Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Invanz

INVANZ 1 g powder for concentrate for solution for infusion · Abschnitt 4.3 · PDF-Seite 3

HOS-109678 · Präparat HOS-093229

• 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, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g., penicillins or cephalosporins).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Invanz

INVANZ 1 g powder for concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 5

HOS-109679 · Präparat HOS-093229

Interactions caused by inhibition of P-glycoprotein-mediated clearance or CYP-mediated clearance of medicinal products are unlikely (see section 5.2).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Invanz

INVANZ 1 g powder for concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 5

HOS-109680 · Präparat HOS-093229

Decreases in valproic acid levels that may fall below the therapeutic range have been reported when valproic acid was co-administered with carbapenem agents. The lowered valproic acid levels can lead to inadequate seizure control; therefore, concomitant use of ertapenem and valproic acid/sodium valproate is not recommended and alternative antibacterial or anti-convulsant therapies should be considered.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): valproate (HOS-085955) sodium (HOS-109681) valproic acid (HOS-088515) lead (HOS-085592)

Nebenwirkungen · Invanz

INVANZ 1 g powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 5

HOS-109682 · Präparat HOS-093229

Summary of the safety profile Adults The total number of patients treated with ertapenem in clinical studies was over 2 200 of which over 2 150 received a 1 g dose of ertapenem. Adverse reactions (i.e., considered by the investigator to be possibly, probably, or definitely related to the medicinal product) were reported in approximately 20 % of patients treated with ertapenem. Treatment was discontinued due to adverse reactions in 1.3 % of patients. An additional 476 patients received ertapenem as a single 1 g dose prior to surgery in a clinical study for the prophylaxis of surgical site infections following colorectal surgery.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Invanz

INVANZ 1 g powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 5

HOS-109683 · Präparat HOS-093229

For patients who received only INVANZ, the most common adverse reactions reported during therapy plus follow-up for 14 days after treatment was stopped were: diarrhoea (4.8 %), infused vein complication (4.5 %) and nausea (2.8 %).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Invanz

INVANZ 1 g powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 5

HOS-109684 · Präparat HOS-093229

For patients who received only INVANZ, the most frequently reported laboratory abnormalities and their respective incidence rates during therapy plus follow-up for 14 days after treatment was stopped

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Invanz

INVANZ 1 g powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 5–6

HOS-109685 · Präparat HOS-093229

5 were: elevations in ALT (4.6 %), AST (4.6 %), alkaline phosphatase (3.8 %) and platelet count (3.0 %).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Invanz

INVANZ 1 g powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 6

HOS-109686 · Präparat HOS-093229

Paediatric population (3 months to 17 years of age): The total number of patients treated with ertapenem in clinical studies was 384. The overall safety profile is comparable to that in adult patients. Adverse reactions (i.e., considered by the investigator to be possibly, probably, or definitely related to the medicinal product) were reported in approximately 20.8 % of patients treated with ertapenem. Treatment was discontinued due to adverse reactions in 0.5 % of patients.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Invanz

INVANZ 1 g powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 6

HOS-109687 · Präparat HOS-093229

For patients who received only INVANZ, the most common adverse reactions reported during therapy plus follow-up for 14 days after treatment was stopped were: diarrhoea (5.2 %) and infusion site pain (6.1 %).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Invanz

INVANZ 1 g powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 6

HOS-109688 · Präparat HOS-093229

For patients who received only INVANZ, the most frequently reported laboratory abnormalities and their respective incidence rates during therapy plus follow-up for 14 days after treatment was stopped were: decreases in neutrophil count (3.0 %), and elevations in ALT (2.9 %) and AST (2.8 %).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Invanz

INVANZ 1 g powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 6

HOS-109689 · Präparat HOS-093229

Tabulated list of adverse reactions For patients who received only INVANZ, the following adverse reactions were reported during therapy plus follow-up for 14 days after treatment was stopped:

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Invanz

INVANZ 1 g powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 6

HOS-109690 · Präparat HOS-093229

Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1 000 to < 1/100); Rare (≥ 1/10 000 to < 1/1 000); Very rare (< 1/10 000); Not known (cannot be estimated from the available data)

