Aripiprazole Eg Stada

Package leaflet: Information for the user

Aripiprazole EG STADA 300 mg powder and solvent for prolonged-release injectable suspension
Aripiprazole EG STADA 400 mg powder and solvent for prolonged-release injectable suspension
Generic medicine

Please read all of 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 further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Aripiprazole EG STADA is and what it is used for
2. What you need to know before you are given Aripiprazole EG STADA
3. How Aripiprazole EG STADA is administered
4. Possible side effects
5. How to store Aripiprazole EG STADA
6. Contents of the pack and other information

1. What Aripiprazole EG STADA is and what it is used for

Aripiprazole EG STADA contains the active substance aripiprazole in a vial. Aripiprazole belongs to a group of medicines called antipsychotics. Aripiprazole EG STADA is used in the treatment of schizophrenia, a disorder characterised by symptoms such as hearing, seeing or sensing things that are not there, suspiciousness, false beliefs, disorganised speech and behaviour, and flattened emotions. People with this disorder may also feel depressed, guilty, anxious or tense.
Aripiprazole EG STADA is intended for adult patients with schizophrenia who are sufficiently stabilised during treatment with oral aripiprazole.

2. What you need to know before receiving Aripiprazole EG STADA

DO NOT use Aripiprazole EG STADA if:

• you are allergic to aripiprazole or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or nurse before receiving Aripiprazole EG STADA.
Suicidal thoughts and behaviours have been reported during treatment with this medicine. Inform your doctor immediately if you experience any self-harming thoughts or feelings, either before or after receiving Aripiprazole EG STADA.
Before starting treatment with Aripiprazole EG STADA, inform your doctor if you have:

• acute agitation or severe psychotic state;
• heart problems or a history of stroke, especially if you know you have other risk factors for stroke;
• high blood sugar levels (characterized by symptoms such as excessive thirst, production of large amounts of urine, increased appetite, and feeling weak) or a family history of diabetes;
• epilepsy (seizures), as your doctor may decide to monitor you more closely;
• involuntary, irregular muscle movements, especially of the face;
• a combination of fever, sweating, rapid breathing, muscle stiffness, and lethargy or drowsiness (which may be signs of neuroleptic malignant syndrome);
• dementia (loss of memory and other mental abilities), especially if you are elderly;
• cardiovascular diseases (heart and circulation problems), family history of cardiovascular disease, stroke or transient ischaemic attack, or blood pressure abnormalities;
• irregular heartbeat, or if someone in your family has had episodes of irregular heartbeat (including so-called QT prolongation observed on electrocardiogram [ECG] monitoring);
• blood clots or a family history of blood clots, as antipsychotics have been associated with blood clot formation;
• difficulty swallowing;
• previous experience of excessive gambling;
• severe liver problems.

If you notice that you are gaining weight, developing unusual movements, experiencing drowsiness that interferes with your normal daily activities, having difficulty swallowing, or developing allergic symptoms, please inform your doctor immediately.
Inform your doctor if you, your family members, or your caregiver notice that you are developing an urge or desire to behave in ways that are unusual for you and that you cannot resist the impulse, drive, or temptation to carry out certain activities that could harm yourself or others. These phenomena are known as impulse control disorders and may include behaviours such as gambling addiction, binge eating, compulsive spending, unusually high sex drive, or preoccupation due to increased sexual thoughts or sensations.
Your doctor may consider it necessary to adjust your dose or discontinue treatment.
This medicine may cause drowsiness, low blood pressure when standing up, dizziness, and disturbances in movement and balance, which may lead to falls. Be cautious, especially if you are an elderly or debilitated patient.

Children and adolescents
Do not use this medicine in children and adolescents under 18 years of age. Its safety and efficacy are not known in these patients.

Other medicines and Aripiprazole EG STADA
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Medicines that lower blood pressure: Aripiprazole EG STADA may enhance the effect of medicines used to lower blood pressure. Inform your doctor if you are taking any medicine to control your blood pressure.
Taking Aripiprazole EG STADA together with certain medicines may require your doctor to adjust the dose of Aripiprazole EG STADA or of the other medicines. It is particularly important to inform your doctor about the following medicines:

• medicines used to correct heart rhythm (e.g., quinidine, amiodarone, flecainide);
• antidepressants or herbal remedies used to treat depression and anxiety (e.g., fluoxetine, paroxetine, St. John’s wort);
• antifungal medicines (e.g., itraconazole);
• ketoconazole (used to treat Cushing's syndrome when the body produces excess cortisol);
• certain medicines used to treat HIV infection (e.g., efavirenz, nevirapine, and protease inhibitors such as indinavir, ritonavir);
• anticonvulsants used to treat epilepsy (e.g., carbamazepine, phenytoin, phenobarbital);
• certain antibiotics used to treat tuberculosis (rifabutin, rifampicin);
• medicines known to prolong the QT interval.

