MIACALCIC

Κύριές Πληροφορίες

  • Εμπορική ονομασία:
  • MIACALCIC 200 IU/DOSE M.D.NAS.SP
  • Φαρμακολογική κατηγορία (ATC):
  • H05BA01
  • Δοσολογία:
  • 200 IU/DOSE
  • Φαρμακοτεχνική μορφή:
  • ΕΚΝΕΦΩΜΑ ΡΙΝΙΚΟ ΣΤΑΘΕΡΩΝ ΔΟΣΕΩΝ
  • Χρήση για:
  • Οι άνθρωποι
  • Τύπος φάρμακου:
  • αλλοπαθητική των ναρκωτικών

Έγγραφα

Εντοπισμός

  • Διατίθεται σε:
  • MIACALCIC 200 IU/DOSE M.D.NAS.SP
    Ελλάδα
  • Γλώσσα:
  • Ελληνικά

Θεραπευτικές πληροφορίες

  • Θεραπευτική περιοχή:
  • ΦΑΡΜΑΚΕΥΤΙΚΟ ΠΡΟΪΟΝ

Άλλες πληροφορίες

Κατάσταση

  • Πηγή:
  • Εθνικός Οργανισμός Φαρμάκων
  • τελευταία ενημέρωση:
  • 09-08-2016

φύλλο οδηγιών χρήσης

ΦΥΛΛΟ ΟΔΗΓΙΩΝ ΧΡΗΣΗΣ: ΠΛΗΡΟΦΟΡΙΕΣ ΓΙΑ ΤΟ ΧΡΗΣΤΗ

Miacalcic 200 IU ρινικό εκνέφωμα

Καλσιτονίνη (σολομού, συνθετική)

Διαβάστε προσεκτικά όλο το φύλλο οδηγιών χρήσης πριν ξεκινήσετε να χρησιμοποιείτε αυτό το 

φάρμακο.

Φυλάξτε αυτό το φύλλο οδηγιών. Ίσως χρειαστεί να το διαβάσετε ξανά.

Αν έχετε περεταίρω απορίες, ρωτήστε το γιατρό ή το φαρμακοποιό σας.

Η συνταγή για αυτό το φάρμακο χορηγήθηκε για σας. Δεν πρέπει να δώσετε το φάρμακο σε άλλους. 

Μπορεί να τους προκαλέσει βλάβη, ακόμα και όταν τα συμπτώματά τους είναι ίδια με τα δικά 

σας.

Εάν κάποια ανεπιθύμητη ενέργεια γίνεται σοβαρή, ή αν παρατηρήσετε κάποια ανεπιθύμητη ενέργεια 

που δεν αναφέρεται στο παρόν φύλλο οδηγιών, παρακαλείσθε να ενημερώσετε το γιατρό ή 

φαρμακοποιό σας.

Το παρόν φύλλο οδηγιών περιέχει:

Τι είναι το ρινικό εκνέφωμα Miacalcic και ποια είναι η χρήση του

Τι πρέπει να γνωρίζετε προτού χρησιμοποιήσετε το ρινικό εκνέφωμα Miacalcic

Πώς να χρησιμοποιήσετε το ρινικό εκνέφωμα Miacalcic

Πιθανές ανεπιθύμητες ενέργειες

Πώς να φυλάσσεται το ρινικό εκνέφωμα Miacalcic

Λοιπές πληροφορίες

ΤΙ ΕΙΝΑΙ ΤΟ ΡΙΝΙΚΟ ΕΚΝΕΦΩΜΑ MIACALCIC ΚΑΙ ΓΙΑ ΠΟΙΑ ΕΙΝΑΙ Η 

ΧΡΗΣΗ ΤΟΥ

Το ρινικό εκνέφωμα Miacalcic περιέχει τη δραστική ουσία καλσιτονίνη (σολομού, συνθετική). 

Η καλσιτονίνη είναι μια ορμόνη που υπάρχει φυσιολογικά στον οργανισμό τόσο των ανθρώπων όσο 

και των ζώων. Ρυθμίζει τα επίπεδα του ασβεστίου στο αίμα. Η καλσιτονίνη χρησιμοποιείται για να 

αναστρέψει την απώλεια οστού και μπορεί επίσης να βοηθήσει στο σχηματισμό οστού. 

Το ρινικό εκνέφωμα Miacalcic χρησιμοποιείται για την αντιμετώπιση της οστεοπόρωσης (λεπτά και 

αδύναμα οστά) στις γυναίκες μετά την εμμηνόπαυση για να μειώσει τον κίνδυνο για κατάγματα 

σπονδύλων.

ΤΙ ΠΡΕΠΕΙ ΝΑ ΓΝΩΡΙΖΕΤΕ ΠΡΙΝ ΝΑ ΧΡΗΣΙΜΟΠΟΙΗΣΕΤΕ ΤΟ ΡΙΝΙΚΟ 

ΕΚΝΕΦΩΜΑ MIACALCIC

Μη χρησιμοποιήσετε το ρινικό εκνέφωμα Miacalcic

αν έχετε αλλεργία (υπερευαισθησία) στην καλσιτονίνη (σολομού, συνθετική) ή σε κάποιο από 

τα άλλα συστατικά του Miacalcic.

αν έχετε πολύ χαμηλά επίπεδα ασβεστίου στο αίμα (υπασβεστιαιμία). 

Προσέξτε ιδιαίτερα με το ρινικό εκνέφωμα Miacalcic

Πριν από τη θεραπεία με το ρινικό εκνέφωμα Miacalcic ενημερώστε το γιατρό σας αν υποπτεύεστε 

ότι είστε αλλεργικός στην καλσιτονίνη (σολομού, συνθετική). Ο γιατρός σας θα πραγματοποιήσει ένα 

δερματικό τεστ προτού αρχίσετε να παίρνετε το ρινικό εκνέφωμα Miacalcic.

Εάν έχετε ρινικό ερεθισμό μην ξεκινήσετε τη χρήση του ρινικού εκνεφώματος Miacalcic. 

Ενημερώστε το γιατρό σας, ο οποίος θα εξετάσει τη μύτη σας πριν αρχίσετε να χρησιμοποιείτε το 

ρινικό εκνέφωμα Miacalcic.

Λήψη άλλων φαρμάκων

Παρακαλείσθε να ενημερώσετε το γιατρό ή τον φαρμακοποιό σας εάν λαμβάνετε ή έχετε λάβει 

πρόσφατα άλλα φάρμακα, συμπεριλαμβανομένων φαρμάκων που μπορεί να ληφθούν χωρίς ιατρική 

συνταγή. Είναι ιδιαίτερα σημαντικό να ενημερώσετε το γιατρό σας αν παίρνετε κάποιο φάρμακο που 

περιέχει λίθιο, καθώς η δόση του λιθίου μπορεί να χρειαστεί να αλλάξει. 

Παιδιά και έφηβοι (κάτω των 18 ετών)

Η χρήση του Miacalcic δεν συνιστάται σε ασθενείς ηλικίας μικρότερης των 18 ετών.

Ηλικιωμένοι 

Το ρινικό εκνέφωμα Miacalcic μπορεί να χρησιμοποιηθεί από ηλικιωμένους χωρίς κάποιες ειδικές 

προϋποθέσεις.

Κύηση και γαλουχία

Το ρινικό εκνέφωμα Miacalcic δεν θα πρέπει να χρησιμοποιείται από έγκυες και γυναίκες που 

θηλάζουν.

