GHRYVELIN 60 mg Granulki Do Sporządzania Zawiesiny Doustnej
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Treść ulotki
GHRYVELIN 60 mg granules for oral suspension in sachet
macimorelin
Read this leaflet carefully before taking this medicine as it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or nurse.
- This medicine has been prescribed only for you. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. See section 4.
Contents of this leaflet
- 1. What GHRYVELIN is and what it is used for
- 2. What you need to know before you receive GHRYVELIN
- 3. How GHRYVELIN is administered
- 4. Possible side effects
- 5. How to store GHRYVELIN
- 6. Contents of the pack and other information
1. What is GHRYVELIN and what is it used for
The medicine contains an active substance called macimorelin. Macimorelin acts as a natural
hormone and induces the release from the pituitary gland of growth hormone into the
bloodstream.
GHRYVELIN is used in adults to test the body's ability to produce growth
hormone. It is used when the doctor believes that you may not have enough growth
hormone (growth hormone deficiency in adults). This is not a treatment for patients
who do not have enough growth hormone. It is a test that helps the doctor diagnose this
condition.
2. What you need to know before receiving GHRYVELIN
Do not take GHRYVELIN
- if you are allergic to macimorelin or any of the other ingredients of this medicine (listed in section 6).
If you have any doubts, ask your doctor or nurse before taking GHRYVELIN.
Warnings and precautions
To ensure that the test results are reliable, you must follow the following rules.
- Fasting: you must not eat for at least 8 hours before the test and during the test.
- Exercise: avoid intense physical activity 24 hours before the test.
- Drinking: up to 100 mL of natural water is allowed within 1 hour before and within 1 hour after taking macimorelin.
Contact your doctor or nurse if:
- you have recently been treated with growth hormone (somatotropin) or with medicines that affect the secretion of growth hormone from the pituitary gland. Such treatment must be stopped at least 1 month before the test;
- you have recently been treated for Cushing's disease (a condition that causes high levels of the hormone cortisol) or if you are receiving a high dose of hydrocortisone-based medicine: the test may lead to false positive test results;
- your body is deficient in any other hormone, e.g. cortisol, thyroid hormones or sex hormones, vasopressin (in diabetes insipidus), such hormone must be adequately replaced before performing the test for growth hormone deficiency. If untreated, other hormonal deficiencies can lead to inaccurate results of the growth hormone stimulation test;
- you suffer from a heart condition or heart rhythm problems (including congenital or acquired long QT syndrome or a history of so-called torsades de pointes tachycardias). GHRYVELIN can cause changes in the ECG (electrocardiogram), including prolongation of the QT interval, associated with an increased risk of arrhythmias. If they occur, such changes are limited in time and do not last long.
If any of the above applies to you, or if you are not sure, contact your doctor or nurse
before receiving this medicine.
GHRYVELIN is indicated as a single-dose diagnostic test. There is no information available on the
safety and effects of macimorelin during long-term use.
The test may need to be repeated in the early stages of the disease
If growth hormone deficiency in adults is in its early stages and if it is caused by a lesion in a
section of the brain called the hypothalamus, then the test result may be negative even if you
have the disease. In such a situation, the test may need to be repeated.
Children and adolescents
GHRYVELIN should not be used in children and adolescents under 18 years of age, because
safety and efficacy in these groups have not yet been established.
