Meropenem Star Pharmasin 500 mg Powder for solution for injection/infusion

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Meropenem Trihydrate

Disponible desde:

Star Pharmasin Ltd

Código ATC:

J01DH02

Designación común internacional (DCI):

Meropenem Trihydrate

Dosis:

500 milligram(s)

formulario farmacéutico:

Powder for solution for injection/infusion

Área terapéutica:

meropenem

Estado de Autorización:

Not marketed

Fecha de autorización:

2020-12-18

Información para el usuario

Size : 450 x 380 mm
500 mg (milligrams)
1 g (gram)
1.5 g
10 ml (millilitres)
20 ml
30 ml
DOSE OF MEROPENEM
AMOUNT OF ‘WATER FOR INJECTIONS’ NEEDED FOR
DILUTION
2 g
40 ml
PACKAGE LEAFLET: INFORMATION FOR THE USER
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or
nurse.
WHAT IS IN THIS LEAFLET
1. What Meropenem Star Pharmasin is and what it is used for
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
- 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.
3. How to use Meropenem Star Pharmasin
4. Possible side effects
2. What you need to know before you use Meropenem Star Pharmasin
5. How to store Meropenem Star Pharmasin
6. Contents of the pack and other information
• Infection affecting the lungs (pneumonia)
• Lung and bronchial infections in patients suffering from cystic
fibrosis
• Infections that you can catch during or after the delivery 1. WHAT MEROPENEM STAR PHARMASIN IS AND WHAT IT IS USED FOR
Meropenem Star Pharmasin contains the active substance meropenem and
belongs to a group of medicines called carbapenem antibiotics. It
works by
killing bacteria, which can cause serious infections.
Meropenem Star Pharmasin is used to treat the following in adults and
children
aged 3 months and older:
• Complicated infections in the abdomen
• Complicated urinary tract infections
In particular, tell your doctor, pharmacist or nurse if you are taking
any of the
following medicines:
If you are not sure if any of the above applies to you, talk to your
doctor or nurse
before using Meropenem.
• Probenecid (used to treat gout).
• Oral anti-coagulant agent (used to treat or prevent blood clots).
Tell your doctor, pharmac

Ficha técnica

Health Products Regulatory Authority
18 December 2020
CRN008TSX
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Meropenem Star Pharmasin 500 mg Powder for solution for
injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous
meropenem.
Excipients with known effect:
Each 500 mg vial contains 104 mg sodium carbonate which equates to
approximately 2 mEq of sodium (approximately 45.1
mg).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
White to slight yellow crystalline powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Meropenem Star Pharmasin 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 Star Pharmasin 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
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 som