Adverse reactions : תופעות לוואי

4.8 Undesirable effects
This list is presented by system organ class, MedDRA preferred term, and frequency using the following frequency categories: very common (≥1/10), common (≥1/100, < 1/10), uncommon (≥1/1000, < 1/100), rare (≥1/10000, < 1/1000), very rare (<1/10000) and not known (cannot be estimated from the available data).
System Organ Class                        Frequency         MedDRA Term Infections and Infestations               Uncommon          Superinfections or colonisation with resistant bacteria or yeasta
Blood and lymphatic system disorders      Rare              Anaemia, eosinophilia Immune system disorders                   Not known         Anaphylactic response (anaphylactic reaction, anaphylactic shock and anaphylactoid reaction),
hypersensitivity
Metabolism and nutrition disorders        Rare              Hypomagnesaemia Nervous system disorders                  Not known         Paralysisa Rare              Tremora, paresthesiaa, headache, balance disordera
Eye disorders                             Rare              Blindnessb, retinal infarctionb Ear and labyrinth Disorders               Rare              Tinnitusa, hypoacusisa Not known         Deafnessa, deafness neurosensorya
Vascular disorders                        Rare              Hypotension Respiratory, thoracic and mediastinal     Not known         Apnoea, bronchopasm disorders
Gastrointestinal disorders                Uncommon          Nausea, vomiting Skin and subcutaneous tissue disorders Uncommon             Rash
Rare              Pruritus, urticaria
Musculoskeletal, connective tissue and Rare                 Arthralgia, muscle twitching a bone disorders
Renal and urinary disorders               Not known         Renal failure acute, nephropathy toxic, cells in urinea Rare              Oliguriaa, blood creatinine increaseda, albuminuriaa, azotemiaa, red blood cells urinea, white blood cells urinea
General disorders and administration      Rare              Pyrexia site conditions aSee section 4.4.
bAmikacin is not formulated for intavitreal use. Blindness and retinal infarction have been reported following intravitreous admistrations (injection into the eye) of amikacin.
All aminoglycosides have the potential to induce ototoxicity, renal toxicity, and neuromuscular blockade. These toxicities occur more frequently in patients with renal impairment, in patients treated with other ototoxic or nephrotoxic drugs, and in patients treated for longer periods and/or with higher doses than recommended (see section 4.4)
Renal function changes are usually reversible when the drug is discontinued.
Toxic effects on the eighth cranial nerve can result in hearing loss, loss of balance, or both.
Amikacin primarily affects auditory function. Cochlear damage includes high frequency deafness and usually occurs before clinical hearing loss can be detected by audiometric testing (see section 4.4).
When the recommended precautions and dosages are followed the incidence of toxic reactions, such as tinnitus, vertigo, and partial reversible deafness, skin rash, drug fever, headache, paraesthesia, nausea and vomiting is low. Urinary signs of renal irritation (albumin, casts, and red or white cells), azotaemia and oliguria have been reported although they are rare.
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 Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form
(https://sideeffects.health.gov.il)