NORMOSANG 25 мг/мл Концентрат для инфузионного раствора
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Инструкция по применению NORMOSANG
Содержание инструкции
Normosang 25 mg/ml, concentrate for solution for infusion.
Human albumin
Read this leaflet carefully before using 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.
- If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What Normosang is and what it is used for
- 2. What you need to know before using Normosang
- 3. How to use Normosang
- 4. Possible side effects
- 5. How to store Normosang
- 6. Contents of the pack and other information
1. What is Normosang and what is it used for
Normosang contains human heme, a substance extracted from human blood.
Normosang is used to treat sudden crises that occur in patients suffering from acute hepatic porphyria; the disease is characterized by the accumulation in the liver of certain compounds (such as porphyrins and their toxic precursors). There are three types of hepatic porphyria, whose medical names are: acute intermittent porphyria, variegated porphyria and hereditary coproporphyria. This accumulation leads to symptoms that include pain (especially in the abdomen, back and thighs), nausea, vomiting and constipation.
2. What you need to know before using Normosang
Do not use Normosang
- if you are allergic to human hemin or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
- Before treatment with Normosang, the doctor must confirm the acute hepatic porphyria crisis through a series of clinical and biological parameters: positive individual or family history; clinical signs indicating; quantitative determination of delta-aminolevulinic acid and porphobilinogen (specific markers of the disease) in urine.
- Early initiation of treatment with Normosang after the onset of the crisis increases its effectiveness.
- As a result of Normosang infusions, abdominal pain and other gastrointestinal symptoms generally disappear within 2-4 days. Conversely, neurological complications (such as paralysis and psychological disorders) are less affected by the treatment itself.
- You will be kept under observation throughout the duration of the treatment, because porphyria crises are often associated with various effects on the heart, circulation and nervous system.
- Do not:
- suddenly change your usual diet, in particular do not fast for prolonged periods
- take medicines or substances such as estrogens (e.g. oral contraceptives), barbiturates (medicines that help you sleep and medicines sometimes used for the treatment of epilepsy) or steroids (medicines similar to the hormones produced by the body), because this may cause or worsen a crisis.
Ask your doctor or pharmacist for advice regarding the medicines and substances that you must not take (now and
in the future).
- To prevent venous irritation, the solution will be administered by infusion into a large vein (blood vessel) in the arm or into a vein in the chest over at least 30 minutes. After the infusion, the vein will be flushed with physiological solution.
- A blood clot (known as “venous thrombosis”) may occlude the vein used for the infusion.
- If the cannula remains inserted for a long time, vascular damage may occur which could cause an involuntary leakage of Normosang from the vein (extravasation). This leakage can cause skin discoloration.
- To limit the risk of extravasation, the nurse or doctor will examine the cannula before the infusion and check it regularly during the infusion.
- The infused solution may give the blood an unusual color.
- To limit the risk of an increase in an iron compound, Normosang should not be used as prophylactic treatment for acute crises.
- Human hemin contains iron. Sometimes it can happen that iron accumulates in the body, after several years of treatment with repeated Normosang infusions. The doctor may perform blood tests from time to time to check the level of iron in the body.
- Standard measures to prevent infections associated with the use of medicinal products prepared from human blood or plasma include donor selection, screening of individual donations for the detection of specific infection markers, and the adoption of effective production steps to inactivate/remove viruses. Despite these precautions, the administration of medicinal products prepared from human blood or plasma cannot be considered completely free from the risk of transmission of infectious agents. The risk is also extended to unknown or emerging viruses and other pathogens.
- The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV. When Normosang is administered to a patient, it is strongly recommended to record the name and batch number of the product in order to maintain a link between the treated subject and the production batch.
Other medicines and Normosang
Do not take medicines or substances such as estrogens (e.g. oral contraceptives), barbiturates (medicines that help you
sleep and medicines sometimes used for the treatment of epilepsy) or steroids (medicines similar to the hormones produced
by the body), because this may cause or worsen a crisis.
Tell your doctor if you are taking, have recently taken or might take any other medicine.
Pregnancy and breastfeeding
It is not known whether there is a risk in using Normosang during pregnancy. However, mothers treated with
Normosang have given birth to normal children.
If you are pregnant, ask your doctor for advice before taking Normosang. He/she will prescribe the
medicine only if absolutely necessary.
Normosang has not been studied during breastfeeding. However, as many medicines are excreted in breast milk,
if you are breastfeeding, tell your doctor and ask for advice before taking Normosang. Your
doctor will prescribe the treatment only if absolutely necessary or may suggest that you stop
breastfeeding.
Normosang contains ethanol (an alcohol). This must be taken into consideration for women during
pregnancy and breastfeeding. See section: “Normosang contains”.
Driving and using machines
This medicine should not affect your ability to drive vehicles or operate machinery.
Normosang contains
Normosang contains ethanol (alcohol) 11.78% vol., i.e. up to 1000 mg per daily dose (one vial),
equivalent to 23.6 ml of beer or 9.8 ml of wine per daily dose. This may be harmful to those suffering from
alcoholism. This must be taken into account in the case of pregnant or breastfeeding women, children and
high-risk groups, such as patients with liver disease or epilepsy.
Ask your doctor for advice before administering Normosang if you are in one of the conditions
listed above.
