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Инструкция по применению SKAVER
Содержание инструкции
SCAVER 3 mg tablets
Ivermectina
“Equivalent medicinal product”
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 pharmacist.
- This medicine has been prescribed for you only. 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 pharmacist. See section 4.
Contents of this leaflet:
- 1. What SCAVER is and what it is used for
- 2. What you need to know before you take SCAVER
- 3. How to take SCAVER
- 4. Possible side effects
- 5. How to store SCAVER
- 6. Contents of the pack and other information
1. What is SCAVER and what is it used for
SCAVER contains the active substance ivermectin. This is a type of medicine that is used
for infections caused by certain parasites.
It is used to treat:
- an infection in the intestine called intestinal strongyloidiasis (anguillulosis). It is caused by a type of roundworm called “ Strongyloides stercoralis”.
- a blood infection called microfilaremia caused by “lymphatic filariasis”. It is caused by an immature worm called “ Wuchereria bancrofti”. SCAVER does not act against adult worms but only against immature worms.
- skin mites (scabies). This happens when tiny mites burrow under the skin. It can cause severe itching. SCAVER should only be taken when the doctor is certain or suspects that you have scabies.
SCAVER does not prevent any of these infections.It does not act against adult worms. SCAVER must
be taken only on the advice of a doctor when the parasitic infection is certain or suspected.
2. What you need to know before you take SCAVER
Do not take SCAVER
- if you are allergic to ivermectin or any of the other ingredients of this medicine (listed in section 6). The signs of an allergic reaction can include skin rash, difficulty breathing or fever.
Do not take SCAVER if the above applies to you. If you are not sure, ask your doctor or pharmacist before taking SCAVER.
Warnings and precautions
Talk to your doctor or pharmacist before taking SCAVER.
In particular, check with your doctor or pharmacist before taking the medicine:
- if you have a weakened immune system
- if you live or have lived in parts of Africa where there are cases of human parasitic infestation with the filarial worm Loa loaalso called the eye worm
- if you currently live or have lived in parts of Africa. The use of diethylcarbamazine citrate (DEC) to treat a co-infection with Onchocerca volvulusmay lead to an increased risk of side effects, sometimes potentially serious.
If you fall into any of these categories (or if you are not sure), ask your doctor or pharmacist before taking SCAVER.
Children
It is not known whether the use of SCAVER in pediatric patients with a body weight of less than 15 kg is safe.
Elderly patients
Clinical studies with ivermectin did not include a sufficient number of subjects aged 65 years or older to determine whether they respond differently from younger subjects. Other clinical experience reported has not identified differences in responses between elderly patients and younger patients. In general, treatment of an elderly patient should be cautious, due to the greater frequency of reduced hepatic, renal or cardiac function and concomitant diseases or other pharmacological therapies.
Other medicines and SCAVER
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breastfeeding
- If you are pregnant, suspect you may be pregnant or are planning to become pregnant, consult your doctor immediately before taking SCAVER. If you are pregnant, you should only take it if clearly necessary. The doctor will decide together with you.
- If you are breastfeeding or intend to breastfeed, ask your doctor. In fact, SCAVER passes into breast milk. The doctor may decide to start treatment one week after the birth of the baby. If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and operating machinery
While taking SCAVER you may experience dizziness, drowsiness, tremor or vertigo. If this happens, do not drive and do not use tools or machinery.
3. How to take SCAVER
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Taking the medicine
- Take this medicine by mouth.
- In children under 6 years of age, crush the tablets before swallowing them.
- Take the number of tablets prescribed by your doctor all at once with water on an empty stomach. Do not consume any food two hours before or two hours after taking the tablets, as the influence of food on the absorption of the medicine in the body is unknown.
Dosage
The treatment consists of a single administration.
- Take the number of tablets prescribed by your doctor all at once.
- The dose depends on your illness and your weight or your height.
- Your doctor will tell you how many tablets you need to take.
For gastrointestinal strongyloidiasis (anguillulosis):
The usual dose is:
For microfilaremia due to lymphatic filariasis - caused by Wuchereria bancrofti:
The usual dose is:
| BODY WEIGHT (kg) | DOSE (number of 3 mg tablets) |
| o ne |
| two |
| three |
| f our |
| f ive |
| ≥ 80 | six |
| WEIGHT BODY (kg) | DOSE when taken once d every 6 months number of 3 mg tablets | a nd DOSE when taken once every 12 months number of 3 mg tablets |
| one | two |
| two | four |
| t hree | six |
| n four | eight |
To be repeated every 6 months or every 12 months.
Alternatively, and if the weight is not available, the dose can be determined by the patient's height
as follows:
| HEIGHT (cm) | t h DOSE when taken once every 6 months n number of 3 mg tablets | DOSE when taken once every 12 months number of 3 mg tablets |
| I one | two |
| two | four |
| three | six |
| > 158 | f our | eight |
For scabies:
- Take a dose of 200 micrograms per kilogram of body weight.
This corresponds to:
| e BODY WEIGHT (kg) | DOSE (number of 3 mg tablets) |
g
| one |
| two |
| three |
A
| four |
| five |
| ≥ 80 | six |
- You will not know if the treatment has been successful before 4 weeks.