These medicines may increase the risk of adverse effects or reduce the effectiveness of Aripiprazole EG STADA. Consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Aripiprazole EG STADA.
Medicines that increase serotonin levels are typically used for conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

• triptans, tramadol, and tryptophan used for conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain;
• SSRIs (e.g., paroxetine and fluoxetine) used for depression, OCD, panic, and anxiety;
• other antidepressants (e.g., venlafaxine and tryptophan) used for major depression;
• tricyclics (e.g., clomipramine and amitriptyline) used for depressive illness;
• St. John’s wort (Hypericum perforatum), used as a herbal remedy for mild depression;
• painkillers (e.g., tramadol and pethidine) used to relieve pain;
• triptans (e.g., sumatriptan and zolmitriptan) used to treat migraine.

These medicines may increase the risk of adverse effects. Consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Aripiprazole EG STADA.

Aripiprazole EG STADA and alcohol
Alcohol should be avoided.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before receiving this medicine.
Aripiprazole EG STADA must not be administered during pregnancy unless you have discussed your situation with your doctor. If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor immediately.
Newborn babies whose mothers have taken Aripiprazole EG STADA during the last three months of pregnancy (third trimester) may experience the following symptoms:
tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems.
If your baby shows any of these symptoms, you must contact your doctor.
If you are receiving Aripiprazole EG STADA, your doctor will discuss with you whether you should breastfeed, considering the benefit of treatment for you and the benefit of breastfeeding for the baby. One choice excludes the other. If you are receiving Aripiprazole EG STADA, discuss with your doctor the best way to feed your baby.

Driving and using machines
Dizziness and visual disturbances may occur during treatment with this medicine (see section 4). This should be taken into account in situations requiring full alertness, such as when driving a vehicle or operating machinery.

Aripiprazole EG STADA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How Aripiprazole EG STADA is administered

Aripiprazole EG STADA is supplied as a powder, which your doctor or nurse will use to prepare a suspension.
Your doctor will decide the appropriate dose of Aripiprazole EG STADA for you. The recommended initial dose is 400 mg, unless your doctor decides to prescribe a lower initial or follow-up dose.
You will receive a single injection of Aripiprazole EG STADA on the first day, and oral aripiprazole treatment will continue for 14 days after the first injection.
Subsequently, treatment will be administered via Aripiprazole EG STADA injections, unless otherwise directed by your doctor.
Your doctor will administer the medicine as a single intramuscular injection into the gluteal or deltoid muscle (buttock or shoulder) once a month. You may experience mild pain during the injection. Your doctor will alternate injections between the right and left side. Injections will not be administered intravenously.

If you receive more Aripiprazole EG STADA than you should
This medicine will be administered under medical supervision, so it is unlikely that you will receive too much. If you are consulting more than one doctor, make sure to inform them that you are being treated with Aripiprazole EG STADA.
Patients who have received an excessive amount of this medicine have experienced the following symptoms:

• rapid heartbeat, agitation/aggression, speech difficulties;
• unusual movements (especially of the face and tongue), and reduced level of consciousness.

Other symptoms may include:

• acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating;
• muscle rigidity and drowsiness or somnolence, slowed breathing, sensation of suffocation, high or low blood pressure, changes in heart rhythm.

If you experience any of these symptoms, contact your doctor immediately or go to a hospital.

If you miss an injection of Aripiprazole EG STADA
It is important not to miss your scheduled dose. You should receive an injection every month, but not earlier than 26 days after the last injection. If you miss an injection, contact your doctor as soon as possible to schedule the next one.

