{"id":131766,"date":"2024-07-09T08:42:37","date_gmt":"2024-07-09T06:42:37","guid":{"rendered":"https:\/\/komtur.pl\/?page_id=131766"},"modified":"2025-10-07T15:50:18","modified_gmt":"2025-10-07T13:50:18","slug":"reporting-adr-ade","status":"publish","type":"page","link":"https:\/\/komtur.pl\/en\/reporting-adr-ade\/","title":{"rendered":"Reporting ADR &#038; ADE"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row unlock_row_content=&#8221;yes&#8221; row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;3&#8243; top_padding=&#8221;3&#8243; bottom_padding=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;474410&#8243;][vc_column column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; gutter_size=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;2\/3&#8243; uncode_shortcode_id=&#8221;499017&#8243;][vc_custom_heading text_color=&#8221;color-130964&#8243; heading_semantic=&#8221;h1&#8243; text_size=&#8221;fontsize-213687&#8243; css_animation=&#8221;curtain&#8221; animation_delay=&#8221;300&#8243; uncode_shortcode_id=&#8221;509526&#8243; text_color_type=&#8221;uncode-palette&#8221;]Reporting ADR &amp; ADE[\/vc_custom_heading][vc_empty_space empty_h=&#8221;2&#8243;][\/vc_column][vc_column width=&#8221;1\/3&#8243;][\/vc_column][\/vc_row][vc_row unlock_row_content=&#8221;yes&#8221; row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;3&#8243; top_padding=&#8221;3&#8243; bottom_padding=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;0&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;234565&#8243;][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;2&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;2&#8243; back_color=&#8221;color-lxmt&#8221; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;-2&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;4\/12&#8243; uncode_shortcode_id=&#8221;507461&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_icon position=&#8221;left&#8221; space_reduced=&#8221;yes&#8221; title_aligned_icon=&#8221;yes&#8221; icon=&#8221;fa fa-th-list&#8221; icon_color=&#8221;color-130964&#8243; text_size=&#8221;h4&#8243; uncode_shortcode_id=&#8221;161836&#8243; icon_color_type=&#8221;uncode-palette&#8221; title=&#8221;PDF downloadable forms&#8221;][\/vc_icon][vc_column_text text_lead=&#8221;yes&#8221; text_color=&#8221;color-130964&#8243; uncode_shortcode_id=&#8221;145141&#8243; text_color_type=&#8221;uncode-palette&#8221;]<\/p>\n<ul class=\"list-none space-y-1.5\">\n<li><a href=\"https:\/\/komtur.pl\/wp-content\/uploads\/2024\/07\/Nowy_formularz_dla_fachowych_pracownikow_01_04_2014-1.rtf\" target=\"_blank\" rel=\"noopener\">For professionals<\/a><\/li>\n<li><a href=\"https:\/\/komtur.pl\/wp-content\/uploads\/2024\/07\/Nowy_formularz_dla_pacjenta_01_04_2014-1.rtf\" target=\"_blank\" rel=\"noopener\">For patients<\/a><\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_empty_space empty_h=&#8221;2&#8243;][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;3&#8243; back_color=&#8221;color-xsdn&#8221; overlay_alpha=&#8221;50&#8243; border_color=&#8221;color-lxmt&#8221; border_style=&#8221;solid&#8221; shift_x=&#8221;-4&#8243; shift_y=&#8221;5&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;8\/12&#8243; uncode_shortcode_id=&#8221;212540&#8243; back_color_type=&#8221;uncode-palette&#8221; css=&#8221;.vc_custom_1721748019057{border-top-width: 