Αν είστε ή νομίζετε ότι μπορεί να είστε έγκυος, ζητήστε τη συμβουλή του γιατρού ή του 

φαρμακοποιού σας προτού πάρετε οποιοδήποτε φάρμακο. 

Οδήγηση και χειρισμός μηχανών

Το ρινικό εκνέφωμα Miacalcic μπορεί να προκαλέσει κόπωση, ζάλη και διαταραχές της όρασης που 

μπορεί να επηρεάσουν τις αντιδράσεις σας. Εάν σας συμβούν αυτά, αποφύγετε την οδήγηση και το 

χειρισμό οποιωνδήποτε μηχανών.

Σημαντικές πληροφορίες σχετικά με ορισμένα συστατικά του ρινικού εκνεφώματος 

Miacalcic

Το ρινικό εκνέφωμα Miacalcic περιέχει χλωριούχο βενζαλκόνιο, το οποίο μπορεί να προκαλέσει 

οίδημα στο εσωτερικό της μύτης ,ιδίως κατά τη μακροχρόνια χρήση. Εάν υποπτευθείτε τ 

παρατηρήσετε ρινική συμφόρηση,επικοινωνήστε με το γιατρό σας. Ο γιατρός σας μπορεί να 

αποφασίσει να σας συνταγογραφήσει κάποια άλλη θεραπεία.

ΠΩΣ ΝΑ ΧΡΗΣΙΜΟΠΟΙΕΙΤΕ ΤΟ ΡΙΝΙΚΟ ΕΚΝΕΦΩΜΑ MIACALCIC

Πάντοτε να παίρνετε το ρινικό εκνέφωμα Miacalcic αυστηρά σύμφωνα με τις οδηγίες του γιατρού 

σας. Εάν έχετε αμφιβολίες, ρωτήστε το γιατρό ή το φαρμακοποιό σας.

Αυτό το φάρμακο είναι μόνο για ρινική χρήση.

Ο φαρμακοποιός σας διατηρούσε το ρινικό εκνέφωμα Miacalcic σε ψυγείο. Πριν από την έναρξη της 

χρήσης θα πρέπει να φτάσει σε θερμοκρασία δωματίου. Το ρινικό εκνέφωμα Miacalcic θα πρέπει να 

φυλάσσεται σε θερμοκρασία δωματίου.

Η συνήθης δόση είναι μία εισπνοή (200 IU) καθημερινά. Συνίσταται να λαμβάνεται το ρινικό 

εκνέφωμα Miacalcic και στις δύο ρινικές χοάνες εναλλάξ.

Συνίσταται να παίρνετε επαρκή ποσότητα ασβεστίου και βιταμίνης D ενόσω λαμβάνετε το ρινικό 

εκνέφωμα Miacalcic. Ζητήστε τη συμβουλή του γιατρού σας.

Πριν χρησιμοποιήσετε το ρινικό εκνέφωμα για πρώτη φορά, η αντλία πρέπει να γεμίσει με τη δόση, 

όπως περιγράφεται παρακάτω στις « Οδηγίες χρήσης του ρινικού εκνεφώματος Miacalcic». Οι 

οδηγίες πρέπει να ακολουθούνται προσεκτικά. 

Οδηγίες χρήσης του ρινικού εκνεφώματος Miacalcic

Παρακαλείσθε να διαβάστε τις οδηγίες προσεκτικά ώστε να ξέρετε πώς να χρησιμοποιείτε το ρινικό 

σας εκνέφωμα. Αυτές οι οδηγίες σας ενημερώνουν:

Για τα διαφορετικά μέρη του ρινικού εκνεφώματος.

Για το πώς να ετοιμάσετε ένα καινούριο ρινικό εκνέφωμα για χρήση.

Για τη χρήση του ρινικού εκνεφώματος.

Για τον έλεγχο του μετρητή .

Ακολουθείτε πάντοτε προσεκτικά τις οδηγίες του γιατρού σας όσον αφορά τη δόση.

Τα διαφορετικά μέρη του φιαλιδίου εκνεφώματος

0100090000032a020000

0200a20100000000a201

000026060f003a03574d

4643010000000000010

0ea33000000000100000

0180300000000000018

030000010000006c0000

0000000000000000003

50000006f00000000000

00000000000700d0000

8a0d000020454d460000

0100180300001200000

0020000000000000000

000000000000008e1200

00981a0000c900000020

0100000000000000000

000000000007c110300d

c650400160000000c000

000180000000a0000001

0000000000000000000

0000090000001000000

02d0300003303000025

0000000c0000000e0000

80250000000c0000000e

000080120000000c0000

0001000000520000007

001000001000000a4ffff

ff000000000000000000

0000009001000000000

0a104400022430061006

c0069006200720069000

0000000000000000000

0000000000000000000

0000000000000000000

0000000000000000000

0000000000000000000

000000001100c09a1100

10000000249e1100a49b

1100fd516032249e1100

1c9b1100100000008c9c

1100089e110094516032

249e11001c9b11002000

00009f712e311c9b1100

249e110020000000ffffff

 Προστατευτικό κάλυμμα: Διατηρεί το ακροφύσιο 

καθαρό και προστατεύει το άνοιγμα. 

Τοποθετείτε πάντοτε στη θέση του το 

προστατευτικό κάλυμμα μετά τη χρήση του 

ρινικού εκνεφώματος. 

 Άνοιγμα: Η μικρή οπή μέσω της οποίας ψεκάζεται το 

φάρμακο. 

 Ακροφύσιο: Το μέρος που εισάγετε στη ρινική χοάνη.

 Αντλία: Το μέρος που πιέζετε για να λειτουργήσει η 

συσκευή.

 Μετρητής: Το παράθυρο μέτρησης δόσεων σε μία 

καινούρια συσκευή δείχνει  , όπως φαίνεται στην 

εικόνα. Η ένδειξη αλλάζει καθώς χρησιμοποιείτε 

την αντλία (βλ. παρακάτω).

Εμβυθισμένος σωλήνας: Ο σωλήνας μέσα στο 

φιαλίδιο του εκνεφώματος που αντλεί το φάρμακο 

όταν πιέζετε την αντλία. 

 Φιαλίδιο: Περιέχει αρκετό φάρμακο για τουλάχιστον 

14 μετρημένες δόσεις.

fffffff0180ffff01803fff0

180ffffffff00000000000

8000000080000430000

0001000000000000005

802000025000000372e9

001a100020f050202020

4030204ef0200a07b200

0400000000000000000

9f000000000000004300

61006c00690062007200

00000000c08fc708c1b7

60325198bb6cdc24ea00

8844e100509b11009c2d

2731060000000100000

08c9b11008c9b1100087

a253106000000b49b110

0fc24ea0064760008000

00000250000000c00000

001000000250000000c0

0000001000000250000

000c0000000100000018

0000000c000000000000

0254000000540000000

0000000000000003500

00006f00000001000000

18698740c25e87400000

0000570000000100000

04c00000004000000000

00000000000002d0300

0033030000500000002

0000e003600000046000

000280000001c0000004

744494302000000fffffff

fffffffff2e030000340300

0000000000460000001

4000000080000004744

4943030000002500000

00c0000000e000080250

000000c0000000e00008

00e00000014000000000

0000010000000140000

0004000000030108000

50000000b0200000000

050000000c028b008a00

040000002e0118001c00

0000fb02030001000000

0000bc02000000a10102

022253797374656d000

0000000000000000000

0000000000000000000

0000000000004000000

2d010000040000002d0

1000004000000020101

001c000000fb02f0ff000

0000000009001000000a

10440002243616c69627

2690000000000000000

0000000000000000000

0000000000000000400

00002d0101000400000

02d010100040000002d

0101000500000009020

00000020d000000320a0

f0000000100040000000

0008a008b0020a809000

40000002d0100000400

00002d0100000300000

00000

Προετοιμάζοντας μία καινούρια συσκευή ρινικού εκνεφώματος για χρήση:

ΠΟΤΕ μην ανακινείτε το φιαλίδιο του ρινικού εκνεφώματος καθώς αυτό θα μπορούσε να προκαλέσει 

το σχηματισμό φυσαλίδων αέρα που μπορεί να επηρεάσουν τη δόση σας. 

