Test Brand B Ampoule

<p>Seasonal Allergic rhinitis, Hay fever, Chronic Idiopathic Urticaria, Allergy</p>

<p><strong>Children:</strong><br /> <strong><em>Seasonal Allergic Rhinitis</em></strong><br /> &lt;2 years: Use not recommended</p> <p>2-12 years: 30 mg PO BID or 5 ml twice daily</p> <p>&gt;12 years: 60 mg PO BID OR 180 mg PO qDay</p> <p>ODT<br /> 6-12 years: 30 mg PO BID</p> <p><em><strong>Chronic Idiopathic Urticaria</strong></em><br /> &lt;6 months: Use not recommended</p> <p>6 months-2 years: 15 mg PO BID or 2.5 ml twice daily<br /> 2-12 years: 30 mg PO BID</p> <p>&gt;12 years: 60 mg PO BID OR 180 mg PO qDay</p> <p>ODT<br /> 6-12 years: 30 mg PO BID</p>

<p><strong>Renal impairment.</strong> Pregnancy, lactation; children &lt;6 yr.</p> <p><strong>Lactation:</strong> Excretion in milk unknown; use with caution (AAP states &ldquo;compatible with nursing&rdquo;)</p>

<p><strong>Pregnancy</strong><br /> Available data from case reports on use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes</p> <p>Animal data<br /> Drug given to pregnant rats and pregnant rabbits during organogenesis caused structural abnormalities in the offspring at maternal doses about 5 to 7 times maximum recommended human dose (MRHD) based on body surface area; when given to rats during late gestation and lactation, pup death and effects on pup growth were seen at ~10 times the MRHD</p> <p><strong>Lactation</strong><br /> There are no data on presence of drug or metabolites in human milk, effects on breastfed infant, or on milk production</p> <p>Ticagrelor and its metabolites were present in rat milk at higher concentrations than in maternal plasma; when a drug is present in animal milk, it is likely that the drug will be present in human milk</p> <p>Breastfeeding is not recommended during therapy</p>

<p><strong>&nbsp;&gt;10%</strong><br /> Vomiting (6-12%)</p> <p><strong>1-10%</strong><br /> Headache (5-10%),Cough (4%),Diarrhea (3-4%),URTI (3%),Back pain (2-3%),Pyrexia (2%),Dysmenorrhea (2%),Dizziness (2%),Stomach discomfort (2%),Pain in extremity (2%),Somnolence (1-3%),Rhinorrhea (1-2%)</p>

Test Brand B Ampoule manufactured by A/S Lundbeck Export DivisionLtd., Denmark. Its generic name is Test Generic B.