• hold with one hand the bottom part of the ampoule
• put the other hand on the top of the ampoule positioning the thumb above the coloured spot and press back using thumb and hand. Please see diagram below.
rage, sleep disturbances/insomnia, sexual arousal, and hallucinations
• Involuntary trembling, vertigo, visual disturbances (including double vision and blurred vision), slurred speech, headache, vomiting, convulsions/seizures, memory loss, coma
• Low blood pressure
• Reduced breathing rate, shortness of breath, temporary cessation of breathing, including during sleep
• Worsening of chronic obstructive lung disease
• Increase in specific liver enzymes (bilirubin, liver transaminases and alkaline phosphatase)
• Allergic skin reactions, hair loss
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. HOW TO STORE ATIVAN INJECTION
Ativan Injection should be stored and transported refrigerated (2°C to 8°C).
Keep ampoule in the outer carton to protect from light.
Keep out of the reach and sight of children.
Do not use Ativan Injection after the expiry date, which is stated on the carton. The expiry date refers to the last day of that month.
6. FURTHER INFORMATION What Ativan Injection contains
The active ingredient in Ativan Injection is lorazepam, and there are 4 mg of lorazepam in each 1 ml of the injection.
The other ingredients in Ativan Injection are polyethylene glycol, benzyl alcohol and propylene glycol.
What Ativan Injection looks like and contents of the pack
Ativan Injection is supplied in small clear glass bottles (called ampoules) and each ampoule contains 1 ml of Ativan Injection.
Ativan Injection is supplied in packs of 10 ampoules.
The Marketing Authorisation Holder is:
Pfizer Limited Ramsgate Road Sandwich Kent, CT13 9NJ United Kingdom
The Manufacturer is:
Haupt Pharma Livron 1 rue Comte de Sinard 26 250 Livron Sur Drome France
This leaflet was last revised in 05/2014
This leaflet can be made available in large print, audio or Braille on request.
Contact 0800 198 5000 to request this, quoting the following number: 00057/1279.
HEALTH PROFESSIONAL’S USER LEAFLET
Ativan Injection contains the active ingredient lorazepam at a concentration of 4 mg/ml.
.orazepam (INN, BAN) is chemically defined as 7-chloro-5-o-chlorphenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one.
Solution for injection
lear, colourless solution supplied in clear glass ampoules containing 4 mg orazepam in 1 ml of solution.
Dre-operative medication or premedication for uncomfortable or prolonged investigations, e.g. bronchoscopy, arteriography, endoscopy.
The treatment of acute anxiety states, acute excitement or acute mania.
The control of status epilepticus.
Dosage and duration of therapy should be individualised. The lowest ffective dose should be prescribed for the shortest time possible.
Treatment in all patients should be withdrawn gradually to minimise possible withdrawal symptoms (See special warnings and precautions for use).
Ativan Injection can be given intravenously or intramuscularly. However, the ntravenous route is to be preferred. Care should be taken to avoid injection into small veins and intra-arterial injection.
Absorption from the injection site is considerably slower if the intramuscular route is used and as rapid an effect may be obtained by oral administration of lorazepam.
Ativan should not be used for long-term chronic treatment.
Preparation of the injection
Ativan Injection is slightly viscid when cool. ntramuscular administration:
A 1:1 dilution of Ativan Injection with normal saline or Sterile Water for Injection BP is recommended in order to facilitate intramuscular administration. ntravenous administration:
-or intravenous administration, Ativan Injection should always be diluted with saline or Sterile Water for Injection BP as a 1:1 dilution.
Ativan Injection is presented as a 1 ml solution in a 2 ml ampoule to facilitate dilution.
Ativan Injection should not be mixed with other drugs in the same syringe. Dosage:
Adults: 0.05 mg/kg (3.5 mg for an average 70 kg man).
By the intravenous route the injection should be given 30-45 minutes before surgery when sedation will be evident after 5-10 minutes and maximal loss of recall will occur after 30-45 minutes.
