Atricurium Besylate Injection USP Taj Pharma SMPC

Atracurium Besylate Inje ction US P 100 mg/10 ml / 50 mg/5 ml / 25 mg/2 .
5ml Taj P harma : Uses, Side Effects, I nteractions, Pi ctures, War nings, Atracurium Besylate Inje ction USP 100 mg/1 0ml / 5 0mg/ 5ml / 2 5mg/ 2.5 ml Taj Phar ma Dosage & Rx Info | Atracurium Besylate Injecti on USP 1 00mg /10 ml / 50 mg/ 5ml / 25 mg/2. 5ml Taj P harma U ses, Side E ffe cts, Atracuri um Besylate Inje ction US P 100 mg/10 ml / 50 mg/5 ml / 25 mg/2. 5ml Taj P harma : I ndicati ons, Side E ffects, Warnings, Atracurium Besylate Inj ection USP 100 mg/1 0ml / 5 0mg/ 5ml / 2 5mg /2.5 ml Taj Phar ma - Drug I nformation - Taj Phar ma, Atracuri um Besylate Inje ction USP 1 00 mg/10 ml / 50 mg/5 ml / 25 mg/2. 5ml Taj P harma dose Taj pharma ceutical s Atracurium Be sylate Injection USP 10 0mg/ 10 ml / 50 mg/5 ml / 25 mg/2.5 ml Taj Phar ma interactions, Taj P harma ceutical Atracurium Besylate Inje ction USP 100 mg/1 0ml / 5 0mg/ 5ml / 2 5mg/ 2.5 ml Ta j
Pharma contraindications, Atracurium Besylate Inje ction USP 1 00 mg/10 ml / 50 mg/5 ml / 25 mg/2. 5ml Taj P harma pri ce, Atracurium Besylate Injecti on USP 1 00 mg/10 ml / 50 mg/5 ml / 25 mg/2. 5ml Taj P harma Taj P harma Atracuri um Besylate Inje ction US P 100 mg/10 ml / 50 mg/5 ml / 25 mg/2. 5ml Taj P ha rma PIL- Taj Phar ma Stay connecte d to all update d on Atracurium Besylate Inje ction USP 100 mg/1 0ml / 5 0mg/ 5ml / 2 5mg /2.5 ml Taj Phar ma Taj Phar mace uticals Taj pharma ceutical s Hyderaba d. Patient Infor mation Leaflets , PIL.
ATRACURIUM BESYLATE 4.2 Posology and method of administration

Route of administration: Intravenous
INJECTION USP injection or continuous infusion.
100MG/10ML / 50MG/5ML / 25MG/2.5ML
TAJ PHARMA Used by injection in adults: Atracurium
Besylate Injection USP 100mg/10ml /
1. NAME OF THE MEDICINAL 50mg/5ml / 25mg/2.5ml Taj Pharma is
PRODUCT administered by intravenous injection.
Atracurium Besylate Injection USP The dosage range recommended for adults is
100mg/10ml Taj Pharma 0.3 to 0.6 mg/kg (depending on the duration
of full block required) and will provide
Atracurium Besylate Injection USP
adequate relaxation for about 15 to 35
50mg/5ml Taj Pharma
minutes.
Endotracheal intubation can usually be
25mg/2.5ml Taj Pharma
accomplished within 90 seconds from the
2. QUALITATIVE AND intravenous injection of 0.5 to 0.6 mg/kg.
QUANTITATIVE COMPOSITION
Full block can be prolonged with
a) Each ml of Injection contains: supplementary doses of 0.1 to 0.2 mg/kg as
Atracurium Besylate equivalent to required. Successive supplementary dosing
Atracurium USP…………………........10mg does not give rise to accumulation of
neuromuscular blocking effect.
b) Each ml of Injection contains:
Atracurium Besylate equivalent to Spontaneous recovery from the end of full
Atracurium USP…………………........10mg block occurs in about 35 minutes as measured
by the restoration of the tetanic response to
c) Each ml of Injection contains: 95% of normal neuromuscular function.
