Sojourn

Package leaflet: information for the patient

Sojourn, 100%, solution for vapour inhalation
Sevofluranum
Please read this leaflet carefully before using the medicine, because it contains
important information for the patient.
Keep this leaflet as you may need to read it again.
If you have any further questions, please consult your doctor or nurse.
If you experience any adverse reactions, including any not listed in this leaflet, inform your
doctor or nurse. See section 4.
Contents of the leaflet:
What Sojourn is and what it is used for
What you need to know before using Sojourn
How to use Sojourn
Possible side effects
How to store Sojourn
Contents of the pack and other information
What Sojourn is and what it is used for
The active substance in Sojourn is sevoflurane, which is an agent used for general anaesthesia
during surgical and other procedures.
Sojourn is an inhaled general anaesthetic administered as a vapour for inhalation.
Sojourn is used to induce deep sleep (anaesthesia induction) and to maintain anaesthesia and
analgesia in patients undergoing surgical procedures (anaesthesia maintenance). If there is no
improvement or the patient feels worse, they should definitely consult their doctor.
What you need to know before using Sojourn
Sojourn must be administered only by trained medical personnel appropriately trained in the
administration of general anaesthetics, under the supervision of an anaesthesiologist or by an
anaesthesiologist.
When not to use Sojourn and to inform your doctor:
if there are medical reasons why the patient should not receive general anaesthesia
if the patient has ever been advised not to undergo general anaesthesia
if the patient has an allergy (hypersensitivity) to sevoflurane or to another anaesthetic agent
if the patient or any family member has experienced a condition called malignant hyperthermia
(sudden high body temperature and severe muscle contractions) during anaesthesia
if the patient has liver disease or has previously been administered general anaesthetics,
especially if administered repeatedly within a short time interval. Some anaesthetic agents may
occasionally cause liver disorders, which may result in yellowing of the skin and eyes (jaundice)
if the patient has ever experienced QT prolongation (prolongation of a specific time interval
on the ECG) or torsade de pointes (a specific type of heart rhythm disturbance), which may
also be associated with QT prolongation. Sevoflurane may sometimes cause these conditions
if the patient has a predisposition to seizures or is at risk of their occurrence
if the patient has a mitochondrial disease
Warnings and precautions
Before starting treatment with Sojourn, discuss with your doctor:
if the patient has previously received general anaesthetics, especially if administered
repeatedly within a short period, there may be an increased risk of liver disorders
if the patient has another illness unrelated to surgery, particularly kidney or heart disease,
low blood pressure, severe headache, nausea or vomiting, or Pompe disease in children
(a metabolic disorder). Sevoflurane may cause cardiac arrhythmias, which in some cases
may be severe
if the patient has a specific type of muscle weakness (myasthenia gravis), as patients
with this condition are highly sensitive to drugs causing reduced respiratory rate and depth
if the patient has ischaemic heart disease
if the patient has hypovolaemia (reduced blood volume) or is debilitated
if the patient has a neuromuscular disorder, particularly Duchenne muscular dystrophy
if the patient has increased intracranial pressure, e.g. due to head injury or brain tumour
if the patient has seizures or a history of seizures, as sevoflurane increases the risk of seizure
occurrence
if the patient is pregnant or breastfeeding
children
if the patient has Down's syndrome
If any of the above circumstances apply to the patient, they should consult their doctor, nurse,
or pharmacist. The patient may require thorough evaluation by a doctor and possibly adjustment
of medications.
The following events may occur during or after administration of Sojourn 100%, solution for
vapour inhalation:
During induction of anaesthesia, sevoflurane and similar agents (halogenated anaesthetics)
may cause coughing. This should be taken into account.
As with other anaesthetic agents, minor mood changes may occur for several days after
administration of sevoflurane.
Young children under six years of age more frequently experience acute confusion (delirium)
after awakening from anaesthesia. In addition, children under six years of age more frequently
experience agitation/anxiety after awakening from anaesthesia.
In susceptible patients, inhaled anaesthetics (inhalational anaesthetics) may cause a state of
excessively accelerated skeletal muscle metabolism (hypermetabolism). This leads to high
muscle oxygen demand due to elevated blood CO₂ levels (hypercapnia). In such cases, muscle
rigidity, increased heart rate (tachycardia), increased respiratory rate (tachypnea), bluish
discoloration of lips, tongue, skin and mucous membranes (cyanosis), cardiac arrhythmias,
and/or unstable blood pressure may occur.
In rare cases, the use of inhaled anaesthetics has led to increased blood potassium levels
(increased serum potassium concentration), resulting in cardiac arrhythmias and death in
children after surgical procedures.
Sevoflurane may cause respiratory depression, which may be intensified by opioid
premedication or other drugs causing respiratory depression. Respiratory function should be
monitored and supported if necessary.
Sojourn with other medicines
Inform your doctor about the following medicines currently or recently taken:
The medicines or active substances listed below may interact with each other when used
concurrently with Sojourn. Some of these medicines are administered to the patient by the
anaesthesiologist during surgery, as indicated in the description.
amphetamines (stimulants): used in the treatment of attention deficit hyperactivity disorder
(ADHD) or narcolepsy
cardiac drugs such as adrenaline or epinephrine
beta-blockers (e.g. atenolol, propranolol). These are cardiac drugs commonly used in the
treatment of high blood pressure
alcohol
barbiturates (sleeping pills)
St. John's wort (a herbal preparation used in the treatment of depression)
decongestants (ephedrine): used to reduce nasal congestion and often contained in cough
and cold medicines
non-selective monoamine oxidase inhibitors (MAO inhibitors) (a group of antidepressant
drugs)
calcium antagonists
verapamil (a cardiac drug used in the treatment of hypertension or cardiac arrhythmias)
sedatives (benzodiazepines, e.g. diazepam, lorazepam). These are calming agents used
when the patient is anxious, e.g. before surgery
strong analgesics such as morphine or codeine
muscle relaxants (non-depolarising, e.g. vecuronium, pancuronium, atracurium and
depolarising, e.g. suxamethonium): These drugs are used in general anaesthesia to induce
muscle relaxation
isoniazid, used in the treatment of tuberculosis
isoprenaline