0100090000032

a0200000200a2

0100000000a20

1000026060f00

3a03574d46430

1000000000001

00ea330000000

0010000001803

0000000000001

8030000010000

006c000000000

0000000000000

350000006f000

0000000000000

000000700d000

08a0d00002045

4d46000001001

8030000120000

0002000000000

0000000000000

Το   παράθυρο   του   μετρητή   δόσεων   σε   ένα   καινούργιο   φιαλίδιο   ρινικού 

εκνεφώματος είναι στη θέση που σημειώνεται με   στην εικόνα.

Πρώτα, βγάλτε το προστατευτικό κάλυμμα.

0100090000032a0200000200a

20100000000a201000026060f

003a03574d46430100000000

000100ea33000000000100000

018030000000000001803000

0010000006c0000000000000

000000000350000006f000000

0000000000000000700d0000

8a0d000020454d4600000100

180300001200000002000000

000000000000000000000000

8e120000981a0000c90000002

001000000000000000000000

00000007c110300dc65040016

0000000c000000180000000a0

000001000000000000000000

0000009000000100000002d0

3000033030000250000000c0

000000e000080250000000c00

00000e000080120000000c000

000010000005200000070010

00001000000a4ffffff0000000

000000000000000009001000

0000000a1044000224300610

06c006900620072006900000

000000000000000000000000

000000000000000000000000

000000000000000000000000

000000000000000000000000

000001100c09a110010000000

249e1100a49b1100fd5160322

49e11001c9b1100100000008c

9c1100089e110094516032249

e11001c9b1100200000009f71

2e311c9b1100249e110020000

000fffffffffc24ea001a722e31ff

ffffffffff0180ffff01803fff0180

ffffffff0000000000080000000

800004300000001000000000

000005802000025000000372

e9001a100020f050202020403

0204ef0200a07b20004000000

000000000009f000000000000

00430061006c006900620072

0000000000c08fc708c1b7603

 Κρατήστε όρθια τη συσκευή του ρινικού εκνεφώματος με το 

ένα ή και τα δύο χέρια και πιέστε την αντλία προς τα 

κάτω σταθερά 3 φορές.

Αυτό κινητοποιεί το νέο ρινικό εκνέφωμα αφαιρώντας τον 

αέρα από τον εμβυθισμένο σωλήνα. Αυτό χρειάζεται να 

γίνει μόνο μια φορά όταν ξεκινάτε τη χρήση μίας νέας 

συσκευής ρινικού εκνεφώματος. 

Μην ανησυχήσετε εάν ψεκαστεί λίγο φάρμακο, είναι 

φυσιολογικό.

0100090000032a020

0000200a201000000

00a201000026060f0

03a03574d46430100

000000000100ea330

00000000100000018 0100090000032a020

0000200a201000000

00a201000026060f0

03a03574d46430100

000000000100ea330

00000000100000018 0100090000032a0200000200a20100000000

a201000026060f003a03574d4643010000000

0000100ea330000000001000000180300000

000000018030000010000006c00000000000

00000000000350000006f000000000000000

0000000700d00008a0d000020454d4600000

Καθώς πιέζετε την αντλία, 

παρατηρείστε τις αλλαγές στο 

παράθυρο του μετρητή δόσεων:  Όταν το παράθυρο του μετρητή δόσεων είναι πράσινο, 

το καινούριο σας ρινικό εκνέφωμα είναι έτοιμο για 

χρήση.

0100090000032a0200000200a2

0100000000a201000026060f00

3a03574d464301000000000001

00ea3300000000010000001803

00000000000018030000010000

006c0000000000000000000000

350000006f0000000000000000

000000700d00008a0d00002045

4d460000010018030000120000

00020000000000000000000000

000000008e120000981a0000c9

00000020010000000000000000

0000000000007c110300dc6504

00160000000c00000018000000

0a000000100000000000000000

00000009000000100000002d03

000033030000250000000c0000

000e000080250000000c000000

0e000080120000000c00000001

00000052000000700100000100

0000a4ffffff0000000000000000

0000000090010000000000a104

400022430061006c0069006200

72006900000000000000000000

00000000000000000000000000

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00249e1100a49b1100fd5160322

49e11001c9b1100100000008c9

c1100089e110094516032249e1

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1c9b1100249e110020000000ffff

fffffc24ea001a722e31ffffffffffff

0180ffff01803fff0180ffffffff000

00000000800000008000043000

00001000000000000005802000

025000000372e9001a100020f05

02020204030204ef0200a07b200

Ακολουθήστε τις οδηγίες «Χρησιμοποιώντας το 

εκνέφωμά σας»

Χρησιμοποιώντας το ρινικό σας εκνέφωμα

 Αφού βγάλετε το προστατευτικό κάλυμμα, σκύψτε το 

κεφάλι ελαφρά προς τα εμπρός και βάλτε το 

ακροφύσιο σε μία ρινική χοάνη. Προσπαθήστε να 

κρατήσετε όρθια τη συσκευή του ρινικού 

εκνεφώματος όμως φαίνεται στην εικόνα. 

 Πιέστε την αντλία σταθερά μόνο μια φορά.

 Απομακρύνετε τη συσκευή του ρινικού εκνεφώματος 

από τη μύτη σας και αναπνεύστε βαθιά μέσω της 

0100090000032a0200000200a20100

000000a201000026060f003a03574d4

6430100000000000100ea330000000

001000000180300000000000018030

000010000006c00000000000000000

00000350000006f0000000000000000

000000700d00008a0d000020454d46

000001001803000012000000020000

000000000000000000000000008e12

0000981a0000c90000002001000000

00000000000000000000007c110300

dc650400160000000c000000180000

000a00000010000000000000000000

000009000000100000002d03000033

030000250000000c0000000e000080

250000000c0000000e000080120000

000c00000001000000520000007001

000001000000a4ffffff000000000000

00000000000090010000000000a104

400022430061006c00690062007200

690000000000000000000000000000

000000000000000000000000000000

000000000000000000000000000000

0000000000000000001100c09a1100

10000000249e1100a49b1100fd51603

2249e11001c9b1100100000008c9c11

00089e110094516032249e11001c9b1

100200000009f712e311c9b1100249e

110020000000fffffffffc24ea001a722e

31ffffffffffff0180ffff01803fff0180ffff

ffff0000000000080000000800004300

000001000000000000005802000025

000000372e9001a100020f050202020

4030204ef0200a07b20004000000000

000000009f000000000000004300610

06c0069006200720000000000c08fc7

08c1b760325198bb6cdc24ea008844e

100509b11009c2d273106000000010

000008c9b11008c9b1100087a253106

000000b49b1100fc24ea00647600080

0000000250000000c0000000100000

0250000000c0000000100000025000

0000c00000001000000180000000c0

000000000000254000000540000000

000000000000000350000006f000000

0100000018698740c25e8740000000

0057000000010000004c0000000400

000000000000000000002d03000033

0300005000000020000e0036000000

46000000280000001c000000474449

4302000000ffffffffffffffff2e03000034

030000000000004600000014000000

080000004744494303000000250000

ρινικής χοάνης για να βοηθήσετε να μείνει το 

φάρμακο μέσα στη μύτη σας. 

