Aripiprazole Sandoz BV

Package leaflet: Information for the user

Aripiprazole Sandoz BV 300 mg powder and solvent for prolonged-release injectable suspension
Aripiprazole Sandoz BV 400 mg powder and solvent for prolonged-release injectable suspension
Equivalent 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 questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

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

1. What Aripiprazole Sandoz BV is and what it is used for

Aripiprazole Sandoz BV contains the active substance aripiprazole in a vial. Aripiprazole belongs to a group of medicines called antipsychotics. Aripiprazole Sandoz BV is used in the treatment of schizophrenia, a disorder characterised by symptoms such as hearing, seeing or perceiving things that are not there, suspiciousness, false beliefs, disorganised speech and behaviour, and flattened emotions. People with this condition may also feel depressed, guilty, anxious or tense.
Aripiprazole Sandoz BV 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 Sandoz BV

Do not use Aripiprazole Sandoz BV:

• 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 Sandoz BV.
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 Sandoz BV.
Before starting treatment with Aripiprazole Sandoz BV, 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), particularly if you are elderly;
• cardiovascular diseases (heart and circulatory diseases), family history of cardiovascular disease, stroke or transient ischemic attack, or blood pressure abnormalities;
• irregular heartbeat, or if someone in your family has had a history of irregular heartbeat (including so-called QT prolongation observed during 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 weight gain, develop unusual movements, feel drowsiness that interferes with normal daily
activities, have difficulty swallowing, or experience allergic symptoms, please inform your doctor immediately.
Inform your doctor if you, your family members, or caregivers 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, excessive spending, abnormally
increased sex drive, or preoccupation due to increased sexual thoughts or sensations.
Your doctor may consider it necessary to adjust the dose or discontinue treatment.
This medicine may cause drowsiness, low blood pressure when standing up, dizziness, and changes in ability to
move and maintain balance, which may lead to falls. Be cautious, especially if you are elderly or otherwise
weakened.
Children and adolescents
Do not use this medicine in children and adolescents under 18 years of age. It is not known whether it is safe
and effective in these patients.
Other medicines and Aripiprazole Sandoz BV
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Medicines that lower blood pressure: Aripiprazole Sandoz BV 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 Sandoz BV together with certain medicines may require your doctor to adjust the dose of
Aripiprazole Sandoz BV or of the other medicines. It is particularly important to inform your doctor about the
following medicines:

• medicines 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 and 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 side effects or reduce the effect of Aripiprazole Sandoz BV; consult
your doctor if you experience any unusual symptoms while taking any of these medicines together with
Aripiprazole Sandoz BV.
Medicines that increase serotonin levels are typically used in 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 in 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 in 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 side effects; consult your doctor if you experience any unusual
symptoms while taking any of these medicines together with Aripiprazole Sandoz BV.
Aripiprazole Sandoz BV 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, ask
your doctor for advice before receiving this medicine.
Do not use Aripiprazole Sandoz BV if you are pregnant, unless you have discussed this 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 received Aripiprazole Sandoz BV during the last three months of
pregnancy (third trimester) may experience the following symptoms: tremors, muscle stiffness and/or weakness,
drowsiness, agitation, breathing problems, and feeding difficulties.
If your baby shows any of these symptoms, consult your doctor.
If you are receiving Aripiprazole Sandoz BV, 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 Sandoz BV, discuss with your doctor the best way to feed your baby.
Driving and using machines
During treatment with this medicine, dizziness and vision disturbances may occur (see section 4). This should
be taken into account when full alertness is required, for example when driving a vehicle or operating machinery.
Aripiprazole Sandoz BV contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.

3. How Aripiprazole Sandoz BV is administered

This medicine is supplied as a powder, which the doctor or nurse will use to prepare a suspension.
Your doctor will determine the appropriate dose of Aripiprazole Sandoz BV for you. The recommended starting dose is 400 mg, unless your doctor decides to prescribe a lower starting or follow-up dose.
You will receive an injection of Aripiprazole Sandoz BV on the first day, and oral aripiprazole treatment will continue for 14 days after the first injection.
Afterwards, treatment is administered via injections of Aripiprazole Sandoz BV, 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. The doctor will alternate injections between the right and left sides. Injections will not be given intravenously.

If you receive more Aripiprazole Sandoz BV than you should
This medicine will be administered under medical supervision, so it is unlikely that you will receive too much.
If you consult more than one doctor, make sure to inform them that you are being treated with Aripiprazole Sandoz BV.
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 or tongue), and reduced level of consciousness.