• other anaesthetic agents, e.g. nitrous oxide: This is an agent used during general anaesthesia which induces unconsciousness and relieves pain; propofol, opioids (e.g. alfentanil and sufentanil): These are strong analgesics often used during general anaesthesia, and sevoflurane may affect their action if administered simultaneously.

Inform your doctor or nurse about all medicines currently or recently taken, including those
obtained without a prescription. Also inform them about herbal remedies, vitamins and
minerals being taken.
Taking Sojourn with food and drink
Sojourn, 100%, solution for vapour inhalation is a medicine that induces and maintains
unconsciousness in the patient to allow surgical procedures. Ask your treating doctor, surgeon
or anaesthesiologist when and what the patient may eat or drink after awakening from
anaesthesia.
Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is breastfeeding, inform the doctor
or anaesthesiologist. It is not known whether sevoflurane or its metabolites pass into human
milk. It is recommended to interrupt breastfeeding for 48 hours after administration of
sevoflurane and to discard milk produced during this period. Sojourn, 100%, solution for vapour
inhalation should not be used if the patient is pregnant unless absolutely necessary.
The use of sevoflurane for anaesthesia during caesarean section is safe for both the patient and
her child. The safety of sevoflurane use during labour and natural childbirth has not been
established. Like other anaesthetic agents, sevoflurane may cause reduced respiratory rate
in newborns. In such cases, the doctor will decide whether sevoflurane may be used.
Driving and operating machinery
Sojourn, 100%, solution for vapour inhalation has a significant effect on the ability to drive
and operate machinery. Do not drive or operate any machinery until the doctor informs the
patient that it is safe to do so.
Receiving a general anaesthetic may impair the patient's psychophysical performance for
several days. This may in turn impair the ability to perform activities requiring adequate
concentration. Ask the anaesthesiologist when the patient will be able to safely drive and
operate machinery again.
How to use Sojourn
Sojourn is administered exclusively in hospital settings by a trained anaesthesiologist who will
determine the appropriate dose and duration of sevoflurane administration for the patient. The
dose will vary depending on age, body weight, type of surgical procedure required, and other
medicines administered to the patient during surgery.
Sojourn in liquid form is converted into vapour in a vaporiser and inhaled by the patient for
anaesthesia.
It may be used to induce unconsciousness before surgery or, if the patient has been anaesthetised
by injection, to maintain anaesthesia during surgery.
Once the anaesthesiologist discontinues administration of Sojourn, the patient will awaken
within a few minutes.
If you have any further questions regarding the use of this medicine, please consult the
anaesthesiologist or nurse.
Use of a higher than recommended dose of Sojourn
Sojourn will be administered to the patient by trained medical personnel, and it is unlikely
that the patient will receive an overdose. If the patient receives an overdose of Sojourn, the
anaesthesiologist will take necessary actions.
Possible side effects
Like all medicines, Sojourn can cause side effects, although not everybody will experience them.
Inform the treating doctor, nurse or anaesthesiologist immediately if the patient does not feel well.
Serious, rare side effects (may be life-threatening):

