PAIN-OUT

Κύριές Πληροφορίες

  • Εμπορική ονομασία:
  • PAIN-OUT 4% W/W ΔΕΡΜΑΤΙΚΟ ΔΙΑΛΥΜΑ
  • Φαρμακολογική κατηγορία (ATC):
  • M02AA15
  • Δοσολογία:
  • 4% W/W
  • Φαρμακοτεχνική μορφή:
  • ΔΕΡΜΑΤΙΚΟ ΔΙΑΛΥΜΑ
  • Σύνθεση:
  • 0015307796 - DICLOFENAC SODIUM - 40.000000 MG
  • Οδός χορήγησης:
  • ΔΕΡΜΑΤΙΚΗ ΧΡΗΣΗ
  • Τρόπος διάθεσης:
  • ΔΕΝ ΑΠΑΙΤΕΙΤΑΙ ΙΑΤΡΙΚΗ ΣΥΝΤΑΓΗ
  • Χρήση για:
  • Οι άνθρωποι
  • Τύπος φάρμακου:
  • αλλοπαθητική των ναρκωτικών

Έγγραφα

Εντοπισμός

  • Διατίθεται σε:
  • PAIN-OUT 4% W/W ΔΕΡΜΑΤΙΚΟ ΔΙΑΛΥΜΑ
    Ελλάδα
  • Γλώσσα:
  • Ελληνικά

Θεραπευτικές πληροφορίες

  • Θεραπευτική περιοχή:
  • DICLOFENAC
  • Περίληψη προϊόντος:
  • 2802799701018 - 01 - BTx1 BOTTLEx30ML - 30.00 - ΧΙΛΙΟΣΤΟΛΙΤΡΟ - Εγκεκριμένο (ΕΟΦ) - ΦΑΡΜΑΚΕIOY; 2802799701025 - 02 - BTx1 BOTTLEx60ML - 60.00 - ΧΙΛΙΟΣΤΟΛΙΤΡΟ - Εγκεκριμένο (ΕΟΦ) - ΦΑΡΜΑΚΕIOY; 2802799701032 - 03 - BTx1 BOTTLEx100ML - 100.00 - ΧΙΛΙΟΣΤΟΛΙΤΡΟ - Εγκεκριμένο (ΕΟΦ) - ΦΑΡΜΑΚΕIOY

Άλλες πληροφορίες

Κατάσταση

  • Πηγή:
  • Εθνικός Οργανισμός Φαρμάκων
  • Καθεστώς αδειοδότησης:
  • Εγκεκριμένο (ΕΟΦ)
  • τελευταία ενημέρωση:
  • 15-02-2018

φύλλο οδηγιών χρήσης

ΦΥΛΛΟ ΟΔΗΓΙΩΝ ΓΙΑ ΤΟ ΧΡΗΣΤΗ

PAIN-OUT

PAIN-OUT

1.

ΠΡΟΣΔΙΟΡΙΣΜΟΣ ΤΟΥ ΦΑΡΜΑΚΕΥΤΙΚΟΥ ΠΡΟΪΟΝΤΟΣ

1.1 Ονομασία: PAIN-OUT, Δερματικό διάλυμα 4% w/w

1.2 Σύνθεση: Δραστικά συστατικά: Diclofenac Sodium.

Έκδοχα:

Isopropyl alcohol, Soybean lecithin, Ethanol, Disodium phosphate heptahydrate,

Sodium

dihydrogen

phosphate

monohydrate,

Disodium

edetate,

Propylene

glycol,

Peppermint oil, Ascorbyl palmitate, Hydrochloric acid 10% (w/v), Sodium hydroxide 10%

(w/v), Water purified.

1.3 Φαρμακοτεχνική μορφή: Δερματικό διάλυμα. To PAIN-OUT είναι ένα χρυσο- κίτρινο,

διαφανές διάλυμα.

1.4 Περιεκτικότητα σε δραστική ουσία:

1 g

δερματικού διαλύματος περιέχει 40 mg

Diclofenac sodium.

