5 mg / ml and 25 mg / ml solution for injection / infusion  
escetamine

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor, pharmacist, or nurse.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Esketamine Orifarm is and what it is used for 
2. What you need to know before you use Esketamine Orifarm 
3. How to use Esketamine Orifarm 
4. Possible side effects 
5. How to store Esketamine Orifarm 6. Contents of the pack 
and other information 

1. What Esketamine Orifarm is and what it is used for

Esketamine Orifarm belongs to a group of medicines called anesthesia medicines. You can get it during surgery as an injection into a blood vessel or a muscle. 

You can get Esketamine Orifarm:

  • for sedation ( anesthesia ) for a long time. You can get it as a single anesthetic or in combination with others.
  • in combination with other anesthetic drugs for numbing larger or smaller areas of the body.
  • as pain relief/anesthesia in emergencies.


Esketamine contained in Esketamine Orifarm may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you use Esketamine Orifarm

Do not use Esketamine Orifarm

  • if you are allergic to escetamine or any of the other ingredients of this medicine (listed in section 6)
  • if you have high blood pressure or high blood pressure ( intracranial pressure )
  • if you have a condition called eclampsia or preeclampsia (a pregnancy complication)
  • which causes high blood pressure )
  • in combination with xanthine derivatives and ergometry (used to initiate labor).

You should not be given Esketamine Orifarm as the only anesthetic if you have calcifications in the blood vessels that supply the heart with blood.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Esketamin Orifarm if you:

  • have a weak heart ( heart failure ) and untreated high blood pressure
  • may have attacks of sudden and severe chest pain ( angina pectoris )
  • have increased pressure in the brain due to stroke or illness
  • have diseases of the brain or spine
  • needs an eye examination or eye surgery
  • is under the influence of alcohol
  • have or have had serious mental health problems
  • has an overactive thyroid gland (insufficiently treated hyperthyroidism )
  • in situations during childbirth where the uterine muscle must be relaxed (eg in threatening uterine rupture or umbilical cord prolapse)
  • have previously abused or been addicted to drugs
  • has impaired liver function
  • should provide blood or urine samples, as Esketamine Orifarm may affect test results
  • suffers from shortness of breath after injection.

With long-term use (one month to several years) or with the abuse of Esketamine Orifarm, there may be a risk of bladder infection. Liver damage has been observed in patients with long-term use (more than 3 days). 

You must be aware of the following:

  • You should be accompanied by someone when you go home after the anesthesia treatment. You should not drive a car yourself.
  • You should abstain from alcohol for the next 24 hours after treatment.

Other medicines and Esketamine Orifarm

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. 

Esketamine Orifarm can affect other medicines and other medicines can affect Esketamine Orifarm. Your dose may need to be changed. 

Tell your doctor or healthcare professional if you are taking:

  • medicines for central nervous system disorders ( sympathomimetics, eg adrenaline or norepinephrine )
  • drugs for slow metabolism ( hypothyroidism )
  • medicines for involuntary urination at night (eg vasopressin )
  • drugs for asthma
  • medicines for epilepsy or symptoms of alcohol withdrawal ( barbiturates )
  • antipsychotic drugs (antipsychotics)
  • sedatives (sleeping pills or benzodiazepines , eg diazepam )
  • strong painkillers (opiates, eg morphine)


Esketamine Orifarm should not be given with ergometry (medicines for postpartum hemorrhage or abortion).

Esketamine Orifarm with food, drink, and alcohol

As with any anesthetic, you should fast for 4-6 hours before taking Esketamine Orifarm.


You should not drink alcohol within 24 hours of receiving this anesthetic.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 

Pregnancy

This medicine should not be used during pregnancy unless your doctor tells you that there is no safer alternative. If the medicine is given during childbirth, it may affect the baby’s respiratory rate. 

Breast-feeding

This medicine can pass into breast milk, but at the recommended dose you are at risk of

the child unlikely.

Driving and using machines

Do not drive or use machines within 24 hours after anesthesia. 
You should be aware that Esketamine Orifarm may lower your reactivity for some time. You should be aware of this in situations where heightened attention is required, e.g. while driving. 

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Esketamine Orifarm contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per ml, ie essentially ‘sodium-free’.

3. How to use Esketamine Orifarm

Esketamine Orifarm injection will be given by a doctor or nurse experienced in anesthesia.

Esketamine Orifarm is given as a slow injection into a vein or muscle. If necessary, an injection can be repeated or the preparation can be given as an infusion.


Your doctor can tell you what dose you are taking and how often you should get it. Only the doctor can change the dose.

If you use more Esketamine Orifarm then you should  

In case of acute overdose with Esketamine Orifarm, you may experience seizures, irregular heartbeat, and shortness of breath. 

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. 

If you have any further questions on the use of this product, ask your doctor or nurse.

4. Possible side effects

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


Serious side effects are

If you get serious side effects, contact your doctor or healthcare professional immediately. 

Rare (may affect up to 1 in 1,000 people):

  • Sudden rash, difficulty breathing, and fainting (within minutes to hours) due to hypersensitivity (anaphylactic reaction/shock). Can be fatal.


Other side effects are


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

  • Increased heart rate
  • Increased blood pressure
  • Sore throat
  • Weakened breathing
  • Increased mucus formation in the lungs
  • Dimsyn
  • Nausea
  • Vomiting
  • Increased salivation
  • Awakening reactions after anesthesia. These are e.g. dreams that feel real, nightmares, dizziness, and restlessness.

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

  • Double vision
  • Increased pressure in the eye
  • Involuntary body movements that can resemble cramps
  • Measles-like rash, skin rash
  • Pain and redness at the injection site.

Rare (may affect up to 1 in 1,000 people):

  • Irregular or slow pulse
  • Low blood pressure.

Has been reported (occurs in an unknown number of users):

  • Hallucinations
  • Anxiety and confusion
  • Emotional fluctuations with tension and irritation
  • Abnormal liver function (asymptomatic)
  • Liver damage after long-term use (more than 3 days).

5. How to store Esketamine Orifarm

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 carton after EXP. The expiration date is the last day of the specified month. 

Store in the original package. Sensitive to light. Do not freeze. 

It is recommended that the product be used as soon as possible after it has been mixed with solvent but can be stored if the instructions at the end of the package leaflet are followed carefully.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is escetamine hydrochloride equivalent to 5 mg escetamine or 25 mg escetamine.
  • The other ingredients are sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.

What the medicine looks like and the contents of the pack

5 mg/ml: clear, colorless solution, ampoule marked with a green and a white ring.

25 mg/ml: clear, colorless solution, ampoule marked with a red and a white ring.


5 mg / ml: 5 x 5 ml, 10 x 5 ml.

25 mg / ml: 5 x 2 ml, 10 x 2 ml.


Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orifarm Generics A / S

Energivej 15

5260 Odense S

Denmark


Local representative

Orifarm Generics AB

Box 56048

102 17 Stockholm 

info@orifarm.com


This medicinal product is authorized under the European Economic Area under the names:

Denmark, and Finland: Esketamine Orifarm

Muhammad Nadeem

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