By the intramuscular route the injection should be given 1-1 '/2 hours before surgery when sedation will be evident after 30-45 minutes and maximal loss of recall will occur after 60-90 minutes.
Children: Ativan Injection is not recommended in children under 12.
Adults: 0.025-0.03 mg/kg (1.75-2.1 mg for an average 70 kg man).
Repeat 6 hourly.
Children: Ativan Injection is not recommended in children under 12.
Adults: 4 mg intravenously Children: 2 mg intravenously
Elderly: The elderly may respond to lower doses and half the normal adult dose may be sufficient.
Patients with Renal or Hepatic impairment:
.ower doses may be sufficient in these patients (See special warnings and precautions for use). Use in patients with severe hepatic insufficiency is ontraindicated.
Acute pulmonary insufficiency
Hypersensitivity to benzodiazepines, including Ativan Injection or any of the vehicle constituents (polyethylene glycol, propylene glycol, benzyl alcohol)
Sleep apnoea syndrome Myasthenia gravis Severe hepatic insufficiency
Ativan Injection contains benzyl alcohol and is contraindicated in infants or young children, up to 3 years old.
Ativan Injection is not recommended for out-patient use unless the patient is accompanied.
Prior to use, Ativan Injection may be diluted for IM administration and should always be diluted for IV administration with equal amounts of compatible diluent (see Posology and method of administration). Intravenous injection hould be administered slowly except in the control of status epilepticus where rapid injection is required.
The possibility that respiratory arrest may occur or that the patient may lave partial airway obstruction should be considered. Therefore, equipment necessary to maintain a patent airway and to support respiration/ventilation hould be available and used where necessary.
The use of benzodiazepines, including lorazepam, may lead to physical and psychological dependence.
Severe anaphylactic/anaphylactoid reactions have been reported with the use of benzodiazepines. Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of benzodiazepines. Some patients taking benzodiazepines have had additional symptoms such as dyspnoea, throat closing, or nausea and vomiting. Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with a benzodiazepine should not be rechallenged with the drug.
It is recommended that patients receiving Ativan Injection should remain under observation for at least eight hours and preferably overnight. When Ativan Injection is used for short procedures on an outpatient basis, the patient should be accompanied when discharged.
Patients should be advised that their tolerance for alcohol and other CNS depressants will be diminished in the presence of Ativan Injection. Alcoholic beverages should not be consumed for at least 24 to 48 hours after receiving Ativan Injection.
Use of benzodiazepines, including lorazepam, may lead to potentially fatal respiratory depression. Extreme care must be taken in administering Ativan Injection to elderly or very ill patients and to those with limited pulmonary reserve or compromised respiratory function (eg, chronic obstructive pulmonary disease [COPD]), because of the possibility that apnoea and/or cardiac arrest may occur. Care should also be exercised when administering Ativan Injection to a patient with status epilepticus, especially when the patient has received other central nervous system depressants.
There is no evidence to support the use of Ativan Injection in coma or shock. Ativan is not intended for the primary treatment of psychotic illness or depressive disorders, and should not be used alone to treat depressed patients. The use of benzodiazepines may have a disinhibiting effect and may release suicidal tendencies in depressed patients.
Pre-existing depression may emerge during benzodiazepine use.
There are no clinical data available for Ativan Injection with regard to abuse or dependence. However, based upon experience with oral benzodiazepines, doctors should be aware that repeated doses of Ativan Injection over a prolonged period of time may lead to physical and psychological dependence. The risk of dependence on Ativan is low when used at the recommended dose and duration, but increases with higher doses and longer term use. The risk of dependence is further increased in patients with a history of alcoholism or drug abuse, or in patients with significant personality disorders. Therefore, use in individuals with a history of alcoholism or drug abuse should be avoided.
Dependence may lead to withdrawal symptoms, especially if treatment is discontinued abruptly. Therefore, the drug should always be discontinued gradually - using the oral preparation if necessary.