 Αν ο γιατρός σας είπε να λάβετε δύο εισπνοές τη φορά, 

επαναλάβετε τη διαδικασία στην άλλη ρινική χοάνη.  

 Μετά τη χρήση, καθαρίστε το ακροφύσιο με ένα στεγνό 

χαρτομάντιλο και ξαναβάλτε το προστατευτικό 

κάλυμμα. 

Ελέγχοντας τον μετρητή.

Κάθε φορά που χρησιμοποιείτε το ρινικό εκνέφωμα, ο αριθμός στο παράθυρο του μετρητή δόσεων 

αλλάζει. Ο αριθμός που φαίνεται σας λέει πόσες εισπνοές έχετε ήδη λάβει. Το ρινικό εκνέφωμα είναι 

εγγυημένο να παρέχει 14 μετρημένες δόσεις. Ενδέχεται να μπορέσετε να λάβετε 2 επιπλέον δόσεις.

Όταν το παράθυρο του μετρητή 

δόσεων γίνει 

κόκκινο και δείχνει το νούμερο (16), 

όπως φαίνεται στην εικόνα, έχετε λάβει 

16 εισπνοές και το εκνέφωμα έχει 

τελειώσει. Μπορεί να προσέξετε ότι 

στο φιαλίδιο του ρινικού εκνεφώματος 

έχει απομείνει μικρή ποσότητα υγρού, 

αλλά αυτό είναι φυσιολογικό.  0100090000032a020000020

0a20100000000a201000026

060f003a03574d464301000

00000000100ea3300000000

01000000180300000000000

018030000010000006c0000

00000000000000000035000

0006f000000000000000000

0000700d00008a0d0000204

54d46000001001803000012

00000002000000000000000

0000000000000008e120000

981a0000c90000002001000

00000000000000000000000

007c110300dc65040016000

0000c000000180000000a00

00001000000000000000000

0000009000000100000002d

03000033030000250000000

c0000000e00008025000000

0c0000000e0000801200000

00c00000001000000520000

007001000001000000a4ffff

ff000000000000000000000

00090010000000000a10440

0022430061006c006900620

07200690000000000000000

00000000000000000000000

00000000000000000000000

00000000000000000000000

00000000000000000000011

00c09a110010000000249e1

100a49b1100fd516032249e

11001c9b1100100000008c9

c1100089e11009451603224

9e11001c9b1100200000009

f712e311c9b1100249e1100

20000000fffffffffc24ea001a

722e31ffffffffffff0180ffff01

803fff0180ffffffff00000000

00080000000800004300000

00100000000000000580200

0025000000372e9001a1000

20f0502020204030204ef02

Αν ο μηχανισμός του εκνεφώματος μπλοκάρει, αυτό μπορεί να διορθωθεί πιέζοντας την αντλία με 

δύναμη. Μην αποπειραθείτε να τον ξεμπλοκάρετε χρησιμοποιώντας ένα μυτερό αντικείμενο καθώς 

μπορεί να προκληθεί βλάβη.

Εάν νομίζετε ότι η συσκευή ρινικού εκνεφώματος δεν λειτουργεί σωστά, επιστρέψτε την στον 

προμηθευτή σας. Ποτέ μην προσπαθήσετε να την επισκευάσετε μόνος σας ή να την 

αποσυναρμολογήσετε, καθώς αυτό ενδέχεται να επηρεάσει τη δόση σας.

Εάν χρησιμοποιήσετε μεγαλύτερη ποσότητα ρινικού εκνεφώματος Miacalcic από την 

κανονική

Εάν κατά λάθος πήρατε μεγάλη ποσότητα ρινικού εκνεφώματος Miacalcic, ενημερώστε αμέσως το 

γιατρό σας. Μπορεί να χρειάζεστε ιατρική φροντίδα.

Αν ξεχάσετε να χρησιμοποιήσετε το ρινικό εκνέφωμα Miacalcic

Αν ξεχάσετε να χρησιμοποιήσετε το ρινικό σας εκνέφωμα, λάβετε την εισπνοή αμέσως μόλις το 

θυμηθείτε, εκτός εάν απομένουν λιγότερες από 4 ώρες ως την επόμενη δόση σας. Σε αυτή την 

περίπτωση, περιμένετε και πάρτε την επόμενη δόση σας στη συνηθισμένη ώρα. Μην πάρετε διπλή 

δόση για να αναπληρώσετε τη δόση που ξεχάσατε.

Εάν έχετε περισσότερες ερωτήσεις σχετικά με τη χρήση αυτού του προϊόντος ρωτήστε το γιατρό ή το 

φαρμακοποιό σας.

4. ΠΙΘΑΝΕΣ ΑΝΕΠΙΘΥΜΗΤΕΣ ΕΝΕΡΓΕΙΕΣ

Όπως όλα τα φάρμακα, έτσι και το ρινικό εκνέφωμα Miacalcic μπορεί να προκαλέσει ανεπιθύμητες 

ενέργειες αν και δεν παρουσιάζονται σε όλους τους ανθρώπους. Οι πιο συχνά παρατηρούμενες 

ανεπιθύμητες ενέργειες είναι εκείνες που αφορούν τη μύτη, όπως φλεγμονή της μύτης, καταρροή ή  

συμφόρηση της μύτης. Αυτές είναι γενικά ήπιες και σπάνια απαιτείται διακοπή της θεραπείας.

Ορισμένες ανεπιθύμητες ενέργειες μπορεί να είναι σοβαρές:

Αυξημένος καρδιακός ρυθμός, κνιδωτικό εξάνθημα (κνίδωση), δύσπνοια, οίδημα της γλώσσας και 

του φάρυγγα, σφίξιμο στο στήθος, απότομη πτώση της αρτηριακής πίεσης ή καταπληξία. Αυτά 

μπορεί να είναι σημεία σοβαρής αλλεργικής αντίδρασης (αναφυλαξία) και είναι πολύ σπάνια. 

Οίδημα του προσώπου, των άκρων ή ολόκληρου του σώματος (όχι συχνά).

Εάν εμφανίσετε κάποιο από τα παραπάνω, ενημερώστε το γιατρό σας αμέσως.

Άλλες ανεπιθύμητες ενέργειες:

Πολύ Συχνές ανεπιθύμητες ενέργειες (επηρεάζουν περισσότερους από 1 στους 10 ασθενείς):

Ευαίσθητη μύτη, ρινική καταρροή ή συμφόρηση (ρινίτιδα), οίδημα, ερυθρότητα και βλάβη του 

εσωτερικού της μύτης, πταρμός, ρινική ξηρότητα, ρινικές αλλεργίες, ερεθισμένη μύτη, δυσάρεστη 

οσμή

Συχνές ανεπιθύμητες ενέργειες (επηρεάζουν λιγότερους από 1 στους 10 ασθενείς):

Διάρροια, πόνος στο στομάχι, ναυτία

Κόπωση

Πόνος στα οστά ή τις αρθρώσεις, 

Ζάλη, 

Πονοκέφαλος, 

Αλλοίωση της γεύσης

Aιφνίδια «κύματα» ερυθρότητας του προσώπου ή του λαιμού (έξαψη), 

Ρινορραγία, 

Αίσθημα πίεσης ή πόνου στη μύτη, στα μάγουλα και πίσω από τα μάτια (φλεγμονή των παραρρίνιων 

κόλπων), ρινική φλεγμονή και βλάβη, 

Ευαισθησία στο φάρυγγα και δυσκολία στην κατάποση (φαρυγγίτιδα)

Όχι συχνές ανεπιθύμητες ενέργειες (επηρεάζουν λιγότερους από 1 στους 100 ασθενείς):

αυξημένη αρτηριακή πίεση (υπέρταση),

συμπτώματα που μοιάζουν με αυτά της γρίπης,

διαταραχή της όρασης, 

αλλεργικές αντιδράσεις,

βήχας,

ναυτία,

κνησμός.