4px !important;border-right-width: 4px !important;border-bottom-width: 4px !important;border-left-width: 4px !important;}&#8221; border_color_type=&#8221;uncode-palette&#8221;][vc_custom_heading text_color=&#8221;color-130964&#8243; text_size=&#8221;fontsize-816752&#8243; uncode_shortcode_id=&#8221;162347&#8243; text_color_type=&#8221;uncode-palette&#8221;]Reporting adverse event or adverse drug reaction[\/vc_custom_heading][vc_column_text uncode_shortcode_id=&#8221;211544&#8243;]The following information, appearing in Polish, refers to the reporting adverse event of adverse drug reaction only on territory of Poland. For more information in English please contact us: <a href=\"tel:+48223507055\"><strong>+48 22 350 70 55<\/strong><\/a><\/p>\n<p><strong>Komtur Polska Sp. z o.o.<\/strong> makes a kind request to report all information on suspected adverse event or adverse drug reaction after the following medicinal products:[\/vc_column_text][vc_custom_heading text_color=&#8221;color-130964&#8243; uncode_shortcode_id=&#8221;130811&#8243; text_color_type=&#8221;uncode-palette&#8221;]Marketing Authorisation Holder:\u00a0<strong>Janssen Cilag<\/strong>[\/vc_custom_heading][uncode_list icon=&#8221;fa fa-check-square-o&#8221; icon_color=&#8221;accent&#8221; uncode_shortcode_id=&#8221;140690&#8243; icon_color_type=&#8221;uncode-palette&#8221;]<\/p>\n<ul>\n<li><strong>Veletri (Epoprostenol)\u00a0<\/strong>0,5mg; powder for solution for infusion<\/li>\n<li><strong>Veletri (Epoprostenol)\u00a0<\/strong>1,5mg; powder for solution for infusion<\/li>\n<\/ul>\n<p>[\/uncode_list][vc_custom_heading text_color=&#8221;color-130964&#8243; uncode_shortcode_id=&#8221;864497&#8243; text_color_type=&#8221;uncode-palette&#8221;]Marketing Authorisation Holder:<strong> Besins Healthcare S.A.<\/strong>[\/vc_custom_heading][uncode_list icon=&#8221;fa fa-check-square-o&#8221; icon_color=&#8221;accent&#8221; uncode_shortcode_id=&#8221;184187&#8243; icon_color_type=&#8221;uncode-palette&#8221;]<\/p>\n<ul>\n<li><strong>Androtop (Testosteronum) <\/strong>16,2 mg\/g; gel<\/li>\n<li><strong>Oestrogel (Estradiolum) <\/strong>0,75 mg\/dawk\u0119; transdermal gel<\/li>\n<li><strong>Progesterone Besins (Progesteronum) <\/strong>100 mg; 200 mg; capsule<\/li>\n<li><strong>Testosterone Undecanoate Besins (Testosteroni undecanoas)<\/strong> 1000 mg\/4 ml; solution for injection<\/li>\n<li><strong>Utrogestan (Progesteronum) <\/strong>200 mg; 400mg; capsule<\/li>\n<\/ul>\n<p>[\/uncode_list][vc_custom_heading text_color=&#8221;color-130964&#8243; uncode_shortcode_id=&#8221;156267&#8243; text_color_type=&#8221;uncode-palette&#8221;]Marketing Authorisation Holder:<strong>\u00a0Cheplapharm Arzneimittel GmbH<\/strong>[\/vc_custom_heading][uncode_list icon=&#8221;fa fa-check-square-o&#8221; icon_color=&#8221;accent&#8221; uncode_shortcode_id=&#8221;106762&#8243; icon_color_type=&#8221;uncode-palette&#8221;]<\/p>\n<ul>\n<li><strong>Atacand<\/strong><strong>(Candesartanum)<\/strong>8 mg; 16 mg; tablets<\/li>\n<li><strong>Biosotal 40; Biosotal 80; (Sotalolum)\u00a0<\/strong>40 mg; 80 mg; tablets<\/li>\n<li><strong>Cymevene (Ganciclovirum)\u00a0<\/strong>500 mg, powder for solution