Zyprexa 10 mg powder. 1
Schizophrenia - a disease with symptoms such as hearing, seeing or sensing things, delusional thinking, suspiciousness, becoming withdrawn. People with this disease may feel depressed, anxious or tense.
Zyprexa 10 mg powder. 1
What is ZYPREXA and what it is used
Injection ZYPREXA belongs to the group of medicines called antipsychotics and are used to treat symptoms of anxiety and anxiety behavior , which may occur in the following conditions :
Schizophrenia - a disease with symptoms such as hearing , seeing or sensing things , delusional thinking , suspiciousness , becoming withdrawn . People with this disease may feel depressed , anxious or tense ;
Mania - a condition with symptoms of excitement or euphoria.
ZYPREXA injection is used when necessary rapid alleviation of excitement and anxiety behavior , and treatment with ZYPREXA tablets is inappropriate. As soon as possible , your doctor will suggest a switch to tablets ZYPREXA.
2 . What you should know before you are given ZYPREXA
Do not take ZYPREXA
If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in Section 6). An allergic reaction may be recognized as a rash , itching, swollen face, swollen lips or shortness of breath . If this happens to you, talk to your doctor ;
If you have been diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
Warnings and Precautions
Talk to your doctor or nurse before you are given an injection ZYPREXA:
Tell your doctor if you feel dizzy or weak after the injection. Perhaps you should lie down until you feel better. The doctor or nurse may want to measure your blood pressure and pulse ;
Not recommended for use ZYPREXA in elderly patients with dementia ( confusion and memory loss ) , as they this medication can have serious side effects ;
Drugs of this type may cause unusual movements mainly of the face and tongue. If this happens after you take ZYPREXA, tell your doctor ;
Very rarely , medicines of this type cause a combination of fever, faster breathing , sweating, muscle stiffness and drowsiness or sleepiness . If this happens , contact your doctor immediately ;
There was weight gain in patients taking ZYPREXA. You and your doctor should regularly check your weight ;
In patients taking ZYPREXA, observed high levels of blood sugar and blood fat (triglycerides and cholesterol) . Your doctor should do blood tests to check blood sugar levels and some fat before you start taking ZYPREXA and regularly during treatment ;
Tell your doctor if you or anyone in your family ever had blood clots, as medicines like it have been associated with formation of blood clots.
If you suffer from any of the following illnesses tell your doctor as soon as possible:
Stroke or " mini " stroke (temporary symptoms of stroke) ;
Prostate problems ;
Intestinal obstruction ( paralytic ileus ) ;
Liver or kidney disease ;
Blood disorders ;
If you have had a recent heart attack or have heart disease, including syndrome sick sinus , unstable angina or suffer from low blood pressure;
If you suffer from dementia, you or the person who takes care of you / your relative should tell your doctor if you have ever had a stroke or " mini " stroke .
Children and adolescents
ZYPREXA is not for patients under 18 years of age.
As a routine precaution, if you are aged over 65 , your blood pressure should be monitored by your doctor.
Other medicines, ZYPREXA
The combination of ZYPREXA with the following products you may feel drowsy : medicines taken for anxiety or to help you sleep (tranquillizers , including benzodiazepines) and antidepressants. During treatment with ZYPREXA take other drugs only if prescribed by your doctor.
If taking ZYPREXA injection is not recommended by the injection of the benzodiazepine same time , as this could lead to excessive sleepiness can have serious effects on the heart rate or breathing you , but in rare cases it can lead to death . If your doctor should give you an injection of a benzodiazepine to treat your disease , there must be an interval of at least one hour after injection of ZYPREXA and be under close observation after injection of a benzodiazepine.
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially tell your doctor if you are taking medicines to treat Parkinson's disease.
ZYPREXA and alcohol
Do not drink alcohol during treatment with ZYPREXA, since simultaneously with alcohol can cause drowsiness .
Pregnancy and lactation
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant , talk to your doctor before taking this medicine. You should not take this medicine when breast-feeding , as small amounts of ZYPREXA can pass into breast milk.
The following symptoms may occur in newborns whose mothers have used ZYPREXA in the last trimester ( last three months of pregnancy ): shaking, numbness and / or muscle weakness , somnolence , agitation, trouble breathing and feeding difficulty . If your baby develops any of these symptoms , seek your doctor .
Driving and using machines
There is a risk of feeling drowsy while taking ZYPREXA. If this happens do not drive or operate any tools or machines. Tell your doctor.
3 . How to use ZYPREXA
Information for the preparation of the solution and its application can be found in a special section at the end of this leaflet.
Your doctor will decide how much ZYPREXA you need and for how long . Typically , the first injection of the dose is 10 mg, but can be less . Can be applied to 20 mg per 24 hours. Dose in patients over 65 years is 2.5 or 5 mg.
ZYPREXA is in the form of powder . Your doctor or nurse will make solution. ZYPREXA as an injection for intramuscular use. Specified amount of solution will be given intramuscularly.
If you take more dose ZYPREXA
Patients who received more than the required amount ZYPREXA experienced the following symptoms: fast heart rate , agitation / aggressiveness, problems with speech , unusual movements ( especially of the face or tongue) and reduced level of impairment ( decrease) in mind . Other symptoms may include: acute confusion , seizures (epilepsy ) , coma , a combination of fever, faster breathing, sweating , muscle stiffness and drowsiness or sleepiness, slow heart rate , aspiration, high or low blood pressure, irregular heart rhythm. Tell your doctor or nurse about your concerns.
It takes only a few doses of inject ZYPREXA. Your doctor will decide when you need an injection of ZYPREXA.
If you have any questions about using this medicine , ask your doctor or nurse.
4 . Possible side effects
As with all medications , ZYPREXA injection may cause side effects, although not everyone gets them.