Symptoms reported following discontinuation of oral benzodiazepines include headaches, muscle pain, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating, and the occurrence of "rebound" phenomena whereby the symptoms that led to treatment with benzodiazepines recur in an enhanced form. These symptoms may be difficult to distinguish from the original symptoms for which the drug was prescribed.
In severe cases the following symptoms may occur: derealisation; depersonalisation; hyperacusis; tinnitus; numbness and tingling of the extremities; hypersensitivity to light, noise, and physical contact; involuntary movements; vomiting; hallucinations; convulsions. Convulsions may be more common in patients with pre-existing seizure disorders or who are taking other drugs that lower the convulsive threshold, such as antidepressants.
It may be useful to inform the patient that treatment will be of limited duration and that it will be discontinued gradually. The patient should also be made aware of the possibility of "rebound" phenomena to minimise anxiety should they occur.
Withdrawal symptoms (eg, rebound insomnia) can appear following cessation of recommended doses after as little as one week of therapy. There are indications that, in the case of benzodiazepines with a short duration of action, withdrawal phenomena can become manifest within the dosage interval, especially when the dosage is high.
When benzodiazepines with a long duration of action are being used, it is important to warn against changing to a benzodiazepine with a short duration of action, as withdrawal symptoms may develop.
Abuse of benzodiazepines has been reported.
Anxiety or insomnia may be a symptom of several other disorders. The possibility should be considered that the complaint may be related to an underlying physical or psychiatric disorder for which there is more specific treatment.
Caution should be used in the treatment of patients with acute narrow-angle glaucoma.
As with all benzodiazepines, the use of lorazepam may worsen hepatic encephalopathy. Patients with impaired renal or hepatic function should be monitored frequently and have their dosage adjusted carefully according to patient response. Lower doses may be sufficient in these patients. The same precautions apply to elderly or debilitated patients and patients with chronic respiratory insufficiency.
As with all CNS-depressants, the use of benzodiazepines may precipitate encephalopathy in patients with severe hepatic insufficiency. Therefore, use in these patients is contraindicated.
Some patients taking benzodiazepines have developed a blood dyscrasia, and some have had elevations in liver enzymes. Periodic haematologic and liver-function assessments are recommended where repeated courses of treatment are considered clinically necessary.
Transient anterograde amnesia or memory impairment has been reported in association with the use of benzodiazepines. This effect may be advantageous when Ativan is used as a premedicant.
Paradoxical reactions have been occasionally reported during benzodiazepine use (see Undesirable effects). Such reactions may be more likely to occur in children and the elderly. Should these occur, use of the drug should be discontinued.
Although hypotension has occurred only rarely, benzodiazepines should be administered with caution to patients in whom a drop in blood pressure might lead to cardiovascular or cerebrovascular complications. This is particularly important in elderly patients.
Ativan Injection contains the excipients polyethylene glycol and propylene glycol. There have been reports of propylene glycol toxicity (e.g. lactic acidosis, hyperosmolality, hypotension) and polyethylene glycol toxicity (e.g. acute tubular necrosis) during administration of Ativan Injection, including at higher than recommended doses. Central nervous system toxicity, including seizures, as well as unresponsiveness, tachypnoea, tachycardia and diaphoresis have also been associated with propylene glycol toxicity. Those prone to propylene glycol accumulation and its potential adverse effects include patients with impaired alcohol and aldehyde dehydrogenase enzyme systems, those with renal or hepatic disease; and paediatric patients.
Not recommended: Concomitant intake with alcohol
The sedative effects may be enhanced when the product is used in combination with alcohol. This affects the ability to drive or use machines.
PACKAGE LEAFLET: need to be reduced before you can take Ativan Injection. You
should also tell your doctor if you are taking a drug called
M^rUnlVIMMUN run inE USER scopolamine, which may be used for gut problems or before
® Taking Ativan Injection with food and drink
A ||VMN INJECMON You should avoid alcohol for at least 24 to 48 hours after l°razepam receiving Ativan Injection.