for injection<\/li>\n<li><strong>Dilatrend (Carvedilolum)\u00a0<\/strong>6,25 mg; 12 mg; 25 mg; tablets<\/li>\n<li><strong>Ditropan (Oxybutyninum)\u00a0<\/strong>5 mg, tablets<\/li>\n<li><strong>Dormicum (Midazolamum)\u00a0<\/strong>7,5 mg; 15 mg, film-coated tablets<\/li>\n<li><strong>Duomox (Amoxicillin)<\/strong>250 mg; 375 mg; 500 mg; 750 mg; 1000 mg; tablets<\/li>\n<li><strong>Ebrantil 25 (Urapidili hydrochloridum)\u00a0<\/strong>5 mg\/ml, solution for injection<\/li>\n<li><strong>Exacyl (Acidum tranexamicum)<\/strong>500 mg; film-coated tablets<\/li>\n<li><strong>Exacyl (Acidum tranexamicum)<\/strong>100 mg\/ml; solution for injection<\/li>\n<li><strong>Exacyl (Acidum tranexamicum)<\/strong>100 mg\/ml; oral solution<\/li>\n<li><strong>Fungizone (Amphotericinum B)\u00a0<\/strong>50 mg, powder for solution for injection<\/li>\n<li><strong>Gutron (Midodrini hydrochloridum)\u00a0<\/strong>2,5 mg, tablets<\/li>\n<li><strong>Heminevrin (Clomethiazolum)\u00a0<\/strong>300 mg, capsules hard<\/li>\n<li><strong>Inhibace (Cilazaprilum)\u00a0<\/strong>1 mg; 2,5 mg; 5 mg; film-coated tablets<\/li>\n<li><strong>Inhibace Plus (Cilazaprilum + Hydrochlorothiazidum)\u00a0<\/strong>5 mg + 12,5 mg; film-coated tablets<\/li>\n<li><strong>Lexotan (Bromazepamum)\u00a0<\/strong>3 mg; 6 mg, tablets<\/li>\n<li><strong>Locoid (Hydrocortisoni butyras)\u00a0<\/strong>1 mg\/ml, solution for use on the skin<\/li>\n<li><strong>Locoid (Hydrocortisoni butyras)\u00a0<\/strong>1 mg\/g, cream<\/li>\n<li><strong>Locoid Crelo (Hydrocortisoni butyras)\u00a0<\/strong>1 mg\/ml, emulsion<\/li>\n<li><strong>Locoid Lipocream (Hydrocortisoni butyras)\u00a0<\/strong>1 mg\/g, cream<\/li>\n<li><strong>Lokren 20<\/strong><strong>(Betaxololi hydrochloridum)<\/strong>20 mg; film-coated tablets<\/li>\n<li><strong>Losec (Omeprazolum)\u00a0<\/strong>20 mg, capsules<\/li>\n<li><strong>Myocet liposomal (Doxorubicini hydrochloridum)\u00a0<\/strong>50 mg; powder, dispersion and solvent for concentrate for dispersion for infusion<\/li>\n<li><strong>Pimafucin (Natamycinum)\u00a0<\/strong>100 mg, vaginal globules<\/li>\n<li><strong>Pimafucin (Natamycinum)\u00a0<\/strong>20 mg\/g, cream<\/li>\n<li><strong>Tarceva (Erlotinibum)\u00a0<\/strong>25 mg, 100 mg, 150 mg; film-coated tablets<\/li>\n<li><strong>Ubretid (Distigmini bromidum)\u00a0<\/strong>5 mg, tablets<\/li>\n<li><strong>Unidox Solutab (Doxycycline)<\/strong>100 mg; tablets for oral suspension<\/li>\n<li><strong>Valcyte (Valganciclovirum)<\/strong>50 mg\/ml; powder for oral solution<\/li>\n<li><strong>Vesanoid (Tretinoinum)\u00a0<\/strong>10 mg, capsules soft<\/li>\n<li><strong>Visudyne (Verteporfinum)\u00a0<\/strong>15 mg, powder for solution for infusion<\/li>\n<li><strong>Xeloda (Capecitabinum)\u00a0<\/strong>150 mg; 500 mg; film-coated tablets<\/li>\n<li><strong>Xenical (Orlistatum)\u00a0<\/strong>120 mg, capsules hard<\/li>\n<li><strong>Zineryt (Erythromycinum cum zinco)\u00a0<\/strong>40 mg + 12 mg)\/ml; powder and solvent for cutaneous solution<\/li>\n<li><strong>Zypadhera (Olanzapinum)<\/strong>\u00a0210 mg; 300 mg; 405 mg; powder and solvent for prolonged release suspension for injection<\/li>\n<li><strong>Zyprexa (Olanzapinum)<\/strong>\u00a02.5mg; 5mg; 7.5mg; 10mg; 15mg; 20mg; coated tablets<\/li>\n<li><strong>Zyprexa Velotab (Olanzapinum)<\/strong>\u00a0 5mg; 10mg; 15mg; 20mg; orodispersible tablets<\/li>\n<\/ul>\n<p>[\/uncode_list][vc_custom_heading text_color=&#8221;color-130964&#8243; uncode_shortcode_id=&#8221;117730&#8243; text_color_type=&#8221;uncode-palette&#8221;]Marketing Authorisation Holder:<strong>\u00a0Zambon S.p.A.