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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
Είσοδος χρηστών
Όνομα χρήστη
Συνθηματικό
Εικονίδιο Είσοδος χρήστη
Εικονίδιο Δωρεάν εγγραφή
Εικονίδιο Ανανέωση συνθηματικού

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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Ovitrelle 250 micrograms/0.5 ml prefilled syringe (2012)

Εκδότης

Εκδότης Merck Serono
Διεύθυνση Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

Name of the medicinal product

Ovitrelle 250 micrograms/0.5 ml solution for injection in a pre-filled syringe.

Qualitative and quantitative composition

Each pre-filled syringe contains 250 micrograms choriogonadotropin alfa* (equivalent to approximately ...

Pharmaceutical form

Solution for injection. Clear, colourless solution. The pH of the solution is 7.0 ± 0.3, its osmolarity ...

Therapeutic indications

Ovitrelle is indicated in the treatment of: Adult women undergoing superovulation prior to assisted reproductive ...

Posology and method of administration

Ovitrelle is intended for subcutaneous administration. Treatment with Ovitrelle should be performed under ...

Contraindications

Hypersensitivity to choriogonadotropin alfa or to any of the excipients of Ovitrelle Tumours of the hypothalamus ...

Special warnings and precautions for use

Before starting treatment, the couples infertility should be assessed as appropriate and putative contraindications ...

Interaction with other medicinal products and other forms of interaction

No specific interaction studies with Ovitrelle and other medicinal products have been performed however ...

Pregnancy and lactation

Pregnancy There is no indication for the use of Ovitrelle during pregnancy. No clinical data on exposed ...

Effects on ability to drive and use machines

Ovitrelle is expected to have no or negligible influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile In comparative trials with different doses of Ovitrelle, the following ...

Overdose

The effects of an overdose of Ovitrelle are unknown. Nevertheless, there is a possibility that OHSS may ...

Pharmacodynamic properties

Pharmacotherapeutic group: Sex hormones and modulators of the genital system, gonadotropins ATC code: ...

Pharmacokinetic properties

Following intravenous administration, choriogonadotropin alfa is distributed to the extracellular fluid ...

Preclinical safety data

Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, ...

List of excipients

Mannitol Methionine Poloxamer 188 Diluted phosphoric acid (for pH adjustment) Sodium hydroxide (for pH ...

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal ...

Shelf life

2 years. After opening, the medicinal product should be used immediately. However, the in-use stability ...

Special precautions for storage

Store in a refrigerator (2°C 8°C). Store in the original package. Within its shelf-life, the solution ...

Nature and contents of container

0.5 ml of solution in a pre-filled syringe (type I glass) with a plunger stopper (halobutyl rubber) and ...

Special precautions for disposal and other handling

Only clear solution without particles should be used. For single use only. Self-administration of Ovitrelle ...

Marketing authorization holder

Merck Serono Europe Limited 56, Marsh Wall London E14 9TP United Kingdom

Marketing authorization number(s)

EU/1/00/165/007

Date of first authorization / renewal of the authorization

Date of first authorization: 2 February 2001 Date of last renewal: 2 February 2006

Date of revision of the text

06/2011
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.