NERIXIA 25 mg Инъекционный Раствор
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Инструкция по применению NERIXIA
Содержание инструкции
NERIXIA 25 mg injectable solution, 100 mg concentrate for infusion solution
Neric acid
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 or pharmacist.
- This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What NERIXIA is and what it is used for
- 2. What you need to know before using NERIXIA
- 3. How to use NERIXIA
- 4. Possible side effects
- 5. How to store NERIXIA
- 6. Contents of the pack and other information
1. What NERIXIA is and what it is used for
NERIXIA is a medicine that contains neridronic acid, an active ingredient that belongs to a group of
drugs for the treatment of bone diseases, called bisphosphonates.
NERIXIA is used in adults and inchildren under 18 years of agefor the treatment of:
- a hereditary disease characterized by skeletal fragility, a decrease in bone mass and a predisposition to fractures (osteogenesis imperfecta or “brittle bone disease”). NERIXIA is also used only inadultsfor:
- the treatment of a bone disease that causes its enlargement and deformation (Paget's disease of bone)
- the symptomatic treatment of a bone disease characterized by pain and swelling, increased pain sensitivity (hyperalgesia), pain following a stimulus that is normally not painful (allodynia), movement disorders, joint stiffness, abnormal constriction or dilation of blood vessels, degeneration of soft tissues (complex regional pain syndrome), with symptoms appearing for less than 4 months.
2. What you need to know before using NERIXIA
Do not use NERIXIA
- If you/the child is allergic to neridronic acid, to other medicines similar to NERIXIA (bisphosphonates) or to any of the other components of this medicine (listed in section 6).
- If you/the child suffers from a severe kidney disease (severe renal insufficiency).
- If you are pregnant and/or breastfeeding (see section 2. “Pregnancy and breastfeeding”).
Warnings and precautions
Consult your doctor before using NERIXIA.
During treatment, your doctor will ask you to undergo blood tests to monitor the
kidney function and the levels of calcium and phosphate in the blood (see section 4. “Possible side
effects”).
In particular, inform your doctor:
- if you/the child has been diagnosed with cancer and is taking bisphosphonates, medicines for treating bone diseases
- if you/the child is undergoing chemotherapy or radiotherapy to treat cancer
- if you/the child is taking medicines to treat inflammation (corticosteroids)
- if you suffer from fragile bones (osteoporosis)
- if you/the child has poor dental health, has gum disease, is planning to have a tooth extraction or does not have regular dental check-ups. In these cases, a disease known as osteonecrosis of the jaw/maxilla may develop (see section 4. Possible side effects). In this case, during treatment with NERIXIA, avoid, if possible, invasive dental procedures. You may also need to undergo preventive dental treatment before starting treatment with NERIXIA (see section
- 4. Possible side effects).
Other medicines and NERIXIA
Tell your doctor or pharmacist if you/the child is taking, has recently taken or might take
any other medicine.
This is particularly important if you/the child is taking aminoglycosides, medicines used to
treat infections.
Pregnancy, breastfeeding and fertility
Do notuse NERIXIA during pregnancy and breastfeeding, as it is contraindicated (see section 2
“ Do not use NERIXIA”).
Driving and using machines
There is no data to suggest that NERIXIA has effects on the ability to drive vehicles and operate
machinery.
NERIXIA contains sodium
NERIXIA 25 mg injectable solution contains 9.6 mg of sodium per dose. This medicine contains less
than 1 mmol (23 mg) of sodium per vial, i.e. essentially ‘sodium-free’.
NERIXIA 100 mg concentrate for infusion solution contains 38.42 mg of sodium (the main component of
table salt) per dose. This is equivalent to 1.9% of the maximum recommended daily intake of sodium with
the diet of an adult.
This should be taken into consideration if you/the child suffers from kidney disease or follows a low-sodium
diet.
3. How to use NERIXIA
Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
This medicine can be given to both adults for injection into a muscle or a vein and to children only
for injection into a vein.
Imperfect osteogenesis
Adults
The recommended dose ranges from 25 mg to 100 mg i.v., depending on body weight, in a single
administration for slow infusion, after dilution in 250-500 ml of 0.9% sodium chloride solution.
The guideline dosage is 2 mg/kg of body weight every 3 months.
The total dose may be divided into intramuscular doses of 25 mg per day for up to 4 consecutive days every
3 months.
Children (under 18 years of age)
The recommended dose is 2 mg/kg of body weight (maximum 100 mg) for slow intravenous infusion
(at least 2 hours) every 3 months. Before administration, dilute in 250–500 ml of 0.9% sodium chloride
solution.
Paget's disease of bone
The most commonly recommended dose is 100 mg per day intravenously, for 2 consecutive days,
for slow infusion (at least 2 hours) after dilution in 250-500 ml of physiological solution. Lower
doses may be sufficient for less severe forms of the disease; the total dose may also be divided
into intramuscular doses of 25 mg/day to be administered on consecutive days for up to 8 days. The
doctor will assess the appropriateness of repeating the therapeutic cycle after no less than 6 months, when the therapeutic effect on bone turnover (serum alkaline phosphatase) of the first cycle has fully manifested.
