Cyanokit · 4.8 Undesirable effects · 1

HOS-094824 · has-adverse-reaction-information · PDF-Seite 19

Summary of the safety profile A total of 347 subjects were exposed to hydroxocobalamin in clinical studies. Of these 347 subjects, 245 patients had suspected exposure to cyanide at the time of hydroxocobalamin administration. The remaining 102 subjects were healthy volunteers who had not been exposed to cyanide at the time of hydroxocobalamin administration. List of adverse reactions The following adverse reactions have been reported in association with Cyanokit use. However, because of the limitations of the available data, it is not possible to apply frequency estimations: Blood and lymphatic system disorders Decrease in the percentage of lymphocytes. Immune system disorders Allergic reactions including angioneurotic oedema, skin eruption, urticaria and pruritus. Psychiatric disorders Restlessness. Nervous system disorders Memory impairment; dizziness. Eye disorders Swelling, irritation, redness. Cardiac disorders Ventricular extrasystoles. An increase in heart rate was observed in cyanide-poisoned patients. Vascular disorders Transient increase in blood pressure, usually resolving within several hours; hot flush. A decrease in blood pressure was observed in cyanide-poisoned patients. Respiratory, thoracic and mediastinal disorders Pleural effusion, dyspnoea, throat tightness, dry throat, chest discomfort. Gastrointestinal disorders Abdominal discomfort, dyspepsia, diarrhoea, vomiting, nausea, dysphagia. 19 Skin and subcutaneous tissue disorders Reversible red colouration of the skin and mucous membranes: most patients will experience it up to 15 days after administration of Cyanokit. Pustular rashes, which may last for several weeks, affecting mainly the face and the neck. Renal and urinary disorders • Acute renal failure with acute tubular necrosis, renal impairment, urine calcium oxalate crystals present (see section 4.4). • Chromaturia: all patients will show a dark red colouration of the urine quite marked during the first three days following administration. Urine colouration may last up to 35 days after administration of Cyanokit (see section 4.4). General disorders and administration site conditions Headache; injection site reaction; peripheral oedema. Investigations Cyanokit may cause red discolouration of the plasma, which may cause artificial elevation or reduction in the levels of certain laboratory parameters (see section 4.4). Paediatric population L

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HOS-094818 · has-adverse-reaction-information · PDF-Seite 7

Summary of the safety profile A total of 347 subjects were exposed to hydroxocobalamin in clinical studies. Of these 347 subjects, 245 patients had suspected exposure to cyanide at the time of hydroxocobalamin administration. The remaining 102 subjects were healthy volunteers who had not been exposed to cyanide at the time of hydroxocobalamin administration. List of adverse reactions The following adverse reactions have been reported in association with Cyanokit use. However, because of the limitations of the available data, it is not possible to apply frequency estimations: Blood and lymphatic system disorders Decrease in the percentage of lymphocytes. Immune system disorders Allergic reactions including angioneurotic oedema, skin eruption, urticaria and pruritus. Psychiatric disorders Restlessness. Nervous system disorders Memory impairment; dizziness. Eye disorders Swelling, irritation, redness. Cardiac disorders Ventricular extrasystoles. An increase in heart rate was observed in cyanide-poisoned patients. Vascular disorders Transient increase in blood pressure, usually resolving within several hours; hot flush. A decrease in blood pressure was observed in cyanide-poisoned patients. Respiratory, thoracic and mediastinal disorders Pleural effusion, dyspnoea, throat tightness, dry throat, chest discomfort. Gastrointestinal disorders Abdominal discomfort, dyspepsia, diarrhoea, vomiting, nausea, dysphagia. 7 Skin and subcutaneous tissue disorders Reversible red colouration of the skin and mucous membranes : most patients will experience it up to 15 days after administration of Cyanokit. Pustular rashes, which may last for several weeks, affecting mainly the face and the neck. Renal and urinary disorders • Acute renal failure with acute tubular necrosis, renal impairment, urine calcium oxalate crystals present (see section 4.4). • Chromaturia : all patients will show a dark red colouration of the urine quite marked during the first three days following administration. Urine colouration may last up to 35 days after administration of Cyanokit (see section 4.4 ). General disorders and administration site conditions Headache; injection site reaction; peripheral oedema. Investigations Cyanokit may cause red discolouration of the plasma, which may cause artificial elevation or reduction in the levels of certain laboratory parameters (see section 4.4). Paediatric popula

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HOS-094814 · has-contraindication-information · PDF-Seite 3

None.