If you stop receiving Aripiprazole EG STADA
Do not stop treatment just because you feel better. It is important that you continue receiving Aripiprazole EG STADA for the full duration prescribed by your doctor.
If you have any questions about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Serious side effects
If you experience any of the following serious side effects, contact your doctor immediately:

• a combination of any of the following symptoms: excessive drowsiness, dizziness, confusion, disorientation, difficulty speaking, difficulty walking, muscle stiffness or tremors, fever, weakness, irritability, aggression, anxiety, increased blood pressure, or seizures, which may lead to loss of consciousness;
• unusual movements, mainly affecting the face or tongue, which may lead your doctor to consider reducing the dose;
• symptoms such as swelling, pain and redness in one leg, which may indicate the presence of a blood clot that could travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, contact your doctor immediately;
• a combination of fever, rapid breathing, sweating, muscle stiffness and drowsiness or sleepiness, as this may be a sign of a condition called neuroleptic malignant syndrome (NMS);
• increased thirst, need to urinate more than usual, intense hunger, feeling weak or tired, nausea, confusion or fruity-smelling breath, as these may be signs of diabetes;
• suicidal thoughts, behaviours or thoughts and feelings of self-harm.

After receiving Aripiprazole EG STADA, the following side effects may also occur. Contact your doctor or nurse if you experience any of these:

Common side effects (may affect up to 1 in 10 people):

• weight gain;
• type 2 diabetes mellitus;
• weight loss;
• feeling restless;
• anxiety;
• inability to stay still, difficulty remaining seated;
• difficulty sleeping (insomnia);
• spasmodic resistance to passive movement, while muscles contract and relax, abnormal increase in muscle tone, slow body movements;
• akathisia (unpleasant sensation of inner restlessness and an irresistible need to keep moving);
• agitation or tremor;
• uncontrollable movements characterised by contractions, jerks or twisting;
• altered level of alertness, drowsiness;
• feeling sleepy;
• dizziness;
• headache;
• dry mouth;
• muscle stiffness;
• inability to achieve or maintain an erection during sexual intercourse;
• pain at the injection site, skin hardening at the injection site;
• weakness, loss of strength or extreme fatigue;
• during blood tests, your doctor may find higher than normal levels of creatine phosphokinase (an enzyme important for muscle function) in the blood.

Uncommon side effects (may affect up to 1 in 100 people):

• low levels of a specific type of white blood cells (neutropenia), haemoglobin or red blood cells, and of platelets;
• allergic reactions (hypersensitivity);
• increased or decreased blood levels of the hormone prolactin;
• high blood sugar levels;
• increased blood fats, such as high cholesterol, high triglycerides, but also low cholesterol and low triglycerides;
• increased levels of insulin, a hormone that regulates blood sugar levels;
• reduced or increased appetite;
• suicidal thoughts;
• a mental disorder characterised by poor or absent contact with reality;
• hallucinations;
• delirium;
• increased sexual interest;
• panic reaction;
• depression;
• emotional lability;
• state of indifference with lack of emotions, feelings of emotional and mental discomfort;
• sleep disorders;
• teeth grinding or clenched jaw;
• reduced sexual interest (decreased libido);
• mood changes;
• muscle problems;
• uncontrollable muscle movements such as grimacing, lip smacking and tongue movements. These usually affect the face and mouth first, but may also affect other parts of the body. These may be signs of a condition known as "tardive dyskinesia";
• parkinsonism, a medical condition that includes various symptoms such as reduced or slowed movements, slowed thinking, jerky movements when bending limbs (cogwheel rigidity), shuffling gait, hurried steps, tremor, limited or absent facial expression, muscle stiffness, drooling;
• movement problems;
• extreme restlessness and restless legs;
• changes in taste and smell;
• eyes fixed in one position;
• blurred vision;
• eye pain;
• double vision;
• eye sensitivity to light;
• abnormal heartbeat, slow or fast heartbeat, electrical conduction abnormalities in the heart, abnormal electrocardiogram (ECG);
• high blood pressure;
• dizziness upon standing up from a lying or sitting position, due to a drop in blood pressure;
• cough;
• hiccups;
• gastroesophageal reflux disease, excessive gastric juice flowing back (refluxing) into the oesophagus (the tube connecting the mouth to the stomach through which food passes), causing heartburn and, sometimes, damaging the oesophagus;
• heartburn;
• vomiting;
• diarrhoea;
• nausea;
• stomach ache;
• stomach discomfort;
• constipation;
• frequent bowel movements;
• reduced saliva production, or excessive saliva;
• abnormal hair loss;
• acne, a skin condition of the face where the nose and cheeks are unusually red, eczema, skin hardening;
• muscle stiffness, muscle spasms, muscle contractions, muscle tension, muscle pain (myalgia), pain in the limbs;
• joint pain (arthralgia), back pain, reduced joint mobility, neck stiffness, limited mouth opening;
• kidney stones, sugar (glucose) in the urine;
• spontaneous milk discharge from the breast (galactorrhoea);
• breast enlargement in men, tender breasts upon palpation, vaginal dryness;
• fever;
• loss of strength;
• gait disturbances;
• chest discomfort;
• injection site reactions such as redness, swelling, discomfort and itching;
• thirst;
• slowness;
• abnormal liver function test results;
• during tests, your doctor may find: higher levels of liver enzymes, higher levels of alanine aminotransferase, higher levels of gamma-glutamyltransferase, higher levels of bilirubin in the blood, higher levels of aspartate aminotransferase, higher or lower blood sugar levels, higher levels of glycated haemoglobin, reduced cholesterol levels in the blood, reduced triglyceride levels in the blood, or increased abdominal circumference.

