Erbitux spc. February 2019 2018-12-24

Erbitux spc Rating: 4,9/10 457 reviews

encorAfenib, biNimetinib and Cetuximab in Subjects witH previOusly Untreated BRAF

erbitux spc

If you become pregnant during your treatment or within 2 months after your last dose, discuss this with your doctor. In combination with fluoropyrimidines, the frequency of cardiac ischaemia including myocardial infarction and congestive heart failure as well as the frequency of hand-foot syndrome palmar-plantar erythrodysaesthesia were increased compared to that with fluoropyrimidines. Care must be taken to ensure aseptic handling when preparing the infusion. Odporúčaná doba infúzie je 120 minút. Vplyvy na samčiu a samičiu fertilitu sa nevyhodnocovali vo formálnych štúdiách na zvieratách pozri časť 5. Dôrazne sa odporúča podávať Erbitux počas tehotenstva a ženám, ktoré nepoužívajú spoľahlivú antikoncepciu len vtedy, ak potenciálny prínos liečby pre matku prevažuje nad rizikom pre plod. Patients with a history of severe or life-threatening hypersensitivity to the active substance or to any of the excipients listed in section 6.

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Head, Neck, and Colorectal Cancer Treatment

erbitux spc

Treatment may only be resumed if the reaction has resolved to grade 2. A case of fatal angioedema occurred in a patient with recurrent and metastatic squamous cell carcinoma of the head and neck treated with Vectibix in a clinical trial. Other precautions This medicinal product contains 0. In vivo cetuximab inhibits expression of angiogenic factors by tumour cells and causes a reduction in tumour neo-vascularisation and metastasis. Nervous system disorders Common: Headache. Erbitux does not contain any antimicrobial preservative or bacteriostatic agent.

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Erbitux

erbitux spc

Limited observations in animals are indicative of a placental transfer of cetuximab, and other IgG 1 antibodies have been found to cross the placental barrier. Od zdravotníckych pracovníkov sa vyžaduje, aby hlásili akékoľvek podozrenia na nežiaduce reakcie prostredníctvom národného systému hlásenia uvedeného v 4. However biosimilars of Erbitux are not expected until 2018. The pharmacokinetic results were comparable to those in adults. In patients requiring treatment for infusion reactions, monitor for more than 1 hour to confirm resolution of the reaction. Tieto príznaky môžu uľahčiť výskyt infekcií pozi časť 4. When it is used on its own or with other anticancer medicines, Erbitux is continued for as long as the patient responds.

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Cetuximab: its unique place in head and neck cancer treatment

erbitux spc

When it is used with radiotherapy, Erbitux is started one week before the radiotherapy starts and continued until the radiotherapy has finished. Informácie o dávkovaní alebo odporúčaných úpravách dávky súbežne podávaných chemoterapeutík nájdete v produktovej informácii pre tieto lieky. The potential for absorption and harm to the infant after ingestion is unknown. The complete response rate primary endpoint was 71%. For clinical management of skin reactions, including dose modification recommendations, see section 4.

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Erbitux

erbitux spc

Some of the dosage forms listed on this page may not apply to the brand name Erbitux. Všeobecne ustúpia bez následkov počas doby nasledujúcej po prerušení liečby, ak sa dodržiavajú odporúčané úpravy dávkového režimu pozri časť 4. Magnesium repletion is recommended, as appropriate. Study Type : Interventional Clinical Trial Estimated Enrollment : 90 participants Intervention Model: Single Group Assignment Masking: None Open Label Masking Description: All involved know the identity of the intervention assignment. Skin lesions induced by cetuximab may predispose patients to superinfections e.

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encorAfenib, biNimetinib and Cetuximab in Subjects witH previOusly Untreated BRAF

erbitux spc

Non-clinical data on genotoxicity and local tolerance including accidental administration by routes other than the intended infusion revealed no special hazard for humans. Acute renal failure Acute renal failure has been observed in patients who develop severe diarrhoea and dehydration. Odporúča sa upozorniť pacientov na možnosť takej neskorej reakcie a inštruovať ich, aby kontaktovali svojho lekára, ak sa u nich vyskytnú symptómy alebo príznaky reakcie súvisiacej s infúziou. Toxicity was manageable with granulocyte colony-stimulating factor support. Príslušný objem roztoku chloridu sodného odoberte z infúzneho vaku použitím vhodnej sterilnej injekčnej striekačky a ihly. Avšak v závislosti od dávky sa pozoroval zvýšený výskyt potratov. The Court considers that that is the case here.

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SPC Erbitux 5 mg/ml infúzny roztok

erbitux spc

The development of acne-like rash was associated with tumor response. Grade 3 toxicity consisted of mucositis in 33% of patients, radiation dermatitis in 15% of patients, anemia in 18% of patients, leucopenia in 18% of patients, neutropenia in 12% of patients, and thrombocytopenia in 3% of patients. Erbitux is contraindicated in patients with known severe grade 3 or 4 hypersensitivity reactions to cetuximab. From a microbiological point of view, the product shall be used immediately after opening. The active substance in Erbitux, cetuximab, is a monoclonal antibody.

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Treatment for Metastatic Colorectal Cancer

erbitux spc

Calculate the required volume of Erbitux. The data presented herein is for information purposes only. Patients who had failed oxaliplatin treatment lived for an average of 4. It is recommended that cetuximab treatment be continued until progression of the underlying disease. Therefore, Vectibix has the potential to cause foetal harm when administered to pregnant women.

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