SHORTAGE NOTIFICATION

Norditropin® FlexPro® 10 mg/1.5 ml solution for injection

in pre-filled pen (PA 0218/040/012)
21 December 2022
Dear Healthcare Professional,

Novo Nordisk Limited, Ireland has become aware of a temporary stock shortage of Norditropin®
FlexPro® 10 mg/1.5 ml. This shortage is due to manufacturing delays and is not a result of any quality
or safety issues.
Novo Nordisk Limited, Ireland would like to inform you of the following:
• Norditropin® FlexPro® 10 mg/1.5 ml is indicated for the treatment of growth failure in children
and as a growth hormone replacement in adults.1 Please refer to Section 4.1 Therapeutic
indications of the Norditropin® FlexPro® 10 mg/1.5 ml Summary of Product Characteristics
(SmPC) available on www.medicines.ie for additional information.
• Delayed awareness of the out-of-stock situation may result in patients missing the required doses,
which may lead to suboptimal treatment of patients.
• Novo Nordisk Limited, Ireland expect to receive a delivery of Norditropin® FlexPro® 10 mg/1.5 ml
into Ireland in early February 2023. Updated information on the availability of Norditropin®
FlexPro® 10 mg/1.5 ml will be available on the shortages section of the HPRA website (www.hpra.ie).
• Affected patients prescribed Norditropin® FlexPro® 10 mg/1.5 ml may be switched to Norditropin®
FlexPro® 5 mg/1.5 ml or Norditropin® FlexPro® 15 mg/1.5 ml (please refer to the Norditropin®
FlexPro® dose chart overleaf) or to a human growth hormone alternative, based on the clinical
judgement of the prescribing healthcare professional.
For Endocrine Consultants, Novo Nordisk would appreciate your support with highlighting this shortage
notification to the Specialist Endocrine Nurses and all other healthcare professionals in your team for
whom the information is relevant.

Call for reporting

Healthcare professionals are asked to report any suspected adverse reactions via HPRA
Pharmacovigilance, website: www.hpra.ie.
Adverse reactions, including medication errors relating to Norditropin® FlexPro® 10 mg/1.5 ml or
alternative Novo Nordisk products, should be reported to Novo Nordisk Limited, Ireland on 01 8629700
or complaintireland@novonordisk.com.
Company contact point
Further information can be obtained by contacting Novo Nordisk Limited, Ireland on 01 8629700 or
infoireland@novonordisk.com.
Ensuring a continuous supply is of utmost importance for Novo Nordisk. We sincerely apologise for
this unfortunate situation and the concerns and inconvenience it may cause.
Yours sincerely

