Meropenem 1g powder for solution for injection vials

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Meropenem trihydrate

Boleh didapati daripada:

Bowmed Ibisqus Ltd

Kod ATC:

J01DH02

INN (Nama Antarabangsa):

Meropenem trihydrate

Dos:

1gram

Borang farmaseutikal:

Powder for solution for injection

Laluan pentadbiran:

Intravenous

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 05010202; GTIN: 5060130130942

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
MEROPENEM 500 MG AND 1 G
POWDER FOR SOLUTION FOR INJECTION/INFUSION
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 any further questions, ask your doctor, pharmacist 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.
What Meropenem is and what it is used for
2.
What you need to know before you use Meropenem
3.
How to use Meropenem
4.
Possible side effects
5.
How to store 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 the following serious infections:
•
Infection affecting the lungs (pneumonia)
•
Lung and bronchial infections in patients suffering from cystic
fibrosis
•
Complicated urinary tract infections
•
Complicated infections in the abdomen (stomach)
•
Infections that you can catch during or after giving birth
•
Complicated skin and soft tissue infections
•
Acute bacterial infection of the brain (meningitis)
Meropenem may be used in the management of neutropenic patients
(patients with low levels of white
blood cells) 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 one
of the infections mentioned above.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MEROPENEM
DO NOT USE MEROPENEM IF:
•
you are allergic (hypersensitive) to meropenem or any of the other
ingredients of this medicine
(listed in section 6).
•
you are allergic (hypersensitive) to o

Ciri produk

OBJECT 1
MEROPENEM 1G POWDER FOR SOLUTION FOR
INJECTION/INFUSION
Summary of Product Characteristics Updated 10-Apr-2018 | Bowmed
Ibisqus Limited
1. Name of the medicinal product
Meropenem 1 g powder for solution for injection/infusion
2. Qualitative and quantitative composition
Each vial contains meropenem trihydrate equivalent to 1 g anhydrous
meropenem.
Excipients with known effect:
Each 1 g vial contains 208 mg sodium carbonate which equates to
approximately 4.0 mEq of sodium
(approximately 90 mg).
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for injection or infusion.
A white to light yellow powder.
4. Clinical particulars
4.1 Therapeutic indications
Meropenem is indicated for the treatment of the following infections
in adults and children aged 3 months
and older (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
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 in the treatment of patients with bacteraemia
that occurs in association with, or
is suspected to be associated with, any of the infections listed
above.
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 so