1.5 Περιγραφή – Συσκευασία: Το φάρμακο συσκευάζεται σε φιάλη. Η φιάλη φέρει ετικέτα

με τυπωμένα τα χαρακτηριστικά του προϊόντος και τα χαρακτηριστικά της παρτίδας. Κάθε

κουτί περιέχει μία φιάλη και ένα φύλλο οδηγιών για το χρήστη.

1.6 Φαρμακοθεραπευτική κατηγορία:

Αντιφλεγμονώδη σκευάσματα, μη-στεροειδή για

τοπική χρήση. (Κωδικός ATC: M02A A15)

1.7 Υπεύθυνος κυκλοφορίας:VERISFIELD (UK) Ltd, 120 East Road, London, N16AA,

1.8

Παρασκευαστής:

Α) RAFARM AEBE, Κορίνθου 12, Ν. Ψυχικό, Τηλ: 210 6776550-1, Fax: 210 6776552

B) HELP ABEE, Βαλαωρίτου 10, Μεταμόρφωση, Τηλ. 210 2815253, Fax. 210 2811850

ΦΥΛΛΟ ΟΔΗΓΙΩΝ ΓΙΑ ΤΟ ΧΡΗΣΤΗ

2. ΤΙ ΠΡΕΠΕΙ ΝΑ ΓΝΩΡΙΖΕΤΕ ΓΙΑ ΤΟ ΦΑΡΜΑΚΟ ΠΟΥ ΣΑΣ ΧΟΡΗΓΗΣΕ Ο ΓΙΑΤΡΟΣ ΣΑΣ

2.1 Ενδείξεις: Το φάρμακο ενδείκνυται για την τοπική συμπτωματική ανακούφιση του ήπιου

έως μέτριου πόνου και της φλεγμονής που ακολουθεί το οξύ αμβλύ τραύμα των μικρών και

μεσαίων αρθρώσεων και των περιαρθρικών δομών.

2.2 Αντενδείξεις:

Υπερευαισθησία στη δραστική ουσία, στο ακετυλοσαλικυλικό οξύ ή σε άλλα μη στεροειδή

αντιφλεγμονώδη φάρμακα (ΜΣΑΦ) ή σε κάποιο από τα συστατικά του προϊόντος.

Ασθενείς με ή χωρίς άσθμα, στους οποίους προκαλούνται ασθματικές κρίσεις, κνίδωση ή

οξεία ρινίτιδα από την ασπιρίνη ή άλλα μη στεροειδή αντιφλεγμονώδη φάρμακα.

Στο τελευταίο τρίμηνο της κυήσεως.

2.3 Ειδικές προειδοποιήσεις και προφυλάξεις κατά τη χρήση: Οι ασθενείς θα πρέπει να

αποφεύγουν την υπερβολική έκθεση στον ήλιο, προκειμένου να μειωθεί η πιθανότητα

εκδήλωσης φωτοευαισθησίας. Η θεραπεία θα πρέπει

να διακοπεί

αν εμφανιστούν

εξανθήματα. Να μη χρησιμοποιείται με κλειστή επίδεση.

Η εφαρμογή του δερματικού διαλύματος PAIN-OUT θα πρέπει να γίνεται μόνο σε άθικτο

δέρμα, όχι σε ανοιχτές πληγές ή μολυσμένες περιοχές. Πρέπει να αποφεύγεται η επαφή με τα

μάτια, τις μεμβράνες των βλεννογόνων, καθώς και η χορήγηση από το στόμα.

Η ταυτόχρονη χορήγηση του φαρμάκου με από του στόματος χορηγούμενα μη στεροειδή

αντιφλεγμονώδη φάρμακα (ΜΣΑΦ) πρέπει να γίνεται με προσοχή, επειδή μπορεί να αυξηθεί

η συχνότητα εμφάνισης συστηματικών ανεπιθύμητων ενεργειών (βλέπε αλληλεπιδράσεις).