The following side effects have been reported after the marketing of medicines containing the same active substance administered orally, but their frequency is unknown (cannot be estimated from available data):

• low levels of white blood cells;
• allergic reaction (e.g. swelling of the mouth, tongue, face and throat, itching, fever), skin rash;
• abnormal heartbeat, unexplained sudden death, heart attack;
• diabetic ketoacidosis (ketones in blood and urine) or diabetic coma;
• loss of appetite (anorexia), difficulty swallowing;
• low sodium levels in the blood;
• suicide and attempted suicide;
• inability to resist an impulse, drive or temptation to perform an action that could be harmful to oneself or others, which may include:
  • strong urge to gamble excessively despite severe personal and family consequences;
  • altered or increased sexual interest and behaviour causing significant concern to self or others, for example increased sexual desire;
  • uncontrollable excessive shopping;
  • uncontrolled eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy appetite);
  • tendency to wander away. Inform your doctor if you experience any of these behaviours; they will explain how to manage or reduce the symptoms.
• nervousness;
• aggression;
• neuroleptic malignant syndrome (a syndrome with symptoms such as fever, muscle stiffness, rapid breathing, sweating, reduced level of consciousness and sudden changes in blood pressure and heart rate);
• epileptic seizures (convulsive attacks);
• serotonin syndrome (a reaction that may cause feelings of extreme happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness);
• speech disorders;
• heart problems including torsades de pointes, cardiac arrest, heart rhythm irregularities that may be due to abnormal nerve impulses in the heart, abnormalities in electrocardiogram (ECG) readings, QT prolongation;
• fainting;
• symptoms related to blood clot formation in veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties;
• spasm of muscles around the vocal cords;
• accidental inhalation of food with risk of pneumonia (lung infection);
• inflammation of the pancreas;
• difficulty swallowing;
• liver failure;
• jaundice (yellowing of the skin and whites of the eyes);
• inflammation of the liver;
• skin rash;
• skin sensitivity to light;
• excessive sweating;
• severe allergic reaction such as drug reaction with eosinophilia and systemic symptoms (DRESS, Drug Reaction with Eosinophilia and Systemic Symptoms). DRESS initially presents with flu-like symptoms with a skin rash on the face that then spreads, high temperature, swollen lymph nodes, increased liver enzyme levels detected in blood tests, and increased levels of a type of white blood cell (eosinophilia);
• weakness, tenderness or muscle pain, especially if accompanied by a feeling of malaise, high body temperature and dark urine. This may be caused by abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis);
• difficulty urinating;
• involuntary loss of urine (incontinence);
• drug withdrawal symptoms in the newborn;
• prolonged and/or painful erection;
• difficulty controlling internal body temperature or conditions of excessive heat;
• chest pain;
• swelling of hands, ankles or feet;
• during tests, your doctor may find: higher levels of alkaline phosphatase; fluctuating results in blood sugar tests.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system at the website 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 Aripiprazole EG STADA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the
last day of that month.
Before opening
Do not freeze.
After reconstitution
Chemical and physical in-use stability has been demonstrated for 6 hours at 25°C. From a microbiological
point of view, the product should be used immediately unless the method of opening/reconstitution precludes
the risk of microbial contamination. If not used immediately, the conditions and duration of storage during
use are the responsibility of the user. Do not store the reconstituted suspension in the syringe.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Aripiprazolo EG STADA contains

• The active substance is aripiprazole.