Tell your doctor if you have:
unusual movements (a common side effect that may affect up to 1 in 10 people) mainly of the face or tongue ;
blood clots in the veins ( an uncommon side effect that may affect up to 1 in 100 people ), especially in the legs ( symptoms include swelling , pain and redness in the leg), which may travel through blood vessels to the lungs causing pain chest and difficulty breathing. If you notice any of these symptoms , seek medical advice immediately;
combination of fever, faster breathing, sweating , muscle stiffness and drowsiness or somnolence (frequency of this side effect can not be estimated from available data).
Common side effects (may affect up to 1 in 10 people) with injection ZYPREXA include slow or fast heart rate , drowsiness , low blood pressure , discomfort at the injection site .
After the injection, some people may feel dizzy or faint (with a slow heart rate ), especially when getting up from a lying or sitting position. This usually resolves on its own but if it does not, tell your doctor or nurse as soon as possible .
Uncommon side effects (may affect up to 1 in 100 people) include slow breathing and heart rhythm disorders that may be serious.
In addition , described below, side effects are observed after the patient takes the oral ZYPREXA .
Other very common side effects ( likely to affect more than 1 in 10 people ), including weight gain and increases in prolactin levels in the blood. At the beginning of treatment , some people may feel dizzy or faint (with a slow heart rate ), especially when getting up from a lying or sitting position. This usually resolves by itself , but if it does not, tell your doctor.
Other common side effects (may affect up to 1 in 10 people) including changes in the levels of some blood cells circulating fats , and early treatment transient increases in liver enzymes , increased levels of sugar in the blood or urine increases in uric acid and creatine phosphokinase in the blood increased hunger , dizziness , anxiety , tremors , abnormal movements ( dyskinesias ) , constipation, dry mouth , rash , loss of strength , extreme tiredness , water retention leading to swelling of the hands , ankles or feet ; fever , joint pain , and sexual dysfunction , such as decreased libido in both men and women or in male erectile dysfunction .
Other uncommon side effects (may affect up to 1 in 100 people) including hypersensitivity reactions (eg , swelling of the mouth and throat, itching, rash ), diabetes or worsening of diabetes occasionally associated with ketoacidosis (ketones in the blood and urine) or coma , seizures, usually associated with seizures in the past ( epilepsy ), muscle stiffness or spasm (including eye movements ), speech problems , slow heartbeat , sensitivity to sunlight , nosebleeds , bloating , loss of memory or forgetfulness , urinary incontinence , difficulty in passing urine , hair, loss or reduction of menstrual cycles and breast changes in males and females such as an abnormal production of breast milk or abnormal growth .
Rare side effects (may affect up to 1 in 1000 people) include lowering of normal body temperature, heart rhythm disorders , sudden unexplained death, inflammation of the pancreas causing severe stomach pain, fever and malaise ; liver disease presenting as yellowing of the skin and whites of the eyes , muscle disease presenting as unexplained aches and pains and prolonged and / or painful erection .
While taking olanzapine , elderly patients with dementia may suffer from stroke , pneumonia, urinary incontinence, falls, extreme tiredness , visual hallucinations, a rise in body temperature, redness of the skin and have trouble walking . In this particular group of patients have been reported in some fatal cases .
In patients with Parkinson's disease ZYPREXA may worsen symptoms.
If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
5 . How to store ZYPREXA
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton.
Do not store above 25 ° C. Store in the original package to protect from light.
After reconstitution ZYPREXA injection , use up to one hour . Do not refrigerate after reconstitution .
Dispose of unwanted content .
6 . Package Contents and more information
What does ZYPREXA injections
The active ingredient is olanzapine . Each vial contains 10 mg of active substance .
The other ingredients are lactose monohydrate , tartaric acid , hydrochloric acid and sodium hydroxide.
ZYPREXA injections looks like and contents of pack
ZYPREXA is available as a yellow powder in a vial. ZYPREXA vial gives you 10 mg olanzapine. Your doctor or nurse will make it a solution that will be applied.
ZYPREXA Injection is available in packs of 1 or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Eli Lilly Nederland BV, the Netherlands.
Lilly Pharma Fertigung und Distribution GmbH & Co., Germany .
INSTRUCTIONS FOR MEDICAL PERSONNEL
Preparation of the solution and application of ZYPREXA
Prepare ZYPREXA powder for injection with water for injections.
ZYPREXA powder for injection should not be combined in the same syringe with any product available in the network due to incompatibilities. See the examples below .
Olanzapine for injection should not be combined into one syringe for injection of haloperidol, since it leads to a low pH -lowering olanzapine over time .
Olanzapine for injection should not be combined in the same syringe or should be used concomitantly with benzodiazepines .
Powder for solution for injection
Reconstitute the solution ZYPREXA powder for injection according to standard techniques for the aseptic reconstitution of parenteral products .
1. Download 2,1 ml of water for injection in a sterile syringe . Inject into vial ZYPREXA powder for solution for injection .
2 . Shake the vial gently until the contents are completely dissolved and a solution with a yellow color. The vial contains 11,0 mg olanzapine as a solution of 5 mg / ml. If downloaded 2,0 ml of the solution of 1 mg olanzapine remaining in the vial and the syringe , enabling the injection of 10 mg of olanzapine.
3 . The following table represents the amount of injection of different doses of olanzapine
Volume of injection (ml)
4 . Apply the solution intramuscularly. Do not administer intravenously or subcutaneously.
5 . Dispose of the syringe and if left unused solution according to clinical requirements.
6 . Use the solution immediately within 1 hour of preparation. Do not store above 25 ° C. Do not freeze.
Medicinal products for parenteral use should be visually examined before use for the presence of small particles.