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Invanz

INVANZ 1 g powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 6

HOS-109691 · Präparat HOS-093229

Adults 18 years of age and older Children and adolescents (3 months to 17 years of age) Infections and infestations Uncommon: Oral candidiasis, candidiasis, fungal infection, pseudomembranous enterocolitis, vaginitis Rare: Pneumonia, dermatomycosis, postoperative wound infection, urinary tract infection Blood and lymphatic system Rare: Neutropenia, disorders thrombocytopenia Immune system disorders Rare: Allergy Not known: Anaphylaxis including anaphylactoid reactions Metabolism and nutrition Uncommon: Anorexia disorders Rare: Hypoglycaemia Psychiatric disorders Uncommon: Insomnia, confusion Not known: Altered mental Rare: Agitation, anxiety, status (including aggression) depression Not known: Altered mental status (including aggression, delirium, disorientation, mental status changes)

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Invanz

INVANZ 1 g powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 6–7

HOS-109692 · Präparat HOS-093229

6  Adults 18 years of age and older Children and adolescents (3 months to 17 years of age) Nervous system disorders Common: Headache Uncommon: Headache Uncommon: Dizziness, Not known: Hallucinations somnolence, taste perversion, seizure (see section 4.4) Rare: Tremor, syncope Not known: Hallucinations, depressed level of consciousness, dyskinesia, myoclonus, gait disturbance, encephalopathy (see section 4.4) Eye disorders Rare: Scleral disorder Cardiac disorders Uncommon: Sinus bradycardia Rare: Arrhythmia, tachycardia Vascular disorders Common: Infused vein Uncommon: Hot flush, complication, hypertension phlebitis/thrombophlebitis Uncommon: Hypotension Rare: Haemorrhage, increased blood pressure Respiratory, thoracic and Uncommon: Dyspnoea, mediastinal disorders pharyngeal discomfort Rare: Nasal congestion, cough, epistaxis, rales/rhonchi, wheezing Gastrointestinal disorders Common: Diarrhoea, nausea, Common: Diarrhoea vomiting Uncommon: Faeces Uncommon: Constipation, acid discoloured, melaena regurgitation, dry mouth, dyspepsia, abdominal pain Rare: Dysphagia, faecal incontinence, pelvic peritonitis Not known: Teeth staining Hepatobiliary disorders Rare: Cholecystitis, jaundice, liver disorder Skin and subcutaneous tissue Common: Rash, pruritus Common: Diaper dermatitis disorders Uncommon: Erythema, urticaria Uncommon: Erythema, rash, Rare: Dermatitis, desquamation, petechiae hypersensitivity vasculitis Not known: Acute Generalised Exanthematous Pustulosis (AGEP), Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome) Musculoskeletal and Rare: Muscle cramp, shoulder connective tissue disorders pain Not known: Muscular weakness Renal and urinary disorders Rare: Renal insufficiency, acute renal insufficiency Pregnancy, puerperium and Rare: Abortion perinatal conditions Reproductive system and Rare: Genital bleeding breast disorders

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Invanz

INVANZ 1 g powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 7–8

HOS-109693 · Präparat HOS-093229

7  Adults 18 years of age and older Children and adolescents (3 months to 17 years of age) General disorders and Uncommon: Extravasation, Common: Infusion site pain administration site conditions asthenia/fatigue, fever, Uncommon: Infusion site oedema/swelling, chest pain burning, infusion site Rare: Injection-site induration, pruritus, infusion site malaise erythema, injection site erythema, infusion site warmth Investigations Chemistry Common: Elevations in ALT, Common: Elevations in ALT AST, alkaline phosphatase and AST Uncommon: Increases in total serum bilirubin, direct serum bilirubin, indirect serum bilirubin, serum creatinine, serum urea, serum glucose Rare: Decreases in serum bicarbonate, serum creatinine, and serum potassium; increases in serum LDH, serum phosphorus, serum potassium Haematology Common: Elevation in platelet Common: Decreases in count neutrophil count Uncommon: Decreases in white Uncommon: Increases in blood cells, platelet count, platelet count, activated segmented neutrophils, partial thromboplastin time, haemoglobin and haematocrit; prothrombin time, decreases increases in eosinophils, in haemoglobin activated partial thromboplastin time, prothrombin time, segmented neutrophils, and white blood cells Rare: Decrease in lymphocytes; increases in band neutrophils, lymphocytes, metamyelocytes, monocytes, myelocytes; atypical lymphocytes Urinalysis Uncommon: Increases in urine bacteria, urine white blood cells, urine epithelial cells, and urine red blood cells; urine yeast present Rare: Increase in urobilinogen Miscellaneous Uncommon: Positive Clostridioides difficile toxin

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Invanz

INVANZ 1 g powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 8

HOS-109694 · Präparat HOS-093229

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.