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Locametz
Eintrag öffnenLocametz · 4.1 Therapeutic indications · 1
Eintrag öffnenLocametz · 4.3 Contraindications · 1
Eintrag öffnenLocametz · 4.3 · Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to any of the comp
Eintrag öffnenLocametz · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenLocametz · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenLocametz · 4.5 · Based on in vitro interaction studies, gallium (68Ga) gozetotide is not expected to have any clinically signif
Eintrag öffnenLocametz · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenLocametz · 4.8 Undesirable effects · 1
Eintrag öffnenLocametz · 4.8 · 5 Tabulated list of adverse reactions
Eintrag öffnenLocametz · 4.8 · Adverse reactions (Table 1) are listed by MedDRA system organ class. Within each system organ class, the adver
Eintrag öffnenLocametz · 4.8 · Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary d
Eintrag öffnenLocametz · 4.8 · Mild to moderate adverse reactions occurred in patients receiving gallium (68Ga) gozetotide, with the exceptio
Eintrag öffnenLocametz · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenLocametz · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenLocametz · 4.8 · Summary of safety profile
Eintrag öffnenLocametz · 4.8 · System organ class Frequency category Adverse reaction Uncommon Nausea Uncommon Constipation Gastrointestinal
Eintrag öffnenLocametz · 4.8 · Table 1 Adverse reactions observed with gallium (68Ga) gozetotide
Eintrag öffnenLocametz · 4.8 · The most common adverse reactions are fatigue (1.2%), nausea (0.8%), constipation (0.5%) and vomiting (0.5%).
Eintrag öffnenLocametz · 4.8 · The safety profile of gallium (68Ga) gozetotide at median dose per body weight of 1.9 MBq/kg (range: 0.9-3.7 M
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