Υπάρχει η πιθανότητα εμφάνισης συστηματικών ανεπιθύμητων ενεργειών όταν το δερματικό

διάλυμα PAIN-OUT

εφαρμόζεται σε μια σχετικά μεγάλη περιοχή (δηλ. πάνω από 600

τετραγωνικά εκατοστά δέρματος) και για μεγάλο χρονικό διάστημα (δηλ. για περισσότερο από

4 εβδομάδες). Εάν απαιτείται τέτοια χρήση, ο ασθενής θα πρέπει να συμβουλευθεί το φύλλο

οδηγιών των από του στόματος χορηγούμενων μορφών του Diclofenac

sodium

(για

παράδειγμα, υπάρχει η πιθανότητα εμφάνισης αντιδράσεων υπερευαισθησίας, ασθματικών

και νεφρικών ανεπιθύμητων ενεργειών).

Σε ασθενείς που πάσχουν ή που έχουν ιστορικό βρογχικού άσθματος ή αλλεργικών

αντιδράσεων, μπορεί να εμφανιστεί βρογχόσπασμος.

Το δερματικό διάλυμα PAIN-OUT, Diclofenac sodium 4% θα πρέπει να χρησιμοποιείται με

προσοχή σε ασθενείς με πεπτικό έλκος, ηπατική ή νεφρική ανεπάρκεια, ή αιμορραγική

προδιάθεση, ή με φλεγμονώδη νόσο του εντέρου, εφόσον έχουν αναφερθεί μεμονωμένες

περιπτώσεις με τοπικά χορηγούμενα σκευάσματα Diclofenac.

Το δερματικό διάλυμα PAIN-OUT περιέχει προπυλενογλυκόλη, που μπορεί να προκαλέσει

ερεθισμό στο δέρμα.

Το δερματικό διάλυμα PAIN-OUT

περιέχει έλαιο μέντας, που μπορεί να προκαλέσει

αλλεργικές αντιδράσεις.

ΦΥΛΛΟ ΟΔΗΓΙΩΝ ΓΙΑ ΤΟ ΧΡΗΣΤΗ

2.4 Αλληλεπιδράσεις με άλλα φάρμακα ή ουσίες: Σε αυτή τη φαρμακοτεχνική μορφή, η

συστηματική διαθεσιμότητα του Diclofenac είναι πολύ χαμηλή. Επομένως, είναι μικρός ο

κίνδυνος αλληλεπιδράσεων με άλλα φαρμακευτικά προϊόντα. Ταυτόχρονη χορήγηση

ασπιρίνης ή άλλων μη στεροειδών αντιφλεγμονωδών φαρμάκων (ΜΣΑΦ) μπορεί να έχει ως

αποτέλεσμα αυξημένη εμφάνιση ανεπιθύμητων ενεργειών.

2.5 Δοσολογία και τρόπος χορήγησης: Για δερματική χρήση μόνο. Να μην χορηγείται από

το στόμα.

Ενήλικες

Εφαρμόζεται επαρκής ποσότητα του PAIN-OUT τοπικά στην πάσχουσα περιοχή. Κανονικά,

0,8 g – 1 g του διαλύματος (32 mg- 40 mg diclofenac sodium) επαρκούν. Η θεραπεία θα

πρέπει να επαναλαμβάνεται 3 φορές τη μέρα, σε τακτά χρονικά διαστήματα. Η μέγιστη

ημερήσια δόση είναι 3,0 g δερματικού διαλύματος (120 mg diclofenac sodium).

Το PAIN-OUT διαχέεται ομοιόμορφα στην πάσχουσα περιοχή κάνοντας ελαφρό μασάζ με τα

χέρια. Μετά την εφαρμογή, πρέπει να πλένονται καλά τα χέρια, εκτός και τα χέρια αποτελούν

την πάσχουσα περιοχή. Μετά την εφαρμογή, θα πρέπει να περιμένετε μερικά λεπτά μέχρι να

στεγνώσει πλήρως το διάλυμα, πριν καλύψετε το δέρμα με ρούχα ή τοποθετήσετε επίδεσμο.