Σπάνιες ανεπιθύμητες ενέργειες (επηρεάζουν λιγότερους από 1 στους 1.000 ασθενείς):

Δερματικό εξάνθημα.

Σε σπάνιες περιπτώσεις, η αποτελεσματικότητα του Miacalcic μπορεί να είναι μειωμένη.

Εάν κάποια ανεπιθύμητη ενέργεια γίνεται σοβαρή, ή αν παρατηρήσετε κάποια ανεπιθύμητη 

ενέργεια που δεν αναφέρεται στο παρόν φύλλο οδηγιών, παρακαλείσθε να ενημερώσετε το 

γιατρό ή το φαρμακοποιό σας.

5. ΠΩΣ ΝΑ ΦΥΛΑΣΣΕΤΑΙ ΤΟ ΡΙΝΙΚΟ ΕΚΝΕΦΩΜΑ MIACALCIC

Να φυλάσσεται σε μέρη που δεν το φτάνουν και δεν το βλέπουν τα παιδιά.

Να μην χρησιμοποιείτε το ρινικό εκνέφωμα Miacalcic μετά την ημερομηνία λήξεως που αναφέρεται 

πάνω στην συσκευασία μετά το «ΗΜ ΛΗΞ». Η ημερομηνία λήξης είναι η τελευταία ημέρα του μήνα 

που αναφέρεται.

Φυλάσσετε σε ψυγείο (2°C – 8°C). Να μην καταψύχεται.

Όταν ανοιχθεί, το ρινικό εκνέφωμα πρέπει να φυλάσσεται σε θερμοκρασία δωματίου (όχι πάνω από 

25°C).

Το ρινικό εκνέφωμα πρέπει να χρησιμοποιείται μέσα σε ένα μήνα από το άνοιγμα.

Διατηρείτε πάντοτε το φιαλίδιο σε όρθια θέση για να μειωθεί ο κίνδυνος εισόδου φυσαλίδων αέρα 

στον εμβυθισμένο σωλήνα.

Μην ανακινείτε το φιαλίδιο.

Τα φάρμακα δεν πρέπει να απορρίπτονται στο νερό της αποχέτευσης ή στα σκουπίδια. Ρωτήστε το 

φαρμακοποιό σας για το πώς να πετάξετε τα φάρμακα που δεν χρειάζονται πια. Αυτά τα μέτρα θα 

βοηθήσουν στην προστασία του περιβάλλοντος.

6. ΛΟΙΠΕΣ ΠΛΗΡΟΦΟΡΙΕΣ

Τι περιέχει το ρινικό εκνέφωμα Miacalcic

Η δραστική ουσία είναι η καλσιτονίνη (σολομού, συνθετική). Κάθε φιαλίδιο ρινικού εκνεφώματος 

Miacalcic 2 ml περιέχει τουλάχιστον 14 μετρημένες δόσεις των 200 IU. Μια IU (Διεθνής 

Μονάδα) αντιστοιχεί σε 0,167 μικρογραμμάρια καλσιτονίνης (σολομού, συνθετική).

Τα άλλα συστατικά είναι χλωριούχο βενζαλκόνιο (σαν συντηρητικό), χλωριούχο νάτριο, υδροχλωρικό 

οξύ και νερό.

Εμφάνιση του ρινικού εκνεφώματος Miacalcic και περιεχόμενο της συσκευασίας

Το Miacalcic 200 IU είναι ένα διάλυμα για ρινικό εκνέφωμα (ρινικό εκνέφωμα).

Το ρινικό εκνέφωμα Miacalcic 200 IU διατίθεται σε συσκευασίες ενός ή δύο φιαλιδίων των 2 ml. 

Το Miacalcic διατίθεται επίσης και ως ρινικό εκνέφωμα 100 IU.

Μπορεί να μην κυκλοφορούν όλες οι συσκευασίες και οι περιεκτικότητες στη χώρα σας.

Κάτοχος Άδειας Κυκλοφορίας και Παραγωγός

{Όνομα και διεύθυνση}

<{τηλ}>

<{fax}>

<{e-mail}>

Αυτό το φαρμακευτικό προϊόν έχει εγκριθεί στα Κράτη-Μέλη του Ευρωπαϊκού Οικονομικού 

Χώρου (ΕΟΧ) με τις ακόλουθες ονομασίες:

Αυστρία Calcitonin “Novartis”

Βέλγιο Miacalcic

Δανία Miacalcic

Φινλανδία Miacalcic

Γερμανία Miacalcic

Ελλάδα Miacalcic

Ισλανδία: Miacalcic

Ιρλανδία Miacalcic

Ιταλία Calcitonina Sandoz

Λουξεμβούργο Miacalcic

Νορβηγία Miacalcic

Πορτογαλία Miacalcic

Ισπανία Miacalcic

Ηνωμένο Βασίλειο Miacalcic

Τελευταία ημερομηνία έγκρισης του παρόντος φύλλου οδηγιών 

03-09-2009

13-11-2018

Alebrije Dist Wholesale Recalls Quesillo Queseria “La Milagrosa” and “Alebrije Cheese” Because of Possible Health Risk

Alebrije Dist Wholesale Recalls Quesillo Queseria “La Milagrosa” and “Alebrije Cheese” Because of Possible Health Risk

ALEBRIJE DIST WHOLESALE is collaborating with health officials due to a positive finding of Salmonella in a sample of Quesillo “Queseria La Milagrosa”. ALEBRIJE DIST WHOLESALE is voluntarily recalling the amount of 100 kilos of Quesillo “Queseria La Milagrosa”. While “Alebrije Cheese” has not been found positive for Salmonella, ALEBRIJE DIST WHOLESALE has decided to voluntarily recall the specific 498 “Alebrije Cheese” pieces that were imported during the same period out of an abundance of caution.

FDA - U.S. Food and Drug Administration

6-11-2018

FDA Investigating Recalled Duncan Hines Cake Mixes Potentially Linked to Salmonella Agbeni Illnesses

FDA Investigating Recalled Duncan Hines Cake Mixes Potentially Linked to Salmonella Agbeni Illnesses

The FDA is investigating the manufacturing facility that made recalled Duncan Hines cake mixes.

FDA - U.S. Food and Drug Administration

6-11-2018

Duncan Hines Classic White, Classic Butter Golden, Signature Confetti and Classic Yellow Cake Mixes Recalled Due to Potential Presence of Salmonella

Duncan Hines Classic White, Classic Butter Golden, Signature Confetti and Classic Yellow Cake Mixes Recalled Due to Potential Presence of Salmonella

Conagra Brands is collaborating with health officials in connection with a positive finding of Salmonella in a retail sample of Duncan Hines Classic White cake mix that may be linked to a Salmonella outbreak that is currently being investigated by CDC and FDA. While it has not been definitively concluded that this product is linked to the outbreak and the investigation is still ongoing, Conagra has decided to voluntarily recall the specific Duncan Hines variety identified (Classic White) and three other ...