HOS-094820 · has-contraindication-information · PDF-Seite 15

None.

HOS-094813 · has-indication-information · PDF-Seite 2

Treatment of known or suspected cyanide poisoning in all age ranges. Cyanokit is to be administered together with appropriate decontamination and supportive measures (see section 4.4).

HOS-094819 · has-indication-information · PDF-Seite 14

Treatment of known or suspected cyanide poisoning in all age ranges. Cyanokit is to be administered together with appropriate decontamination and supportive measures (see section 4.4).

HOS-094816 · has-interaction-information · PDF-Seite 6

No interaction studies have been performed.

HOS-094822 · has-interaction-information · PDF-Seite 18

No interaction studies have been performed.

HOS-094817 · has-pregnancy-information · PDF-Seite 6

Pregnancy Animal studies have shown teratogenic effects following daily exposure throughout organogenesis (see section 5.3). There are no adequate data from the use of hydroxocobalamin in pregnant women and the potential risk for humans is unknown. However, taken into account: - that no more than two injections of hydroxocobalamin are to be administered, - the potentially life threatening condition, - the lack of alternative treatment, hydroxocobalamin may be given to a pregnant woman. In case of known pregnancy at the time of treatment with Cyanokit or in case that pregnancy becomes known after treatment with Cyanokit, health care professionals are requested to promptly report the exposure during pregnancy to the Marketing Authorisation Holder and/or Health Authorities and to carefully follow-up on the pregnancy and its outcome. Breast-feeding Because hydroxocobalamin will be administered in potentially life-threatening situations, breast- feeding is not a contraindication to its use. In the absence of data in breast-fed infants, breast-feeding discontinuation is recommended after receiving Cyanokit. Fertility No studies on fertility have been performed (see section 5.3).

HOS-094823 · has-pregnancy-information · PDF-Seite 18

Pregnancy Animal studies have shown teratogenic effects following daily exposure throughout organogenesis (see section 5.3). There are no adequate data from the use of hydroxocobalamin in pregnant women and the potential risk for humans is unknown. However, taken into account: - that no more than two injections of hydroxocobalamin are to be administered, - the potentially life threatening condition, - the lack of alternative treatment, hydroxocobalamin may be given to a pregnant woman. In case of known pregnancy at the time of treatment with Cyanokit or in case that pregnancy becomes known after treatment with Cyanokit, health care professionals are requested to promptly report the exposure during pregnancy to the Marketing Authorisation Holder and/or Health Authorities and to carefully follow-up on the pregnancy and its outcome. Breast-feeding Because hydroxocobalamin will be administered in potentially life-threatening situations, breast- feeding is not a contraindication to its use. In the absence of data in breast-fed infants, breast-feeding discontinuation is recommended after receiving Cyanokit. Fertility No studies on fertility have been performed (see section 5.3).