Η θεραπεία μπορεί να διακοπεί όταν υποχωρήσουν τα συμπτώματα (το πρήξιμο και ο

πόνος). Η χορήγηση δεν θα πρέπει να συνεχιστεί πέραν των 7-8 ημερών, χωρίς

επανεξέταση. Εάν μετά την 3

ημέρα δεν εμφανιστεί βελτίωση, ο ασθενής θα πρέπει να

συμβουλευτεί το γιατρό του.

Ηλικιωμένοι

Να ακολουθείται η ίδια δοσολογία όπως στους ενήλικες.

Παιδιά

Η χρήση σε παιδιά κάτω των 15 ετών δεν έχει μελετηθεί. Επομένως, δεν συνιστάται η

χορήγηση σε αυτές τις ηλικίες.

2.6 Υπερδοσολογία – Αντιμετώπιση: Όταν χορηγείται η συνιστώμενη δοσολογία, δεν

υπάρχει ουσιαστικά κίνδυνος υπερδοσολογίας. Αν χορηγηθεί το δερματικό διάλυμα PAIN-

OUT, Diclofenac sodium 4% από το στόμα, συνιστάται συμπτωματική θεραπεία.

Τηλ. Κέντρου Δηλητηριάσεων Αθηνών: 210-77.93.777.

2.7 Ανεπιθύμητες ενέργειες: Έχουν αναφερθεί συχνά δερματικές διαταραχές.

Δέρμα: αντιδράσεις στο σημείο της εφαρμογής, εξανθήματα, κνησμός και κνίδωση, ξηρότητα,

ερυθρότητα, αίσθημα καύσου, δερματίτιδα εξ επαφής.

Σε μια κλινική μελέτη σε 236 ασθενείς με προβλήματα στον αστράγαλο χορηγήθηκαν 0,8- 1,0

g του δερματικού διαλύματος Diclofenac sodium 4% (120 ασθενείς) ή εικονικό φάρμακο (116

ασθενείς) για 14 ημέρες. Αναφέρθηκαν οι ακόλουθες ανεπιθύμητες ενέργειες για το

Diclofenac sodium 4%:

ΦΥΛΛΟ ΟΔΗΓΙΩΝ ΓΙΑ ΤΟ ΧΡΗΣΤΗ

Οργανικό

σύστημα

Πολύ συχνή

(>1/10)

Συχνή

(>1/100, <1/10)

Μη συχνές

(>1/1000, 1/100)

Σπάνιες

(>1/10000, 1/1000)

Δερματικές

και

υποδόριες

διαταραχές

Κνησμός

0,9%

Οι

ανεπιθύμητες

ενέργειες

μπορεί

να

μειωθούν

χρησιμοποιώντας

την

ελάχιστη

αποτελεσματική δόση και το μικρότερο δυνατόν χρονικό διάστημα θεραπείας. Η συνολική

δόση του φαρμάκου δεν θα πρέπει να υπερβαίνει το 1 g.

Παρόλα αυτά, κατά τη μακροχρόνια θεραπεία (>3 εβδομάδες) και/ ή όταν θεραπεύονται

μεγάλες επιφάνειες (δηλ. περισσότερο από 600 cm

δέρματος) υπάρχει η πιθανότητα να

εμφανιστούν συστηματικές παρενέργειες. Αντιδράσεις όπως κοιλιακό άλγος, δυσπεψία,

γαστρικές ή νεφρικές διαταραχές μπορεί να εμφανιστούν.

Σπανίως, έχει αναφερθεί η εκδήλωση άσθματος σε ασθενείς που χρησιμοποιούν μη

στεροειδή αντιφλεγμονώδη φάρμακα (ΜΣΑΦ). Σε μεμονωμένες περιπτώσεις έχουν αναφερθεί

γενικευμένο δερματικό εξάνθημα, αντιδράσεις υπερευαισθησίας όπως αγγειοοίδημα και

αντιδράσεις φωτοευαισθησίας.

2.8 Ημερομηνία λήξης του προϊόντος: Η ημερομηνία λήξης αναγράφεται στην εξωτερική

και στην εσωτερική συσκευασία του προϊόντος. Σε περίπτωση που η ημερομηνία αυτή έχει

παρέλθει, μην το χρησιμοποιήσετε.