FDA - U.S. Food and Drug Administration

2-11-2018

Barcelona Nut Company Recalls Roasted and Salted in Shell Pistachios Because of Possible Health Risk

Barcelona Nut Company Recalls Roasted and Salted in Shell Pistachios Because of Possible Health Risk

Barcelona Nut Company of Baltimore, Maryland is recalling 239 cases of roasted and salted in shell pistachios, because it has the potential to be contaminated with Salmonella, an organism that can cause serious and sometimes-fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

FDA - U.S. Food and Drug Administration

30-10-2018

Food Recall of Fit & Active Southwest Veggie Stuffed Sandwiches Due to Possible Listeria monocytogenes and Salmonella Contamination in Vegetables

Food Recall of Fit & Active Southwest Veggie Stuffed Sandwiches Due to Possible Listeria monocytogenes and Salmonella Contamination in Vegetables

J&J Snack Foods Handheld Corp. of Holly Ridge, NC is voluntarily recalling two lots of Fit & Active Southwest Veggie Stuffed Sandwiches due to potential contamination with Listeria monocytogenes and Salmonella. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

FDA - U.S. Food and Drug Administration

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

Multi-country outbreak of Listeria monocytogenes linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes linked to consumption of salmon products

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

19-10-2018

Hy-Vee Voluntarily Recalls Several Meat and Potato Products

Hy-Vee Voluntarily Recalls Several Meat and Potato Products

Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling six of its meat and potato products across its eight-state region due to possible contamination with Salmonella and Listeria monocytogenes. The potential for contamination was discovered after Hy-Vee’s supplier, McCain Foods, announced it was recalling its caramelized mushrooms and fire-roasted tomatoes, which are ingredients that are used in six Hy-Vee products. To date, no illnesses have been reported in connection with these prod...

FDA - U.S. Food and Drug Administration

10-10-2018

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

BazziniI LLC of Allentown, PA out of an abundance of caution, is recalling 4,000 pounds of Roasted and Salted Colossal Natural, Super Colossal Natural and Rams Head Natural in Shell Pistachios received from one of its suppliers because it has the potential to be contaminated with Salmonella. NO OTHER BAZZINI PISTACHIOS OR BAZZINI PRODUCTS ARE IMPACTED OR PART OF THIS RECALL. The recall is being initiated voluntarily and no illnesses have been reported to date.

FDA - U.S. Food and Drug Administration

9-10-2018

Notice of call for expressions of interest - Salmonella molecular serotyping

Notice of call for expressions of interest - Salmonella molecular serotyping

France - Agence Nationale du Médicament Vétérinaire

20-9-2018

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Published on: Wed, 19 Sep 2018 00:00:00 +0200 The third Joint Meeting of the ECDC's Food‐ and Waterborne Disease and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network was held on 16 and 17 October 2017 in Parma. The meeting was constructed around the principle of ‘One health approach to collaborative response to foodborne disease outbreaks in EU/EEA’ and served as an opportunity for public health authorities and food safety/veterinary authorities to meet and exchange information on the...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Synthetic pitches: the expert assessments currently available conclude that the risks to health are negligible

Synthetic pitches: the expert assessments currently available conclude that the risks to health are negligible

In recent years, the increasing use of tyre granulates for sports pitches and playgrounds has raised concerns about their potential impact on health and the environment. ANSES has analysed the studies and expert assessments currently available on this topic and reports the main findings regarding the potential risks associated with the use or installation of synthetic pitches. The existing studies conclude that the health risks are of little concern, but point to potential risks to the environment.

France - Agence Nationale du Médicament Vétérinaire

13-9-2018

Bravo Packing, Inc. Recalls Performance Dog Raw Pet Food Because of Possible Salmonella Health Risk to Humans and Animals

Bravo Packing, Inc. Recalls Performance Dog Raw Pet Food Because of Possible Salmonella Health Risk to Humans and Animals

Bravo Packing, Inc. of Carneys Point, NJ is recalling all Performance Dog products, a frozen raw pet food, because it has the potential to be contaminated with Salmonella. Salmonella can cause illness in animals eating the products, as well as people who handle contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products, infected animals or any surfaces exposed to these products.

FDA - U.S. Food and Drug Administration

10-9-2018

FDA Investigating Multistate Outbreak of Salmonella Enteritidis Linked to Shell Eggs from Gravel Ridge Farms

FDA Investigating Multistate Outbreak of Salmonella Enteritidis Linked to Shell Eggs from Gravel Ridge Farms

Outbreak of Salmonella Enteritidis Linked to Shell Eggs

FDA - U.S. Food and Drug Administration

8-9-2018

Steve’s Real Food Voluntarily Recalls One Lot of Turducken Recipe, One Lot of Quest Emu, and One Lot of Quest Beef Due to Possible Salmonella and L. Mono Contamination

Steve’s Real Food Voluntarily Recalls One Lot of Turducken Recipe, One Lot of Quest Emu, and One Lot of Quest Beef Due to Possible Salmonella and L. Mono Contamination

Steve’s Real Food of Salt Lake City, Utah is voluntarily recalling one lot of 5lb Turducken Recipe, one lot of 2lb Quest Emu Diet, and one lot of 2lb Quest Beef Diet, due to their possible Salmonella and/or L. mono contamination.

FDA - U.S. Food and Drug Administration

8-9-2018

Gravel Ridge Farms Recalls Cage Free Egg Due to Possible Salmonella Contamination

Gravel Ridge Farms Recalls Cage Free Egg Due to Possible Salmonella Contamination

Gravel Ridge Farms is recalling Cage Free Large Eggs due to a potential contamination of Salmonella. The recall was initiated because reported illnesses were confirmed at locations using Gravel Ridge Farm Eggs, and we are voluntarily recalling out of an abundance of caution.

FDA - U.S. Food and Drug Administration

16-8-2018

Zakah Life Recalls Kratom Because Of Possible Health Risk

Zakah Life Recalls Kratom Because Of Possible Health Risk

Zakah Life, LLC of Ankeny, Iowa, is recalling the following Kratom products (Super Green Maeng Da Premium Kratom powder, Powerful Red Vein Bali Premium Kratom powder, Super Green Maeng Da Premium Kratom capsules, and Powerful Red Vein Bali Premium Kratom capsules) with expiration dates prior to 01/01/2023 because they have the potential of being contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weak...

FDA - U.S. Food and Drug Administration

14-8-2018

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful...

FDA - U.S. Food and Drug Administration

26-7-2018

Multi country Salmonella Agona outbreak possibly linked to ready-to-eat food

Multi country Salmonella Agona outbreak possibly linked to ready-to-eat food

Multi country Salmonella Agona outbreak possibly linked to ready-to-eat food

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

25-7-2018

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

Associated Milk Producers Inc. (AMPI) of New Ulm, Minn., is recalling dry whey powder packaged in 50-pound and 25-kg bags that were produced at the cooperative’s Blair, Wis., dry whey plant from May 1-5, 2018; May 24-29, 2018; June 2-5, 2018; and June 7-14, 2018 due to the potential to be contaminated with Salmonella. This is a precautionary recall. All products shipped to the marketplace tested negative for Salmonella.

FDA - U.S. Food and Drug Administration

24-7-2018

Pepperidge Farm® Announces Voluntary Recall of Four Varieties of Goldfish® Crackers

Pepperidge Farm® Announces Voluntary Recall of Four Varieties of Goldfish® Crackers

Pepperidge Farm has been notified by one of its ingredient suppliers that whey powder in a seasoning that is applied to four varieties of crackers has been the subject of a recall by the whey powder manufacturer due to the potential presence of Salmonella. Pepperidge Farm initiated an investigation and, out of an abundance of caution, is voluntarily recalling four varieties of Goldfish crackers. The products were distributed throughout the United States. No illnesses have been reported. ...

