Tigecycline Atb 50mg powder for solution for infusion

Negara: Malta

Bahasa: Inggris

Sumber: Medicines Authority

Bahan aktif:

TIGECYCLINE

Tersedia dari:

Antibiotice S.A. 1 Valea Lupului Street, 707410, Iasi, Romania

Kode ATC:

J01AA12

INN (Nama Internasional):

TIGECYCLINE 50 mg

Bentuk farmasi:

POWDER FOR SOLUTION FOR INFUSION

Komposisi:

TIGECYCLINE 50 mg

Jenis Resep:

POM

Area terapi:

ANTIBACTERIALS FOR SYSTEMIC USE

Status otorisasi:

Authorised

Tanggal Otorisasi:

2017-07-18

Selebaran informasi

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PACKAGE LEAFLET: INFORMATION FOR THE USER
TIGECYCLINE ATB 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.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist 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 Atb is and what it is used for
2.
What you need to know before you use Tigecycline Atb
3.
How to use Tigecycline Atb
4.
Possible side effects
5.
How to store Tigecycline Atb
6.
Contents of the pack and other information
1.
WHAT TIGECYCLINE ATB IS AND WHAT IT IS USED FOR
Tigecycline Atb is an antibiotic of the glycylcycline group that works
by stopping the growth of
bacteria that cause infections.
Your doctor prescribed Tigecycline Atb 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 is only used when your doctor thinks other antibiotics are
not suitable.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TIGECYCLINE ATB
DO NOT USE TIGECYCLINE ATB
•
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, PHARMACIST OR NURSE BEFORE RECEIVING TIGECYCLINE
ATB:
•
If you have poor or slow wound healing.
•
If you are suffering from diarrhoea before you are given tigecycline.
If you develop diarrhoea
during or after your treatment, tell your doctor at once. Do not take
any diarrhoea medicine
without first checking with your doctor.

Karakteristik produk

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tigecycline Atb 50 mg powder for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 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, lyophilized cake or powder, free of visible
evidence of contamination.
The pH of the reconstituted solution ranges between 4.0 and 6.0, and
the osmolarity ranges between
240 – 320 mOsm/Kg depending on the reconstitution solvent.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tigecycline Atb 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 Atb 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.
_ _
_Elder