
diabetic foot infections.
•
Complicated infection in the abdomen
Tigecycline Anfarm is only used when your doctor thinks other
antibiotics are not suitable.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE TIGECYCLINE ANFARM
Do not use Tigecycline Anfarm
•
If you are allergic to tigecycline, or any of the other ingredients of
this medicine (listed in
section 6). If you are allergic to tetracycline class antibiotics
(e.g., minocycline, doxycycline,
etc.), you may be allergic to tigecycline.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR NURSE BEFORE RECEIVING TIGECYCLINE ANFARM:
•
If you have poor or slow wound healing.
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•
If you are suffering from diarrhoea before you are given Tigecycline
Anfarm. If you develop
diarrhoea during or after your treatment, tell your doctor at once. Do
not take any

Характеристики продукта

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1.
NAME OF THE MEDICINAL PRODUCT
Tigecycline Anfarm 50 mg powder for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL Tigecycline Anfarm vial contains 50 mg of tigecycline. After
reconstitution, 1 mL
contains 10 mg of tigecycline.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion (powder for infusion).
Orange to orange-red powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tigecycline Anfarm is indicated in adults and in children from the age
of eight years for the treatment
of the following infections (see sections 4.4 and 5.1):
•
Complicated skin and soft tissue infections (cSSTI), excluding
diabetic foot infections (see
section 4.4);
•
Complicated intra-abdominal infections (cIAI).
Tigecycline Anfarm should be used only in situations where other
alternative antibiotics are not
suitable (see sections 4.4, 4.8 and 5.1).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The recommended dose for adults is an initial dose of 100 mg followed
by 50 mg every 12 hours for
5 to 14 days.
The duration of therapy should be guided by the severity, site of the
infection, and the patient’s
clinical response.
_Children and adolescents (8 to 17 years of age) _
Tigecycline is only to be used to treat patients aged 8 years and
older after consultation with a
physician with appropriate experience in the management of infectious
diseases.
Children aged 8 to <12 years: 1.2 mg/kg of tigecycline every 12 hours
intravenously to a
maximum dose of 50 mg every 12 hours for 5 to 14 days.
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Adolescents aged 12 to <18 years: 50 mg of tigecycline every 12 hours
for 5 to 14 days.
_Elderly _
No dosage adjustment is necessary in elderly patients (see section
5.2).
_Hepatic impairment _
No dosage adjustment is warranted in patients with mild to moderate
hepatic impairment (Child–
Pugh A and Child–Pugh B).
In patien