GENCEBOK 10 mg /Ml Roztwór Do Infuzji
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Treść ulotki
Gencebok 10 mg/ml solution for infusion
caffeine citrate
Read this leaflet carefully before treatment with this medicine as it contains
important information for your newborn.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your child's doctor.
- If your newborn experiences any side effects, including those not listed in this leaflet, ask your child's doctor. See section 4.
Contents of this leaflet
- 1. What Gencebok is and what it is used for
- 2. What you need to know before Gencebok is given to your child
- 3. How to use Gencebok
- 4. Possible side effects
- 5. How to store Gencebok
- 6. Contents of the pack and other information
1. What is Gencebok and what is it used for
Gencebok contains the active substance caffeine citrate, which is a stimulant of the central nervous system that belongs to a group of drugs called methylxanthines.
Gencebok is used for the treatment of respiratory cessation in premature infants (primary apnea of premature infants).
These brief interruptions in the breathing of premature infants are caused by the incomplete development of the baby's respiratory centers.
This medicine has been shown to reduce the number of episodes of respiratory cessation in premature infants.
2. What you need to know before Gencebok is given to your child
Do not use Gencebok:
- if your child is allergic to caffeine citrate or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your child’s doctor before giving Gencebok.
Before starting treatment for prematurity apnea with Gencebok, your child’s doctor must have excluded, or appropriately treated, other possible causes of apnea.
Gencebok must be used with caution. Tell your doctor if:
- your child suffers from convulsions
- your child has any heart disease
- your child has problems with the kidneys or liver
- your child experiences frequent episodes of regurgitation
- your child produces more urine than usual
- your child has a low body weight or does not eat enough
- if you (mother) have taken caffeine before delivery.
Other medicines and Gencebok
Tell your child’s doctor if the newborn is taking, has recently taken, or might
take any other medicine.
Tell your child’s doctor if the newborn has previously been treated with theophylline.
Do not use the following medicines during treatment with Gencebok without first
consulting your child’s doctor. The doctor may need to adjust the dosage or
change one of the medicines:
- theophylline (used to treat breathing difficulties)
- doxapram (used to treat breathing difficulties)
- cimetidine (used to treat stomach disorders)
- ketoconazole (used to treat fungal infections)
- phenobarbital (used to treat epilepsy)
- phenytoin (used to treat epilepsy)
This medicine may increase the risk of a serious intestinal disease with blood in the stool
(necrotizing enterocolitis) if given at the same time as medicines used to treat
a stomach disorder (such as H2 receptor blockers or proton pump inhibitors that reduce stomach acid secretion).
Pregnancy and breastfeeding
If you (the mother) are breastfeeding while your child is being treated with Gencebok, do not
drink coffee or take other products with a high caffeine content because it is excreted into
breast milk.
Gencebok contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially “sodium-free”.
3. How to use Gencebok
Gencebok must be used only in a neonatal intensive care unit equipped with
suitable equipment for monitoring and monitoring patients. Treatment should be
initiated under the supervision of a physician experienced in neonatal intensive care.
Dosage
Your child's doctor will prescribe the correct dose of Gencebok based on weight.
The initial dose is 20 mg per kg of body weight (equivalent to 2 ml per kg of body weight).
The maintenance dose is 5 mg per kg of body weight (equivalent to 0.5 ml per kg of body weight)
every 24 hours.
Route of administration and method
Gencebok will be administered by controlled intravenous infusion, through a syringe
infusion pump or other measured delivery device. This method is also
known as “drip”.
Some doses (maintenance doses) may be given orally.
It may be necessary for your child's doctor to decide, during treatment, to periodically check
caffeine levels in their blood to avoid toxic effects.
Duration of treatment
Your child's doctor will decide exactly how long the therapy with
Gencebok should continue. If your child has been without apnea attacks for 5 to 7 days, the doctor will stop the
treatment.
If your child receives more Gencebok than they should
Your child may experience fever, rapid breathing (tachypnea), a feeling of agitation,
muscle tremors, vomiting, high blood sugar levels (hyperglycemia), low potassium
levels (hypokalemia) in the blood, high levels of certain chemicals (urea) in the blood, a number
high of certain blood cells (leukocytes) and convulsions, if they receive more caffeine citrate than
they should.
In such a case, treatment with Gencebok must be stopped immediately and your child's doctor must treat the overdose.
If you have any doubts about the use of this medicine, consult your child's doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
However, it is difficult to distinguish them from some frequent complications that occur in
premature infants and from complications due to the disease.
During treatment with Gencebok, your newborn may experience some of the following reactions:
Serious side effects
Side effectswhose frequency cannot be defined on the basis of the available data
Also, other side effects that follow may be considered serious by your child's doctor in the context of the overall clinical assessment.
Other side effects
Side effects commonreported (may affect up to 1 in 10 people)
- local inflammatory reactions at the infusion site
- heart disorders such as an accelerated heart rate (tachycardia)
- changes in blood sugar or serum levels (hyperglycemia)
Side effects uncommonreported (may affect up to 1 in 100 people)
- stimulation of the central nervous system such as convulsions
- heart disorders such as an irregular heart rate (arrhythmia)
Side effects rare(may affect up to 1 in 1,000):
- allergic reactions
Side effectswhose frequency cannot be estimated on the basis of the available data
- blood infections (sepsis)
- changes in blood sugar or serum levels (hypoglycemia), growth delay, food intolerance
- stimulation of the central nervous system such as irritability, nervousness and restlessness; brain injury
- deafness
- regurgitation, increased gastric aspirate
- increased urine flow, increased levels of some urine components (sodium and calcium)
- changes in blood tests (reduced hemoglobin levels after prolonged treatment and reduced thyroid hormone levels at the beginning of treatment)
Reporting of side effects
If your newborn experiences any side effect, including those not listed in this
leaflet, please inform your child's doctor. You can also report side effects directly
through the national reporting system as reported in Annex V.
