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What ABILIFY solution for injection is and what it is used for
ABILIFY solution for injection contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics. ABILIFY solution for injection is used to rapidly treat symptoms of agitation and behavioral disorders that may occur in a condition characterized by symptoms such as:
Hearing, seeing or feeling things that do not really exist, suspicion, misconceptions, confused (unrelated) speech and behavior, and boredom. People in such a state may experience depression, feeling guilt, anxiety or tension;
Feeling overwhelmed, over-energized, needing much less sleep than usual, very fast talking with racing ideas, and sometimes severe irritability.
ABILIFY solution for injection is given when treatment with oral ABILIFY can not be given. Your doctor will replace your ABILIFY oral solution as soon as possible.
2. What you need to know before using ABILIFY solution for injection
Do not use ABILIFY solution for injection:
If you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before you are given ABILIFY solution for injection.
Before treatment with ABILIFY solution for injection, tell your doctor if you suffer from:
High blood sugar (characterized by symptoms such as excessive thirst, excessive urine output, increased appetite, feeling weak) or have previous diabetes in the family;
Seizures, as your doctor may wish to monitor you more closely;
Involuntary, irregular movements of the muscles, especially the face;
Cardiovascular disease, family history of cardiovascular disease, stroke or mini-incontinence, deviation from normal blood pressure;
The presence of blood clots or familial data for them as the use of antipsychotic agents is associated with blood clotting;
A strong attraction to gambling in the past.
If you notice weight gain, develop unusual movements, have somnolence that interferes with your normal daily activities, have difficulty in swallowing or allergic symptoms, please tell your doctor.
If you are an adult patient and suffer from dementia (loss of memory or other mental abilities), you or your relative should tell your doctor whether you have had a stroke or a "micro" stroke.
Tell your doctor or nurse if you experience dizziness or weakness. You'll probably need to lie down until you feel an improvement. Your doctor may also want to measure your blood pressure and your heartbeat.
Tell your doctor immediately if you have thoughts or feelings that are aimed at self-harm. There have been reports of thoughts and suicidal attempts during treatment with aripiprazole.
Tell your doctor immediately if you suffer from muscle stiffness or lack of flexibility accompanied by fever, sweating, altered mental status, or an accelerated or uneven heartbeat.
Children and adolescents
ABILIFY solution for injection should not be used in children and adolescents under 18 years of age.
Ask your doctor or pharmacist for advice before taking ABILIFY solution for injection.
Other medicines and ABILIFY solution for injection
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Blood pressure lowering medicines: ABILIFY solution for injection may increase the effect of medicines used to lower blood pressure. Make sure your doctor knows you are taking medicines to control your blood pressure.
The use of ABILIFY solution for injection together with other medicines may require a change in the dosage of ABILIFY solution for injection. It is especially important to tell your doctor about the following medicines:
Heart rate correction medications;
Antidepressants or herbal preparations used to treat depression and anxiety;
Some medicines to treat HIV infection;
Anticonvulsants used to treat epilepsy.
Serotonin elevators: tryptans, tramadol, tryptophan, SSRI (for example paroxetine and fluoxetine), tricyclic antidepressants (eg clomipramine, amitriptyline), pethidine, St. John's wort and venlafaxine. Because these medicines increase the risk of side effects, if you get any unusual symptoms while taking any of these medicines in combination with ABILIFY solution for injection,
Talk to your doctor.
If you are taking tranquillizers in combination with ABILIFY solution for injection, you may feel sleepy or dizzy. While you are using ABILIFY solution for injection, other medicines can only be taken if your doctor has told you this.
ABILIFY solution for injection with food, beverages and alcohol
ABILIFY solution for injection can be given regardless of diet (with or without food).
Alcohol should be avoided.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor before taking this medicine.
The following symptoms may occur in newborns whose mothers have used ABILIFY during the last trimester (the last three months of pregnancy): trembling, muscle stiffness and / or weakness, drowsiness, agitation, breathing problems and eating difficulties. If any of these symptoms occur with your baby, contact your doctor.
When breastfeeding, tell your doctor immediately.
If you are taking ABILIFY solution for injection, you should not breast-feed.
Driving and using machines
Do not drive or use any tools or machines if you feel sleepy after taking ABILIFY solution for injection.
3. How to use ABILIFY solution for injection
Your doctor will decide on the dose of ABILIFY solution for injection you need and how long you will need it. The recommended dose is 9.75 mg (1.3 ml) for the first injection. Up to 3 injections per 24 hours may be given. The total dose of ABILIFY (all forms) should not exceed 30 mg per day.
ABILIFY solution for injection is a ready-to-use solution. The exact amount of solution will be injected intramuscularly by your doctor or nurse.