Other possible symptoms may include:

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

Contact your doctor or go to the hospital immediately if you experience any of these symptoms.

If you miss an injection of Aripiprazole Sandoz BV
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 Sandoz BV
Do not stop treatment just because you feel better. It is important to continue taking Aripiprazole Sandoz BV for the full duration prescribed by your doctor.
If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

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

Serious side effects
If you experience any of the serious side effects listed below, inform your doctor immediately.

• a combination of any of the following symptoms: excessive drowsiness, dizziness, confusion, disorientation, difficulty speaking, difficulty walking, muscle stiffness or tremor, 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 reduce your dose.

• symptoms such as swelling, pain, and redness in the 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, consult your doctor immediately.

• a combination of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sedation, 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, behaviors, or thoughts and feelings of self-harm.

The following side effects may also occur after receiving Aripiprazole Sandoz BV. Consult your doctor or nurse if you experience any of these:

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

• weight gain
• diabetes mellitus
• weight loss
• feeling restless
• feeling anxious
• inability to stay still, difficulty remaining seated
• trouble sleeping (insomnia)
• spasmodic resistance to passive movement, while muscles contract and relax, abnormal increase in muscle tone, slow body movements
• akathisia (an unpleasant sensation of internal restlessness and an irresistible need to keep moving)
• shaking or tremor
• uncontrollable movements characterized by contractions, jerks, or twisting
• changes in level of alertness, drowsiness
• sleepiness
• dizziness
• headache
• dry mouth
• muscle stiffness
• inability to achieve or maintain an erection during sexual intercourse
• injection site pain, skin hardening at the injection site
• weakness, loss of strength, or extreme fatigue
• blood tests may show higher levels of creatine phosphokinase (an enzyme important for muscle function)

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

• low levels of a specific type of white blood cells (neutropenia), hemoglobin, red blood cells, or platelets
• allergic reactions (hypersensitivity)
• increased or decreased plasma levels of the hormone prolactin
• hyperglycemia
• increased blood fats, such as high cholesterol, high triglycerides, but also low levels of cholesterol and triglycerides
• increased levels of insulin, a hormone that regulates blood sugar levels
• reduced or increased appetite
• suicidal thoughts
• mental disorder characterized by impaired or absent contact with reality
• hallucinations
• delirium
• increased sexual interest
• panic reaction
• depression
• affective lability
• state of indifference with lack of emotions, feelings of emotional and mental discomfort
• sleep disorder
• teeth grinding or jaw clenching
• reduced sexual interest (libido is decreased)
• 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 body parts. These could be signs of a condition called "tardive dyskinesia"
• parkinsonism: a medical condition with various symptoms, including 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
• difficulty moving
• extreme restlessness and leg agitation
• altered sense of taste and smell
• eyes fixed in one position
• blurred vision, eye pain
• double vision
• light sensitivity in the eyes
• irregular heartbeat, slow or fast heartbeat, conduction abnormalities in the heart, electrocardiogram (ECG) abnormalities
• high blood pressure
• dizziness upon standing up from a lying or sitting position due to a drop in blood pressure
• cough
• hiccups
• gastroesophageal reflux. An excessive amount of gastric juice flows back (refluxes) into the esophagus (the tube connecting the mouth to the stomach through which food passes), causing heartburn and, sometimes, damaging the esophagus.
• heartburn
• vomiting
• diarrhea
• nausea
• stomach ache
• stomach discomfort
• constipation
• frequent bowel movements
• reduced saliva production, or excessive salivation
• abnormal hair loss
• acne, a skin condition where the nose and cheeks are unusually flushed, eczema, skin hardening
• muscle stiffness, muscle spasms, muscle contractions, muscle tension, muscle pain (myalgia), limb pain
• joint pain (arthralgia), back pain, reduced joint mobility, neck stiffness, limited mouth opening
• kidney stones, sugar (glucose) in urine
• spontaneous milk discharge from the breasts (galactorrhea)
• 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
• liver function tests may show abnormal results
• blood tests may show
  • 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 levels of blood sugar;
  • higher levels of glycated hemoglobin;
  • reduced levels of cholesterol in the blood;
  • reduced levels of triglycerides in the blood;
  • increased abdominal circumference.

