Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - nutropinaq

Document Subject

Generated Narrative: MedicinalProductDefinition mp72e43cd2bff034f1d9129ee8db99e248

identifier: http://ema.europa.eu/identifier/EU/1/00/164/003

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: NutropinAq 10 mg/2 ml (30 IU) solution for injection.

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-72e43cd2bff034f1d9129ee8db99e248

identifier: http://ema.europa.eu/identifier/EU/1/00/164/003

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - nutropinaq

Attesters

What is in this leaflet

1. What NutropinAq is and what it is used for
2. What you need to know before you use NutropinAq
3. How to use NutropinAq
4. Possible side effects
5. How to store NutropinAq
6. Contents of the pack and other information

NutropinAq contains somatropin which is a recombinant growth hormone similar to the human s natural growth hormone made by your body. It is recombinant, meaning it is made outside of the body by a special process. Growth Hormone (GH) is a chemical messenger made by a small gland in your brain called the pituitary. In children it tells the body to grow, help the bones to develop normally and, in later adult life, GH helps to maintain a normal body shape and metabolism.

In children, NutropinAq is used:

• When your body does not make enough growth hormone and for this reason you are not growing properly.
• When you have Turner syndrome. Turner syndrome is a genetic abnormality in girls (absence of female sexual chromosome(s)) that prevents growth.
• When your kidneys are damaged and they lose their ability to function normally with an impact on growth.

In adults NutropinAq is used for:

• If your body does not make enough growth hormone as an adult. This can start during adult life or continue from when you were a child.

Benefits if using this medicine

In children, it helps the body to grow and the bones to develop normally. In adults, it helps to maintain normal body shape and metabolism for example lipid profile and glucose levels.

Do not use NutropinAq:

• if you are allergic to somatropin or any of the other ingredients of this medicine (listed in section 6).
• in children if the bones have already stopped growing.
• if you have an active tumour (cancer). Tell your doctor if you have or have had an active tumour. Tumours must be inactive and you must have finished your anti-tumour treatment before you start treatment with NutropinAq.
• if you have complications after a major surgery (open-heart or abdominal surgery), a multiple trauma, acute respiratory failure, or similar conditions.

Warning and Precautions

Talk to you doctor or pharmacist before using NutropinAq.

• If you experience visual changes, bad or frequent headache, associated with feeling sick (nausea) or vomiting, especially at the start of treatment, tell your doctor immediately. These could be signs of a temporary increase in pressure within the brain (intracranial hypertension).
• If during growing, a limp or hip or knee pain develops, ask the doctor for advice.
• If you notice a curve of your spine (scoliosis) you will need to be checked often by your doctor as scoliosis may progress in any child during rapid growth.
• Your doctor should monitor you for high blood sugar levels (hyperglycemia) during treatment with NutropinAq. If you are treated with insulin, your doctor may need to adjust your insulin dose. If you have diabetes and associated severe/worsening eye disease you should not be treated with NutropinAq.
• Your doctor should check your thyroid function periodically and if necessary prescribe adequate treatment. If you have an underactive thyroid gland leading to low levels of thyroid hormone (hypothyroidism) it should be treated before you start NutropinAq treatment. If your hypothyroidism is not treated, it could stop NutropinAq from working.
• If you have a replacement therapy with glucocorticoids you should consult your doctor regularly as you may need adjustment of your glucocorticoid dose.
• If you have had a tumour (cancer) in the past, specially a tumour affecting the brain, your doctor should pay special attention and examine you regularly for a possible return of the tumour.
• A small number of growth hormones deficient patients treated with growth hormone have had leukaemia (blood cancer). However, no cause and effect relationship with growth hormone treatment has been proven.
• If you undergo a kidney transplant NutropinAq treatment should be stopped.
• If you have complications after major surgery (open-heart or abdominal surgery), multiple trauma, acute respiratory failure, or similar conditions, your doctor should decide whether it is safe to continue NutropinAq treatment.
• There may be an increased risk of developing an inflammation of the pancreas (pancreatitis), which causes severe pain in the abdomen and back. Contact your doctor if you or your child develops stomach ache after taking NutropinAq.
• If you have Prader-Willi syndrome, you should not be treated with NutropinAq unless you have growth hormone deficiency.