2.9 Ιδιαίτερες προφυλάξεις κατά τη φύλαξη του προϊόντος:

Το

φάρμακο

πρέπει

να

φυλάσσεται σε θερμοκρασία περιβάλλοντος (<25

C), προστατευμένο από το φως και μακριά

από τα παιδιά.

2.10 Ημερομηνία τελευταίας αναθεώρησης του φύλλο οδηγιών

ΦΥΛΛΟ ΟΔΗΓΙΩΝ ΓΙΑ ΤΟ ΧΡΗΣΤΗ

3. ΠΛΗΡΟΦΟΡΙΕΣ ΓΙΑ ΤΗΝ ΟΡΘΟΛΟΓΙΚΗ ΧΡΗΣΗ ΤΩΝ ΦΑΡΜΑΚΩΝ

Το φάρμακο αυτό σας το έγραψε ο γιατρός σας μόνο για το συγκεκριμένο ιατρικό σας

πρόβλημα. Δεν θα πρέπει να το δίνετε σε άλλα άτομα ή να το χρησιμοποιείτε για κάποια

άλλη πάθηση, χωρίς προηγουμένως να έχετε συμβουλευτεί το γιατρό σας.

Εάν κατά τη διάρκεια της θεραπείας εμφανισθεί κάποιο πρόβλημα με το φάρμακο,

ενημερώστε αμέσως το γιατρό σας ή το φαρμακοποιό σας.

Εάν έχετε οποιαδήποτε ερωτηματικά γύρω από τις πληροφορίες που αφορούν το φάρμακο

που λαμβάνετε ή χρειάζεστε καλύτερη ενημέρωση για το ιατρικό σας πρόβλημα μη

διστάσετε να ζητήσετε τις πληροφορίες αυτές από το γιατρό σας ή το φαρμακοποιό σας.

Για να είναι αποτελεσματικό και ασφαλές το φάρμακο που σας χορηγήθηκε θα πρέπει να

λαμβάνεται σύμφωνα με τις οδηγίες που σας δόθηκαν.

Για την ασφάλεια σας και την υγεία σας είναι απαραίτητο να διαβάσετε με προσοχή κάθε

πληροφορία που αφορά το φάρμακο που σας χορηγήθηκε.

Να μη διατηρείτε τα φάρμακα σε ερμάρια του λουτρού, διότι η ζέστη και η υγρασία μπορεί

να αλλοιώσουν το φάρμακο και να το καταστήσουν επιβλαβές για την υγεία σας.

Να μην κρατάτε φάρμακα που δεν τα χρειάζεστε πλέον ή που έχουν λήξει.

Για μεγαλύτερη ασφάλεια κρατάτε όλα τα φάρμακα σε ασφαλές μέρος μακριά από τα

παιδιά.

4. ΤΡΟΠΟΣ ΔΙΑΘΕΣΗΣ

Το φάρμακο αυτό χορηγείται μόνο με ιατρική συνταγή.

ΦΥΛΛΟ ΟΔΗΓΙΩΝ ΓΙΑ ΤΟ ΧΡΗΣΤΗ

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

14-11-2018

FDA alerts doctors, patients about risk of complications when certain implanted pumps are used to deliver pain medications not approved for use with the devices

FDA alerts doctors, patients about risk of complications when certain implanted pumps are used to deliver pain medications not approved for use with the devices

FDA alerted health care providers and patients about the serious complications that can occur when using medications not approved for use with implanted pumps that deliver medication into the spinal fluid to treat or manage pain.

FDA - U.S. Food and Drug Administration

14-11-2018

Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration

Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration

The FDA is aware that patients undergoing treatment or management of pain are commonly given pain medicines in the spinal fluid (intrathecal administration) that are not FDA approved for use with the implanted pump.

