Інструкція із застосування NALOXONE KLORIDRATO GALENIKA SENESE
Зміст інструкції
- NALOXONE CLORIDRATO GALENICA SENESE adults 0.4 mg/ml injectable solution, children 0.04 mg/2ml injectable solution
- What is NALOXONE CLORIDRATO GALENICA SENESE and what is it used for
- What you need to know before using NALOXONE HYDROCHLORIDE GALENICA SENESE
- How to use NALOXONE HYDROCHLORIDE GALENICA SENESE
- Possible side effects
- How to store NALOXONE CLORIDRATO GALENICA SENESE
- Contents of the pack and other information
NALOXONE CLORIDRATO GALENICA SENESE adults 0.4 mg/ml injectable solution, children 0.04 mg/2ml injectable solution
Naloxone hydrochloride
Equivalent medicine
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, pharmacist or nurse.
- 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 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 NALOXONE CLORIDRATO GALENICA SENESE is and what it is used for
- 2. What you need to know before you use NALOXONE CLORIDRATO GALENICA SENESE
- 3. How to use NALOXONE CLORIDRATO GALENICA SENESE
- 4. Possible side effects
- 5. How to store NALOXONE CLORIDRATO GALENICA SENESE
- 6. Contents of the pack and other information
1. What is NALOXONE CLORIDRATO GALENICA SENESE and what is it used for
NALOXONE CLORIDRATO GALENICA SENESE contains the active ingredient naloxone hydrochloride
dihydrate, belonging to the class of opioid antagonists. It works by blocking the activity of
opioid derivatives, such as morphine and heroin.
NALOXONE CLORIDRATO GALENICA SENESE adults is used to counteract the effects
of acute intoxication due to overdose of opioid derivatives (analgesics, narcotics).
NALOXONE CLORIDRATO GALENICA SENESE children 0.04 mg/2 ml is indicated for respiratory
depression of the newborn caused by maternal exposure to opioid derivatives before delivery.
This medicine is used only in emergency situations and by specialized medical personnel.
2. What you need to know before using NALOXONE HYDROCHLORIDE GALENICA SENESE
Do not use NALOXONE HYDROCHLORIDE GALENICA SENESE
- if you are allergic to naloxone or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor, pharmacist or nurse before using NALOXONE HYDROCHLORIDE
GALENICA SENESE.
The symptoms of acute (overdose) poisoning from opioids are:
- irregular and sometimes absent breathing (respiratory depression);
- absence of reflexes (comatose state, precoma or coma and in the most severe cases profound);
- constriction of the pupil of the eye (miosis). To treat these symptoms, in addition to naloxone, resuscitation techniques will be necessary, such as cardiac massage, artificial respiration and the administration of drugs that increase pressure (vasopressors).
NALOXONE HYDROCHLORIDE GALENICA SENESE is not effective against respiratory depression
caused by the use of non-opioid medicines.
This medicine should be administered with caution:
- if, in the hours preceding the administration of this medicine, you have had serious respiratory problems (laryngospasm);
- if you suffer from heart or circulatory problems or are taking other drugs harmful to the heart.
After the first intervention, the patient must be transferred to hospital and must be carefully monitored,
as the symptoms of poisoning may reappear.
Children and infants
Naloxone can be used in newborns of mothers who have taken an opioid substance within 4 hours
before delivery and in newborns who do not have independent breathing, but only as an adjunct therapy.
In newborns of drug-dependent mothers, the use of naloxone is not recommended, as it may worsen withdrawal symptoms and convulsions.
Other medicines and NALOXONE HYDROCHLORIDE GALENICA SENESE
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other
medicine.
Pay particular attention and consult your doctor if you are taking clonidine, a medicine used for
the treatment of high blood pressure.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
There is no data available to establish the effect of this medicine during pregnancy and breastfeeding
with breast milk.
Driving and using machines
There is no data available to establish the effect of this medicine on the ability to drive vehicles and
use machines.
3. How to use NALOXONE HYDROCHLORIDE GALENICA SENESE
Use this medicine following exactly the instructions of the doctor, pharmacist or
nurse. If you have any doubts, consult your doctor or pharmacist or nurse.
This medicine will be injected by the doctor or another healthcare professional, into a vein (intravenously),
under the skin (subcutaneously) or into a muscle (intramuscularly), depending on your needs.
In emergency situations, the intravenous route is recommended, as it produces a faster effect.
For intravenous infusion (drip) NALOXONE HYDROCHLORIDE GALENICA SENESE can be diluted
in solvents for parenteral use (e.g. sodium chloride 0.9% solution or glucose 5% solution).
Following treatment, the patient must be constantly monitored and transferred to hospital as soon as
possible, as symptoms may reappear. If necessary, the administration of the drug
may be repeated.
Use in adults
Treatment of opioid overdose (known or suspected)
The recommended initial dose is 0.4 mg/ml (1 vial).
If, after intravenous administration, there is no improvement in breathing, it is advisable to
repeat the dose at intervals of 2 - 3 minutes.