Other medicines and NutropinAq

Tell your doctor or pharmacist if you are using, have recently used or might take any other medicines.

• if you have a replacement therapy with glucocorticoids it may reduce the effect of NutropinAq on growth. You should consult your doctor regularly as you may need adjustment of your glucocorticoid dose.

• if you are treated with insulin, your doctor may need to adjust your insulin dose.

• if you are treated with sex steroids, anticonvulsants or cyclosporin ask the doctor for advice. If you are diagnosed with adrenal insufficiency during NutropinAq treatment, you require steroid treatment. If you are already treated for adrenal insufficiency you may require an adjustment of your steroid dose.

• in particular, inform your doctor if you are taking or have recently taken any of the following medicines. Your doctor may need to adjust the dose of NutropinAq or of the other medicines:

• Oestrogen taken orally or other sex hormones

Pregnancy and breast-feeding

You should stop taking NutropinAq if you are pregnant. Caution should be exercised while breast-feeding during treatment with NutropinAq. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

No effect on ability to drive or use machines has been noticed while using NutropinAq.

NutropinAq is essentially sodium free

This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially sodium- free .

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. NutropinAq therapy should be carried out under regular guidance of a doctor who is experienced in growth hormone deficiency.

The dose of NutropinAq to be injected will be decided by your doctor. Do not change the dosage without consulting your doctor. The recommended dose is:

In children with growth hormone deficiency: 0.025 - 0.035 mg/kg bodyweight injected each day under the skin (subcutaneous injection).

In girls with Turner syndrome: Up to 0.05 mg/kg bodyweight injected each day under the skin (subcutaneous injection).

In children with chronic renal insufficiency: Up to 0.05 mg/kg bodyweight injected each day under the skin (subcutaneous injection). You can continue treatment with NutropinAq until you have a kidney transplant.

In adults with growth hormone deficiency: Low initial doses of 0.15 - 0.3 mg injected each day under the skin (subcutaneous injection). Then the doctor can increase the dose depending on your response. The final dose is rarely above 1.0 mg/day. In general, the lowest dose leading to a response should be given to you.

Treatment with NutropinAq is a long-term therapy. For further information ask your doctor.

How to inject NutropinAq

The dose of NutropinAq to be injected will be decided by your doctor. You have to inject NutropinAq every day under the skin (subcutaneous injection). It is important to change the place where you have your injection every day to avoid damaging your skin. NutropinAq is supplied as a multi-dose solution. After removal from the refrigerator, if the solution is cloudy, the content must not be injected. Gently swirl. Do not shake vigorously as it could denature the protein.

To inject NutropinAq you should use the NutropinAq Pen. For each injection you should use a new sterile injection needle. Read all the instructions for use carefully (on the reverse) before you start using NutropinAq Pen. At the start of therapy, it is recommended that a doctor or a nurse give you the injection and train you with the NutropinAq Pen. After this training, you will be able to inject yourself or be injected by a trained care-giver. If you use more NutropinAq than you should

If you have injected more NutropinAq than you should have, contact your doctor for advice. If you inject too much NutropinAq, your blood sugar level may decrease and become too low and then rise too high (hyperglycaemia).

If you inject too much NutropinAq over a long period of time (years), you may experience some overgrowth of parts of your body such as ears, nose, lips, tongue and cheekbone (gigantism and/or acromegaly).

If you forget to take NutropinAq

Do not take a double dose to make up for a missed dose. Continue with your usual dosage the next day and tell your doctor at your next appointment.

If you stop using NutropinAq

Ask advice from you doctor before you stop using NutropinAq. If you stop using NutropinAq too early or for too long, the results will not be as expected.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if you notice any change or increase in growth of birthmarks and/or moles (melanocytic naevus). In case of a tumour or re-growth of previous tumours (confirmed by your doctor), treatment with NutropinAq must be stopped immediately. This side effect is uncommon, it may affect up to 1 in 100 patients.

