VENOFER 5 ML Roztwór do wstrzykiwań
Ocena recepty online
Lekarz przeanalizuje Twój przypadek i zdecyduje, czy wystawienie recepty jest medycznie uzasadnione.
Porozmawiaj z lekarzem o tym leku
Omów swoje objawy i opcje leczenia podczas szybkiej konsultacji online.
Jak stosować VENOFER
Treść ulotki
Venofer 20 mg of iron/mL,
Injectable solution or concentrate for infusion solution
Iron Sucrate
This medicinal product is subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.
Read this leaflet carefully before you are given this medicine because
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 you get any side effects, see your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Venofer is and what it is used for
- 2. What you need to know before you are given Venofer
- 3. How Venofer is given
- 4. Possible side effects
- 5. How to store Venofer
- 6. Contents of the pack and other information
1. What is Venofer and what is it used for
Venofer is a medicine containing iron.
Medicines containing iron are used when you do not have enough iron in your body.
This condition is called “iron deficiency”.
Venofer is administered when:
- You cannot take iron by mouth, for example when iron tablets cause discomfort.
- You have already taken iron by mouth and it has had no effect.
2. What you need to know before you are given Venofer
Do not be given Venofer if:
- you are allergic (hypersensitive) to the product or to any of the other ingredients of this medicine (listed in section 6).
- you have had severe allergic reactions (hypersensitivity) to other injectable iron preparations.
1 / 7
- you have anaemia that is not caused by iron deficiency;
- you have a high amount of iron in your body or disorders in the use of iron by your body.
Do not be given Venofer if you fall into one of the above cases. If you have any
doubts, consult your doctor before you are given Venofer.
Warnings and precautions
Talk to your doctor or nurse before receiving Venofer if:
- you have had allergies to medicines in the past.
- you have systemic lupus erythematosus.
- you have rheumatoid arthritis.
- you have severe asthma, eczema or other allergies.
- you have any infection.
- you have liver problems.
If you are not sure if you fall into one of the above cases, consult your doctor or pharmacist before
you are given Venofer.
Other medicines and Venofer
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription and herbal remedies.
This is because Venofer can affect the action of other medicines. Likewise, other
medicines can affect the action of Venofer.
In particular, tell your doctor or pharmacist if you are taking:
- Medicines that contain iron, taken by mouth. These medicines may not be effective if they are used at the same time as Venofer.
Pregnancy and breastfeeding
Venofer has not been evaluated in women in the first trimester of pregnancy. It is important
to tell your doctor if you are pregnant, suspect you are pregnant or are planning a
pregnancy.
If you become pregnant during treatment, you should ask your doctor for advice.
The doctor will decide whether or not you should be given this
medicine.
If you are breastfeeding, ask your doctor for advice before you are given
Venofer.
Ask your doctor or pharmacist for advice before taking any medicine if you are
pregnant or breastfeeding.
Driving and using machines
2 / 7
You may feel dizzy, confused or lightheaded after receiving Venofer. In
that case, you should not drive vehicles or use tools or machinery. If you have any doubts, ask your
doctor.
3. How Venofer is administered
Your doctor will decide how much Venofer to administer. The doctor will also decide the frequency of
administration you need and the duration of treatment. To establish the dose, the doctor will
perform a blood test.
The doctor or nurse will administer Venofer to you via one of the following routes:
- Slow intravenous injection - 1 to 3 times a week.
- As an intravenous infusion (drip) - 1 to 3 times a week.
- During dialysis - introduced into the venous line of the dialysis machine. Venofer will be administered in a facility where immunoallergic events can receive immediate and appropriate treatment. You will be monitored for at least 30 minutes by the doctor or nurse after each administration.
Venofer is a brown-colored liquid, so the injection or infusion will also be brown in
color.
Use in children
The use of Venofer is not recommended in children.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Allergic reactions(uncommon)
If you have an allergic reaction, tell your doctor or nurse immediately. Signs may include:
- Low blood pressure (feeling dizzy, lightheaded or fainting).
- Swelling of the face.