Treatment of postoperative opioid depression
The recommended dose is 0.1 to 0.2 mg administered intravenously in increasing doses at intervals of
- 2 - 3 minutes, until adequate improvement of symptoms is obtained. Within 1 - 2 hours of the first administration, it may be necessary to repeat the dose, also intramuscularly. Excessive doses of naloxone can determine a decrease in the analgesic effect of the analgesic and increase blood pressure. A reversal of the effects of the opioid medicine that is too rapid can induce nausea, vomiting, sweating or palpitations (tachycardia).
Use in children and adolescents
For the treatment of an opioid overdose (known or suspected) the recommended initial dose is
0.01 mg/kg of body weight, administered intravenously, intramuscularly or subcutaneously.
The dose may be repeated according to the instructions for administration in adults.
If you use more NALOXONE HYDROCHLORIDE GALENICA SENESE than you should
This medicine will be administered by trained personnel, so an
overdose is unlikely.
In case of ingestion/accidental intake of an excessive dose of Naloxone hydrochloride, immediately inform
your doctor or go to the nearest hospital.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
- nausea;
- tremor;
- sweating;
- increase or decrease in blood pressure;
- convulsions, agitation;
- heart disorders (fibrillation, cardiac arrest);
- fluid accumulation around the lung (pulmonary edema).
- increased levels of growth hormone;
- altered sensitivity of the limbs (paresthesia);
- memory disorders;
- difficulty breathing (dyspnea, hypoxia and respiratory depression, hyperventilation);
- difficulty swallowing (dysphagia);
- hot flashes and redness;
- urge to urinate (micturition);
- vomiting;
- acceleration of the heartbeat (ventricular tachycardia);
- hallucinations.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at http://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 NALOXONE CLORIDRATO GALENICA SENESE
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 packaging after “Exp.”. The expiry date refers to the last day of that month.
Store this medicine in the original packaging to protect it from light.
It is for a single and uninterrupted administration and any remaining medicine cannot be used.
After the first opening of the packaging, the medicine must be used immediately for a single and uninterrupted administration.
Do not dispose of any medicine in wastewater 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 NALOXONE HYDROCHLORIDE GALENICA SENESE
NALOXONEHYDROCHLORIDE GALENICA SENESE adults 0.4 mg/ml injectable solution contains:
- The active ingredient is naloxone hydrochloride dihydrate. Each 1 ml vial contains 0.4 mg of naloxone hydrochloride dihydrate.
- The other ingredients are water for injections q. s., hydrochloric acid.
NALOXONE HYDROCHLORIDE GALENICA SENESE children 0.04 mg/2 ml injectable solution:
- The active ingredient is naloxone hydrochloride dihydrate. Each 2 ml vial contains 0.04 mg of naloxone hydrochloride dihydrate.
- The other ingredients are water for injections q. s., hydrochloric acid.
Description of the appearance of NALOXONE HYDROCHLORIDE GALENICA SENESE and contents of the
pack
NALOXONE HYDROCHLORIDE GALENICA SENESE adults 0.4 mg/ml injectable solution
Pack of 10 vials of 1 ml injectable solution.
NALOXONE HYDROCHLORIDE GALENICA SENESE children 0.04 mg/2 ml injectable solution
Pack of 5 vials of 2 ml injectable solution.
Marketing Authorisation Holder and Manufacturer
Industria Farmaceutica Galenica Senese S.r.l.
Via Cassia Nord, 351
53014 Monteroni d'Arbia (SI)
Italy
- Країна реєстрації
- Лікарська формаInjectable solution, 0.04 MG/2 ML
- Код АТХV03AB15
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до NALOXONE KLORIDRATO GALENIKA SENESEЛікарська форма: Injectable/infusion solution in pre-filled syringe, 0.4 MG/MLДіюча речовина: НалоксонВиробник: ACCORD HEALTHCARE, S.L.U.Потрібен рецептЛікарська форма: Injectable solution, 0.4 MG/MLДіюча речовина: НалоксонВиробник: B. BRAUN MELSUNGEN AGПотрібен рецептЛікарська форма: Injectable solution, 0.4 MG/MLДіюча речовина: НалоксонРецепт не потрібен
Аналоги NALOXONE KLORIDRATO GALENIKA SENESE в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог NALOXONE KLORIDRATO GALENIKA SENESE у Іспанія
Аналог NALOXONE KLORIDRATO GALENIKA SENESE у Польща
Аналог NALOXONE KLORIDRATO GALENIKA SENESE у Україна
Лікарі онлайн щодо NALOXONE KLORIDRATO GALENIKA SENESE
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на NALOXONE KLORIDRATO GALENIKA SENESE онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
NALOXONE KLORIDRATO GALENIKA SENESE потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у NALOXONE KLORIDRATO GALENIKA SENESE — Налоксон. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
NALOXONE KLORIDRATO GALENIKA SENESE виробляється компанією INDUSTRIA FARMACEUTICA GALENICA SENESE S.R.L.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування NALOXONE KLORIDRATO GALENIKA SENESE з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати NALOXONE KLORIDRATO GALENIKA SENESE у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (Налоксон) включають NALOXONE AKKORD, NALOXONE B.BRAUN, NALOXONE KLORIDRATO MOLTENI. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
