Atracurium Besylate equivalent to
Atracurium USP…………………........10mg The neuromuscular block produced by
For a full list of excipients, see section 6.1. 100mg/10ml / 50mg/5ml / 25mg/2.5ml Taj
3. PHARMACEUTICAL FORM Pharma can be rapidly reversed by standard
doses of anticholinesterase agents, such as
Injection neostigmine and edrophonium, accompanied
4. CLINICAL PARTICULARS or preceded by atropine, with no evidence of
recurarisation.
4.1 Therapeutic indications
Atracurium Besylate Injection USP Use as an infusion in adults: After an initial
100mg/10ml / 50mg/5ml / 25mg/2.5ml Taj bolus dose of 0.3 to 0.6 mg/kg, Atracurium
Pharma is a highly selective, competitive or Besylate Injection USP 100mg/10ml /
non-depolarising neuromuscular blocking 50mg/5ml / 25mg/2.5ml Taj Pharma can be
agent. It is used as an adjunct to general used to maintain neuromuscular block during
anaesthesia or sedation in the intensive care long surgical procedures by administration as
unit (ICU), to relax skeletal muscles, and to a continuous infusion at rates of 0.3 to
facilitate tracheal intubation and mechanical 0.6mg/kg/hour.
ventilation.
Atracurium Besylate Inje ction US P 100 mg/10 ml / 50 mg/5 ml / 25 mg/2 .5ml Taj P harma : Uses, Side Effects, I nteractions, Pi ctures, War nings, Atracurium Besylate Inje ction USP 100 mg/1 0ml / 5 0mg/ 5ml / 2 5mg/ 2.5 ml Taj Phar ma Dosage & Rx Info | Atracurium Besylate Injecti on USP 1 00mg /10 ml / 50 mg/ 5ml / 25 mg/2. 5ml Taj P harma U ses, Side E ffe cts, Atracuri um Besylate Inje ction US P 100 mg/10 ml / 50 mg/5 ml / 25 mg/2. 5ml Taj P harma : I ndicati ons, Side E ffects, Warnings, Atracurium Besylate Inj ection USP 100 mg/1 0ml / 5 0mg/ 5ml / 2 5mg /2.5 ml Taj Phar ma - Drug I nformation - Taj Phar ma, Atracuri um Besylate Inje ction USP 1 00 mg/10 ml / 50 mg/5 ml / 25 mg/2. 5ml Taj P harma dose Taj pharma ceutical s Atracurium Be sylate Injection USP 10 0mg/ 10 ml / 50 mg/5 ml / 25 mg/2.5 ml Taj Phar ma interactions, Taj P harma ceutical Atracurium Besylate Inje ction USP 100 mg/1 0ml / 5 0mg/ 5ml / 2 5mg/ 2.5 ml Ta j
Atracurium Besylate Injection USP recommended in neonates since there are

100mg/10ml / 50mg/5ml / 25mg/2.5ml Taj insufficient data available (see section 5.1).
Pharma can be administered by infusion
Use in the elderly: Atracurium Besylate
during cardiopulmonary bypass surgery at
Injection USP 100mg/10ml / 50mg/5ml /
the recommended infusion rates. Induced
25mg/2.5ml Taj Pharma may be used at
hypothermia to a body temperature of 25° to
standard dosage in elderly patients. It is
26°C reduces the rate of inactivation of
recommended, however, that the initial dose
atracurium, therefore full neuromuscular
be at the lower end of the range and that it be
block may be maintained by approximately
administered slowly.
half the original infusion rate at these low
temperatures. Use in patients with reduced renal and/or
hepatic function: Atracurium Besylate
100mg/10ml / 50mg/5ml / 25mg/2.5ml Taj
25mg/2.5ml Taj Pharma may be used at
Pharma is compatible with the following
standard dosage at all levels of renal or
infusion solutions for the times stated below:
hepatic function, including end stage failure.