Aripiprazolo EG STADA 300 mg powder and solvent for prolonged-release injectable suspension
Each vial contains 300 mg of aripiprazole as aripiprazole monohydrate.
After reconstitution, each mL of suspension contains 200 mg of aripiprazole.
Aripiprazolo EG STADA 400 mg powder and solvent for prolonged-release injectable suspension
Each vial contains 400 mg of aripiprazole as aripiprazole monohydrate.
After reconstitution, each mL of suspension contains 200 mg of aripiprazole.

• The other components are:
  Powder: Sodium carmellose, mannitol, monosodium dihydrogen phosphate monohydrate, sodium hydroxide.
  Solvent: Water for injections.

Description of the appearance of Aripiprazolo EG STADA and contents of the pack
Aripiprazolo EG STADA consists of powder and solvent for prolonged-release injectable suspension.
Aripiprazolo EG STADA is presented as a white to off-white lyophilized powder in a clear glass vial. The doctor or nurse will reconstitute the suspension for injection using the solvent vial of Aripiprazolo EG STADA, which is a clear, colourless solution in a clear glass vial.

Single pack
Filled and sealed vials (powder and solvent) are packaged together in a plastic tray, together with a 3 mL Luer lock syringe with pre-inserted 38 mm (1.5 inch), 21 gauge hypodermic safety needle, a single-use 3 mL Luer lock syringe, a vial adapter, a 25 mm (1 inch), 23 gauge hypodermic safety needle, a 38 mm (1.5 inch), 22 gauge hypodermic safety needle, and a 51 mm (2 inch), 21 gauge hypodermic safety needle.

Multiple pack
Pack of 3 single packs.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., via Pavia 6, 20136 Milano
Manufacturers
Pharmathen International S.A., Industrial Park, Building, Block No 5, Sapes, Rodopi 69300, Greece
Pharmathen S.A., Dervenakion 6, Pallini Attiki, 15351, Greece
STADA Arzneimittel AG, Stadastraße 2-18, 61118 Bad Vilbel, Germany
STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Vienna, Austria
Laboratori Fundació Dau, C/C, 12-14 Pol. Ind. Zona Franca 08040 Barcelona, Spain

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
AT Aripiprazol STADA 300 mg; 400 mg Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension
CY Aripiprazole/STADA
DE Aripiprazol AL 300 mg; 400 mg Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension
DK Aripiprazole STADA
EE Aripiprazole STADA
EL Aripiprazole/STADA
ES Aripiprazol STADA 300 mg; 400 mg polvo y disolvente para suspensión inyectable de liberación prolongada EFG
FI Aripiprazole STADA 400 mg injektiokuiva-aine ja liuotin depotsuspensiota varten
FR ARIPIPRAZOLE EG LP 300 mg; 400 mg, poudre et solvant pour suspension injectable à libération prolongée
HR Aripiprazol STADA 400 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem
IT Aripiprazolo EG STADA
LT Aripiprazole STADA 300 mg; 400 mg milteliai ir tirpiklis pailginto atpalaidavimo injekcinei suspensijai
LV Aripiprazole STADA 300 mg; 400 mg pulveris un šķīdinātājs ilgstošas darbības injekciju suspensijas pagatavošanai
NL Aripiprazol CF 400 mg, poeder en oplosmiddel voor suspensie voor injectie met verlengde afgifte
NO Aripiprazole STADA
PT Aripiprazol Stada
RO Aripiprazol STADA 300 mg; 400 mg pulbere şi solvent pentru suspensie injectabilă cu eliberare prelungită
SE Aripiprazole STADA 300 mg pulver och vätska till injektionsvätska, depotsuspension
SK Aripiprazol STADA 400mg prášok a disperzné prostredie na injekčnú suspenziu s predĺženým uvoľňovaním

The following information is intended exclusively for healthcare professionals:
INSTRUCTIONS FOR HEALTHCARE PROFESSIONALS
Any unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.
Aripiprazolo EG STADA 300 mg powder and solvent for prolonged-release injectable suspension
Aripiprazolo EG STADA 400 mg powder and solvent for prolonged-release injectable suspension
Aripiprazole

