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THE ONLY CISPLATIN POWDER IN EUROPE. Registered in Germany and Spain.

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SmPC

SmPC

PlatiCept 50 mg powder for solution for injection. Active ingredient: cisplatin. Qualitative and quantitative composition: 1 vial contains 50 mg of cisplatin. List of excipients: Mannitol(Ph.Eur.) (E 421) , Sodium chloride, Hydrochloric acid 0,36 %. This medicinal product contains 177 mg (7.7 mmol) of sodium per vial, which must be considered when treating patients with low-sodium diets. Therapeutic indications: Metastatic testicular and ovarian tumours, Advanced bladder cancer, Squamous cell carcinoma of the head and neck, Lung carcinoma (small cell and non-small cell). Contraindications: Cisplatin is contraindicated in: Hypersensitivity to the active ingredient or to any of the excipients. Patients with renal impairment. Patients with dehydration. Patients with myelosuppression. Patients with hearing impairment. Patients with cisplatin-induced neuropathy. Patients who breastfeeding. In combination with attenuated vaccines, including the yellow fever vaccine. Start of new anticonvulsivant treatment with phenytoin. Undesirable effects: Very common: Bone marrow failure, thrombocytopenia, leukopenia, anaemia, hyponatraemia, ototoxicity, vomiting, nausea, anorexia, diarrhoea, acute renal failure, renal tubular disorders. Common: sepsis, neurotoxicity, deafness and vestibular toxicity combined with vertigo, arrhythmia, bradycardia, tachycardia, phlebitis, dyspnoea, pneumonia, respiratory failure, hepatic dysfunction with elevated serum levels of transaminase and bilirubin which is reversible, erythema, skin ulcers, localised oedema, pain, Uncommon: anaphylactic reaction, rash, urticaria, erythema or pruritus, fever, hypomagnesaemia, metallic colouration of the gums, alopecia, dysfunctional spermatogenesis and ovulation, painful gynecomastia, Rare: acute leukaemia, anaphylactic reactions, immunosuppression, inappropriate antidiuretic hormone secretion syndrome, Hypercholesterolaemia, hypocalcaemia, hypokalaemia, hypophosphataemia, tetany, Convulsion, peripheral neuropathy, leukoencephalopathy, reversible posterior leukoencephalopathy syndrome, Optic neuritis, eye movement disorder, papilloedema and cortical blindness, blurred vision and altered colour perception, Inability to hold a normal conversation, myocardial infarction, hypertension, severe coronary artery disease, hypertension, stomatitis, decreased levels of serum albumin. Very rare: inappropriate antidiuretic hormone secretion, elevated iron concentrations, seizures, cardiac arrest, cerebral or coronary ischaemia, impaired peripheral circulation associated with Raynaud’s syndrome, Not known: infections, coombs-positive haemolytic anaemia, increased blood amylase, dehydration, hyperuricaemia, cerebrovascular accident, haemorrhagic stroke, ischaemic stroke, ageusia, cerebral arteritis, Lhermitte’s sign, myelopathy, autonomic neuropathy, retinal pigmentation, tinnitus, cardiac disorder, thrombotic microangiopathy (haemolytic uraemic syndrome), pulmonary embolism, hiccups, skin rash, alopecia, muscle spasms, pyrexia (very common), asthenia, malaise, extravasation at the injection site. Warnings: Keep out of the sight and reach of children. For further warnings, precautions and interation with other medical products see SmPC. Prescription only. PharmaCept GmbH, Bessemerstr. 82, 12103 Berlin, Germany. Date of revision of the text: October 2018

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