Period of Use in patients with cardiovascular disease:
Infusion solution
stability In patients with clinically significant
Sodium Chloride Intravenous cardiovascular disease, the initial dose of
Infusion British Pharmacopoeia 24 hours Atracurium Besylate Injection USP
(BP) (0.9% w/v) 100mg/10ml / 50mg/5ml / 25mg/2.5ml Taj
Glucose Intravenous Infusion BP Pharma should be administered over a
8 hours period of 60 seconds.
(5% w/v)
Ringer's Injection United States Use in intensive care unit (ICU) patients:
8 hours
Pharmacopoeia (USP) After an optional initial bolus dose of
Sodium Chloride (0.18%w/v) Atracurium Besylate Injection USP
and Glucose (4% w/v) 8 hours 100mg/10ml / 50mg/5ml / 25mg/2.5ml Taj
Intravenous Infusion BP Pharma of 0.3 to 0.6 mg/kg, Atracurium
Compound Sodium Lactate
50mg/5ml / 25mg/2.5ml Taj Pharma can be
Intravenous Infusion BP
4 hours used to maintain neuromuscular block by
(Hartmann's Solution for
administering a continuous infusion at rates
Injection)
of between 11 and 13 micrograms/kg/min
When diluted in these solutions to give (0.65 to 0.78 mg/kg/hr). There may be wide
atracurium besilate concentrations of 0.5 inter-patient variability in dosage
mg/ml and above, the resultant solutions will requirements and these may increase or
be stable in daylight for the stated periods at decrease with time. Infusion rates as low as
temperatures of up to 30°C. 4.5 microgram/kg/min (0.27 mg/kg/hr) or as
Use in Children: The dosage in children over high as 29.5 microgram/kg/min (1.77
the age of one month is similar to that in mg/kg/hr) are required in some patients.
adults on a bodyweight basis. The rate of spontaneous recovery from
Use in Neonates: The use of Atracurium neuromuscular block after infusion of
Besylate Injection USP 100mg/10ml / Atracurium Besylate Injection USP
50mg/5ml / 25mg/2.5ml Taj Pharma is not 100mg/10ml / 50mg/5ml / 25mg/2.5ml Taj
Pharma in ICU patients is independent of the Injection USP 100mg/10ml / 50mg/5ml /

duration of administration. 25mg/2.5ml Taj Pharma to patients with a
history suggestive of an increased sensitivity
Spontaneous recovery to a train-of-four ratio
to the effects of histamine. In particular,
>0.75 (the ratio of the height of the fourth to
bronchospasm may occur in patients with a
the first twitch in a train-of-four) can be
history of allergy and asthma.
expected to occur in approximately 60
minutes. A range of 32 to 108 minutes has High rates of cross-sensitivity between
been observed in clinical trials. neuromuscular blocking agents have been
reported. Therefore, where possible, before
Monitoring: In common with all
administering atracurium, hypersensitivity to
neuromuscular blocking agents,
other neuromuscular blocking agents should
monitoring of neuromuscular function is
be excluded. Atracurium should only be used
recommended during the use of
when absolutely essential in susceptible
patients. Patients who experience a
hypersensitivity reaction under general
Pharma in order to individualise dosage
anaesthesia should be tested subsequently for
requirements.
hypersensitivity to other neuromuscular
4.3 Contraindications blockers.
Atracurium is contraindicated in patients
Monitoring of serial creatinine phosphate
known to be hypersensitive to atracurium,
(cpk) values should be considered in
cisatracurium or benzenesulfonic acid.
asthmatic patients receiving high dose
4.4 Special warnings and precautions for corticosteroids and neuromuscular blocking
use agents in ICU.
Precautions: In common with all the other
neuromuscular blocking agents,
Pharma does not have significant vagal or
ganglionic blocking properties in the
Pharma paralyses the respiratory
recommended dosage range. Consequently,
muscles as well as other skeletal muscles
but has no effect on consciousness.