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store Gencebok
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 label. The expiry date
refers to the last day of that month.
This medicine does not require any particular storage conditions.
Before administration, the vials of all solutions for parenteral use must be inspected
visually to exclude the presence of any suspended particles.
After opening the vial, the medicine must be used immediately.
6. Package contents and other information
What Gencebok contains
The active ingredient is caffeine citrate.
Each ml contains 10 mg of caffeine citrate (equivalent to 5 mg/ml of caffeine base).
Each 1 ml vial contains 10 mg of caffeine citrate (equivalent to 5 mg of caffeine base).
The other ingredients are citric acid, sodium citrate and water for injections.
Description of the appearance of Gencebok and contents of the pack
Gencebok is a solution for infusion.
Gencebok is a transparent, colourless solution, supplied in glass vials marked with 2
blue rings. Each pack contains 50 vials.
Marketing Authorisation Holder
Gennisium Pharma
Swen Parc de Vitrolles
Chemin de la Bastide Blanche
13127 Vitrolles - France
Manufacturer (Batch Release)
Cenexi
52 rue Marcel et Jacques Gaucher
94120 Fontenay Sous-Bois
France
Gennisium Pharma
Swen Parc de Vitrolles (Bâtiment E)
Chemin de la Bastide Blanche
13127 Vitrolles
France
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:
België/Belgique/Belgien
Gennisium Pharma
Tél/Tel: +33 9 70 19 79 90
[email protected]
Lietuva
UAB PharmaDIA
Tel: +370 69 94 76 12
[email protected]
България
Gennisium Pharma
Teл.: +33 9 70 19 79 90
[email protected]
Luxembourg/Luxemburg
Gennisium Pharma
Tél/Tel: +33 9 70 19 79 90
[email protected]
Česká republika
Gennisium Pharma
Tel: +33 9 70 19 79 90
[email protected]
Magyarország
Gennisium Pharma
Tel.: +33 9 70 19 79 90
[email protected]
Danmark
Nordic Prime ApS
Tlf.: +45 75 15 13 40
[email protected]
Malta
Cherubino
Tel: +365 2134 3270
[email protected]
Deutschland
Gennisium Pharma
Tel: +33 9 70 19 79 90
[email protected]
Nederland
Gennisium Pharma
Tel: +33 9 70 19 79 90
[email protected]
Eesti
UAB PharmaDIA
Tel: +370 69 94 76 12
[email protected]
Norge
Nordic Prime ApS
Tlf: +45 75 15 13 40
[email protected]
Ελλάδα
Specialty Therapeutics IKE
Τηλ: +30 213 02 33 913
[email protected]
Österreich
Gennisium Pharma
Tel: +33 9 70 19 79 90
[email protected]
España
Gennisium Pharma
Tel: +33 9 70 19 79 90
[email protected]
Polska
Gennisium Pharma
Tel: +33 9 70 19 79 90
[email protected]
France
Gennisium Pharma
Tél: +33 9 70 19 79 90
[email protected]
Portugal
Gennisium Pharma
Tel: +33 9 70 19 79 90
[email protected]
Hrvatska
Gennisium Pharma
Tel: +33 9 70 19 79 90
[email protected]
România
Euromedex
Tel: 0745.038.006
[email protected]
Ireland
Gennisium Pharma
Tel: +33 9 70 19 79 90
[email protected]
Slovenija
Gennisium Pharma
Tel: +33 9 70 19 79 90
[email protected]
Ísland
Nordic Prime ApS
Sími: +45 75 15 13 40
[email protected]
Slovenská republika
Gennisium Pharma
Tel: +33 9 70 19 79 90
[email protected]
Italia
Gennisium Pharma
Tel: +33 9 70 19 79 90
[email protected]
Suomi/Finland
Nordic Prime ApS
Puh/Tel: +45 75 15 13 40
[email protected]
Κύπρος
Specialty Therapeutics IKE
Τηλ: + 30 213 02 33 913
[email protected]
Sverige
Nordic Prime ApS
Tel: +45 75 15 13 40
[email protected]
Latvija
UAB PharmaDIA
Tel: +370 69 94 76 12
[email protected]
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu .
-------------------------------------------------------------------------------------------------------------------------
The following information is intended exclusively for healthcare professionals:
For detailed information, please refer to the enclosed summary of product characteristics for
Gencebok.
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- Kraj rejestracji
- Postać farmaceutycznaInfusion solution, 10 MG / ML
- Kod ATCN06BC01
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki JENKEBOKPostać farmaceutyczna: Infusion solution, 20MG/MLSubstancja czynna: caffeineProducent: CHIESI FARMACEUTICI S.P.A.Wymaga receptyPostać farmaceutyczna: Coated tablet, 5 MGSubstancja czynna: dexamfetamineProducent: MEDICE ARZNEIMITTEL PUETTER GMBH & CO.KGWymaga receptyPostać farmaceutyczna: Injectable solution, 250 MGSubstancja czynna: citicolineProducent: S.F. GROUP S.R.L.Wymaga recepty
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Często zadawane pytania
JENKEBOK wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w JENKEBOK jest caffeine. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
JENKEBOK jest produkowany przez GENNISIUM PHARMA. 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 JENKEBOK 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 JENKEBOK 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 (caffeine) to m.in. PEYONA, AMFEXA, KIDILIN. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
