NutropinAq - patient leaflet, side effects, dosage

- If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

1. What NutropinAq is and what it is used for

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.

2. What you need to know before you use NutropinAq

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”.

3. How to use NutropinAq

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.

4. Possible side effects

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.

5. How to store NutropinAq

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.

Content of the pack and other information

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’Activites 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.

Lietuva

Ipsen Pharma SAS Lietuvos filialas

• T. Narbuto 5,

08105 Vilnius

Tel. +370 700 33305

Danmark, Norge, Suomi/Finland, Sverige, island

Institut Produits Synthèse (IPSEN) AB

Kista Science Tower Farogatan 33

SE- 164 51 Kista Sverige/Riiot­si/Svi|ijôô

Tlf/Puh/Tel/Simi: +46 8 451 60 00

Deutschland, Österreich Ipsen Pharma GmbH Einsteinstraße 174D-81677 München Tel: + 49 89 2620 432 89	Nederland Ipsen Farmaceutica B.V. Taurusavenue 33b NL-2132 LS Hoofddorp Tel: + 31 (0) 23 55 41 600
Eesti CentralPharma Communications OÜ Selise 26 – 11, 13522 Tallinn Tel: +372 601 5540	Polska Ipsen Poland Sp. z o.o. Al. Jana Pawla II 29 00–867 Warszawa Tel.: + 48 (0) 22 653 6800
EXXáSa, Kúnpog, Malta Ipsen Movonpóoonn EnE Ay. An^nTpiou 63 AXi^og GR-17456 A0^va EXXáSa TnX: + 30 – 210 – 984 3324	Portugal Ipsen Portugal – Produtos Farmacéuticos, S.A. Alameda Fernao Lopes, n° 16A, 1°B 1495–190 Algés Portugal Tel: + 351 – 21 – 412 3550
España Ipsen Pharma S.A. Torre Realia, Plaza de Europa, 41–43 08908 L’Hospitalet de Llobregat, Barcelona Tel: + 34 – 936 – 858 100	Romania Ipsen Pharma Romania SRL Sectorul 1, Strada Grigore Alexandrescu nr. 59, Etaj 1 Bucuresti, 010623 Tel: + 40 (021) 231 27 20
France, Hrvatska Ipsen Pharma 65 quai Georges Gorse F-92100 Boulogne-Billancourt Tél : + 33 – 1 – 58 33 50 00	Slovenija PharmaSwiss d.o.o. Brodišče 32 SI-1236 Trzin Tel: + 386 1 236 47 00
Ireland Ipsen Pharmaceuticals Limited. Blanchardstown Industrial Park Blanchardstown IRL-Dublin 15	Slovenská republika Ipsen Pharma, organizačná zložka Zámocká 3 SK-811 01 Bratislava Tel: + 420 242 481 821

Tel: +353 (0) 1 809 8256

Italia Ipsen SpA Via del Bosco Rinnovato n. 6 Milanofiori Nord Palazzo U7 20090 Assago (Mi) Tel: + 39 – 02 – 39 22 41

United Kingdom Ipsen Limited. 190 Bath Road Slough, Berkshire SL1 3XE Tel: + 44 (0)1753 – 62 77 00

Efc^rapufl

PharmaSwiss EOOD

16, Troyanski Prohod Street

Floor 3, Office 8, Lagera 1612 Sofia

Ten.: +359 2 8952 110

This leaflet was last revised in <{Month/YYYY}>

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

NutropinAq Pen Instruction for use with NutropinAq

DO NOT INJECT THE MEDICI NE UNTIL YOUR DOC TOR OR NU RSE HAS THOROUG HLY TRAINE D YOU IN THE PROPE R TECHNI QUES.

Caution:

Before u sing your NutropinAq Pen, please re ad the following instruct ions carefull y. We also s uggest you cons ult your doctor or nurse for a demon stration.

The NutropinAq Pen is designed for use only with cartrid ges of Nutro pinAq (for s ubcutaneous use only).

As shown by the illustrations below, Nutropin Aq pen and cartridges a re available in two desig ns (with or without additional yellow colo ur). The wo rking of the pen and the content of th e cartridges are the same for both designs. Either of t he Nutropin Aq cartridge designs can be used wit h either of th e Nutropin Aq Pen designs.