FDA - U.S. Food and Drug Administration

14-11-2018

Several children's strawberry-flavoured acetaminophen syrups recalled because of defective child-resistant safety caps on the bottles

Several children's strawberry-flavoured acetaminophen syrups recalled because of defective child-resistant safety caps on the bottles

Laboratoire RivaInc. and Laboratoires Trianon Inc. are voluntarily recalling several over-the-counter children’s strawberry-flavoured acetaminophen syrups labeled as Biomedic, Option, or Laboratoires Trianon Inc. The products, which are used for pain and fever relief, are being recalled because the child-resistant safety cap may be defective.

Health Canada

9-11-2018

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

7-11-2018

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

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Vita Health Products is voluntarily recalling several store-brand (Care, Exact, Life, and Pharmasave) over-the-counter drugs used for pain or sinus relief because of a labelling issue. Consumers may be unable to peel open the wrap-around label on the bottle to access the warning statements, or the label may not peel off completely, which may make it difficult to read some of the important safety information.

Health Canada

5-11-2018

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Plant protection products containing metam-sodium are used in market gardening and horticulture to disinfect the soil. Following the substance's approval at European level, ANSES reassessed the dossiers and notified the industrial companies concerned of its intention to withdraw all marketing authorisations for metam-sodium products. ANSES is also taking this opportunity to reiterate the importance of phytopharmacovigilance and the requirement for professionals to report any adverse effects on humans or ...

France - Agence Nationale du Médicament Vétérinaire

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

Pest categorisation of Sternochetus mangiferae

Pest categorisation of Sternochetus mangiferae

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Sternochetus mangiferae (Coleoptera: Curculionidae), a monophagous pest weevil whose larvae exclusively feed on mango seeds, whereas adults feed on mango foliage. S. mangiferae is a species with reliable methods available for identification. It is regulated in the EU by Council Directive 2000/29/EC where it is listed in Annex IIB as a harmful organism whose introduction into EU Protec...

Europe - EFSA - European Food Safety Authority Publications

19-10-2018

Working Cow Homemade, Inc. Expands Recall of Ice Cream Products Because of Possible Health Risk

Working Cow Homemade, Inc. Expands Recall of Ice Cream Products Because of Possible Health Risk

Working Cow Homemade, Inc. of St. Petersburg, FL is expanding its voluntary recall to include all ice cream manufactured from August 29, 2017 – October 11, 2018, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nause...

FDA - U.S. Food and Drug Administration

10-10-2018

BSN SPORTS recalls Rubber Critter Toys

BSN SPORTS recalls Rubber Critter Toys

The paint on the toys contained levels of lead in excess of the allowable limit. Lead is toxic to children even at low exposure levels. Children can ingest harmful amounts of lead when they chew or suck items containing lead.

Health Canada

6-10-2018

Ladyfingers Gourmet to Go Voluntarily Recalls Signature Shaved Country Ham Rolls Due to Possible Health Risk

Ladyfingers Gourmet to Go Voluntarily Recalls Signature Shaved Country Ham Rolls Due to Possible Health Risk

Ladyfingers Caterers is voluntarily recalling its Signature Shaved Country Ham Rolls as a result of the Johnston County Hams recall. The rolls were made with ham produced by Johnston County Hams, which recently initiated a recall of its ham products due to possible contamination with Listeria monocytogenes. Listeria monocytogenes can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer onl...

FDA - U.S. Food and Drug Administration

5-10-2018

Working Cow Homemade, Inc. Recalls Product Because of Possible Health Risk

Working Cow Homemade, Inc. Recalls Product Because of Possible Health Risk

Working Cow Homemade Ice Cream, Inc. of St. Petersburg, FL is conducting a voluntary recall of No Sugar Added Vanilla and No Sugar Added Chocolate ice cream manufactured in three-gallon tubs during the month of May 2018. The recall is being conducted due to a potential contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only...

FDA - U.S. Food and Drug Administration

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Prizer-Painter Stove Works, Inc. recalls BlueStar and Big Chill Brand Gas Ranges and Wall Ovens

Prizer-Painter Stove Works, Inc. recalls BlueStar and Big Chill Brand Gas Ranges and Wall Ovens

Use of the convection oven fan during pre-heating or broiling can cause accumulated gas to ignite, posing a burn hazard to consumers when oven door is opened.

