PHARMORUBICIN Solution for injection or infusion (2021)
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Περιεχόμενα
1. Name of the medicinal product
Pharmorubicin 2 mg/ml Solution for Injection or Infusion.
2. Qualitative and quantitative composition
Epirubicin hydrochloride 2 mg per ml 5 ml vials contain 10 mg of epirubicin hydrochloride 10 ml vials contain 20 mg of epirubicin hydrochloride 25 ml vials contain 50 mg of epirubicin hydrochloride 100 ...
3. Pharmaceutical form
Solution for injection or infusion. Red, sterile, preservative-free, aqueous solution.
4.1. Therapeutic indications
Pharmorubicin has produced responses in a wide range of neoplastic conditions, including breast, ovarian, gastric, lung and colorectal carcinomas, malignant lymphomas, leukaemias and multiple myeloma. ...
4.2. Posology and method of administration
Posology Pharmorubicin is not active when given orally and should not be injected intramuscularly or intrathecally. It is advisable to give the drug via the tubing of a freely-running IV saline infusion ...
4.3. Contraindications
Hypersensitivity to epirubicin or to any of the excipients listed in section 6.1, other anthracyclines or anthracenediones. Lactation Intravenous use: persistent myelosuppression severe hepatic impairment ...
4.4. Special warnings and precautions for use
General Epirubicin should be administered only under the supervision of qualified physicians experienced in the use of cytotoxic therapy. Patients should recover from acute toxicities (such as stomatitis, ...
4.5. Interaction with other medicinal products and other forms of interaction
Epirubicin is mainly used in combination with other cytotoxic drugs. Additive toxicity may occur especially with regard to bone marrow/haematologic and gastro-intestinal effects (see section 4.4). The ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no studies in pregnant women. Experimental data in animals suggest that epirubicin may cause foetal harm when administered to a pregnant woman, particularly in the first trimester. ...
4.7. Effects on ability to drive and use machines
There have been no reports of particular adverse events relating to effects on ability to drive and to use machines.
4.8. Undesirable effects
The following undesirable effects have been observed and reported during treatment with epirubicin with the following frequencies: Very Common ≥1/10, Common ≥1/100 to <1/10, Uncommon ≥1/1,000 to <1/100, ...
4.9. Overdose
Acute overdosage with epirubicin will result in severe myelosuppression (mainly leucopoenia and thrombocytopenia), gastrointestinal toxic effects (mainly mucosal inflammation) and acute cardiac complications. ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Anthracyclines and related substances <b>ATC code:</b> L01DB03 The mechanism of action of Pharmorubicin is related to its ability to bind to DNA. Cell culture studies ...
5.2. Pharmacokinetic properties
In patients with normal hepatic and renal function, plasma levels after I.V. injection of 60-150mg/m² of the drug follow a tri-exponential decreasing pattern with a very fast first phase and a slow terminal ...
5.3. Preclinical safety data
The main target organs in rat, rabbit and dog following repeated dosing were the haemolymphopoietic system, GI tract, kidney, liver and reproductive organs. Epirubicin was also cardiotoxic in the species ...
6.1. List of excipients
Hydrochloric acid Sodium chloride Water for injections
6.2. Incompatibilities
Prolonged contact with any solution of an alkaline pH should be avoided as it will result in hydrolysis of the drug. Pharmorubicin should not be mixed with heparin due to chemical incompatibility which ...
6.3. Shelf life
<u>a) Shelf life of the product as package for sale:</u> Glass vials: 3 years. Polypropylene Cytosafe vials: 3 years. <u>b) Shelf life after first opening the container:</u> Pharmorubicin Solution for ...
6.4. Special precautions for storage
Store at 2°C-8°C (in a refrigerator). Keep the vial in the outer carton in order to protect from light. Storage of the solution for injection or infusion at refrigerated conditions can result in the formation ...
6.5. Nature and contents of container
Colourless glass 5ml, 10ml, 25ml, or 100ml vial (type I), with Teflon-faced chlorobutyl rubber bung and aluminium cap with inset grey polypropylene disk. Colourless polypropylene 5ml, 10ml, 25ml or 100ml ...
6.6. Special precautions for disposal and other handling
<b>Intravenous administration.</b> Epirubicin should be administered into the tubing of a freely flowing intravenous infusion (0.9% sodium chloride). To minimize the risk of thrombosis or perivenous extravasation, ...
7. Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
8. Marketing authorization number(s)
PL 00057/1023
9. Date of first authorization / renewal of the authorization
14<sup>th</sup> May 2004
10. Date of revision of the text
07/2021
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