Complex Regional Pain Syndrome
The recommended dose is 100 mg per day intravenously, every 3 days for a total of 400 mg of
neridronate, administered in slow intravenous infusion (at least 2 hours) after dilution in 250-500 ml of
physiological solution.
In cases where intravenous administration of NERIXIA 100 mg concentrate for
infusion solution is not possible, if the doctor deems home treatment appropriate, the recommended dose of
NERIXIA 25 mg injectable solution is 25 mg (1 vial) intramuscularly per day for 16
consecutive days, for a total of 400 mg of neridronate.
Repetition of treatment is not recommended due to the lack of clinical data.
Children and adolescents (under 18 years of age)
The use of NERIXIA is not recommended due to the lack of clinical data.
If you use more NERIXIA than you should
In case of accidental intake of an excessive dose of NERIXIA, immediately contact your doctor or
the nearest hospital.
Symptoms of overdose may include:
- Lowering of calcium levels in the blood Treatment A significant lowering of calcium levels in the blood can be corrected with the intravenous administration of calcium gluconate.
If you forget to use NERIXIA
Do not use a double dose to make up for a missed dose.
If you stop using NERIXIA
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects are listed below according to their frequency.
Uncommon (may affect up to 1 in 100 people)
- Pain at the injection site, which decreases after a few minutes (in case of administration into a muscle).
Rare (may affect up to 1 in 1,000 people)
- Atypical femur fracture (long bone of the leg), particularly in patients treated for a long time for osteoporosis. Contact your doctor if you experience pain, weakness or discomfort in the thigh, hip or groin, as this could be an early sign of a possible femur fracture
- Flu-like syndrome with fever, malaise, chills and bone and/or muscle pain. In most cases, no specific treatment is necessary and symptoms disappear within a few hours or days.
Very rare (may affect up to 1 in 10,000 people)
- Osteonecrosis of the jaw/maxilla (see section 4. Warnings and precautions)
- Contact your doctor if you experience ear pain, ear discharge and/or ear infection. These episodes may be signs of bone damage in the ear (Osteonecrosis of the external auditory canal)
- Skin rash
- Hives
- Dizziness
- Pain at the injection site, which decreases after a few minutes (in case of intravenous administration)
Not known (frequency cannot be estimated from available data)
- Eye inflammation that can manifest, for example, with eye pain, redness, light sensitivity, tearing, blurred vision, discharge (conjunctivitis, anterior uveitis, episcleritis)
- Decreased calcium levels in the blood (hypocalcemia)
- Decreased phosphate levels in the blood (hypophosphatemia).
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system 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 NERIXIA
This medicine does not require any special storage conditions.
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 pack after Scad.
The expiry date refers to the last day of that month.
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 NERIXIA contains
NERIXIA 25 mg injectable solution
- The active ingredient in a 2 ml vial is Sodium neridronate 27 mg, equivalent to 25 mg of neridronic acid.
- The other ingredients are Sodium chloride; disodium citrate dihydrate(see section 2. NERIXIA contains sodium), citric acid monohydrate; water for injections.
NERIXIA 100 mg concentrate for solution for infusion
- The active ingredient in an 8 ml vial is Sodium neridronate 108 mg, equivalent to 100 mg of neridronic acid.
- The other ingredients are Sodium chloride; disodium citrate dihydrate(see section 2. NERIXIA contains sodium), citric acid monohydrate; water for injections.
Description of the appearance of NERIXIA and contents of the pack
NERIXIA 25 mg injectable solution presents as a clear and colourless injectable solution in vials
of 2 ml for intramuscular and intravenous use.
It is available in packs of 1 vial, 4 vials or 8 vials.
NERIXIA 100 mg concentrate for solution for infusion presents as a clear and
colourless solution in packs of 2 vials of 8 ml for intravenous use.
Not all pack sizes may be marketed
Marketing authorisation holder and manufacturer
ABIOGEN PHARMA S.p.A. - Via Meucci 36 –Loc. Ospedaletto – Pisa, Italy
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- Страна регистрации
- Форма выпускаInjectable solution, 25 MG
- Отпускается по рецептуДа
- Производитель
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- Аналоги NERIXIAФорма выпуска: Film-coated tablet, 70 MGДействующее вещество: алендроната натрияПроизводитель: LABORATORI ALTER S.R.L.Отпускается по рецептуФорма выпуска: Coated tablet, 70 MGДействующее вещество: алендроната натрияПроизводитель: AUROBINDO PHARMA (ITALIA) S.R.L.Отпускается по рецептуФорма выпуска: Coated tablet, 70 MGДействующее вещество: алендроната натрияПроизводитель: FG S.R.L.Отпускается по рецепту
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NERIXIA производится компанией ABIOGEN PHARMA S.P.A.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
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