The following side effects have been reported after the marketing of medicines containing the same active substance taken 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, hives), skin rash
• irregular heartbeat, unexplained sudden death, heart attack
• diabetic ketoacidosis (ketones in blood and urine) or coma
• loss of appetite (anorexia), difficulty swallowing
• low sodium levels in the blood
• suicide and attempted suicide
• inability to resist the impulse, urge, or temptation to perform an action that could be harmful to you or others, which may include:
  • strong impulse to gamble excessively despite severe personal or family consequences;
  • altered or increased sexual interest and behavior causing significant concern to you or others, for example, increased sexual drive;
  • excessive and uncontrollable shopping;
  • uncontrolled eating (consuming large amounts of food in a short 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 behaviors; 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 caused by abnormal nerve impulses reaching the heart, abnormalities in electrocardiogram (ECG) readings, QT prolongation
• fainting
• symptoms related to blood clot formation in veins, especially in the legs (symptoms include leg swelling, pain, and redness), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties
• spasm of muscles surrounding the vocal cords
• accidental inhalation of food with risk of pneumonia (lung infection)
• pancreatitis
• difficulty swallowing
• liver failure
• jaundice (yellowing of the skin and whites of the eyes)
• hepatitis (liver inflammation)
• skin rash
• skin sensitivity to light
• excessive sweating
• severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially presents with flu-like symptoms and a rash on the face that then spreads, high fever, swollen lymph nodes, increased liver enzyme levels in blood tests, and increased levels of a type of white blood cell (eosinophilia).
• weakness, tenderness, or muscle pain, especially if accompanied by a general feeling of illness, high body temperature, and dark urine. This may be caused by abnormal muscle breakdown, potentially life-threatening and possibly leading 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 regulating internal body temperature or conditions of excessive heat
• chest pain
• swelling of hands, ankles, or feet
• blood tests may show
  • 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, consult your doctor or nurse. You may also report side effects directly via 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 Aripiprazole Sandoz BV

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard carton and on the bottle.
The expiry date refers to the last day of that month.

Before opening
This medicine requires no special storage conditions.

After reconstitution
Do not freeze.
Chemical and physical in-use stability has been demonstrated for 6 hours at 25 °C. From a microbiological
standpoint, unless the method of opening/reconstitution precludes the risk of microbial contamination, the
product should be used immediately. Otherwise, the times and conditions 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 Sandoz BV contains

• The active substance is aripiprazole. Each vial contains 300 mg of aripiprazole as aripiprazole monohydrate. After reconstitution, each mL of suspension contains 200 mg of aripiprazole. 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 phosphate monohydrate, sodium hydroxide
Solvent
Water for injections
Description of the appearance of Aripiprazolo Sandoz BV and package contents
Aripiprazolo Sandoz BV is a powder and solvent for prolonged-release injectable suspension.
The powder of Aripiprazolo Sandoz BV is white to off-white in colour and is contained in a clear glass vial. The doctor or nurse will reconstitute the suspension for injection using the solvent vial of Aripiprazolo Sandoz BV, which is a clear, colourless solution contained in a clear glass vial.
Single pack
Each single pack contains one vial of powder, one 3 mL vial of water for injections (solvent), packaged together in a plastic tray, with a 3 mL syringe with Luer-lock connector, pre-attached 38 mm (1.5 inch) 21 gauge hypodermic safety needle with needle shield, one single-use 3 mL syringe with Luer-lock connector, a vial adapter, and three hypodermic safety needles: one 25 mm (1 inch) 23 gauge, one 38 mm (1.5 inch) 22 gauge, and one 51 mm (2 inch) 21 gauge.
Multiple pack
Pack of 3 single packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz B.V.
Hospitaaldreef 29
1315 RC Almere
The Netherlands
Representative in Italy:
Sandoz S.p.A.
Viale Luigi Sturzo, 43
20154 Milan
Italy
Manufacturer
Pharmathen International S.A.
Industrial Park Sapes Rodopi Prefecture
Building Block No 5
693 00 Rodopi
Greece
Pharmathen S.A.
Dervenakion 6
153 51 Pallini
Greece
Salutas Pharma GmbH
Otto-Von-Guericke-Allee 1
39179 Barleben
Germany
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia
This medicinal product is authorised in the European Economic Area countries under the following
names
Denmark Aripiprazole Hexal
Austria Aripiprazol Sandoz 300 mg - Powder and solvent for preparation
of a depot injection suspension
Aripiprazol Sandoz 400 mg - Powder and solvent for preparation
of a depot injection suspension
Finland Aripiprazole Hexal
France ARIPIPRAZOLE SANDOZ LP 300 mg, powder and solvent for
prolonged-release injectable suspension
Germany Aripiprazol - 1 A Pharma 300 mg Powder and solvent for preparation
of a depot injection suspension
Aripiprazol - 1 A Pharma 400 mg Powder and solvent for preparation of a
depot injection suspension
Greece Aripiprazole/Ebewe
Iceland Aripiprazole Hexal
Italy Aripiprazolo Sandoz BV
Norway Aripiprazole Hexal
The Netherlands Aripiprazol Sandoz 400 mg, powder and solvent for suspension for
injection with prolonged release
Portugal Aripiprazol Sandoz
Czech Republic Aripiprazole Sandoz
Spain Aripiprazol Sandoz 300 mg powder and solvent for prolonged-release
injectable suspension EFG
Aripiprazol Sandoz 400 mg powder and solvent for prolonged-release
injectable suspension EFG
Sweden Aripiprazole Hexal
Hungary Aripiprazol Sandoz 300 mg por és oldószer retard szuszpenziós injekcióhoz
Aripiprazol Sandoz 400 mg por és oldószer retard szuszpenziós injekcióhoz