Novo Nordisk Ireland Limited,

First Floor, Block A
The Crescent Building
Dr Donna Sexton
Northwood Business Park Clinical, Medical and Regulatory Director
Santry, Dublin 9
Norditropin® and FlexPro® are registered trademarks owned by Novo Nordisk Health Care AG DO9 X8W3, Ireland
Novo Nordisk Limited, Ireland
The Apis bull logo is a registered trademark owned by Novo Nordisk A/S www.novonordisk.ie
Tel: (01) 862 9700
Date of preparation: December 2022, IE22NP00012. infoireland@novonordisk.com Reference: 1. Novo Nordisk. Norditropin® FlexPro® (somatropin) Summary of Product Characteristics (SmPC). Updated 2021. www.medicines.ie
How many pens Norditropin® FlexPro® 5 mg pen Norditropin® FlexPro® 10 mg pen Norditropin® FlexPro® 15 mg pen
to prescribe for Dosing increments of 0.025 mg;
Maximum dose = 2.0 mg
Dosing increments of 0.050 mg;
Maximum dose = 4.0 mg
Dosing increments of 0.1 mg;
Maximum dose = 8.0 mg
your patient
Daily dose Doses/days of Pens per Daily dose Doses/days of Pens per Daily dose Doses/days of Pens per
(mg) use per pen‡ 3-month supply† (mg) use per pen‡ 3-month supply† (mg) use per pen‡ 3-month supply†
0.175 28 4 0.4 25 4 0.6 25 4
0.2 25 4 0.45 22 5 0.7 21 5
Norditropin® FlexPro® 0.225
0.25
22
20
5
5
0.5
0.55
20
18
5
6
0.8
0.9
18
16
5
6
0.275
5 mg pen 0.3
18
16
6
6
0.6
0.65
16
15
6
6
1.0
1.1
15
13
7
7
0.325 15 6 0.7 14 7 1.2 12 8
0.35 14 7 0.75 13 7 1.3 11 8
0.375 13 7 0.8 12 8 1.4 10 9
0.4 12 8 0.85 11 8 1.5 10 10
Dosing increments of 0.025 mg; 0.425 11 8 0.9 11 9 1.6 9 10
Maximum dose = 2.0 mg 0.45 11 9 0.95 10 9 1.7 8 11
0.475 10 9 1.0 10 10
0.5 1.8 8 12
10 10 1.05 9 10
0.525 1.9 7 12
9 10 1.1 9 11
0.55 2.0 7 13
9 11 1.15 8 11
0.575 8 11 2.1 7 13
1.2 8 12
0.6 8 12 2.2 6 14
1.25 8 12
Norditropin® FlexPro® 0.625
0.65
8
7
12
12
1.3 7 12
2.3
2.4
6
6
15
15
1.35 7 13
10 mg pen 0.675
0.7
7
7
13
13
1.4 7 13
2.5
2.6
6
5
16
16
1.45 6 14
0.725 6 14 1.5 6 2.7 5 17
14
0.75 6 14 1.55 2.8 5 18
6 15
0.775 6 15 1.6 2.9 5 18
6 15
0.8 6 15 1.65 3.0 5 19
6 16
Dosing increments of 0.050 mg; 0.825 6 16 3.1 4 20
1.7 5 16
Maximum dose = 4.0 mg 0.85 5 16 1.75 5 17 3.2 4 20
0.875 5 17 3.3 4 21
1.8 5 17
0.9 5 17 3.4
1.85 5 18 4 21
0.925 5 18 3.5
1.9 5 18 4 22
0.95 5 18 1.95 5 18 3.6 4 23
0.975 5 18 2.0 5 19 3.7 4 23
1.0 5 19 2.05
Norditropin® FlexPro® 1.025
1.05
4
4
19
20
2.1
4
4
19
20
3.8
3.9
3
3
24
24
2.15
15 mg pen 1.075
1.1
4
4
20
21
2.2
4
4
20
21
4.0
4.1
3
3
25
26
1.125 2.25 4 21 4.2 3 26
4 21
1.15 2.3 4 22 4.3 3 27
4 22
1.175 2.35 4 22 4.4 3 27
4 22
1.2 2.4 4 23 4.5 3 28
4 23
1.225 2.45 4 23
Dosing increments of 0.1 mg; 4 23
1.25 4
2.5 4 23
Maximum dose = 8.0 mg 23
1.275 3 24 2.55 3 24 8 1 50
1.3 3 24 2.6 3 24
1.325 3 25 2.65 3 25
1.35 3 25 2.7 3 25
1.375 3 26 2.75 3 26
Please note: Doses in the shaded bars 1.4 3 26 2.8 3 26
are not marked on the barrel of the pen. 1.425 3 27 2.85 3 27 Novo Nordisk Limited
1.45 3 27 2.9 3 27 1st Floor, Block A
‡ Rounded down to nearest whole dose. 2.95 3 28 The Crescent Building
1.475 3 28 Northwood Business Park
† Rounded up to nearest whole pen. 1.5 3 28 3.0 3 28 Santry, Dublin 9, Ireland
Tel: 01 862 9700
Fax: 01 862 9725
2.0 2 37 4.0 2 37 infoireland@novonordisk.com
www.novonordisk.ie