FDA - U.S. Food and Drug Administration

24-7-2018

Statement from FDA Commissioner Scott Gottlieb, M.D. on voluntary recalls of Ritz, Goldfish and other products issued out of an abundance of caution

Statement from FDA Commissioner Scott Gottlieb, M.D. on voluntary recalls of Ritz, Goldfish and other products issued out of an abundance of caution

The U.S. Food and Drug Administration is working with Mondelēz International, Inc., Pepperidge Farm Inc. and Flowers Foods, Inc. to initiate voluntarily recalls of certain products due to a potential risk that one of the ingredients may have been contaminated with Salmonella.

FDA - U.S. Food and Drug Administration

23-7-2018

Flowers Foods Issues Voluntary Recall on Mrs. Freshley’s and Other Brands of Swiss Rolls and Captain John Derst’s Old Fashioned Bread

Flowers Foods Issues Voluntary Recall on Mrs. Freshley’s and Other Brands of Swiss Rolls and Captain John Derst’s Old Fashioned Bread

As a precautionary measure, Flowers Foods, Inc. (NYSE: FLO) is voluntarily recalling Swiss Rolls sold under the brand names Mrs. Freshley’s, Food Lion, H-E-B, Baker’s Treat, Market Square, and Great Value, distributed nationwide, and Captain John Derst’s Old Fashioned Bread distributed in Alabama, Florida, Georgia, North Carolina, and South Carolina, due to the potential presence of Salmonella in an ingredient, whey powder. The ingredient recall was initiated by a third-party whey powder manufacturer and...

FDA - U.S. Food and Drug Administration

23-7-2018

Mondelēz Global LLC Conducts Voluntary Recall of Certain Ritz Cracker Sandwiches and Ritz Bits Product in the U.S., including Puerto Rico & U.S. Virgin Islands Due to Possible Health Risk

Mondelēz Global LLC Conducts Voluntary Recall of Certain Ritz Cracker Sandwiches and Ritz Bits Product in the U.S., including Puerto Rico & U.S. Virgin Islands Due to Possible Health Risk

Mondelēz Global LLC announced today a voluntary recall in the United States, including Puerto Rico & the U.S. Virgin Islands, of certain Ritz Cracker Sandwiches and Ritz Bits product. These products contain whey powder as an ingredient, which the whey powder supplier has recalled due to the potential presence of Salmonella.

FDA - U.S. Food and Drug Administration

19-7-2018

Statement from FDA warning about significant health risks of contaminated illegal synthetic cannabinoid products that are being encountered by FDA

Statement from FDA warning about significant health risks of contaminated illegal synthetic cannabinoid products that are being encountered by FDA

Statement from FDA warning about significant health risks of contaminated illegal synthetic cannabinoid products that are being encountered by FDA

FDA - U.S. Food and Drug Administration

18-7-2018

FDA Investigating Multistate Outbreak of Salmonella Sandiego Infections Linked to Hy-Vee Spring Pasta Salad

FDA Investigating Multistate Outbreak of Salmonella Sandiego Infections Linked to Hy-Vee Spring Pasta Salad

The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, is investigating a multi-state outbreak of Salmonella Sandiego illnesses linked to Spring Pasta Salad sold at Hy-Vee locations in Iowa, Illinois, Kansas, Minnesota, Missouri, Nebraska, South Dakota, and Wisconsin.

FDA - U.S. Food and Drug Administration

18-7-2018

Hy-Vee Voluntarily Recalls Spring Pasta Salad Due to Reported Illnesses

Hy-Vee Voluntarily Recalls Spring Pasta Salad Due to Reported Illnesses

WEST DES MOINES, Iowa (July 17, 2018) — Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling its Hy-Vee Spring Pasta Salad due to the potential that it may be contaminated with Salmonella. The potential for contamination was brought to Hy-Vee’s attention last night when approximately 20 illnesses in Minnesota, South Dakota, Nebraska and Iowa were potentially linked back to customers consuming the salad. The voluntary recall includes Hy-Vee Spring Pasta Salads in both 1 pound (16 oz.) an...

FDA - U.S. Food and Drug Administration

2-7-2018

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies., is voluntarily recalling only Lot No.: 112710 with expiration 03/2019 found embedded on the top of package of kratom ( mitragyn a speciosa) powder products, it manufactured, processed, packed, and/or held, between “March 1, 2018” to “April 30, 2018” to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing to have salmonella contamination. Blissful Remedies has not received reports of adverse events related to this recall. ...

FDA - U.S. Food and Drug Administration

22-6-2018

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

The products have been found by the FDA via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines

FDA - U.S. Food and Drug Administration

21-6-2018

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., is voluntarily recalling all kratom (mitragyna speciosa) powder products, with Lot No.: 0102031800 it manufactured, processed, packed, and/or held, between March 18, 2018 to March 30, 2018 to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordanc...

FDA - U.S. Food and Drug Administration

21-6-2018

Now Health Group Inc. Recalls Select Now Real Food® Zesty Sprouting Mix Because of Possible Health Risk

Now Health Group Inc. Recalls Select Now Real Food® Zesty Sprouting Mix Because of Possible Health Risk

NOW Health Group, Inc. (NOW), of Bloomingdale, Illinois, is recalling its NOW Real Food® Zesty Sprouting Mix – Product Code 7271, Lot #3031259 and Lot #3038165 – because its primary ingredient, Crimson Clover Seeds, has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may b...

FDA - U.S. Food and Drug Administration

15-6-2018

FDA Investigating Multistate Outbreak of Salmonella Mbandaka Infections Likely Linked to Kellogg’s Honey Smacks Cereal

FDA Investigating Multistate Outbreak of Salmonella Mbandaka Infections Likely Linked to Kellogg’s Honey Smacks Cereal

The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, are investigating a multistate outbreak of Salmonella Mbandaka illnesses that may be linked to Kellogg’s Honey Smacks cereal.

FDA - U.S. Food and Drug Administration

15-6-2018

Kellogg Company Voluntarily Recalls Honey Smacks Cereal Due to Possible Health Risk

Kellogg Company Voluntarily Recalls Honey Smacks Cereal Due to Possible Health Risk

Kellogg Company today announced it is voluntarily recalling 15.3 oz. and 23 oz. packages of Kellogg’s® Honey Smacks® cereal (with code dates listed below) because these products have the potential presence of Salmonella. No other Kellogg products are impacted by this recall.

FDA - U.S. Food and Drug Administration

9-6-2018

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk

Caito Foods is voluntarily recalling fresh cut watermelon, honeydew melon, cantaloupe and fresh-cut mixed fruit containing one of these melons, produced at the Caito Foods facility in Indianapolis, because these products have the potential to be contaminated with Salmonella.

FDA - U.S. Food and Drug Administration

9-6-2018

FDA Investigating Multistate Outbreak of Salmonella Adelaide Infections Linked to Pre-Cut Melons

FDA Investigating Multistate Outbreak of Salmonella Adelaide Infections Linked to Pre-Cut Melons

The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, are investigating a multistate outbreak of Salmonella Adelaide illnesses that may be linked to cut melons.

