LOMUSTINE MEDAC Capsule (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Lomustine medac 40 mg.
Qualitative and quantitative composition
Lomustine (CCNU) 40 mg per capsule.
Pharmaceutical form
Hard capsule.
Therapeutic indications
As palliative or supplementary treatment, usually in combination with radiotherapy and/or surgery as part of multiple drug regimens in: brain tumours (primary or metastatic) lung tumours (especially oat-cell ...
Posology and method of administration
Posology Adults Lomustine medac is given by mouth. The recommended dose in patients with normally functioning bone marrow receiving Lomustine medac as their only chemotherapy is 120–130 mg/m² as a single ...
Contraindications
Lomustine can cause birth defects. Men and women are recommended to take contraceptive precautions during therapy with lomustine and for 6 months after treatment. Men should be informed about the risk ...
Special warnings and precautions for use
Patients receiving Lomustine medac chemotherapy should be under the care of doctors experienced in cancer treatment. Delayed bone marrow suppression, notably thrombocytopenia and leukopenia, which may ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Lomustine medac use in combination with theophylline or with the H2 receptor antagonist cimetidine may potentiate bone marrow toxicity. Cross-resistance with ...
Fertility, pregnancy and lactation
Pregnancy Lomustine medac is contraindicated during pregnancy (see section 4.3). Safe use in pregnancy has not been established. Animal studies have shown reproductive toxicity (see section 5.3). If this ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Lomustine medac capsules can impair the ability to drive and use machines, e.g. because of nausea and vomiting. ...
Undesirable effects
The list is presented by system organ class and frequency: Very common (≥1/10) 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 ...
Overdose
Symptoms Accidental overdose with lomustine has been reported, including fatal cases. Symptoms of overdose with Lomustine medac will probably include bone marrow toxicity, haematological toxicity, abdominal ...
Pharmacodynamic properties
Pharmacotherapeutic group: cytostatics, alkylating agents ATC code: L01AD02 The mode of action is believed to be partly as an alkylating agent and partly by inhibition of several steps in the synthesis ...
Pharmacokinetic properties
Lomustine medac is readily absorbed from the intestinal tract. A maximum plasma concentration of 0.5–2 ng/ml is reached after 3 hours following an oral dose of 30–100 mg/m². The plasma disappearance of ...
Preclinical safety data
Lomustine is embryotoxic and teratogenic in rats and embryotoxic in rabbits at dose levels equivalent to the human dose.
List of excipients
Capsule contents: Lactose Wheat starch Talc Magnesium stearate Capsule shell: Gelatine Indigo carmine E132 Titanium dioxide E171
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years as packaged for sale.
Special precautions for storage
Do not store above 25°C. Store in the original container in order to protect from light and moisture.
Nature and contents of container
Securitainers containing 20 capsules.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements..
Marketing authorization holder
medac, Gesellschaft für klinische Spezialpräparate mbH, Theaterstr. 6, 22880 Wedel, Germany
Marketing authorization number(s)
PL 11587/0003
Date of first authorization / renewal of the authorization
25 August 2006
Date of revision of the text
01/2019
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