HOS-094815 · has-warning-information · PDF-Seite 3

Treatment of cyanide poisoning must include immediate attention to airway patency, adequacy of oxygenation and hydration, cardiovascular support, and management of seizures. Consideration must be given to decontamination measures based on the route of exposure. Cyanokit does not substitute oxygen therapy and must not delay the set up of the above measures. The presence and extent of cyanide poisoning are often initially unknown. There is no widely available, rapid, confirmatory cyanide blood test. Treatment decisions must be made on the basis of clinical history and/or signs and symptoms of cyanide intoxication. Cyanide poisoning may result from exposure to smoke from closed space fires, inhalation, ingestion, or dermal exposure. Sources of cyanide poisoning include hydrogen cyanide and its salts, cyanogens, including cyanogenic plants, aliphatic nitriles, or prolonged exposure to sodium nitroprusside. Signs and symptoms of cyanide poisoning Common signs and symptoms of cyanide poisoning include: nausea, vomiting, headache, altered mental status (e.g. confusion, disorientation), chest tightness, dyspnoea, tachypnoea or hyperpnoea (early), bradypnoea or apnoea (late), hypertension (early) or hypotension (late), cardiovascular collapse, seizures or coma, mydriasis, and plasma lactate concentration > 8 mmol/L. In the setting of multiple casualties such as terrorism or chemical disaster, panic symptoms including tachypnoea and vomiting may mimic early cyanide poisoning signs. The presence of altered mental status (confusion and disorientation) and/or mydriasis is suggestive of true cyanide poisoning. 3 Smoke inhalation Not all smoke inhalation victims necessarily will have cyanide poisoning, but may present with burns, trauma, and exposure to additional toxic substances aggravating the clinical picture. Before Cyanokit is administered, it is recommended to check affected persons for the presence of the following: • exposure to fire smoke in an enclosed area • soot present around mouth, nose and/or oropharynx • altered mental status In this setting hypotension and/or a plasma lactate concentration ≥ 10 mmol/L (higher than the one mentioned under signs and symptoms due to the fact that carbon monoxide contributes to lactic acidaemia) are highly suggestive of cyanide poisoning. In the presence of the above signs, treatment with Cyanokit must not be delayed to obtain a plasma lactate conce

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HOS-094821 · has-warning-information · PDF-Seite 15

Treatment of cyanide poisoning must include immediate attention to airway patency, adequacy of oxygenation and hydration, cardiovascular support, and management of seizures. Consideration must be given to decontamination measures based on the route of exposure. Cyanokit does not substitute oxygen therapy and must not delay the set up of the above measures. The presence and extent of cyanide poisoning are often initially unknown. There is no widely available, rapid, confirmatory cyanide blood test. Treatment decisions must be made on the basis of clinical history and/or signs and symptoms of cyanide intoxication. Cyanide poisoning may result from exposure to smoke from closed space fires, inhalation, ingestion, or dermal exposure. Sources of cyanide poisoning include hydrogen cyanide and its salts, cyanogens, including cyanogenic plants, aliphatic nitriles, or prolonged exposure to sodium nitroprusside. Signs and symptoms of cyanide poisoning Common signs and symptoms of cyanide poisoning include: nausea, vomiting, headache, altered mental status (e.g. confusion, disorientation), chest tightness, dyspnoea, tachypnoea or hyperpnoea (early), bradypnoea or apnoea (late), hypertension (early) or hypotension (late), cardiovascular collapse, seizures or coma, mydriasis, and plasma lactate concentration > 8 mmol/L. In the setting of multiple casualties such as terrorism or chemical disaster, panic symptoms including tachypnoea and vomiting may mimic early cyanide poisoning signs. The presence of altered mental status (confusion and disorientation) and/or mydriasis is suggestive of true cyanide poisoning. 15 Smoke inhalation Not all smoke inhalation victims necessarily will have cyanide poisoning, but may present with burns, trauma, and exposure to additional toxic substances aggravating the clinical picture. Before Cyanokit is administered, it is recommended to check affected persons for the presence of the following: • exposure to fire smoke in an enclosed area • soot present around mouth, nose and/or oropharynx • altered mental status In this setting hypotension and/or a plasma lactate concentration ≥ 10 mmol/L (higher than the one mentioned under signs and symptoms due to the fact that carbon monoxide contributes to lactic acidaemia) are highly suggestive of cyanide poisoning. In the presence of the above signs, treatment with Cyanokit must not be delayed to obtain a plasma lactate conc

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