Pharma has no clinically significant effects
on heart rate in the recommended dosage
Pharma should be administered only with
range and it will not counteract the
adequate general anaesthesia and only by
bradycardia produced by many anaesthetic
or under the close supervision of an
agents or by vagal stimulation during
experienced anaesthetist with adequate
surgery.
facilities for endotracheal intubation and
artificial ventilation. In common with other non-depolarising
neuromuscular blocking agents, increased
The potential for histamine release exists in
sensitivity to atracurium may be expected in
susceptible patients during Atracurium
patients with myasthenia gravis and other
forms of neuromuscular disease.
50mg/5ml / 25mg/2.5ml Taj Pharma
administration. Caution should be exercised As with other neuromuscular blocking agents
in administering Atracurium Besylate severe acid-base and/or serum electrolyte
abnormalities may increase or decrease the In common with other non-depolarising

sensitivity of patients to aAtracurium neuromuscular blocking agents, resistance
Besylate Injection USP 100mg/10ml / may develop in patients suffering from burns.
50mg/5ml / 25mg/2.5ml Taj Pharma . Such patients may require increased doses,
dependent on the time elapsed since the burn
As with other non-depolarising
injury and the extent of the burn.
neuromuscular blockers hypophosphataemia
may prolong recovery. Recovery may be Intensive Care Unit (ICU) patients: When
hastened by correcting this condition. administered to laboratory animals in high
doses, Laudanosine, a metabolite of
aAtracurium Besylate Injection USP
Pharma should be administered over a
Pharma has been associated with transient
period of 60 seconds to patients who may be
hypotension and, in some species, cerebral
unusually sensitive to falls in arterial blood
excitatory effects. Although seizures have
pressure, for example those who are
been seen in ICU patients receiving
hypovolaemic.
atracurium, a causal relationship to
Atracurium Besylate Injection USP laudanosine has not been established (see
100mg/10ml / 50mg/5ml / 25mg/2.5ml Taj Undesirable Effects).
Pharma is inactivated by high pH and so
4.5 Interaction with other medicinal
must not be mixed in the same syringe with
products and other forms of interaction
thiopental or any alkaline agent.
The neuromuscular block produced by
When a small vein is selected as the injection Atracurium Besylate Injection USP
site, Atracurium Besylate Injection USP 100mg/10ml / 50mg/5ml / 25mg/2.5ml Taj
100mg/10ml / 50mg/5ml / 25mg/2.5ml Taj Pharma may be increased by the
Pharma should be flushed through the vein concomitant use of inhalational anaesthetics
with physiological saline after injection. such as halothane, isoflurane and enflurane.
When other anaesthetic drugs are
In common with all non-depolarising
administered through the same in-dwelling
neuromuscular blocking agents the
needle or cannula as Atracurium Besylate
magnitude and/or duration of a non-
depolarising neuromuscular block may be
25mg/2.5ml Taj Pharma it is important that
increased as a result of interaction with:
each drug is flushed through with an adequate
volume of physiological saline. Atracurium - antibiotics, including the aminoglycosides,
besilate is hypotonic and must not be polymyxins, spectinomycin, tetracyclines,
administered into the infusion line of a blood lincomycin and clindamycin
transfusion.
- anti-arrhythmic drugs: propranolol, calcium
Studies in malignant hyperthermia in channel blockers, lidocaine, procainamide
susceptible animals (swine), and clinical and quinidine
studies in patients susceptible to malignant
- diuretics: furosemide and possibly
hypothermia indicate that Atracurium
mannitol, thiazide diuretics and
acetazolamide
50mg/5ml / 25mg/2.5ml Taj Pharma does
not trigger this syndrome. - magnesium sulfate
- ketamine Treatment with anticholinesterases,

commonly used in the treatment of
- lithium salts
Alzheimer's disease e.g. donepezil, may
- ganglion blocking agents, trimetaphan, shorten the duration and diminish the
hexamethonium. magnitude of neuromuscular blockade with
atracurium.
