MERONEM 1 Grams Pdr for Soln Inj/Inf

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MEROPENEM TRIHYDRATE

Available from:

AstraZeneca UK Limited

ATC code:

J01DH02

INN (International Name):

MEROPENEM TRIHYDRATE

Dosage:

1 Grams

Pharmaceutical form:

Pdr for Soln Inj/Inf

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Carbapenems

Authorization status:

Transfer Pending

Authorization date:

2000-05-19

Patient Information leaflet

BODY TEXT SIZE
12.0 pt
SMALLEST TEXT SIZE
6.0 pt
561847-A01
21-02-17
P043820
400560L1
1236
GP
Meronem 0.5g, 1g Leaflet:
Patient IE
Black
Technical Info
Profile
PACKAGE LEAFLET: INFORMATION FOR
THE USER
Meronem IV 0.5 g and 1 g
Powder for solution for
injection or infusion
meropenem
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 Meronem is and what it is used for
2.
What you need to know before you use
Meronem
3.
How to use Meronem
4.
Possible side effects
5.
How to store Meronem
6.
Contents of the pack and other information
1.
What Meronem is and what it is used for
Meronem belongs to a group of medicines called
carbapenem antibiotics. It works by killing bacteria,
which can cause 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
•
Infections that you can catch during or after
the delivery
•
Complicated skin and soft tissues infections
•
Acute bacterial infection of the brain
(meningitis)
Meronem may be used in the management of
neutropenic patients with fever that is suspected
to be due to a bacterial infection.
Meronem 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 use
Meronem
Do not use Meronem if:
•
you are allergic (hypersensitive) to
meropenem or any of the other ingredients of
Meronem

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Meronem I.V. 1g Powder for solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains meropenem trihydrate equivalent to 1 g anhydrous
meropenem.
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
Meronem 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
Meronem may be used in the management of neutropenic patients with
fever that is suspected to be due to a bacterial
infection.
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
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.
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