If you have been given more ABILIFY solution for injection than you should
This medicine will be given to you under medical supervision; Therefore it is unlikely that you will be given a larger amount. If you are attending more than one doctor, be sure to tell your doctor that you are being given ABILIFY solution for injection.
If you miss an injection with ABILIFY solution for injection
It is important that you do not miss the planned dose. If you miss an injection, you should contact your doctor to arrange the next injection as soon as possible. If you have any further questions on the use of this medicine, ask your doctor or nurse.
If you stop using ABILIFY solution for injection
Do not stop your treatment just because you feel better. It is important that you continue to use ABILIFY solution for injection for as long as your doctor tells you.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Common side effects (may affect up to 1 in 10 patients):
Feeling unrestrained and unable to sit together, sitting problems in one place;
Uncontrolled twitching, convulsions or convulsions, restless leg syndrome;
Trembling and blurred vision;
Reduced number of stools or difficulty walking;
More saliva in the mouth than usual;
Uncommon side effects (may affect up to 1 in 100 patients):
Increased levels of the hormone prolactin in the blood;
Increased blood sugar;
Changed or increased sexual interest;
Uncontrolled movements of the mouth, tongue and limbs (tardive dyskinesia);
Muscle spasm causing spastic movements (dystonia);
Decreasing blood pressure when straightening, causing dizziness, dizziness or fainting.
The following side effects have been reported following oral aripiprazole, but the frequency of their occurrence is unknown:
Low levels of white blood cells;
Low levels of blood platelets;
An allergic reaction (eg swelling of the mouth, tongue, face and throat, itching, urticaria);
The onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma;
High blood glucose levels;
Insufficient sodium in the blood;
Loss of appetite (anorexia);
Suicidal thoughts, attempted suicide and suicide;
Strong gambling appeal;
A sense of aggression;
Combination of high fever, muscle stiffness, rapid breathing, sweating, blurred consciousness and sudden changes in blood pressure and heart rate, fainting (malignant neuroleptic syndrome);
Serotonin syndrome (a reaction that may cause a feeling of excessive happiness, sleepiness, clumsiness, restlessness, feeling of being intoxicated, fever, sweating or stiffness in the muscles);
Sudden unexplained death;
Life-threatening irregular heartbeat;
Heart attack (heart attack);
Slow heart rate;
Blood clots in the veins, especially in the legs (symptoms include swelling of the limb, pain and redness) that can reach the blood vessels to the lungs and cause chest pain and difficulty in breathing (in the presence of these symptoms, immediately look for medical assistance);
high blood pressure;
Accidental inhalation of food at risk of pneumonia (pulmonary infection);
Spasm of the muscles around the voice box;
Inflammation of the pancreas;
Inflammation of the liver;
Yellowing of the skin and white eyes;
Reports of liver function test abnormalities;
Sensitivity to light;
Abnormal muscle breakdown that can lead to kidney problems;
Involuntary urine (incontinence);
Withdrawal symptoms in neonates in case of exposure during pregnancy;
Prolonged and / or painful erection;
Problems in body thermoregulation or overheating;
Swelling of the hands, ankles or legs;
In blood tests: changing blood sugar levels, elevated glycated hemoglobin.
In elderly patients with dementia, more fatal cases have been reported during aripiprazole administration. In addition, cases of stroke or "micro" stroke have also been reported.
Additional side effects in children and adolescents
Adverse reactions in adolescents at or above 13 years of age are similar in frequency and type to those in adult patients, with the exception of insomnia, uncontrolled convulsions and shivering, restlessness and tiredness, which are very common (more than 1 in 10 patients); Upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrollable movements of the limbs, dizziness, especially when getting up from a lying or sitting position, which are common side effects - frequencies of 1 per 100 patients).
Reporting of side effects
If any of the side effects gets serious, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet
How to store ABILIFY solution for injection
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and on the vial after EXP. The expiry date refers to the last day of that month.
Keep the vial in the outer carton in order to protect from light.
Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What ABILIFY contains solution for injection
The active substance is aripiprazole.
Each ml contains 7.5 mg aripiprazole.
Each vial contains 9.75 mg (1.3 ml) of aripiprazole.
The other ingredients are: Sulbutyl β-cyclodextrin (SBECD), tartaric acid, sodium hydroxide and water for injections.
What ABILIFY solution for injection looks like and contents of the pack
ABILIFY solution for injection is a clear, colorless, aqueous solution.
Each box contains one Type I glass vial for single use with a rubber butyl stopper sealed with an aluminum cap.
Each box contains a disposable Type I glass vial with a rubber butyl stopper and a tear-off aluminum cap.
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