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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Proleukin (2011)

Εκδότης

Εκδότης Novartis Pharmaceuticals UK Ltd
Διεύθυνση Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
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Περιεχόμενα

Name of the medicinal product

PROLEUKIN® 18 10^6^ IU Powder for solution for injection or infusion.

Qualitative and quantitative composition

After reconstitution with 1.2 ml water for injections, according to the instructions (see section 6.6), ...

Pharmaceutical form

Powder for solution for injection or infusion. The powder is sterile, white and lyophilized.

Therapeutic indications

Treatment of metastatic renal cell carcinoma. Risk factors associated with decreased response rates and ...

Posology and method of administration

Proleukin should be administered intravenously by continuous infusion or by subcutaneous injection. The ...

Contraindications

Proleukin therapy is contra-indicated in the following patients: Patients with hypersensitivity to the ...

Special warnings and precautions for use

Patient screening See also section 4.3. Clinical studies have shown that patients with metastatic renal ...

Interaction with other medicinal products and other forms of interaction

Fatal Tumour Lysis Syndrome has been reported in combination with treatment with cis-platinum, vinblastine ...

Pregnancy and lactation

Both sexually active men and women should use effective methods of contraception during treatment. There ...

Effects on ability to drive and use machines

Proleukin causes adverse events that affect the ability to drive and operate machines. Patients should ...

Undesirable effects

Frequency and severity of adverse reactions to Proleukin have generally been shown to be dependent on ...

Overdose

Adverse reactions following the use of Proleukin are dose-related. Therefore patients can be expected ...

Pharmacodynamic properties

ATC classification system: immunostimulants, cytokines and immunomodulators, interleukins, aldesleukin ...

Pharmacokinetic properties

The pharmacokinetic parameters of IL-2, following an intravenous or subcutaneous administration of aldesleukin ...

Preclinical safety data

Animal studies are insufficient with respect to effects on fertility, embryo/foetal development and peri- ...

List of excipients

Mannitol (E421) Sodium laurilsulfate Sodium dihydrogen phosphate monohydrate (pH adjuster) Disodium hydrogen ...

Incompatibilities

Reconstitution and dilution procedures other than those recommended may result in incomplete delivery ...

Shelf life

2 years After reconstitution: 24 hours Diluted Proleukin should be used within 48 hours after reconstitution, ...

Special precautions for storage

Store at 2°C to 8 °C (in a refrigerator). Do not freeze. When reconstituted or reconstituted and diluted ...

Nature and contents of container

Proleukin is supplied in 5 ml single-use clear Type I glass vials with a stopper of synthetic rubber. ...

Special precautions for disposal and other handling

Reconstitution of Proleukin powder for solution for injection or infusion Vials (which contain 22 million ...

Marketing authorization holder

Novartis Pharmaceuticals UK Limited Frimley Business Park Frimley Camberley Surrey GU167SR

Marketing authorization number(s)

PL 00101/0936

Date of first authorization / renewal of the authorization

18th October 2006

Date of revision of the text

9th February 2011
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.