Rarely certain drugs may aggravate or
unmask latent myasthenia gravis or actually 4.6 Fertility, pregnancy and lactation
induce a myasthenic syndrome; increased Fertility
sensitivity to Atracurium Besylate Injection
Fertility studies have not been performed
USP 100mg/10ml / 50mg/5ml / 25mg/2.5ml
Taj Pharma would be consequent on such a Pregnancy
development. Such drugs include various
Animal studies have indicated that
antibiotics, β-blockers (propranolol,
oxprenolol), antiarrhythmic drugs
(procainamide, quinidine), antirheumatic
Pharma has no significant effects on foetal
drugs (chloroquine, D-penicillamine),
development.
trimetaphan, chlorpromazine, steroids,
phenytoin and lithium. In common with all neuromuscular blocking
agents, Atracurium Besylate Injection USP
The onset of non-depolarising neuromuscular
block is likely to be lengthened and the
Pharma should be used during pregnancy
duration of block shortened in patients
only if the potential benefit to the mother
receiving chronic anticonvulsant therapy.
outweighs any potential risk to the foetus.
The administration of combinations of non-
depolarising neuromuscular blocking agents
in conjunction with Atracurium Besylate
Pharma is suitable for maintenance of
muscle relaxation during Caesarean section
25mg/2.5ml Taj Pharma may produce a
as it does not cross the placenta in clinically
degree of neuromuscular blockage in excess
significant amounts following recommended
of that which might be expected were an
doses.
equipotent total dose of Atracurium Besylate
Injection USP 100mg/10ml / 50mg/5ml / Breast-feeding
25mg/2.5ml Taj Pharma administered. Any
It is not known whether Atracurium Besylate
synergistic effect may vary between different
drug combinations.
25mg/2.5ml Taj Pharma is excreted in
A depolarising muscle relaxant such as human milk.
suxamethonium chloride should not be
4.7 Effects on ability to drive and use
administered to prolong the neuromuscular
machines
blocking effects of non-depolarising
This precaution is not relevant to the use of
blocking agents such as atracurium, as this
atracurium. Atracurium will always be used
may result in a prolonged and complex block
in combination with a general anaesthetic and
which can be difficult to reverse with
therefore the usual precautions relating to
anticholinesterase drugs.
performance of tasks following general
anaesthesia apply.
4.8 Undesirable effects Not Seizures

The most commonly reported adverse known
reactions during treatment are hypotension There have been reports of seizures in ICU
(mild, transient) and skin flushing, these patients who have been receiving atracurium
events are attributed to histamine release. concurrently with several other agents.
Very rarely, severe anaphylactoid or These patients usually had one or more
anaphylactic reactions have been reported in medical conditions predisposing to seizures
patients receiving atracurium in conjunction (e.g. cranial trauma, cerebral oedema, viral
with one or more anaesthetic agents. encephalitis, hypoxic encephalopathy,
Adverse reactions are listed below by system uraemia). A causal relationship to
organ class and frequency. Frequencies are laudanosine has not been established. In
defined as: very common > 1/10, common clinical trials, there appears to be no
>1/100 and < 1/10, uncommon >1/1000 and correlation between plasma laudanosine
< 1/100, rare >1/10,000 and < 1/1000, very concentration and the occurrence of
rare < 1/10,000. seizures.
Very common, common and uncommon Skin and subcutaneous tissue disorders
frequencies were determined from clinical Rare Urticaria
trial data. Rare and very rare frequencies Musculoskeletal and connective tissue
were generally derived from spontaneous disorders
data. The frequency classification "Not
Not Myopathy, muscle weakness
known" has been applied to those reactions
known
where a frequency could not be estimated
from the available data. There have been some reports of muscle
weakness and/or myopathy following
Clinical Trial Data prolonged use of muscle relaxants in
severely ill patients in the ICU. Most
Vascular Disorders
patients were receiving concomitant
Common Hypotension (mild, transient)#, corticosteroids. These events have been seen
Skin flushing# infrequently in association with atracurium
Respiratory, thoracic and mediastinal and a causal relationship has not been
disorders established.