Read all of this leaflet carefully before you start taking this Pregnancy and breast-feeding
medicine: If you are pregnant or might become pregnant do not take this
• Keep this leaflet. You may need to read it again. medicine without consulting your doctor first. Benzodiazepines
• If you have further questions, please ask your doctor or including Ativan Injectior1, may cause damage to the foetus if pharmacist taken during early pregnancy. If you take this medicine during
late pregnancy or during labour, your baby, when born, may be
• If any o the side efltectsgets serous, or you ndr* any ^ Active than other bibies, have a low body temperature sideeffects. n(ot listed in this leaflet, please te" your doctor be floppy or have breathing or feeding difficulties for a while.
Your baby’s response to the cold might be temporarily impairec IN THIS LEAFLET' also. If this medicine is taken regularly in late pregnancy, your
1. What Ativan Injection is and what it is used for. baby may develop withdrawal symptoms after birth.
2. Before you take Ativan Injection. Talk to your doctor or pharmacist if you are breast-feeding,
3. Receiving Ativan Injection. since the drug may pass into breast milk.
4. Possible side effects.
5. How to store Ativan Injection. Driving and using machines
B. Further information. Do not drive or use machinery within 24 to 48 hours of
receiving Ativan Injection. The medicine can affect your ability
1. WHAT ATIVAN INJECTION IS AND WHAT IT IS to drive as it may make you sleepy or dizzy.
USED FOR • Do not drive while taking this medicine until you know how The name of your medicine is Ativan Injection. The active it affects you.
ngredient in Ativan Injection is lorazepam, which is a member • It is an offence to drive if this medicine affects your ability of a group of medicines called benzodiazepines. It helps to to drive.
relieve anxiety and muscle tension. • However, you would not be committing an offence if:
Ativan Injection is usually prescribed as - has dbeen prescribed to treat a medical or
pre-medication to help you to relax before an operation or ,,, prob^m and.......
before uncomfortable or prolonged investigations. It may also - You have taken it. acpording to the igiven by be used to relieve short periods of anxiety, excitement or theprescriber or in the information provided with the
agitation, and in the control of convulsions. medicine and
- It was not affecting your ability to drive safely
2. BEFORE YOU TAKE ATIVAN INJECTION Talk to your doctor or pharmacist if you are not sure whether it
is safe for you to drive while taking this medicine.
You should not be given Ativan Injection if:
Important information about some of the ingredients of
• You have severe breathing or chest problems. Ativan Injection
- You rc Jegictoofthe ^c effects (incl uding seizures) caused by the ingredients SS- Ativan Injection (see Section 6 for a fu" list of conta ined in Ativan Injection (pdyethylen e g ly/col agnd propylene g ). glycol) have been reported following very high doses of Ativan
• You have myasthenia gravis (a disease causing weakened Injection. muscles and excessive tiredness).
• You have serious liver problems. 3. RECEIVING ATIVAN INJECTION
• You suffer from sleep apnoea (breathing problems when Your doctor will give you Ativan Injection, by injecting it into one you are asleep). of your veins (intravenously) or into one of your muscles. Ativan
Injection may be diluted with water or saline just before it is
f you are an out-patIent you shobuld ntot be g iven Ativa^ g^o to you.The amount of Ativan Injection you are give; n r njection unless you have somebody to take you home. will depend on how much you weigh UsU why it is being Ativan Injection contains benzyl alcohol and should not be given to you:
used in infants or young children up to 3 years old. • Before an operation or investigation, you will usually be
Tell your doctor or pharmacist if: given 0:°5 m of Ativan ^ct™ . for each kilogram that
you weigh (e.g. if you weigh 70 kilograms you will receive
• You are pregnant or trying to become pregnant. 3.5 mg of Ativan Injection).