- Difficulty breathing. In some patients, these allergic reactions (rare) can become serious or potentially life-threatening (known as anaphylactoid/anaphylactic reactions). If you think you are having an allergic reaction, tell your doctor or nurse immediately. Other side effects include:Common(may affect up to 1 in 10 people)
- Changes in taste, for example, metallic taste. This is usually not a long-lasting effect.
- Low or high blood pressure.
- Feeling unwell (nausea).
3 / 7
- Reactions around the injection/infusion site such as pain, irritation, itching, bruising or discoloration following leakage of the injection into the skin. Uncommon(may affect up to 1 in 100 people)
- Headache or dizziness.
- Stomach pain or diarrhea.
- Vomiting.
- Wheezing, difficulty breathing.
- Itching, rash.
- Muscle spasms, cramps or pain
- Tingling or "pins and needles".
- Reduced sense of touch.
- Inflammation of the veins.
- Redness, burning sensation.
- Constipation.
- Joint pain.
- Pain in the limbs.
- Back pain.
- Chills.
- Weakness, fatigue.
- Swelling of the hands and feet.
- Pain.
- Increased levels of liver enzymes (ALT, AST, GGT) in the blood.
- Increased levels of serum ferritin.
Rare(may affect up to 1 in 1,000)
- Fainting.
- Drowsiness or sleepiness.
- Heartbeat racing (palpitations).
- Change in urine color.
- Chest pain.
- Increased sweating.
- Fever.
- Increased levels of lactate dehydrogenase in the blood.
Other side effects with unknown frequency include: decreased alertness; feeling confused; loss of consciousness; anxiety; tremor or agitation; swelling of the face, mouth, tongue or throat which can cause difficulty breathing; slowed pulse rate; accelerated pulse rate; circulatory collapse; inflammation of the veins causing a blood clot to form; acute narrowing of the airways; itching, hives, rash or redness of the skin; cold sweat, feeling generally unwell; pale skin; sudden, life-threatening allergic reactions. A flu-like illness may occur a few hours to several days after the injection and is usually characterized by symptoms such as high temperature and muscle and joint pain.
Reporting of side effects
4 / 7
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 at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Venofer
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 after "Scad".
Do not store at a temperature above 25°C. Do not freeze. Keep the vials or bottles
in the outer packaging.
Once opened, the vials of Venofer or the bottles of Venofer must be used
immediately. After dilution with sodium chloride solution, the diluted solution must
be used immediately.
Venofer is normally stored by the doctor or the hospital.
6. Package Contents and Other Information
What Venofer contains
- The active ingredient is iron (as iron saccharate). Each millilitre contains 20 mg of iron.
- The other ingredients are water for injections and sodium hydroxide.
Description of the appearance of Venofer and contents of the pack
Venofer is an aqueous solution of dark brown colour, not transparent.
Venofer is available in the following packs:
- 5 glass vials of 5 mL. Each 5 mL vial corresponds to 100 mg of iron.
- 5 glass ampoules of 2.5 mL. Each 2.5 mL ampoule corresponds to 50 mg of iron.
- 5 glass ampoules of 5 mL. Each 5 mL ampoule corresponds to 100 mg of iron. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Vifor France
100-101 Terrasse Boieldieu
Tour Franklin La Défense 8
92042 Paris La Défense Cedex
France
Tel. +33 (0)1 41 06 58 90
Fax +33 (0)1 41 06 58 99
DISTRIBUTOR FOR SALES:
Vifor Pharma Italia Srl
Via Paolo di Dono, 73
5 / 7
00142 Rome
Italy
For any information regarding this medicine, contact the local representative of the Marketing
Authorisation Holder.
The following information is intended exclusively for healthcare professionals:
Administration
Carefully monitor patients for the appearance of signs and symptoms of hypersensitivity reactions
during and after each administration of Venofer.
Venofer must only be administered if personnel trained to assess and manage anaphylactic reactions are
immediately available, in a facility where complete resuscitation equipment can be guaranteed. The patient
must be kept under observation for the possible occurrence of adverse reactions for at least 30 minutes after each
administration of Venofer.
Method of administration:
Venofer must be administered exclusively by intravenous route, which may consist of a
drip infusion, a slow intravenous injection or a direct injection into the venous line
of the dialysis machine.
Paravenous leakage must be avoided, as leakage of Venofer at the injection site may
cause pain, inflammation and brownish discolouration of the skin.
