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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Calcium Folinate 10 mg/ml Injection (2011)

Εκδότης

Εκδότης Hospira UK Ltd
Διεύθυνση Queensway, Royal Leamington Spa, Warwickshire, CV31 3RW
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Περιεχόμενα

Name of the medicinal product

Calcium Folinate 10 mg/mL Injection.

Qualitative and quantitative composition

Each vial of 10 ml solution contains 10 mg/ml of folinic acid provided as calcium folinate. For excipients, ...

Pharmaceutical form

Solution for Injection.

Therapeutic indications

Calcium folinate is indicated: a) to diminish the toxicity and counteract the action of folic acid antagonists ...

Posology and method of administration

For intravenous and intramuscular administration only. In the case of intravenous administration, no ...

Contraindications

Known hypersensitivity to calcium folinate, or to any of the excipients. Pernicious anaemia or other ...

Special warnings and precautions for use

Calcium folinate should only be given by intramuscular or intravenous injection and must not be administered ...

Interaction with other medicinal products and other forms of interaction

When calcium folinate is given in conjunction with a folic acid antagonist (e.g. cotrimoxazole, pyrimethamine) ...

Pregnancy and lactation

Pregnancy There are no adequate and well-controlled clinical studies conducted in pregnant or breast-feeding ...

Effects on ability to drive and use machines

There is no evidence that calcium folinate has an effect on the ability to drive or use machines.

Undesirable effects

Immune system disorders Very rare (<0.01%): allergic reactions, including anaphylactoid reactions and ...

Overdose

There have been no reported sequelae in patients who have received significantly more calcium folinate ...

Pharmacodynamic properties

Pharmacotherapeutic group: Detoxifying agents for antineoplastic treatment ATC code: V03AF03 Calcium ...

Pharmacokinetic properties

Absorption Following intramuscular administration of the aqueous solution, systemic availability is comparable ...

Preclinical safety data

There are no preclinical data considered relevant to clinical safety beyond data included in other sections ...

List of excipients

Sodium Chloride Water for Injections

Incompatibilities

Incompatibilities have been reported between injectable forms of calcium folinate and injectable forms ...

Shelf life

Product as packaged for sale: 24 months. In use: From a microbial point of view, the product should be ...

Special precautions for storage

Store in a refrigerator (+2°C to +8°C) Keep vial in the outer carton in order to protect from light. ...

Nature and contents of container

5 mL Type I glass vials (50 mg/5 mL) 10 mL Type I glass vials (100 mg/10 mL) 30 mL Type I glass vials ...

Special precautions for disposal and other handling

Prior to administration, calcium folinate should be inspected visually. The solution for injection or ...

Marketing authorization holder

Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW UK

Marketing authorization number(s)

PL 04515/0069

Date of first authorization / renewal of the authorization

March 2003

Date of revision of the text

January 2008
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.