• anaphylactic or anaphylactoid reactions (see more details under "Side effects of unknown frequency")

The following adverse reactions are serious and may require immediate medical consultation.
During anaesthesia, the patient remains under medical supervision and will receive immediate
assistance if required.
Inform the doctor or nurse immediately:
if the patient has an allergic reaction, which may be severe, with swelling of the face,
tongue and throat, and difficulty breathing
if the patient develops malignant hyperthermia (very high fever), which requires intensive
treatment and may lead to death. This condition may occur in family members
if elevated blood potassium levels (hyperkalaemia) are observed, which may lead to
cardiac arrhythmias. Hyperkalaemia may lead to death, especially in children in the
postoperative period. Such cases have been reported in patients with neuromuscular
disorders, particularly Duchenne muscular dystrophy
Inform the doctor or nurse if:
Very common side effects (may affect more than 1 in 10 people):
anxiety (agitation) in children
slow heart rate (bradycardia)
hypotension
cough
nausea and vomiting
Common side effects (may affect up to 1 in 10 people):
anxiety (agitation) in adult patients
headache
dizziness
drowsiness
rapid heartbeat
hypertension
respiratory disturbances
airway obstruction
slow and shallow breathing
laryngospasm, respiratory disorders
excessive salivation
hypothermia, shivering
fever
abnormal blood glucose levels, abnormal liver function test parameters or abnormal white
blood cell count, i.e. increased susceptibility to infections
increased blood fluoride levels
Uncommon side effects (may affect up to 1 in 100 people):
confusion
cardiac rhythm and function disturbances
atrioventricular block (disturbance of electrical conduction in the heart)
respiratory arrest, low oxygen levels, fluid in the pleura
urinary retention and glucosuria
increased blood creatinine levels (indicator of poor kidney function) detected in blood
sample testing
Other side effects [of unknown frequency (frequency cannot be estimated from available
data)]:
asthma
allergic reactions, e.g.:
rash
flushing
urticaria
itching
eyelid swelling, dyspnoea
anaphylactic and anaphylactoid reactions. These reactions develop rapidly and may be
life-threatening. Symptoms of anaphylaxis include:
malignant hyperthermia
angioedema (swelling of the skin of the face, limbs, lips, tongue or throat)
difficulty breathing
drop in blood pressure
urticaria
seizure attacks
sudden muscle tremors
cardiac arrest
bronchoconstriction
dyspnoea or wheezing
apnoea
breathlessness
impaired liver function or hepatitis, characterised by, e.g., loss of appetite, fever, nausea,
vomiting, abdominal discomfort, jaundice and dark urine
dangerously high increase in body temperature
chest discomfort
increased intracranial pressure
irregular heartbeat or palpitations
pancreatitis
increased blood potassium levels detected in blood sample testing
muscle rigidity
jaundice
kidney inflammation (symptoms may include fever, disorientation or drowsiness, rash,
swelling, urine appearing more or less normal, and presence of blood in urine)
oedema
Seizures (convulsions) have occasionally been observed. They may occur during administration
of Sojourn 100% solution for vapour inhalation or within one day after anaesthesia. They occur
mainly in children and young adults.
In children with Down's syndrome receiving sevoflurane, slowing of heart rate may occur.
Children with Pompe disease, a congenital disorder, may have irregular heart rhythm during
sevoflurane anaesthesia.
During or immediately after anaesthesia, blood fluoride levels may be slightly elevated, but are
not considered harmful and quickly return to normal.