Intravenous drip infusion:
Venofer must be diluted exclusively in a sterile solution of sodium chloride (NaCl) 0.9% w/v.
Dilution must occur immediately before the infusion and the solution must be
administered as follows:
| i z Dose of Venofer (mg of iron) n | a Dose of Venofer (mL of Venofer) | Maximum dilution volume of sterile NaCl 0.9% w/v solution | Minimum infusion time |
| 50 mg | 2.5 mL | 50 mL | 8 minutes |
| e 100 mg | 5 mL | 100 mL | 15 minutes |
| 200 mg | 10 mL | 200 mL | 30 minutes |
For stability reasons, dilutions to concentrations lower than those of Venofer are not permitted.
Intravenous injection:
6 / 7
Venofer can be administered by slow intravenous injection, at a rate of 1 mL of
undiluted solution per minute, not administering more than 10 mL of Venofer (200 mg of iron)
per injection.
Injection into the venous line of the dialysis machine:
Venofer can be administered during a haemodialysis session directly into the venous line
of the dialysis machine under the same conditions as described for intravenous injection.
Incompatibilities
Venofer must not be mixed with medicines other than sterile sodium chloride solution
0.9% w/v. If mixed with other solutions or medicines, there is a risk of
precipitation and/or interaction. The compatibility of the product with containers other than
glass, polyethylene and PVC is unknown.
Shelf life and storage
Do not use this medicine after the expiry date which is stated on the pack after "Scad". Do
not store above 25°C. Do not freeze. Store in the original package.
Shelf life after first opening of the container
From a microbiological point of view, the diluted product must be used immediately.
Shelf life after dilution with sterile sodium chloride (NaCl) 0.9% w/v solution
From a microbiological point of view, the diluted product must be used immediately after
dilution.
Instructions for use and handling
Before use, vials or ampoules must be visually inspected for the presence of any
sediment or damage. Use only those that do not
contain sediment and in which the solution is homogeneous. The diluted solution must
be brown and transparent.
Unused medicine and waste derived from this medicine must be disposed of in
accordance with local regulations.
7 / 7
Nie jesteś pewien, czy ten lek jest odpowiedni dla ciebie?
Omów swoje objawy i leczenie z lekarzem online.
Zacząłeś przyjmować lek i masz pytania?
Omów swoje objawy i leczenie z lekarzem online.
- Kraj rejestracji
- Postać farmaceutycznaInjectable solution, 5 ML
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki VENOFERPostać farmaceutyczna: Effervescent tablet, 80 MGSubstancja czynna: ferrous gluconateBez receptyPostać farmaceutyczna: Hard capsule, 30 MGSubstancja czynna: ferric maltolProducent: NORGINE BVBez receptyPostać farmaceutyczna: Oral solution, 40 MG/15 MLSubstancja czynna: ferric proteinsuccinylateProducent: LIFEPHARMA S.P.A.Bez recepty
Odpowiedniki VENOFER w innych krajach
Leki z tą samą substancją czynną dostępne w innych krajach.
Odpowiednik VENOFER w Hiszpania
Odpowiednik VENOFER w Polska
Odpowiednik VENOFER w Ukraina
Lekarze online w sprawie VENOFER
Omów stosowanie VENOFER, bezpieczeństwo i ocenę zasadności recepty zgodnie z obowiązującymi przepisami.
Uzyskaj receptę na VENOFER online
Wypełnij 2-minutowy formularz
Opisz swoje objawy, historię choroby i lek, o który prosisz.
Wybierz lekarza lub pozwól nam przydzielić
Wybierz specjalistę lub dopasujemy Cię do najbliższego dostępnego lekarza.
Lekarz analizuje Twój przypadek
Zazwyczaj w ciągu 30 minut. Może zadawać dodatkowe pytania przez czat.
Odbierz w dowolnej aptece
Recepta elektroniczna wysłana na Twój e-mail — ważna w całej Polsce.
Często zadawane pytania
VENOFER nie wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
VENOFER jest produkowany przez VIFOR FRANCE. 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 VENOFER 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 VENOFER 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 () to m.in. KROMATONFERRO, FERAKKRU, FERLATUM. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