Health Canada

11-9-2018

Risk assessment of white willow (Salix alba) in food

Risk assessment of white willow (Salix alba) in food

Published on: Tue, 28 Aug 2018 00:00:00 +0200 This Technical Report contains a description of the activities within the work programme of the EU‐FORA Fellowship on the risk assessment of white willow in food. The bark of different varieties of willow has had a long history of medical use as a means to reduce fever and as a painkiller. Willow bark is also used in weight loss and sports performance food supplements. The labelling of these products usually does not mention any restrictions to the length of...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

31-8-2018

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA is warning the public about a voluntary recall of one lot of montelukast sodium tablets made by Camber Pharmaceuticals due to incorrect drug in bottles

FDA - U.S. Food and Drug Administration

29-8-2018

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

Requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.

FDA - U.S. Food and Drug Administration

21-8-2018

Lipari Foods Issues Voluntary Recall of Premo Brand Turkey & Cheese Wedge Sandwiches Because of Possible Health Risk

Lipari Foods Issues Voluntary Recall of Premo Brand Turkey & Cheese Wedge Sandwiches Because of Possible Health Risk

Lipari Foods, LLC has issued a voluntary recall of Premo Brand turkey and cheese wedge sandwiches produced and packaged by sister company JLM due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal...

FDA - U.S. Food and Drug Administration

15-8-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new resource guide to support responsible opioid prescribing for pain management in animals

Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new resource guide to support responsible opioid prescribing for pain management in animals

Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new resource guide in support of responsible opioid prescribing for safe, effective pain management in animals

FDA - U.S. Food and Drug Administration

31-7-2018

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. One vial from lot# PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot# PP0317059-A was fo...

FDA - U.S. Food and Drug Administration

31-7-2018

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition, a division of Archer Daniels Midland Company (NYSE: ADM), is recalling 200-pound tubs of Mintrate® 36-15 Breed Right Tub cattle feed, product number 54549AAA6H, because the product may contain elevated levels of non-protein nitrogen, which could be harmful to cattle. Excessive levels of non-protein nitrogen can be toxic to cattle and can cause muscle tremors (especially of face and ears), abdominal pain, bloat, frothy salivation, excessive urination, teeth grinding, incoordination, ...

FDA - U.S. Food and Drug Administration

28-7-2018

Lipari Foods Issues Voluntary Recall of Premo Brand & Fresh Grab Turkey & Swiss Submarine Sandwiches Due to Potential Contamination of Listeria Monocytogenes

Lipari Foods Issues Voluntary Recall of Premo Brand & Fresh Grab Turkey & Swiss Submarine Sandwiches Due to Potential Contamination of Listeria Monocytogenes

Lipari Foods, LLC has issued a voluntary recall of Premo Brand and Fresh Grab turkey and Swiss submarine sandwiches produced and packaged by sister company JLM due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness,...

FDA - U.S. Food and Drug Administration

24-7-2018

Opinion/decision on a Paediatric investigation plan (PIP):    Penthrox, Methoxyflurane, Therapeutic area: Pain

Opinion/decision on a Paediatric investigation plan (PIP): Penthrox, Methoxyflurane, Therapeutic area: Pain

Europe - EFSA - European Food Safety Authority EFSA Journal

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

11-7-2018

MyNicNaxs, LLC Issues Voluntary Nationwide Recall of Various Dietary Supplements Due to Undeclared Active Pharmaceutical Ingredient (API)

MyNicNaxs, LLC Issues Voluntary Nationwide Recall of Various Dietary Supplements Due to Undeclared Active Pharmaceutical Ingredient (API)

MyNicNaxs, LLC, Deltona, FL is voluntarily recalling all lots of dietary supplements distributed nationwide to the consumer level. The products have been found to contain undeclared active pharmaceutical ingredients (API). The presence of Sildenafil, Sibutramine, Diclofenac and/or Phenolphthalein in the dietary supplements renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. These products were distributed from January 2013, to December ...