Step 1: Preparation prior to reconstitution of the powder
Assemble the components and verify the presence of the following items:

• Package leaflet for Aripiprazolo EG STADA and instructions for healthcare professionals;
• Powder vial;
• Solvent vial (3 mL) Important: The solvent vial contains a volume greater than stated.
• One 3 mL syringe with pre-inserted Luer-lock 38 mm (1.5 inch), 21 gauge hypodermic safety needle with needle shield;
• One single-use 3 mL Luer-lock syringe;
• One vial adapter;
• One 25 mm (1 inch), 23 gauge hypodermic safety needle with needle shield;
• One 38 mm (1.5 inch), 22 gauge hypodermic safety needle with needle shield;
• One 51 mm (2 inch), 21 gauge hypodermic safety needle with needle shield;
• Syringe and needle instructions.

Step 2: Reconstitution of the powder
a) Remove the caps from the solvent vial and the powder vial, and clean the tops of the containers with an alcohol-impregnated sterile swab.
b) Using the syringe with pre-inserted needle, withdraw the predetermined volume of solvent from the solvent vial into the syringe.
300 mg vial:
Add 1.5 mL of solvent to reconstitute the powder.
400 mg vial:
Add 1.9 mL of solvent to reconstitute the powder.
After withdrawal, a small amount of residual solvent will remain in the vial. Any excess must be discarded.

c) Slowly inject the solvent into the vial containing the powder.
d) To equalize pressure in the vial, gently pull back the plunger to draw air into the syringe.

e) Then, remove the needle from the vial.
Engage the needle shield using the one-handed technique.
Gently press the shield against a flat surface until the needle is securely locked into the needle shield.
Visually confirm that the needle is fully enclosed in the needle shield and dispose of the entire unit.

f) Shake the vial vigorously for at least 30 seconds until the suspension appears uniform, homogeneous, opaque, and white to off-white in colour.

g) Before administration, visually inspect the reconstituted solution for particulate matter and discoloration. The reconstituted medicinal product is a fluid suspension, white to off-white in colour. Do not use if the reconstituted suspension contains particulate matter or shows any discoloration.
h) If the injection is not administered immediately after reconstitution, store the vial at a temperature below 25°C for up to 6 hours and shake vigorously for at least 60 seconds before injection to resuspend the product.
i) Do not store the reconstituted suspension in the syringe.

Step 3: Preparation prior to injection
a) Remove the cover, but not the adapter, from its packaging.
b) Handling the vial adapter through its packaging, attach the syringe with pre-inserted Luer-lock connector.

c) Remove the vial adapter from its packaging using the Luer-lock syringe and discard the adapter packaging. Never touch the piercing end of the adapter.

d) Determine the recommended volume for injection.

e) Clean the top of the vial containing the reconstituted suspension using a sterile alcohol swab.
f) Place and hold the vial of reconstituted suspension on a firm surface. Attach the adapter-syringe assembly by grasping the outer surface of the adapter and firmly push the adapter's piercing pin through the rubber stopper until the adapter clicks into place.
g) To allow injection, slowly draw the recommended volume from the vial into the Luer-lock syringe.
A small amount of product will remain in the vial as overfill.

Step 4: Injection procedure
a) Detach the Luer-lock syringe containing the recommended volume of reconstituted Aripiprazole EG STADA suspension from the vial.
b) Select one of the following hypodermic safety needles depending on the injection site and patient weight, and attach the needle to the Luer-lock syringe containing the injectable suspension. Ensure the needle is securely inserted into the needle shield by pushing and simultaneously turning clockwise; then immediately remove the needle cap.

c) Slowly inject the recommended volume as a single intramuscular injection into the gluteal or deltoid muscle. Do not massage the injection site. Take care to avoid inadvertently injecting the medicinal product into a blood vessel. Do not inject in areas showing signs of inflammation, skin lesions, nodules, and/or bruising.
For deep intramuscular injection only, into the gluteal or deltoid muscle.

Remember to alternate injection sites between the two gluteal or deltoid muscles.
Check for any signs or symptoms of accidental intravenous administration.
Step 5: Procedures after injection
Replace the needle cap as described in Step 2 e). After injection, dispose of the vials, adapter, needles, and syringe appropriately. The vials for powder and solvent are for single use only.