Other medicines and GHRYVELIN
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Tell your doctor if you are taking medicines that can alter the heart rhythm, such as:
- medicines for the treatment of psychosis (such as chlorpromazine, haloperidol)
- medicines for the treatment of infections (antibiotics such as erythromycin, clarithromycin, moxifloxacin)
- medicines for the correction of heart rhythm (antiarrhythmic medicines such as amiodarone, procainamide, quinidine or sotalol)
- any other medicines that can prolong the QT interval or induce torsades de pointes
Tell your doctor if you are taking medicines that can increase the breakdown of
macimorelin, such as medicines specifically for the treatment of:
- seizures/epilepsy (carbamazepine, eslicarbazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone)
- sleep disorder (modafinil, pitolisant)
- mild to moderate depressive episodes [St. John's wort (Hypericum perforatum)]
- cystic fibrosis (lumacaftor)
- infections (antibiotics such as rifabutin, rifampicin)
- HIV (efavirenz, nevirapine)
- type II diabetes (pioglitazone)
- cancer (dabrafenib, enzalutamide)
Tell your doctor if you are taking medicines that can affect the accuracy of the
diagnostic test. Avoid the simultaneous use of medicines:
- that can directly affect the pituitary gland secretion of growth hormone: for example, somatostatin, insulin, glucocorticoids, acetylsalicylic acid, indometacin
- that can increase the levels of growth hormone: for example, clonidine, levodopa, insulin
- that can reduce the response of growth hormone to macimorelin: for example, atropine, propylthiouracil, growth hormone-based medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are
breastfeeding, ask your doctor or nurse for advice before receiving this medicine.
GHRYVELIN is not recommended during pregnancy. If you are a woman of childbearing potential, you should
use effective contraceptive methods to ensure that you are not pregnant at the time of the test.
If you are breastfeeding or intend to breastfeed, the risk to the infant cannot be excluded. Ask your
doctor if you should stop breastfeeding or refrain from the macimorelin test.
Driving and using machines
Dizziness may occur with GHRYVELIN. If this happens, do not drive vehicles or use
machines.
GHRYVELIN contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before
taking this medicine.
GHRYVELIN contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per sachet, i.e. it is essentially
“sodium-free”.
3. How GHRYVELIN is administered
A healthcare professional must monitor the preparation and use of GHRYVELIN. Instructions on
test.
You must be fasting for at least 8 hours before receiving GHRYVELIN. You should not undergo intense
physical exercise 24 hours before the test. You may drink up to 100 mL of natural water within 1 hour before and within
1 hour after taking GHRYVELIN.
Dose
The recommended dose is 0.5 mg of GHRYVELIN per kg of body weight.
This corresponds to a volume of 1 mL of the prepared suspension per kg of body weight.
You must drink the entire test dose within 30 seconds.
Three blood samples will be taken to measure growth hormone, one sample at a
time after 45, 60 and 90 minutes from taking the test dose.
If you take more GHRYVELIN than you should
If you take more GHRYVELIN than you should, inform your doctor or nurse. In cases of
overdose, possible undesirable effects may include headache, nausea, vomiting and diarrhoea. In the
event of cardiac rhythm disturbances, an ECG monitoring will be performed.
If you have any doubts about the use of this medicine, consult your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects(may affect up to 1 in 10 people):
- a bitter or metallic taste (dysgeusia)
- fatigue
- headache
- feeling unwell (nausea)
- dizziness
- diarrhoea
- feeling of heat
These side effects are mostly mild, do not last long and usually disappear quickly
without treatment.
Uncommon side effects(may affect up to 1 in 100 people):
- abdominal pain
- feeling cold
- hunger
- palpitations
- slower than normal heartbeat (sinus bradycardia)
- drowsiness
- thirst
- tremor
- vertigo
- changes in the electrocardiogram (ECG)
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
nurse. You can also report side effects directly through the national reporting system listed in
Appendix V. By reporting side effects you can help to provide more information on the safety of
this medicine.
5. How GHRYVELIN is stored
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer packaging and on the sachet
after “Exp.”. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light and moisture.
Store in a refrigerator (2 ° C - 8 ° C).
Intact sachet
The shelf life of a sachet is 5 years.
Reconstituted suspension
The suspension must be taken within 30 minutes of preparation.
The doctor or nurse must dispose of any residual suspension in accordance with
local regulations.
Do not dispose of any medicine in wastewater or household waste. This will help protect
the environment.
6. Package contents and other information
What GHRYVELIN contains
- The active ingredient is macimorelin. Each sachet contains 60 mg of macimorelin (as acetate). 1 mL of the reconstituted suspension contains 500 micrograms of macimorelin.