• You are breast-feeding, since the drug may pass into • For anxiety or excitement, the usual dose is 0.025 to breast milk. 0.03 mg for each kilogram that you weigh (e.g. if you
• You abuse or have in the past abused drugs or alcohol. weigh 70 kilograms you will probably receive 1.75 to
• You have a personality disorder. If so, you have a greater 2^ mg of Ativan Injection).
chance of becoming dependent on lorazepam. • When Ativan Injection is used to control convulsions a
• You have any kidney or liver problems. dose of 4 mg is usually given intravenously to adults.
A lower dose of 2 mg given intravenously is usually given
• You have suffered from ^pram the past since rt to control convulsions in children. could re-occur during treatment with lorazepam.
• You are currently suffering from depression, since Your doctor may prescribe a different dose or length of lorazepam may increase any suicidal feelings, which you especially if you are elderly.
may have. Some people feel sleepy after receivisg Ativun
• You suffer from breathing problems. Injection. Therefore, you muy neeU to stay in hospital
• You suffer from an eye problem called glaucoma. for at least 8 hours, or overnight, after receiving your
• You enter hospital for treatment. injection: f you ^ to leuve ’hortly ^
receiving Ativun Injection you should have someone
Taking other medicines with you.
You should tell your to or pharmacist if you are takmg Ativan Injection is usually only prescribed for one
any other medicines includingthose which h^ fot teen or two doses, or for a short course of treatment. prescribed by a doctor, since they may affect the way Ativan
njection works. Ativan Injection tay also affect the vwajr other Lhis ^U^ the risk ^ becomin9 on h Urugs work Ativun Injection, or suffering unpleusunt effects when
g . you stop taking it (See 'Stopping your medicine',
n particular, you should tell your doctor if you are taking any below).
other sedative, anti-anxiety drugs, antidepressants, strong pain . 5 killers (e.g. methadone), drugs for epilepsy, antihistamines, Instructions for use: drugs for mood or mental disorders (e.g. chlorpromazine, Ativun umpoules ure equipped with the OPC (One clozapine and haloperidol), drugs for respiratory diseases, Point Cut) opening system and must be opened using 1 drugs for gout (probenecid). The dose of these drugs may the following instructions:
The benzodiazepines, including Ativan Injection, produce additive CNS * Benzodiazepine effects on the CNS are dose dependent, with more
depressant effects when co-administered with other medications which severe CNS depression occurring with higher doses.
hemselves produce CNS depression, e.g. barbiturates, antipsychotics,
sedatives/hypnotics, anxiolytics, antidepressants, narcotic analgesics, sedative yascular disorders
antihistamines, anticonvulsants and anaesthetics.
Concurrent administration of lorazepam with sodium valproate may result in Undetermined: Hypotension.
■educed clearance (20 to 40%) and increased concentrations of lorazepam. Respiratory thoracic and mediastinal disorders*
Therefore clinical monitoring is advised and lorazepam dosage should be
reduced when appropriate. Undetermined: Respiratory depression, apnoea, worsening
Concurrent administrat!on of lorazeram with pratenecri may resit in reduced Worsening of obstructive pulmonary disease. clearance, increased elimination half-life and increased concentrations of t
orazepam. Therefore clinical monitoring is advised and lorazepam dosage ,The e!<tent °ff,respiratory depression with terira^zepres is dose should be reduced when appropriate. dependent with more severe depression occurring with high doses.
An enhancement of the euphoria induced by narcotic analgesics may occur Gastrointestinal disorders with benzodiazepine use, leading to an increase in psychic dependence. Uncommon: Nausea.
Compounds which inhibit certain hepatic enzymes (particularly cytochrome Undetermined: Constipation.
P450) may enhance the activity of benzodiazepines. To a lesser degree this Hepatobiliary disorders also applies to benzodiazepines which are metabolised only by conjugation. Hepatobiliary disorders
The addition of scopolamine to Ativan Injection is not recommended, since llnteimrred Incre^ h Motorr hcre^ein ^ to
heir combination has been observed to cause an increased incidence of increase in alkaline phosphatase.
sedation, hallucination and irrational behaviour. Skin and subcutaneous tissue disorders
Concomitant use of clozapine and lorazepam may produce marked sedation, Undetermined: Allergic skin reactions, alopecia.
excessive salivation, and ataxia.