The following information is intended exclusively for healthcare professionals:

INSTRUCTIONS FOR HEALTHCARE PROFESSIONALS
Unused medicine and waste material derived from this medicine must be disposed of in accordance with
applicable local regulations.
Aripiprazole Sandoz BV 300 mg powder and solvent for prolonged-release injectable suspension
Aripiprazole Sandoz BV 400 mg powder and solvent for prolonged-release injectable suspension

Step 1: Preparation prior to reconstitution of the powder.
Gather and verify the presence of the following components:

• Package leaflet for Aripiprazole Sandoz BV and instructions for healthcare professionals
• Vial of powder
• Vial of solvent containing 3 mL Important: The solvent vial contains a volume greater than stated.
• One 3 mL syringe with pre-attached Luer-lock safety hypodermic needle, 21 gauge, 38 mm (1.5 inches), with needle shield
• One single-use 3 mL syringe with Luer-lock connector
• One vial adapter
• One safety hypodermic needle, 23 gauge, 25 mm (1 inch), with needle shield
• One safety hypodermic needle, 22 gauge, 38 mm (1.5 inches), with needle shield
• One safety hypodermic needle, 21 gauge, 51 mm (2 inches), with needle shield
• Instructions for syringe and needle

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 a sterile alcohol swab.
b) Using the syringe with the pre-attached needle, withdraw the predetermined volume of solvent from the solvent vial.
Vial 300 mg:
Add 1.5 mL of solvent to reconstitute the powder.
Vial 400 mg:
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, draw back the plunger slightly to aspirate air.

e) Subsequently, remove the needle from the vial.
Attach the needle shield using the one-handed technique.
Gently press the shield against a flat surface until the needle is securely seated within the needle shield.
Visually confirm that the needle is fully enclosed within the needle shield and dispose of the entire unit.

f) Shake the vial vigorously for at least 30 seconds until the suspension appears uniform.

g) Prior to administration, visually inspect the reconstituted suspension for particulate matter and discoloration. The reconstituted medicine is a fluid suspension, white to off-white in color. 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. Shake vigorously for at least 60 seconds immediately 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) Handle the vial adapter through its packaging; attach the syringe with pre-attached Luer-lock connector to the adapter.

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-impregnated swab.
f) Place and hold the vial containing the reconstituted suspension on a firm surface. Attach the adapter-syringe assembly to the vial by holding the outer surface of the adapter and firmly pushing its spike through the rubber stopper until the adapter clicks into place.
g) To allow injection, slowly withdraw 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 from the vial the Luer-lock syringe containing the recommended volume of reconstituted Aripiprazole Sandoz BV suspension.
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 rotating clockwise; then immediately remove the cap from the needle.

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 accidental
injection into a blood vessel. Do not inject in areas showing signs of inflammation, skin lesions,
nodules, and/or bruising.
For deep intramuscular injection only in the gluteal or deltoid muscle.

deltoid deltoid
gluteal
Do not forget to alternate injection sites between the two gluteal or deltoid muscles.
Monitor 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 vials, adapter, needles, and syringe appropriately. The vials for powder and solvent are for single use only.