BEGRIVAC 15/15/15mc %v/v Suspension for Injection
देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
उत्पाद विशेषताएं
(SPC)
18-04-2024
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
A/CALIFORNIA/7/2009 (H1N1) - DERIVED STRAIN USED NYMC X-181 REASS A/CALIFORNIA/7/2009 (H1N1) - DERIVED STRAIN USED NYMC X-181 REASS B/BRISBANE/60/2008
थमां उपलब्ध:
Novartis Vaccines and Diagnostics GmbH
INN (इंटरनेशनल नाम):
A/CALIFORNIA/7/2009 (H1N1) - DERIVED STRAIN USED NYMC X-181 REASS A/CALIFORNIA/7/2009 (H1N1) - DERIVED STRAIN USED NYMC X-181 R
डोज़:
15/15/15mc %v/v
फार्मास्यूटिकल फॉर्म:
Suspension for Injection
प्रिस्क्रिप्शन प्रकार:
Product subject to prescription which may not be renewed (A)
प्राधिकरण का दर्जा:
Withdrawn
प्राधिकरण की तारीख:
0000-00-00
उत्पाद विशेषताएं
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Begrivac 2010/2011 suspension for injection
Influenza vaccine (split virion, inactivated)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus (inactivated, split) of the following strains*
A/California/7/2009 (H1N1) – derived strain used
NYMC X-181
15.0 micrograms HA **
A/Perth/16/2009 (H3N2) – like strain used
15.0 micrograms HA **
NYMC X-187 – derived from A/Victoria/210/2009
B/Brisbane/60/2008 – derived strain used
15.0 micrograms HA **
NYMC BX-35
per 0.5 ml dose
*propagated in fertilized hen eggs from healthy chicken flocks, purified, split by tween-ether, inactivated by
formaldehyde
**haemagglutinin
The vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for the 2010/2011
season.
_For a full list of excipients see section 6.1._
3 PHARMACEUTICAL FORM
Suspension for injection
Slightly opalescent.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis of influenza, especially in those who run an increased risk of associated complications.
The use of Begrivac 2010/2011 should be based on official recommendations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children from 36 months: 0.5 ml.
Children from 6 months to 35 months: Clinical data are limited. Dosages of 0.25 ml or 0.5 ml have been used.
For children who have not previously been vaccinated, a second dose should be given after an interval of at least 4
weeks.
Immunisation should be carried out by intramuscular or deep subcutaneous injection.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 23/11/2010_
_CRN 2091815_
_page number: 1_
_For instructions for preparation, see section 6.6._
4.3 CONTRAINDICATIONS
Hypersensitivity to t
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