Administration of theophylline or aminophylline may reduce the sedative Reproductive system and breast disorders
effects of benzodiazepines, including lorazepam. Uncommon: Change in libido, impotence, decreased
There have been reports of apnoea, coma, bradycardia, heart arrest and death orgasm.
with the concomitant use of lorazepam injection solution and haloperidol. General disorders and administration site conditions
4.6 F’regnancy and toctahon Very common: Fatigue.
Ativan Injection should not be used during pregnancy, especially during Common: Muscle weakness, asthenia. he first and last trimesters, unless in the judgement of the physician such Und^rnin^ Hypothermia administration is clinically justifiable. Benzodiazepines may cause foetal
damage when administered to pregnant women Tolerance at the injection site is generally good ^tagd rarely pain and
redness have been reported after Ativan Injection.
f the drug is prescribed to a woman of childbearing potential, she should
be warned to contact her physician about stopping the drug if she intends to Transient anterograde amnesia or memory impam^ay crajr usung become, or suspects that she is, pregnant. therapeutic the nsk rereMg at higher tas; (see Speaal mrnitigs
and precautions for use).
Use of Ativan Injection during the late phase of pregnancy may require
ventilation of the infant at birth Paradoxical reactions may be more likely to occur in children and the elderly
(see Special warnings and precautions for use). f, for compelling medical reasons, the product is administered during the late 4q O ’ d phase of pregnancy, or during labour at high doses, effects on the neonate, 4.q Overdose
such as hypothermia, hypotonia and moderate respiratory depression, can be In the management of overdosage with any drug, it should be borne in mind expected, due to the pharmacological action of the compound. that multiple agents may have been taken. nfants of mothers who ingested benzodiazepines for several weeks or more Overdosage of benzodiazepines is usually manifested by degrees of central preceding delivery have been reported to have withdrawal symptoms during nervous system depression ranging from drowsiness to coma. In mild cases, he postnatal period symptoms include drowsiness, mental confusion and lethargy. In more serious
Symptoms such as hypotonia, hypothermia, respiratory depression, apnoea, cases; and espfciallV when C^p^S drugs or s|s , eeding problems, and impaired metabolic response to cold stress have been touted symptoms may hypotension, hypotonia, re^ratoty reported in neonates born of mothers who have received benzodiazepines depression, cardiovascular depression, coma and, very rarely, death. during the late phase of pregnancy or at delivery. Propylene glycol toxicity and polyethylene glycol toxicity have been reported
There are insufficient data regarding obstetrical safety of parenteral Ativan, ,higher ^ dfs of Ativan Injection (see Section ncluding use in caesarean section. Such use, therefore, is not recommended. 44 Special warnings andprecautions for use).
Since benzodiazepines are found in breast milk, Ativan Injection should not T^enndtcC|00eVeorC0fagndiOSnmoatnhley S^AS andCeUqdiagemn0r,n,!n0,risnhgo0fldVital re given to breastfeeding mothers; unless the expected benefit to the woman begnmSnnSntdniSl°dSfa°dSnesrVa!e0Cr l0,fstphient!0r!en,!ednnndnddddatd HyS/S'1 the potential risk to the infant be maintained and assisted respiration used as needed. ^pto^d °utweighs the potential risk to the infant. though unlikely, may be controlled with noradrenaline. Lorazepam is poorly
