Severe respiratory depression or severe obstructive lung conditions.

ACUITY major bleeding TIMI major bleeding2 1

From clinical investigations it is known that major hypoglycaemia, defined as requirement for third party intervention, occurs in approximately 6 of the patients treated with Levemir.

Any

Preferred Term

23 26 12 15 2

2 4 1 3 0

All Grades n ( )

1 (0.2 )

System Organ Class

Frequency

19 (3.5 ) 8 (1.5 )

Severity

heavy

Chronic Phase CML 100 mg once daily 140 mg once daily 50 mg twice daily 70 mg twice daily n 166 n 163 n 166 n 167 All Grade All Grade All Grade All Grade Grades 3 4 Grades 3 4 Grades 3 4 Grades 3 4

final judgments in respect of serious crimes or other serious offences

Annex V

Major bleeding

severe increase in blood pressure

Severe pulmonary dysfunction.

Severe infection

Severe hepatic insufficiency

Severe renal impairment.

Serious infections

Serious Infections

events 3 and 5

angina, myocardial

Severe hepatic impairment.

Uncommon severe anaemia

ut 30 ml min.

creatinine clearance between 20 and 30 ml min.

Any severity

Any severity

Severe hepatic impairment.

All Grades n ( )

Investigations

11 (2 ) 0 (0 )

Any

Placebo N 256

Severe renal impairment

Serious side effects.

Sympto matic VTE

Major bleedings

Delayed reactions

Delayed