ERTAPENEM HIKMA
As listed in the register: ERTAPENEM HIKMA 1 G POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION EFG
1.000 mg · polvo para concentrado para solución para perfusión
- Prescription only
- Antibiotics, antivirals and antifungals taken into the body
- Active substance
- Ertapenem
- Made by
- Hikma Farmaceutica (Portugal) S.A.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (ERTAPENEM SODIUM). It describes the substance, not this exact product.
Ertapenem sodium is a carbapenem antibiotic [see Clinical Pharmacology ( 12.4 )].
In vitro studies in human liver microsomes indicate that ertapenem does not inhibit metabolism mediated by any of the following cytochrome p450 (CYP) isoforms: 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4.
Ertapenem is eliminated primarily by the kidneys.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-12-24
Safety of the active substance
From the US prescribing label for the same active substance (ERTAPENEM SODIUM). It describes the substance, not this exact product.
- Ertapenem for injection is contraindicated in patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactams.
- Due to the use of lidocaine HCl as a diluent, Ertapenem for injection administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type.
- Known hypersensitivity to product components or anaphylactic reactions to β-lactams.
- ( 4 ) Due to the use of lidocaine HCl as a diluent, Ertapenem for injection administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type.
The most common adverse reactions (≥5%) in pediatric patients treated with Ertapenem for injection, including those who were switched to therapy with an oral antimicrobial, were diarrhea, vomiting and infusion site pain.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
European UnionNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Hikma Farmaceutica (Portugal) S.A. |
|---|---|
| Active substance | Ertapenem |
| Used in | Antibiotics, antivirals and antifungals taken into the body |
| Strength | 1.000 mg |
| Form | polvo para concentrado para solución para perfusión |
| Classification | J01DH03 · Antibiotics, antivirals and antifungals taken into the body |
| Route | vía intravenosa |
| Marketed | Yes, according to the register |
| Generic | Yes — a generic medicine, according to the register |
| Name in the register | ERTAPENEM HIKMA 1 G POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION EFG |
| Nº Registro | 83230 |
Source: CIMA — Centro de Información online de Medicamentos · 2026-09-30 · not reviewed by a clinician
Fuente: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), CIMA. Reuse terms: Aviso legal AEMPS.
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.