If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur,
inform the doctor or pharmacist.
If any change in well-being is observed after administration of sevoflurane, inform the doctor or
pharmacist. Some adverse effects may require treatment.
Reporting of adverse reactions
If you experience any adverse reactions, including any not listed in this leaflet, inform your
doctor, pharmacist or nurse.
Adverse reactions can also be reported directly to the national system for reporting adverse
reactions, to the Department of Monitoring Adverse Drug Reactions of the Office for Registration
of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C,
02-222 Warsaw, tel. 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, additional information on the safety of the medicine can be
collected.
How to store Sojourn
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date (month/year) stated on the bottle label and
carton. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Store the bottle in an upright position.
After first opening, the contents of the bottle should be used within 8 weeks.
Do not store in a refrigerator.
Keep the bottle tightly closed due to the volatility of the anaesthetic agent.
Contents of the pack and other information
What Sojourn contains
Sojourn contains 100% sevoflurane as the active substance. The medicine does not contain any
other excipients.
This medicine contains fluorinated greenhouse gases.
Each pack contains 380 g of Sevofluranum, equivalent to 0.0741 tonnes of CO₂ equivalent
(global warming potential GWP = 195).
What Sojourn looks like and contents of the pack
Sojourn is a colourless liquid, packed in 250 ml amber glass bottles (with or without an external
PVC coating) with a cap or closure with an integrated connector.
Pack sizes: 1 and 6 bottles.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Marketing authorisation holder
Piramal Critical Care B.V.
Rouboslaan 32 (ground floor), 2252 TR
Voorschoten
The Netherlands
Manufacturer
Piramal Critical Care B.V.
Rouboslaan 32 (ground floor), 2252 TR
Voorschoten
The Netherlands
OR
(For the United Kingdom only)
Piramal Critical Care Limited
Apartment 4, Ground Floor,
Heathrow Boulevard – East Wing,
280 Bath Road, West Drayton,
UB7 0DQ,
United Kingdom
This medicine is authorised for marketing in the European Economic Area under the
following names:
Austria - Sevofluran Piramal 100 % Flüssigkeit zur Herstellung eines Dampfes zur Inhalation
Bulgaria - Sevoflurane Piramal 100% Inhalation Vapour, liquid
Cyprus - Sevoflurane - Piramal
Czech Republic - Sojourn 100% tekutina k přípravě inhalace parou
Denmark - Sojourn
Estonia - Sevoflurane- Piramal, inhalatsiooniaur, vedelik 100%
Germany - Sevofluran Piramal 100 % Flüssigkeit zur Herstellung eines Dampfs zur Inhalation
Greece - Sojourn Sevoflurane 100% Inhalation Vapour, liquid
Hungary - Sevoflurane Piramal folyadék inhalációs gőz képzéséhez
Iceland - Sevoflurane Piramal 100% innöndunargufa, vökvi
Ireland - Sevoflurane 100% Inhalation Vapour, liquid
Italy - Sewofluran Piramal
Latvia - Sevoflurane Piramal 100 % Inhalation Vapour, liquid
Lithuania - Sevoflurane Piramal 100% inhaliaciniai garai skystis
Luxembourg - Sevoflurane 100%
Malta - Sevoflurane 100% Inhalation Vapour, liquid
Netherlands - Sevoflurane 100% (Piramal), Vloeistof voor inhalatiedamp
Norway - Sevoflurane Piramal væske til inhalasjonsdamp
Poland - Sojourn
Portugal - Sevoflurano Ojourn 100% líquido para inalação por vaporização
Slovenia - Sevofluran Piramal 250 ml para za inhaliranje, tekocina
Spain - Sevoflurano Piramal 100% líquido para inhalación del vapor
United Kingdom - Sevoflurane 100% Inhalation Vapour, liquid

Additional information for doctors or medical professionals is available in the product
characteristics of this medicinal product.