<\/strong>[\/vc_custom_heading][uncode_list icon=&#8221;fa fa-check-square-o&#8221; icon_color=&#8221;accent&#8221; uncode_shortcode_id=&#8221;148353&#8243; icon_color_type=&#8221;uncode-palette&#8221;]<\/p>\n<ul>\n<li><strong>Fluimucil Forte (Acetylocysteinum)<\/strong>600 mg; effervescent tablets<\/li>\n<li><strong>Fluimucil Muko (Acetylocysteinum)<\/strong>200 mg; granules for oral solution<\/li>\n<li><strong>Fluimucil Muko Junior (Acetylocysteinum)<\/strong>100 mg; granules for oral solution<\/li>\n<\/ul>\n<p>[\/uncode_list][vc_custom_heading text_color=&#8221;color-130964&#8243; uncode_shortcode_id=&#8221;138464&#8243; text_color_type=&#8221;uncode-palette&#8221;]Marketing authorisation holder:<strong>\u00a0ALK-Abell\u00f3 A\/S<\/strong>[\/vc_custom_heading][uncode_list icon=&#8221;fa fa-check-square-o&#8221; icon_color=&#8221;accent&#8221; uncode_shortcode_id=&#8221;307366&#8243; icon_color_type=&#8221;uncode-palette&#8221;]<\/p>\n<ul>\n<li><strong>Acarizax (Standardised allergen extract from the house dust mites)<\/strong>, oral lyophilisate<\/li>\n<li><strong>Alutard SQ (Allergen from animal sources (Canis Familiaris and Felis Domesticus)),\u00a0<\/strong>suspension for injection<\/li>\n<li><strong>Alutard SQ (Allergen from honey bee and wasp venom)<\/strong>, suspension for injection<\/li>\n<li><strong>Grazax (Standardised allergen extract of grass pollen from Timothy (Phleum pratense)),<\/strong>oral lyophilisate<\/li>\n<li><strong>Jext<sup>\u00ae<\/sup>(Adrenaline)<\/strong>150 mcg; 300 mcg, solution for injection<\/li>\n<li><strong>Pharmalgen Hymenoptera venoms (Allergen from honey bee and wasp venom)<\/strong>, powder and solvent for solution for injection<\/li>\n<li><strong>Itulazax (Standardised allergen extract of pollen from white birch (Betula verrucosa))<\/strong>, oral lyophilisate<\/li>\n<li><strong>EURneffy\u00ae (Adrenaline) <\/strong>2 mg, nasal spray<\/li>\n<\/ul>\n<p>[\/uncode_list][vc_empty_space empty_h=&#8221;1&#8243;][vc_custom_heading text_color=&#8221;color-130964&#8243; uncode_shortcode_id=&#8221;115285&#8243; text_color_type=&#8221;uncode-palette&#8221;]Forms for download:[\/vc_custom_heading][uncode_list icon=&#8221;fa fa-check-square-o&#8221; icon_color=&#8221;accent&#8221; uncode_shortcode_id=&#8221;536769&#8243; icon_color_type=&#8221;uncode-palette&#8221;]<\/p>\n<ul>\n<li><strong><a href=\"https:\/\/komtur.pl\/wp-content\/uploads\/2024\/07\/Nowy_formularz_dla_fachowych_pracownikow_01_04_2014-1.rtf\" target=\"_blank\" rel=\"noopener\">New form for professionals<\/a><\/strong><\/li>\n<li><strong><a href=\"https:\/\/komtur.pl\/wp-content\/uploads\/2024\/07\/Nowy_formularz_dla_pacjenta_01_04_2014-1.rtf\" target=\"_blank\" rel=\"noopener\">New form for patients<\/a><\/strong><\/li>\n<\/ul>\n<p>[\/uncode_list][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row unlock_row_content=&#8221;yes&#8221; 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