3. How to use Normosang
The medicine will only be administered to you in a hospital setting by qualified healthcare professionals.
The dose to be administered will be calculated based on body weight and is approximately 3 mg per kg of body weight per
day, but not exceeding 250 mg (1 vial) per day. The quantity thus calculated will be diluted in a saline
solution (0.9% sodium chloride) in a glass bottle, forming a dark-colored solution.
The solution will be administered by infusion into a large vein (blood vessel) in the arm or into a vein
in the chest over at least 30 minutes. The infused solution may give the blood an unusual color.
After the infusion, the vein must be flushed with a saline solution.
Usually, you will receive an infusion per day for four days.
If, after this first cycle of treatment, no relief of symptoms is observed, the doctor may decide, in exceptional
cases, to start a second cycle of treatment.
If you have received more Normosang than you should
If you have received more Normosang than you should, the doctor will subject you to treatment to prevent
the onset of harmful effects.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.
Rare(may affect up to 1 in 1,000 people):
- Fever and serious allergic reactions (skin rash, swelling of the tongue), including anaphylactoid reactions, can occur rarely.
Anaphylactoid reactions are sudden and potentially life-threatening reactions, which can occur rarely.
If symptoms such as facial edema, dyspnea, chest tightness, tachycardia, low blood pressure,
urticaria, spontaneous loss of consciousness (caused by insufficient blood supply to the brain),
occur, stop the infusion and contact your doctor immediately.
Very common (may affect more than 1 in 10 people):
- After repeated treatments, access to the veins in the arm may become difficult, which may require insertion of a catheter into a vein in the chest.
Common(may affect up to 1 in 10 people):
- - Administration into a vein that is too small can cause pain and inflammation.
Uncommon (may affect up to 1 in 100 people):
- Following repeated treatments over several years, the amount of an iron compound (called ferritin) in the blood may increase. To limit the risks of increased ferritin, Normosang should not be used as prophylactic treatment for acute attacks.
Frequency not known (the frequency cannot be estimated from available data):
- Headache.
- Venous thrombosis (formation of blood clots in peripheral or central veins), including thrombosis at the injection site.
- Leakage of infusion fluid into the surrounding tissue (extravasation).
- Skin damage (necrosis).
- Redness of the skin at the injection site (erythema at the injection site).
- Itching at the injection site.
- Increased creatinine levels (a substance excreted by the kidneys) in the blood.
- Skin discoloration.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through
the national reporting system listed at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse.
By reporting side effects you can help provide more information on the safety of this
medicine
5. How to store Normosang
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the vial label and on the package after
Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2 C – 8 C).
Keep the vial in the outer packaging to protect the medicine from light.
The solution must be used within one hour of dilution.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to eliminate the
medicines that you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Normosang contains
- The active ingredient is human heme (25 mg/ml). One 10 ml vial contains 250 mg of human heme. After dilution of one 10 ml vial in 100 ml of 0.9% sodium chloride solution, the diluted solution contains 2273 micrograms per ml of human heme.
- The other ingredients are arginine, ethanol (96%), propylene glycol and water for injections.
Description of the appearance of Normosang and contents of the pack
Normosang is presented as concentrate for infusion solution (10 ml vials – pack of 4).
Normosang is a dark-coloured solution, even after dilution of the concentrate for solution for
infusion.
Marketing Authorisation Holder
Recordati Rare Diseases
Tour Hekla
52, avenue du Général de Gaulle
F-92800 Puteaux
France
Manufacturer
Recordati Rare Diseases
Tour Hekla
52, avenue du Général de Gaulle
F-92800 Puteaux
France
or
Recordati Rare Diseases
Eco River Parc
30, rue des Peupliers
F-92000 Nanterre
France
This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Normosang – Austria / Belgium / Cyprus / Czech Republic / Denmark / Estonia / Finland / France /
Germany/ Greece/ Hungary / Iceland / Ireland/ Italy / Latvia / Lithuania / Luxembourg / Malta / Netherlands /
Norway/ Portugal/ Spain / Sweden / Slovenia / Slovakia / England
Human Hemin Orphan Europe - Poland
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- Страна регистрации
- Форма выпускаConcentrate for infusion solution, 25 MG/ML
- Код АТХB06AB01
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги NORMOSANGФорма выпуска: Concentrate for infusion solution, 10 MG / MLДействующее вещество: crizanlizumabПроизводитель: NOVARTIS EUROPHARM LIMITEDОтпускается по рецептуФорма выпуска: Solution for infusion in pre-filled syringe, 200 mgДействующее вещество: Drugs used in hereditary angioedemaПроизводитель: CSL BEHRING GMBHОтпускается по рецептуФорма выпуска: Powder and solvent for injectable/infusion solution, <500 IUДействующее вещество: c1-inhibitor, plasma derivedПроизводитель: CSL BEHRING GMBHОтпускается по рецепту
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Аналог NORMOSANG в Украина
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Часто задаваемые вопросы
NORMOSANG требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество NORMOSANG — Гемин. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
NORMOSANG производится компанией RECORDATI RARE DISEASES SARL. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения NORMOSANG с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить NORMOSANG в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (Гемин) включают ADAKVEO, ANDEMBRY, BERINERT. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
