Vancomycin AptaPharma 1000 mg powder for concentrate for solution for infusion

国家: 马耳他

语言: 英文

来源: Medicines Authority

有效成分:

VANCOMYCIN

可用日期:

Apta Medica Internacional d.o.o Likozarjeva Ulica 6, 1000 Ljubljana, , Slovenia

ATC代码:

J01XA01

INN（国际名称）:

VANCOMYCIN 50 mg/ml

药物剂型:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

组成:

VANCOMYCIN 50 mg/ml

处方类型:

POM

治疗领域:

ANTIBACTERIALS FOR SYSTEMIC USE

產品總結:

Licence number in the source country: NOT APPLICAPABLE

授权状态:

Authorised

授权日期:

2021-08-09

资料单张

PAGE 1 OF 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
VANCOMYCIN APTAPHARMA 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
VANCOMYCIN APTAPHARMA 1000 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
Vancomycin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have further questions, ask your doctor or hospital
pharmacist or nurse.
- If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Vancomycin AptaPharma is and what it is used for
2. What you need to know before you use Vancomycin AptaPharma
3. How to use Vancomycin AptaPharma
4. Possible side effects
5. How to store Vancomycin AptaPharma
6. Contents of the pack and other information
1. WHAT VANCOMYCIN APTAPHARMA IS AND WHAT IT IS USED FOR
Vancomycin is an antibiotic that belongs to a group of antibiotics
called “glycopeptides”. Vancomycin
works by eliminating certain bacteria that cause infections.
Vancomycin is used in in all age groups by infusion for the treatment
of the following serious
infections:
•
Infections of the skin and tissues below the skin
•
Infections of the bones and joints
•
An infection of the lungs called "pneumonia"
•
An infection of the lungs called "pneumonia" acquired in hospital,
including ventilator-associated
pneumonia
•
Infection of the inside lining of the heart (endocarditis) and to
prevent endocarditis in patients at
risk when undergoing major surgical procedures
Vancomycin can be given orally in adults and children for the
treatment of infection of the mucosa of
the small and the large intestines with damage to the mucosae
(pseudomembranous colitis), caused by
the
_Clostridium difficile _
bacterium.
Vancomycin powder is made into a solution for infusion or oral
solution.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE VANCOMYCIN APTAPHARMA
DO NOT U

产品特点

Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 19
1. NAME OF THE MEDICINAL PRODUCT
Vancomycin AptaPharma 500 mg powder for concentrate for solution for
infusion
Vancomycin AptaPharma 1000 mg powder for concentrate for solution for
infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Vancomycin AptaPharma 500 mg powder for concentrate for solution for
infusion
Each vial contains 500 mg vancomycin hydrochloride equivalent to
500,000 IU vancomycin. When
reconstituted with 10 ml water for injections, the concentrate for
solution contains vancomycin 50
mg/ml.
Vancomycin AptaPharma 1000 mg powder for concentrate for solution for
infusion
Each vial contains 1 g vancomycin hydrochloride equivalent to
1,000,000 IU vancomycin. When
reconstituted with 20 ml water for injections, the concentrate for
solution contains vancomycin 50
mg/ml.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to off-white or pinkish sterile lyophilized porous cake.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Intravenous administration
Vancomycin is indicated in all age groups for the treatment of the
following infections (see sections
4.2, 4.4 and 5.1):
•
complicated skin and soft tissue infections (cSSTI)
•
bone and joint infections
•
community acquired pneumonia (CAP)
•
hospital acquired pneumonia (HAP), including ventilator-associated
pneumonia (VAP)
•
infective endocarditis
Vancomycin is also indicated in all age groups for the perioperative
antibacterial prophylaxis in
patients that are at high risk of developing bacterial endocarditis
when undergoing major surgical
procedures.
Oral administration
Vancomycin is indicated in all age groups for the treatment of
_Clostridium difficile_
infection (CDI)
(see sections 4.2, 4.4 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
Page 3 of 19
Where appropriate, vancomycin should be admini