FDA - U.S. Food and Drug Administration

9-7-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on balancing access to appropriate treatment for patients with chronic and end-of-life pain with need to take steps to stem misuse and abuse of opioids

Statement by FDA Commissioner Scott Gottlieb, M.D., on balancing access to appropriate treatment for patients with chronic and end-of-life pain with need to take steps to stem misuse and abuse of opioids

FDA Commissioner statement on balancing access to appropriate treatment for patients with chronic and end-of-life pain with need to take steps to stem opioid misuse and abuse.

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

19-6-2018

Opinion/decision on a Paediatric investigation plan (PIP):    -, Tanezumab, Therapeutic area: Pain

Opinion/decision on a Paediatric investigation plan (PIP): -, Tanezumab, Therapeutic area: Pain

Europe - EFSA - European Food Safety Authority EFSA Journal

30-5-2018

As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion

As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion

As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion

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

14-11-2018

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or   manage pain:  https://go.usa.gov/x

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or manage pain: https://go.usa.gov/x

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or manage pain: https://go.usa.gov/xPfuw  #FDA #MedicalDevice pic.twitter.com/kgDSx2PQzn

FDA - U.S. Food and Drug Administration

21-10-2018

It’s concerning that many women who qualify for a mammogram don’t go for regular screening, in part due to common myths like mammograms “are painful” or “cause cancer.”  During this Breast Cancer Awareness month, I urge women to check the facts  https://g

It’s concerning that many women who qualify for a mammogram don’t go for regular screening, in part due to common myths like mammograms “are painful” or “cause cancer.” During this Breast Cancer Awareness month, I urge women to check the facts https://g

It’s concerning that many women who qualify for a mammogram don’t go for regular screening, in part due to common myths like mammograms “are painful” or “cause cancer.” During this Breast Cancer Awareness month, I urge women to check the facts https://go.usa.gov/xPnyD . pic.twitter.com/DGz5Xvquky

FDA - U.S. Food and Drug Administration

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

3-8-2018

Sodium oxybate

Sodium oxybate

Sodium oxybate (Active substance: Sodium oxybate) - Centralised - Art 28 - (PSUR - Commission Decision (2018)5381 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10612/201710

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Active substance: Combination of carboplatin and sodium valproate) - Orphan designation - Commission Decision (2018)5275 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/036/18

Europe -DG Health and Food Safety

11-7-2018

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Active substance: Alendronate Sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4518 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/619/T/42

Europe -DG Health and Food Safety

10-7-2018

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Active substance: Alendronate sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4477 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/759/T/39

Europe -DG Health and Food Safety

10-7-2018

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Active substance: Sodium phenylbutyrate) - Centralised - Yearly update - Commission Decision (2018)4483 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Withdrawn application:  Prohippur, sodium benzoate, Initial authorisation

Withdrawn application: Prohippur, sodium benzoate, Initial authorisation

Europe - EMA - European Medicines Agency

19-6-2018

Xyrem (UCB Pharma S.A.)

Xyrem (UCB Pharma S.A.)

Xyrem (Active substance: Sodium oxybate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3912 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/593/T/74

Europe -DG Health and Food Safety

5-6-2018

#DYK The misuse of prescription drugs means taking a medication in a manner or dose other than prescribed; taking someone else’s prescription, even if for a legitimate medical complaint such as pain; or taking a medication to feel euphoria. #FDAInnovation

#DYK The misuse of prescription drugs means taking a medication in a manner or dose other than prescribed; taking someone else’s prescription, even if for a legitimate medical complaint such as pain; or taking a medication to feel euphoria. #FDAInnovation

#DYK The misuse of prescription drugs means taking a medication in a manner or dose other than prescribed; taking someone else’s prescription, even if for a legitimate medical complaint such as pain; or taking a medication to feel euphoria. #FDAInnovationChallenge pic.twitter.com/QI0mrJactV

FDA - U.S. Food and Drug Administration

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

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety