Ruconest · 4.4 Special warnings and precautions for use · 1

HOS-095668 · has-adverse-reaction-information · PDF-Seite 4

Summary of the safety profile One case of hypersensitivity was observed in clinical trials with Ruconest. The most common adverse reaction observed after administration of Ruconest is nausea. Tabulated lists of adverse reactions Adverse reactions reported with Ruconest in the treatment of acute HAE attacks obtained from clinical trials and post-marketing surveillance are tabulated below. In clinical trials, the incidence of adverse reactions was similar for all dose groups and did not increase upon repeated administration. The frequency of adverse reactions listed below is defined using the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), 4 Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data). System Organ Class Adverse reaction Frequency Headache Uncommon Vertigo Uncommon Nervous system disorders Hypoaesthesia Uncommon Dizziness Uncommon Ear and labyrinth disorders Auricular swelling Uncommon Respiratory, thoracic and Throat irritation Uncommon mediastinal disorders Nausea Common Diarrhoea Uncommon Gastrointestinal disorders Abdominal discomfort Uncommon Oral paraesthesia Uncommon Skin and subcutaneous tissue Urticaria Uncommon disorders Anaphylaxis* Uncommon Immune system disorders Hypersensitivity reactions* Not known *Further information is found in section 4.4 Paediatric population In the clinical development program, 37 children and adolescents (aged 5 to 17 years) with HAE were treated for 124 acute angioedema attacks. Frequency, type and severity of adverse reactions in children and adolescents were similar to those in adults. Reporting of suspected adverse rea

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095674 · has-adverse-reaction-information · PDF-Seite 13

Summary of the safety profile One case of hypersensitivity was observed in clinical trials with Ruconest. The most common adverse reaction observed after administration of Ruconest is nausea. Tabulated lists of adverse reactions Adverse reactions reported with Ruconest in the treatment of acute HAE attacks obtained from clinical trials and post-marketing surveillance are tabulated below. In clinical trials, the incidence of adverse reactions was similar for all dose groups and did not increase upon repeated administrations. The frequency of adverse reactions listed below is defined using the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data). System Organ Class Adverse reaction Frequency Headache Uncommon Vertigo Uncommon Nervous system disorders Hypoaesthesia Uncommon Dizziness Uncommon Ear and labyrinth disorders Auricular swelling Uncommon Respiratory, thoracic and Throat irritation Uncommon mediastinal disorders Nausea Common Diarrhoea Uncommon Gastrointestinal disorders Abdominal discomfort Uncommon Oral paraesthesia Uncommon Skin and subcutaneous tissue Urticaria Uncommon disorders Anaphylaxis* Uncommon Immune system disorders Hypersensitivity reactions* Not known *Further information is found in section 4.4 Paediatric population In the clinical development program, 37 children and adolescents (aged 5 to 17 years) with HAE were treated for 124 acute angioedema attacks. Frequency, type and severity of adverse reactions in children and adolescents were similar to those in adults. Reporting of suspected adverse reactions Reporting suspected adverse reaction

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095670 · has-contraindication-information · PDF-Seite 11

• Known or suspected allergy to rabbits (see section 4.4) • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

HOS-095664 · has-contraindication-information · PDF-Seite 3

• Known or suspected allergy to rabbits (see section 4.4) • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

HOS-095669 · has-indication-information · PDF-Seite 10

Ruconest is indicated for treatment of acute angioedema attacks in adults, adolescents, and children (aged 2 years and above) with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency.

HOS-095663 · has-indication-information · PDF-Seite 2

Ruconest is indicated for treatment of acute angioedema attacks in adults, adolescents, and children (aged 2 years and above) with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency.

HOS-095666 · has-interaction-information · PDF-Seite 4

No interaction studies have been performed. Scientific literature indicates an interaction of tissue-type plasminogen activator (tPA) and C1-INH containing medicinal products. Ruconest should not be administered simultaneously with tPA.

HOS-095672 · has-interaction-information · PDF-Seite 12

No interaction studies have been performed. Scientific literature indicates an interaction of tissue-type plasminogen activator (tPA) and C1-INH containing medicinal products. Ruconest should not be administered simultaneously with tPA.

HOS-095667 · has-pregnancy-information · PDF-Seite 4

Pregnancy and breast-feeding There is no experience with the use of Ruconest in pregnant and breast-feeding women. In one animal study reproductive toxicity was observed (see section 5.3). Ruconest is not recommended for use during pregnancy or breast-feeding, unless the treating physician judges the benefits to outweigh the possible risks. Fertility There are no data on the effects of Ruconest on male or female fertility.

HOS-095673 · has-pregnancy-information · PDF-Seite 12

Pregnancy and breast-feeding There is no experience with the use of Ruconest in pregnant and breast-feeding women. In one animal study reproductive toxicity was observed (see section 5.3). Ruconest is not recommended for use during pregnancy or breast-feeding, unless the treating physician judges the benefits to outweigh the possible risks. Fertility There are no data on the effects of Ruconest on male or female fertility.

HOS-095671 · has-warning-information · PDF-Seite 11

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered products should be clearly recorded. Conestat alfa is derived from milk of transgenic rabbits and contains traces of rabbit protein. Before initiating treatment with Ruconest, patients should be queried about prior exposure to rabbits and signs and symptoms suggestive of an allergic reaction. 11 Hypersensitivity reactions cannot be excluded and may have symptoms similar to angioedema attacks. All patients must be closely monitored and carefully observed for any symptoms of hypersensitivity during and after the administration period. Patients should be informed of the early signs of hypersensitivity reactions, e.g., hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. If these symptoms occur after administration, they should alert their physician. In case of anaphylactic reactions or shock, emergency medical treatment should be administered. Although cross-reactivity between cow milk and rabbit milk is considered unlikely, the possibility of such a cross-reactivity in a patient who has evidence of clinical allergy to cow milk cannot be excluded and the patient should be observed for signs and symptoms of hypersensitivity following Ruconest administration. Thromboembolic events Serious arterial and venous thromboembolic (TE) events have been reported at the recommended dose of plasma derived C1 esterase inhibitor products in patients with known risk factors (e.g., indwelling catheters, prior history of thrombosis, underlying atherosclerosis, use of oral contraceptives or certain androgens, morbid obesity, immobility). Patients with known risk factors should be monitored closely. Sodium Each vial of Ruconest contains 19.5 mg of sodium. To be taken into consideration by patients on a controlled sodium diet. Home-treatment and self-administration There are limited data on the use of this medicinal product in home- or self-administration. Potential risks associated with home-treatment are related to the administration itself as well as the handling of adverse reactions, particularly hypersensitivity. The decision on the use of home-treatment for an individual patient should be made by the treating physician, who should ensure that appropriate training is provided and the use reviewed at intervals.

HOS-095665 · has-warning-information · PDF-Seite 3

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered products should be clearly recorded. Conestat alfa is derived from milk of transgenic rabbits and contains traces of rabbit protein. Before initiating treatment with Ruconest, patients should be queried about prior exposure to rabbits and signs and symptoms suggestive of an allergic reaction. Hypersensitivity reactions cannot be excluded and may have symptoms similar to angioedema attacks. All patients must be closely monitored and carefully observed for any symptoms of hypersensitivity during and after the administration period. Patients should be informed of the early signs of hypersensitivity 3 reactions e.g., hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. If these symptoms occur after administration, they should alert their physician. In case of anaphylactic reactions or shock, emergency medical treatment should be administered. Although cross-reactivity between cow milk and rabbit milk is considered unlikely, the possibility of such a cross-reactivity in a patient who has evidence of clinical allergy to cow milk cannot be excluded and the patient should be observed for signs and symptoms of hypersensitivity following Ruconest administration. Thromboembolic events Serious arterial and venous thromboembolic (TE) events have been reported at the recommended dose of plasma derived C1 esterase inhibitor products in patients with known risk factors (e.g., indwelling catheters, prior history of thrombosis, underlying atherosclerosis, use of oral contraceptives or certain androgens, morbid obesity, immobility). Patients with known risk factors should be monitored closely. Sodium Each vial of Ruconest contains 19.5 mg of sodium. To be taken into consideration by patients on a controlled sodium diet.