- The other ingredients are: anhydrous colloidal silicon dioxide, crospovidone type A, sodium saccharin dihydrate and sodium stearyl fumarate (see section 2 regarding “GHRYVELIN contains sodium”).
Description of the appearance of GHRYVELIN and package contents
GHRYVELIN is presented as an oral suspension granules, from white to off-white. Each sachet
contains 1817 mg of granules. Each cardboard box contains 1 sachet.
Marketing Authorisation Holder
Atnahs Pharma Netherlands B. V.
Copenhagen Towers
Ørestads Boulevard 108, 5.tv
DK-2300 København S
Denmark
Manufacturer
Aeterna Zentaris GmbH
Weismüllerstrasse 50
D-60314 Frankfurt am Main
Germany
Other sources of information
More detailed information about this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
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The following information is intended exclusively for healthcare professionals:
INSTRUCTIONS FOR PREPARATION AND USE
The suspension must be prepared and administered by a healthcare professional.
Items needed: GHRYVELIN sachet, tap water in a jug, transparent plastic or glass container with graduated scale, stirrer, 50 mL graduated syringe without needle, glass
Step 1
Weigh the patient.
Step 2
Determine the number of GHRYVELIN sachets needed based on body weight: one sachet will be needed for a
patient weighing up to 120 kg, two sachets will be needed if the patient weighs more than 120 kg.
Step 3
Add the required volume of water to a transparent plastic or glass container with a graduated scale. Dissolve the entire contents of the sachet in water: one sachet in 120 mL, two sachets in
240 mL, as appropriate.
Gently stir the suspension for 2 minutes (a small amount of undissolved particles will remain, resulting in a slightly cloudy suspension). The suspension must be stirred
until it is slightly cloudy without particles at the bottom of the container. The suspension
must be re-mixed when some particles settle at the bottom of the container,
for example after the suspension has been left to stand for a certain time.
Step 4
Determine the volume of suspension needed for the recommended dose of macimorelin of
0.5 mg/kg. The volume of the suspension in mL is equal to the patient's body weight in kg. For example,
a 70 kg patient will need 70 mL of macimorelin suspension.
Measure the required volume using a 50 mL graduated syringe without a needle.
Transfer the measured amount to a glass.
Step 5
Have the patient drink the entire contents of the glass within 30 seconds.
The suspension must be used within 30 minutes of preparation. Any remaining suspension
must not be stored but must be discarded.
Unused medicine and waste from this medicine must be disposed of in accordance with
current local regulations.
Step 6
Take venous blood samples to determine growth hormone after
45, 60 and 90 minutes after administration.
Step 7
Prepare plasma or serum samples and send them to a laboratory for determination of growth hormone.
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- Kraj rejestracji
- Postać farmaceutycznaGranules for oral suspension, 60 MG
- Kod ATCV04CD06
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki GRYVELINPostać farmaceutyczna: Soft capsule, 250 MGSubstancja czynna: metyraponeProducent: ESTEVE PHARMACEUTICALS SAWymaga receptyPostać farmaceutyczna: Oral solution, 75MG/10MLSubstancja czynna: 13C-ureaProducent: AB ANALITICA S.R.L.Wymaga receptyPostać farmaceutyczna: Powder for oral solution, 75 MGSubstancja czynna: 13C-ureaProducent: RICHEN EUROPE S.R.L.Bez recepty
Odpowiedniki GRYVELIN w innych krajach
Leki z tą samą substancją czynną dostępne w innych krajach.
Odpowiednik GRYVELIN w Hiszpania
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GRYVELIN nie wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w GRYVELIN jest macimorelin. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
GRYVELIN jest produkowany przez ATNAHS PHARMA NETHERLANDS BV. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie GRYVELIN jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić GRYVELIN w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (macimorelin) to m.in. KORMETO, BREATQUALITY-UBT, KITREDIKI UBT KIT. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