4.7 Effects on ability to drive and use machines dialysable.
Sedation, amnesia, impaired^ concentration and impaired muscular function The benzodiazepine antagonist, flumazenil, may be useful in hospitalised may adversely affect the ability to drive or use machines. Therefore, patients patients for the management of benzodiazepine overdosage. Flumazenil should not drive or operate machinery within 24-48 hours of administration product information should be consulted prior to use. The physician should be of Ativan Injection and should be advised not to take a|coho| (see also aware of a risk of seizure in association with flumazenil treatment, particularly 'nteractions). in long-term benzodiazepine users and in tricyclic antidepressant overdose. This medicine can impair cognitive function and can affect a patient’s ability to 5 PHARMACOLOGICAL PROPERTIES drive safely. This class of medicine is in the list of drugs included in regulations
under 5a of the Road Traffic Act 1988. When prescribing this medicine, 5.1 ^armacoctynamc properties
patients should be told: Ativan is a benzodiazepine with anxiolytic, sedative, hypnotic, anticonvulsant The medicine is likely to affect your ability to drive and muscle relaxant properties.
Do not drive until you know how the medicine affects you 52 ^armacoldntfto properties
It is an offence to drve while under the influence of this medicine Ativan Injection is readily absorbed when given intramuscularly. Peak It is an offence to drve while under the influence of this medicine plasma concentrations occur approximately 60-90 minutes following 1 However, you would sot be committing as offence (called ‘statutory defence) if: intramuscular administration
- You Sestet Ativan is metabolised by a simple one-step process to a pharmacologically S “Onnltan°Cn0^Ov?dt°dthW^thntS^eUCntle0dniSciSe anndby p irrngdaVdggl^:°W!Cdd m^S "sk of accumulation after repeated
- at was not affecting your ability to drve safely doses, giving a wide margin of safety.
18 Undesirable effects There are no major active metabolites. The elimination half-life is about 4.o undesirame effects 12-16 hours when given intramuscularly or intravenously.
Adverse reactions are listed in the table in CIOMS frequency categories: 5 3 Preclinical safety data
ter > 1 %%and < 10% Nothing of relevance to the prescriber
Uncommon: > 0.1% and < 1% 6. PHARMACEUTICAL PARTICULARS
Rare: > 0.01% and < 0.1% 61 ,.t . evcipients Very rare: < 0.01% 61 List of evcipients
Undetermined: Insufficient data to calculate significant frequencies. Polyethylene glycol 400
System Organ Class Adverse Reaction PeSpyieriecocilv(!ol and Frequency propylene g|yco|
Blood and lymphatic system disorders None known Undetermined: Thrombocytopenia, agranulocytosis, pancytopenia. 6.3 Shelf life
Immune system disorders
Undetermined: Hypersensitivity reactions, anaphylactic/ 6.4 Spe<cial precautions for s*°rage
oid reactions, angioedema. Store and transport refrigerated (2°C to 8°C).
Keep ampoule in the outer carton.
Endocrine disorders 6.5 Nature and contents of container
Undetermined: Syndrome of Inappropriate Antidiuretic 1ml solution in 2ml ampoules (Type I glass) with a one-point-cut opening, Hormone secretion (SIADH). position marked by red spot in pack sizes of 10.
Metabolism and nutrition disorders 6.6 Special preca^ore; for d^po^ and ota handhng
Undetermined: Hyponatremia. None
7. MARKETING AUTHORISATION HOLDER
Psychiatric disorders Pfizer Limited Common: Confusion, depression, unmasking of depression. Ramsgate Road Undetermined: Disinhibition, euphoria, suicidal ideation/attempt. Sandwich
Paradoxical reactions, including anxiety, ^iU CT13 9NJ agitation, excitation, hostility, aggression, rage, United Kingdom sleep disturbances/insomnia, sexual arousal, 8. MARKETING AUTHORISATION NUMBER and hallucinations. pL 00057/1279
Nervous system disorders* 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE
Very common: Sedation, drowsiness. AUTH°RISATI°N Common: Ataxia, dizziness. 11 August 2011
Undetermined: Extrapyramidal symptoms, tremor, vertigo, visual 10. DATE OF REVISION OF THE TEXT disturbances (including diplopia and blurred 05/2014 vision), dysarthria/slurred speech, headache, convulsions/seizures, amnesia, coma.
Ref: AT 6_1
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