- The doctor may decide to prescribe a second single administration within 8-15 days
If you think that the effect of SCAVER is too strong or too weak, consult your doctor or pharmacist.
If you take more SCAVER than you should
If you take more SCAVER than you should, contact your doctor immediately.
If you forget to take SCAVER
Try to take SCAVER as prescribed. Do not take a double dose to make up for the missed dose.
If you have any doubts about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects are usually not serious and do not last long. They may be more likely to occur in people infected with various parasites. This occurs especially in cases of infections
caused by the worm “ Loa loa”. After taking this medicine, the following side effects may occur:
Allergic reactions
If you experience an allergic reaction, consult a doctor immediately. Signs may include:
- sudden fever
- sudden skin reactions (such as rash or itching) or other serious skin reactions
- difficulty breathing If you notice any of the above side effects, consult a doctor immediately.
Other side effects:
- Liver disease (acute hepatitis).Alteration of some laboratory tests (increased liver enzymes, increased bilirubin in the blood, increased eosinophils).
- Blood in the urine
The side effects listed below depend on the reason you are taking SCAVER. They also depend on other ongoing infections.
People with intestinal strongyloidiasis (anguillulosis)may experience the following side effects:
- unusual feeling of weakness
- loss of appetite, stomach pain, constipation or diarrhea
- nausea or vomiting
- drowsiness or dizziness
- agitation or tremors
- decreased number of white blood cells (leukopenia)
- decreased amount of red blood cells or hemoglobin in the blood (anemia). In addition, in cases of intestinal strongyloidiasis (anguillulosis), adult roundworms may be found in the stool.
People with microfilaremia due to lymphatic filariasis caused by Wuchereria bancrofti
may experience the following side effects:
- sweating or fever
- headache
- unusual feeling of weakness
- muscle, joint and generalized body pain
- loss of appetite, nausea
- stomach pain (abdominal and epigastric pain)
- cough or sore throat
- discomfort during breathing
- low blood pressure when getting up or standing - you may feel dizzy or lightheaded
- chills
- dizziness
- pain or discomfort in the testicles.
People with scabiesmay experience the following side effects:
- itching that may worsen at the beginning of treatment. It is usually short-lived.
People with a severe infection with the worm “Loa loa”may experience the following side effects:
- abnormal brain function
- neck or back pain
- bleeding in the white of the eye (also known as red eye)
- shortness of breath
- loss of bladder or bowel control
- difficulty standing or walking
- altered mental status
- feeling sleepy or confused
- unresponsiveness to stimuli or coma.
People infected with the worm “Onchocerca volvulus” that causes river blindnessmay have the
following side effects:
- itching or rash
- joint or muscle pain
- fever
- nausea or vomiting
- swollen lymph nodes
- swelling, especially in the hands, ankles or feet
- diarrhea
- dizziness
- low blood pressure (hypotension). You may feel dizzy or lightheaded when standing
- fast heart rate
- headache or feeling tired
- vision changes and other eye problems such as infection, redness or unusual sensations
- bleeding in the white of the eye or swelling of the eyelids
- worsening of asthma.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse .
Reporting side effects can help provide more information on the safety of
this medicine.
5. How to store SCAVER
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 package and on the blister after
Exp. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What SCAVER contains
- The active ingredient is ivermectin. Each tablet contains 3 mg of ivermectin. The other components are microcrystalline cellulose (E460), pregelatinized corn starch, butylated hydroxyanisole (E320), anhydrous citric acid (E330), magnesium stearate (E572).
Description of the appearance of SCAVER and contents of the pack
SCAVER are round, white tablets with the code “A300” imprinted on one side.
The tablets are available in boxes containing blister strips of 1, 4, 10 or 20 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Holder
S.F. Group S.r.l.
Via Tiburtina, 1143
00156 Rome
Italy
Manufacturer
CORIPHARMA EHF.
Reykjavíkurvegur 78
Hafnarfjörður IS-220
Iceland
This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Netherlands: Ivermectine Sigillata 3 mg tablets
Germany: Ivermectin Sigillata 3 mg Tablets
France: Ivermectine Sigillata
Italy: SCAVER
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- Страна регистрации
- Форма выпускаTablet, 3 MG
- Код АТХP02CF01
- 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 SKAVERФорма выпуска: Coated tablet, 3 MGДействующее вещество: ИвермектинПроизводитель: DIFA COOPER S.P.A.Отпускается по рецептуФорма выпуска: Coated tablet, 3 MGДействующее вещество: ИвермектинПроизводитель: SUBSTIPHARMОтпускается по рецептуФорма выпуска: Coated tablet, 100 MGДействующее вещество: мебендазолаПроизводитель: JANSSEN CILAG S.P.A.Отпускается по рецепту
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
SKAVER требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество SKAVER — Ивермектин. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
SKAVER производится компанией S.F. GROUP S.R.L.. 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 SKAVER 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 SKAVER 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 (Ивермектин) включают IVERMEKTINA DIFA, IVERSKAB, VERMOX. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