Tell your doctor immediately if you experience visual changes, bad or frequent headaches, associated with feeling sick (nausea) or vomiting. These could be symptoms of a temporary increase in pressure within the brain (intracranial hypertension). If you have intracranial hypertension, your doctor may decide to temporarily reduce or discontinue NutropinAq therapy. Then therapy may be started again after the episode is over. This side effect is rare, it may affect up to 1 in 1,000 patients.

Other side effects include:

Very common (may affect more than 1 in 10 patients)

Swelling of the hands and feet due to an accumulation of fluid (peripheral oedema) sometimes associated with localised muscle pain (myalgia) and pain in joints (arthralgia). These side effects appear usually in adults early in treatment and are short-lived. Oedema was reported as common in children.

Common (may affect up to 1 in 10 people)

Underactivity of the thyroid gland leading to low levels of thyroid hormone (hypothyroidism). If your hypothyroidism is not treated, it could stop NutropinAq from working. Your doctor should check your thyroid function periodically and if necessary prescribe adequate treatment.

Reduced ability to absorb sugar (glucose) from your blood leading to high blood sugar levels (hyperglycemia). Your doctor should monitor you for signs of this during treatment with NutropinAq. If you are treated with insulin, your doctor may need to adjust your insulin dose.

Feeling of weakness (asthenia) and increased muscle tension (hypertonia) Pain, bleeding, bruising, rash and itching at the site of injection. These can be avoided by using the correct injection technique and changing the sites of injection.

Some patients may develop antibodies (a type of protein produced by the body) to somatropin. When these antibodies were found in patients, it did not prevent them from growing.

Uncommon (may affect up to 1 in 100 people)

Decrease in the number of red blood cells in the blood (anaemia), decrease in blood sugar level (hypoglycaemia) and increase in phosphate levels (hyperphosphatemia).

Personality changes or abnormal behaviour.

Persistent stinging, burning sensation, pain and/or numbness in the palm of the hand due to a trapped nerve at the wrist (carpal tunnel syndrome).

Rapid involuntary movements of the eyes (nystagmus), swelling of the optic nerve in the eye (papilloedema), double vision (diplopia), headache, somnolence and vertigo.

Increased heart rate (tachycardia) and high blood pressure (hypertension). Vomiting, stomach pain, wind (flatulence) and feeling of sickness (nausea).

Sensitive and dry skin (exfoliative dermatitis), changes in thickness of the skin, excessive growth of hair on the face and body (hirsutism), hives (urticaria).

Curvature of the spine (scoliosis). If you have scoliosis, you will need to be frequently checked for an increase in the curve.

Bone disorder where the upper leg (femur) moves apart from the hip (slipped capital femoral epiphysis). This happens generally in patients who grow rapidly. Patients with endocrinological disorders are more prone to develop a slipped capital femoral epiphysis.

Decrease in muscle size (muscle atrophy), joint pain (arthralgia) and bone pain.

Difficulty to hold-in urine (urinary incontinence), high frequency (pollakiuria) and volume (polyuria) of urination.

Bleeding from the womb (uterine haemorrhage), genital discharge and breast enlargement (gynaecomastia).

Localised loss/gain of fat from the skin (lipodystrophy, injection site atrophy/hypertrophy)
Enlarged adenoids with similar symptoms as enlarged tonsils (see rare).

Rare (may effect up to 1 in 1,000 people)

Increase in blood sugar levels (hyperglycaemia, diabetes mellitus). Diabetes mellitus can lead to increased urination, thirst and hunger. If you experience any of these symptoms, you should inform your doctor.

Enlarged tonsils leading to snoring, difficulty breathing or swallowing, brief interruption of breathing during sleep (sleep apnea), or fluid in the ear, as well as infections of the ear. If this appears to be particularly troublesome, you should discuss it with your doctor.

Abnormal sensations of tingling, pricking or numbness (paraesthesia), abnormal bone development, disease affecting progress of bone growth (osteochondrosis) and muscle weakness.

Other rare side effects seen with NutropinAq treatment include itching over the whole body, rash, blurred vision, increased weight, dizziness, diarrhoea, swelling of the face, fatigue, pain, fever, depression and difficulty to sleep (insomnia).