Only use the pen needles recomm ended by yo ur doctor or nurse.

The dosa ge scale located beside t he window of the cartridge holder sh ould not be used as a do se measurem ent. It should only be u sed to estim ate the dosag e remaining in the cartri dge. Always refer to the LCD (Liquid Crystal Display ), not audibl e clicks, for setting an in jection of Nu tropinAq. T he clicks are only audible confirmat ion that the b lack dose knob has been moved.

Always s tore the pen and cartridg es in a clean , safe place in the refrigerator at a te mperature b etween 2–8°C and out of children’s reach and sight. P rotect from intense light. Use a coole r to store yo ur Nutropin Aq Pen when travelling. The Nutrop inAq is desi gned to with stand a nom inal (one hour maximum) period of time outside of the refrig erator on a daily basis. A void areas of extreme temperat ure. Check the expiry da te of the car tridge before use.

To guard against the spread of infection, follow these safety measures:

• Wash your hands thoroughly with soap and water before using your pen.
• Clean the cartridge rubber seal with an alcohol swab or cotton ball saturated with alcohol.
• Avoid touching the cartridge rubber seal at all times.
• If you accidentally touch the cartridge rubber seal, clean it with an alcohol swab.
• Do not use the same needle for more than one person.
• Use needles only once.

NutropinAq Pen Components:

Shown below are the items neces sary for givi ng an injecti on. Gather a ll of these c omponents p rior to use.

Your NutropinAq cartridge and Pen will be supplied separately.

Part I: Preparing and Injecting

Follow t he instructions in this sec tion if you a re using the pen for the first time or are replacing an empty ca rtridge.

Inspect a ll new cartridges prior to use. Occasi onally, after refrigeration, you may n otice that sm all colourless particles are present in the Nutropi nAq solution. This is no t unusual for solutions containin g proteins like Nutropin Aq and does not affect the strength o f the produc t. Allow the cartridge to come to room temper ature and ge ntly swirl. D o not shake. If the solut ion is cloudy or hazy or contai ns any solid matter, the cartridge sho uld not be u sed. Return the cartridge to your pha rmacist or prescr ibing doctor.

• 1. Remove the green pen c ap and unsc rew the cartr idge holder from the pen. If necessary, rem ove the emp ty cartridge and discard it properly.

• 2. Pres s the white reset button.

  
  
  
  

• 3. Turn the bla ck dose kno b counter-cl ockwise bac k to its starti ng position until it no longer turn s. (See illus t ration.) Then turn the do se knob cloc kwise until the first click position is reached (a pproximately 1/4 turn). This ensures that the plu nger push rod is res et to the star ting position. If this is n ot done whe n the dosage knob is first pushed in , NutropinA q will be wa sted or the c artridge may crack.

• 4. Insert cartri dge into the cartridge ho lder, then sc rew the cartr idge holder back onto the pen. (Be careful n ot to touch t he rubber s e al.)

• 5. Rem ove the paper seal from a new needl e assembly a nd screw it onto the cart ridge holder.

• 6. Car efully remove both prote ctive caps fr om the need le by pulling gently. Do not throw th e larger cap aw ay as it will be used late r for proper needle remo val and disp osal.

  
  

• 7. Holding the pen with th e needle poi nting upward, gently tap the cartridge holder to move any a ir bubbles to the top. Wh ile still hold ing the pen i n the uprigh t position, push in the black dose knob until it clicks into positio n. You shou ld see a drop of solution appear.

Be patient. If the medicine does not appear within a few seconds, you may need to push the reset button again.

• 8. If no drop o f medicine a ppears, push the white r eset button a gain. Now t urn the black dose knob clockwise (See illustration) by on e click (0.1m g). If you accidentally tu rn it too far , go back one click (0.1 m g).

• 9. Wh ile still holding the pen in the upright position, pu sh in the bla ck dose kno b again and watch the needle tip for a drop of med icine to app ear. Repeat steps 8 and 9 until it app ears.

• 10. Press the white reset button.

  
  

• 11. Set the req uired dose b y turning the black dose knob. If you cannot dial the full dose, either st art a new car tridge (as de scribed in P art I), or inje ct the partia l dose. Then, start a n ew cartridge (as described in Part I) to administe r the remain ing portion of you r medication. Your doctor or nurse w ill advise yo u on the pro cedure for administer ing the last d ose in the cartridge.

Prepare the injection site by wiping with an antiseptic impregnated swab. Injection sites include the upper arms, abdomen, and upper thighs. Change the injection sites to avoid discomfort. Even if you develop a preference for one site, you still should rotate the injection site.

• 12. If you are using the pa ssive shield (or no shield ) proceed to step 13. If y ou are using the activ e shield, slid e the shield onto the pen and push th e 2 black lock knobs on the n eedle shield toward the tip.

• 13. Set the tip of the pen on the prepared inj ection site and press the needle into t he skin by p ushing the pen downward until the shie ld is totally depressed. Your doctor o r nurse will show you how to do this. Now you are ready to administer the dose. Press down on the black dose knob. Wait 5 seconds after the button is pushed, then withdraw the pen from the skin. A drop of blood may appear. Put a plaster on the injection site if you wish.

• 14. Pull the needle shield off the pen (if you have used one) and place the larger needle cap on a flat surface. Slide the needle in to pick it up and push the cap completely down over the needle. Twist off the needle and discard it properly. Your doctor or nurse will tell you how to dispose of the items you have used for the injection. Always store your disposal container out of the reach of children.

• 15. Attach the pen cap and return it to its case with the black dose knob pressed in. You should always store the pen in a refrigerator. Do not remove cartridge between injections. DO NOT FREEZE.

For subsequent injections with the NutropinAq Pen, attach a new needle, push the white reset button and dial your dose.

• Part II: Storage and Maintenance

Follow these tips to ensure proper care of your NutropinAq Pen:

• Always keep your NutropinAq Pen and cartridge refrigerated and protected from light when not in use.
• You may remove the pen and cartridge from the refrigerator up to 45 minutes prior to use.
• Do not let your NutropinAq Pen and/or cartridge freeze. Contact your doctor or nurse for a replacement if either the pen or cartridge does not work.
• Avoid excessive temperatures. The solution in the cartridge is stable for up to 28 days after first use when stored at 2 – 8°C.
• If your pen requires cleaning, do not place under water. Use a damp cloth to wipe away dirt. Do not use alcohol.
• When priming a new cartridge, you may need to repeat Part I, steps 8 and 9 up to a total of 6 times (0.6 mg) to remove air bubbles. Small bubbles may remain and will not affect the dose.
• The pen should contain the NutropinAq that is being used. Do not remove cartridge between injections.
• The NutropinAq cartridge may be used for up to 28 days.
• Do not store the NutropinAq Pen with needle attached.

• Part III: Needles for the NutropinAq Pen

Your doctor or nurse will recommend a needle that is appropriate for you. Always use the needles recommended.

Needles from other countries may not fit on your NutropinAq Pen. If you travel outside the European Union, make sure you take enough needles for the duration of your stay.

• Part IV: Commonly Asked Questions

Annex IV

Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR(s) for somatropin, the scientific conclusions of CHMP are as follows:

In view of available data on risk(s) from clinical trial(s), the literature, spontaneous reports including in some cases a close temporal relationship, a positive de-challenge and/or re-challenge, the PRAC Rapporteur considers a causal relationship between somatropin and acute pancreatitis is at least a reasonable possibility. The PRAC Rapporteur concludes that Section 4.4 of the SmPC of products containing somatropin should be amended to add a warning on pancreatitis.

Additionally, the PRAC Rapporteur considers a causal relationship between somatropin and gynecomastia is established and concludes that section 4.8 of the SmPC of products containing somatropin should be amended, to add the adverse reaction gynecomastia with a frequency uncommon.

The Package leaflet is updated accordingly.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the marketing authorisation(s)

On the basis of the scientific conclusions for somatropin the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing somatropin is unchanged subject to the proposed changes to the product information

The CHMP recommends that the terms of the marketing authorisation(s) should be varied.

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