RopenTRONN powder for solution for injection/infusion

국가: 아르메니아

언어: 영어

출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

유효 성분:

meropenem (meropenem trihydrate)

제공처:

Sanjivani Paranteral Limited R-40

ATC 코드:

J01DH02

INN (국제 이름):

meropenem (meropenem trihydrate)

복용량:

1000mg

약제 형태:

powder for solution for injection/infusion

패키지 단위:

(1) glass vial 20ml

처방전 유형:

Prescription

승인 상태:

Registered

승인 날짜:

2019-01-18

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE USER
ROPENTRONN
POWDER FOR SOLUTION FOR INJECTION OR INFUSION
meropenem
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or
nurse.
-
This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs of
illness are the same as yours.
-
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 RopenTRONN is and what it is used for
2.
What you need to know before you take RopenTRONN
3.
How to take RopenTRONN
4.
Possible side effects
5.
How to store RopenTRONN (Hereinafter Meropenem)
6.
Contents of the pack and other information 1. WHAT MEROPENEM IS AND WHAT IT IS USED FOR
Meropenem belongs to a group of medicines called
carbapenem antibiotics. It works by killing bacteria, which can
cause serious infections.
Meropenem is used to treat the following in adults and children
aged 3 months and older:
•
Infection affecting the lungs (pneumonia).
•
Lung and bronchial infections in patients suffering from
cystic fibrosis.
•
Complicated urinary tract infections.
•
Complicated infections in the abdomen.
•
Infections that you can catch during or after the delivery.
•
Complicated skin and soft tissues infections.
•
Acute bacterial infection of the brain (meningitis).
Meropenem may be used in the management of neutropenic
patients with fever that is suspected to be due to a bacterial
infection.
Meropenem may be used to treat bacterial infection of the
blood which might be associated with a type of infection
mentioned above.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEROPENEM
DO NOT TAKE MEROPENEM
•
If you are allergic to meropenem or any of the other
ingredients of this medicine (listed in section 6).
•
If you are allergic to other antib

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
RopenTRONN
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder for solution for injection or infusion contains
meropenem trihydrate equivalent to
0.5 g or 1 g anhydrous meropenem.
Excipients: sodium carbonate
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
A White to pale yellow powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Meropenem is indicated for the treatment of the following infections
in adults and children over 3
months of age (see sections 4.4 and 5.1):
• Severe pneumonia, including hospital and ventilator-associated
pneumonia.
• Broncho-pulmonary infections in cystic fibrosis
• Complicated urinary tract infections
• Complicated intra-abdominal infections
• Intra- and post-partum infections
• Complicated skin and soft tissue infections
• Acute bacterial meningitis
Treatment of patients with bacteraemia that occurs in association
with, or is suspected to be
associated with, any of the infections listed above.
Meropenem may be used in the management of neutropenic patients with
fever that is suspected to
be due to a bacterial infection.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The tables below provide general recommendations for dosing.
The dose of meropenem administered and the duration of treatment
should take into account the type
of infection to be treated, including its severity, and the clinical
response.
A dose of up to 2 g three times daily in adults and adolescents and a
dose of up to 40 mg/kg three
times daily in children may be particularly appropriate when treating
some types of infections, such as
nosocomial infections due to Pseudomonas aeruginosa or Acinetobacter
spp.) or very severe
infections.
Additional considerations for dosing are needed when treating patients
with renal insufficiency (see
further below