Indication specific side effects seen during clinical trials

In children with growth hormone deficiency brain (central nervous system) tumours were commonly reported. From the 236 patients enrolled into the clinical studies 3 patients had a central nervous system tumour. Of the 3 patients with a central nervous system tumour, 2 patients experienced a recurrent medulloblastoma and 1 patient experienced a histiocytoma. See also section warning and precautions .

Girls with Turner syndrome commonly reported abnormally heavy bleeding at menstruation.

Children with chronic renal insufficiency commonly reported inflammation of the lining of the abdomen (peritonitis), bone necrosis and an increase of creatinine blood levels. They are more likely to develop increased pressure in the brain (intracranial hypertension), with the greatest risk at the beginning of treatment, although children with organic growth hormone deficiency and Turner syndrome also have an increased incidence.

Adults with growth hormone deficiency commonly reported abnormal sensations of tingling, pricking or numbness (paraesthesia), abnormally high levels of blood glucose, excess of lipids (fat) in the blood, sleeplessness, joint disorders, arthrosis (degenerative joint disease), muscle weakness, back pain, breast pain and breast enlargement (gynaecomastia).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label of the cartridge and the carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C - 8 C). Do not freeze. Keep the blister in the outer carton.

After first use, the cartridge may be stored for up to 28 days at 2 C - 8 C. Do not remove the cartridge that is being used from the NutropinAq Pen between injections.

Do not use NutropinAq if you notice that the solution is cloudy.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

What NutropinAq contains

The active substance of NutropinAq is somatropin*.

• Somatropin is a human growth hormone produced in Escherichia coli cells by recombinant DNA technology.

The other ingredients are sodium chloride, liquefied phenol, polysorbate 20, sodium citrate dihydrate, citric acid anhydrous and water for injections.

What NutropinAq looks like and contents of the pack

NutropinAq is a solution for injection (in a cartridge (10 mg/2 ml) - pack size of 1, 3 and 6). The solution for multidose use is clear and colourless.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Ipsen Pharma, 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

Manufacturer : IPSEN PHARMA BIOTECH S.A.S., Parc d Activit s du Plateau de Signes, CD no 402, 83870 Signes, France

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

Belgi /Belgique/Belgien Luxembourg/Luxemburg
Ipsen NVT l/Tel: + 32 - 9 - 243 96 Latvija
Ipsen Pharma p rst vniec ba Tel: +371 676 22
Biomapas UAB .: + 370 37 366 esk republika
Ipsen Pharma, s.r.o.
Tel: + 420 242 481 Lietuva Ipsen Pharma SAS Lietuvos filialas
Tel. +370 700 33Danmark, Norge, Suomi/Finland, Sverige, sland Institut Produits Synth se (IPSEN) AB Tlf/Puh/Tel/S mi: +46 8 451 60 Magyarorsz g Ipsen Pharma Hungary Kft. Tel.: + 36-1-555-5Deutschland, sterreich
Ipsen Pharma GmbH
Tel: + 49 89 2620 432 Nederland Ipsen Farmaceutica B.V.
Tel: + 31 (0) 23 55 41 Eesti CentralPharma Communications O
Tel: +372 601 5Polska Ipsen Poland Sp. z o.o.
Tel.: + 48 (0) 22 653 6 , , Malta Ipsen E

: + 30 - 210 - 984 3Portugal Ipsen Portugal Produtos Farmac uticos, S.A.
Portugal Tel: + 351 - 21 - 412 3Espa a Ipsen Pharma S.A.U. Tel: + 34 - 936 - 858 Rom nia
Ipsen Pharma Rom nia SRL Tel: + 40 (021) 231 27 France Ipsen Pharma T l : + 33 - 1 - 58 33 50 Slovenija Biomapas UAB Tel: + 370 37 366Ireland, United Kingdom (Northern Ireland)
Ipsen Pharmaceuticals Limited
Tel: + 44 (0)1753 62 77 Slovensk republika Ipsen Pharma, organiza n zlo ka Tel: + 420 242 481 Italia Ipsen SpA Tel: + 39 - 02 - 39 22 Hrvatska Biomapas Zagreb d.o.o. Tel: + 385 17 757 This leaflet was last revised in <{Month/YYYY}>

Detailed information on this medicine is available on the European Medicines Agency web site: