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SPC, UK: MERONEM IV 1g Powder for solution for injection or infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Meronem IV 1g.

Qualitative and quantitative composition

Meronem IV 1 g. 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 ...

Pharmaceutical form

Powder for solution for injection or infusion. A white to light yellow powder.

Therapeutic indications

Meronem 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 ...

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 ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to any other carbapenem antibacterial agent. Severe hypersensitivity (e.g. anaphylactic reaction, ...

Special warnings and precautions for use

The selection of meropenem to treat an individual patient should take into account the appropriateness of using a carbapenem antibacterial agent based on factors such as severity of the infection, the ...

Interaction with other medicinal products and other forms of interaction

No specific medicinal product interaction studies other than probenecid were conducted. Probenecid competes with meropenem for active tubular secretion and thus inhibits the renal excretion of meropenem ...

Pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of meropenem in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see ...

Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed. However, when driving or operating machines, it should be taken into account that headache, paraesthesia and convulsions ...

Undesirable effects

Summary of the safety profile In a review of 4,872 patients with 5,026 meropenem treatment exposures, meropenem-related adverse reactions most frequently reported were diarrhoea (2.3%), rash (1.4%), nausea/vomiting ...

Overdose

Relative overdose may be possible in patients with renal impairment if the dose is not adjusted as described in section 4.2. Limited post-marketing experience indicates that if adverse reactions occur ...

Pharmacodynamic properties

Pharmacotherapeutic group: antibacterials for systemic use, carbapenems ATC code: J01DH02 Mechanism of action Meropenem exerts its bactericidal activity by inhibiting bacterial cell wall synthesis in Gram-positive ...

Pharmacokinetic properties

In healthy subjects the mean plasma half-life is approximately 1 hour; the mean volume of distribution is approximately 0.25 l/kg (11-27 l) and the mean clearance is 287 ml/min at 250 mg falling to 205 ...

Preclinical safety data

Animal studies indicate that meropenem is well tolerated by the kidney. Histological evidence of renal tubular damage was seen in mice and dogs only at doses of 2000 mg/kg and above after a single administration ...

List of excipients

Meronem 1 g: Anhydrous sodium carbonate

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Shelf life

Shelf life 4 years. After reconstitution Intravenous bolus injection administration A solution for bolus injection is prepared by dissolving the drug product in water for injection to a final concentration ...

Special precautions for storage

Do not store above 30°C. Do not freeze the reconstituted solution. For storage conditions after reconstitution of the medicinal product, see section 6.3.

Nature and contents of container

Meronem 1 g: 1348 mg powder in a 30 ml Type 1 glass vial with stopper (grey halobutilic rubber with an aluminium cap). The medicinal product is supplied in pack sizes of 1 or 10 vials. Not all pack sizes ...

Special precautions for disposal and other handling

Injection Meropenem to be used for bolus intravenous injection should be constituted with sterile water for injection. Infusion For intravenous infusion meropenem vials may be directly constituted with ...

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Marketing authorization number(s)

Meronem 1 g: PL 00057/1536

Date of first authorization / renewal of the authorization

09 February 2009

Date of revision of the text

01/2019

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