FDA - U.S. Food and Drug Administration

29-5-2018

Pious Lion Voluntary Recall Due to Possible Health Risk

Pious Lion Voluntary Recall Due to Possible Health Risk

Pious Lion located in Asheville, NC is voluntarily recalling two of their Kratom products: Pious Lion Pure Premium Potent Limited Release Pink Bali, 1 oz and Pious Lion Pure Premium Potent White Maeng DA, Bright Uplifting Energy, 4 oz due to the presence of Salmonella . Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhe...

FDA - U.S. Food and Drug Administration

23-5-2018

Golden International Corporation  Issues Public Safety Warning For Stolen Tilapia Because  of Possible Health Risk

Golden International Corporation Issues Public Safety Warning For Stolen Tilapia Because of Possible Health Risk

Golden International Corporation of Renton, WA is issuing a public safety notice for 405 cartons of stolen frozen tilapia, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection wi...

FDA - U.S. Food and Drug Administration

21-5-2018

Ziyad Brothers Importing Recalls Tahini Because of Possible Health Risk

Ziyad Brothers Importing Recalls Tahini Because of Possible Health Risk

Ziyad Brothers Importing is voluntarily recalling certain lot codes of Ziyad Brand Tahini because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into ...

FDA - U.S. Food and Drug Administration

4-5-2018

Badger Botanicals Recalls Red Suma, Green Suma, Green Hulu 2, And Red Hulu 2 Kratom Supplements Because Of Possible Salmonella Health Risk

Badger Botanicals Recalls Red Suma, Green Suma, Green Hulu 2, And Red Hulu 2 Kratom Supplements Because Of Possible Salmonella Health Risk

Badger Botanicals, LLC of Springville, Utah is recalling Green Suma, Red Suma, Green Hulu 2, and Red Hulu 2 kratom dietary supplements sold directly to consumers via the company website from January 1st, 2018 to April l 12th, 2018 in pouches of 250g, because it has the potential to be contaminated with Salmonella.

FDA - U.S. Food and Drug Administration

4-5-2018

Maya Distribution, LLC Recalls Dragon Label Kratom Because Of Possible Salmonella Contamination

Maya Distribution, LLC Recalls Dragon Label Kratom Because Of Possible Salmonella Contamination

Maya Distribution, LLC of South Salt Lake City, Utah is voluntarily recalling Dragon Kratom labeled bottles and sealed packages of encapsulated and raw powder product because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. 

FDA - U.S. Food and Drug Administration

3-5-2018

FDA Approves Application for AquaBounty Salmon Facility in Indiana

FDA Approves Application for AquaBounty Salmon Facility in Indiana

FDA approved a supplemental New Animal Drug Application submitted by AquaBounty Technologies, Inc. The supplemental NADA requested FDA approval to raise AquAdvantage Salmon at a land-based contained facility near Albany, Indiana.

FDA - U.S. Food and Drug Administration

24-4-2018

One lot of Traditional Medicinals "Throat Coat Lemon Echinacea" herbal tea recalled because of potential contamination with Salmonella

One lot of Traditional Medicinals "Throat Coat Lemon Echinacea" herbal tea recalled because of potential contamination with Salmonella

Health Canada is advising Canadians that one lot of “Throat Coat Lemon Echinacea” herbal tea is being voluntarily recalled by Traditional Medicinals after a company supplier found Salmonella contamination in a tea ingredient (lemon myrtle leaf). An infection caused by Salmonella bacteria may pose serious health risks, particularly for young children, pregnant women, the elderly and people with weak immune systems.

Health Canada

20-4-2018

Dietary Supplements by Nutrizone: Recall - Potential for Salmonella Contamination

Dietary Supplements by Nutrizone: Recall - Potential for Salmonella Contamination

Expanded recall of various kratom dietary supplements to additional lot numbers due to possible Salmonella Health Risk.

FDA - U.S. Food and Drug Administration

19-4-2018

Certain Kratom-Containing Powder Products by Viable Solutions: Recall -Possible Salmonella Contamination

Certain Kratom-Containing Powder Products by Viable Solutions: Recall -Possible Salmonella Contamination

Viable Solutions of Nampa, ID has initiated a recall of certain Kratom-containing powder products, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result...

FDA - U.S. Food and Drug Administration

19-4-2018

NxtGen Botanicals Maeng Da Kratom by NGB Corp.: Recall - Possible Salmonella Contamination

NxtGen Botanicals Maeng Da Kratom by NGB Corp.: Recall - Possible Salmonella Contamination

NGB Corp. of West Jordan, Utah is voluntarily recalling NxtGen Botanicals Maeng Da Kratom labeled bottles of encapsulated product because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infec...

FDA - U.S. Food and Drug Administration

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

22-8-2018

CLYNAV (Elanco GmbH)

CLYNAV (Elanco GmbH)

CLYNAV (Active substance: Salmon pancreas disease vaccine (recombinant DNA plasmid)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5624 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2390/T/02

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Active substance: N-acetylgalactosamine-conjugated synthetic double-stranded oligomer specific to serpin family A member 1 gene) - Orphan designation - Commission Decision (2018)5280 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/061/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2051 (Wave life Sciences Ireland Limited)

EU/3/18/2051 (Wave life Sciences Ireland Limited)

EU/3/18/2051 (Active substance: Synthetic antisense oligonucleotide directed against human dystrophin pre-mRNA) - Orphan designation - Commission Decision (2018)5283 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/032/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2052 (Dicerna EU Limited)

EU/3/18/2052 (Dicerna EU Limited)

EU/3/18/2052 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues) - Orphan designation - Commission Decision (2018)5284 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/052/18

Europe -DG Health and Food Safety

27-7-2018

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Active substance: Synthetic cyclic 8 amino acid analogue of human unacylated ghrelin) - Transfer of orphan designation - Commission Decision (2018)5049 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/066/17/T/01

Europe -DG Health and Food Safety

1-6-2018

#DYK #Opioids are a type of drug that includes the illegal drug heroin, synthetic opioids such as fentanyl, and pain relievers available legally by prescription, such as oxycodone (OxyContin®) #FDAInnovationChallenge (1 of 2 messages)

#DYK #Opioids are a type of drug that includes the illegal drug heroin, synthetic opioids such as fentanyl, and pain relievers available legally by prescription, such as oxycodone (OxyContin®) #FDAInnovationChallenge (1 of 2 messages)

#DYK #Opioids are a type of drug that includes the illegal drug heroin, synthetic opioids such as fentanyl, and pain relievers available legally by prescription, such as oxycodone (OxyContin®) #FDAInnovationChallenge (1 of 2 messages)

FDA - U.S. Food and Drug Administration

29-5-2018

EU/3/18/2026 (Alnylam UK Limited)

EU/3/18/2026 (Alnylam UK Limited)

EU/3/18/2026 (Active substance: Synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2'-fluoro and thirty-five 2'-O-methyl nucleoside residues in the sequence, which is covalently linked via a phosphodiester group to a ligand containing three N-acetylgalactosamine residues) - Orphan designation - Commission Decision (2018)3394 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/18

Europe -DG Health and Food Safety

29-5-2018

EU/3/11/857 (Alnylam Netherlands B.V.)

EU/3/11/857 (Alnylam Netherlands B.V.)

EU/3/11/857 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against transthyretin mRNA) - Transfer of orphan designation - Commission Decision (2018)3398 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/142/10/T/02

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1298 (Genzyme Europe B.V.)

EU/3/14/1298 (Genzyme Europe B.V.)

EU/3/14/1298 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2018)3148 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/041/14/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1297 (Genzyme Europe B.V.)

EU/3/14/1297 (Genzyme Europe B.V.)

EU/3/14/1297 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2018)3147 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/039/14/T/01

Europe -DG Health and Food Safety