Uncommon Bronchospasm# Events which have been attributed to
Post-Marketing Data histamine release are indicated by a hash (#)
Reporting of suspected adverse reactions
Immune system disorders
Very Anaphylactic reaction, Reporting suspected adverse reactions after
rare anaphylactoid reaction including authorisation of the medicinal product is
shock, circulatory failure and important.
cardiac arrest 4.9 Overdose
Very rarely, severe anaphylactoid or Symptoms: Prolonged muscle paralysis and
anaphylactic reactions have been reported in its consequences are the main signs of
patients receiving atracurium in conjunction overdosage.
with one or more anaesthetic agents.
Nervous system disorder
Management: It is essential to maintain a produces breakdown products which are

patient airway together with assisted positive inactive. Degradation also occurs by ester
pressure ventilation until spontaneous hydrolysis catalysed by non-specific
respiration is adequate. Full sedation will be esterases. Elimination of atracurium is not
required since consciousness is not impaired. dependent on kidney or liver function.
Recovery may be hastened by the
The main breakdown products are
administration of anticholinesterase agents
laudanosine and a monoquaternary alcohol
accompanied by atropine or glycopyrrolate,
which have no neuromuscular blocking
once evidence of spontaneous recovery is
activity. The monoquaternary alcohol is
present.
degraded spontaneously by hofmann
5. PHARMACOLOGICAL elimination and excreted by the kidney.
PROPERTIES Laudanosine is excreted by the kidney and
metabolised by the liver. The half-life of
5.1 Pharmacodynamic properties
laudanosine ranges from 3-6h in patients with
Pharmacotherapeutic group: Peripherally
normal kidney and liver function. It is about
acting muscle relaxants: Other quaternary
15h in renal failure and is about 40h in renal
ammonium compounds.
and hepatic failure. Peak plasma levels of
Atracurium is a highly selective competitive laudanosine are highest in patients without
(non-depolarising) neuromuscular blocking kidney or liver function and average 4 μg/ml
agent with an intermediate duration of action. with wide variation.
Non-depolarising agents antagonise the
Concentration of metabolites are higher in
neurotransmitter action of acetylcholine by
ICU patients with abnormal renal and/or
binding with receptor sites on the motor-end-
hepatic function (see Special Warnings and
plate. Atracurium can be used in a wide range
Special Precautions for Use). These
of surgical procedures and to facilitate
metabolites do not contribute to
controlled ventilation.
neuromuscular block.
Paediatric population:
5.3 Preclinical safety data
The limited data in neonates from literature Carcinogenicity: Carcinogenicity studies
reports suggest variability in the time to onset have not been performed.
and duration of action of atracurium in this
There are no pre-clinical data of relevance to
population as compared to children (see
the prescriber which are additional to that
section 4.2).
already included in other sections of the
5.2 Pharmacokinetic properties SmPC.
The pharmacokinetics of Atracurium in man
6. PHARMACEUTICAL
are essentially linear with the 0.3-0.6 mg/kg
PARTICULARS
dose range. The elimination half-life is
approximately 20 minutes, and the volume of 6.1 List of excipients
distribution is 0.16 L/kg. Atracurium is 82% Benzene Sulfonic acid, Water for Injections
bound to plasma proteins.
6.2 Incompatibilities
Atracurium is degraded spontaneously None
mainly by a non-enzymatic decomposition
6.3 Shelf life
process (Hofmann elimination) which occurs
24 months
at plasma pH and at body temperature and
6.4 Special precautions for storage

Store at temperatures between 2 and 8°C. Do
not freeze. Keep container in the outer carton
in order to protect from light.
Any unused Atracurium Besylate Injection
USP 100mg/10ml / 50mg/5ml / 25mg/2.5ml
Taj Pharma from opened ampoules or vials
should be discarded.
6.5 Nature and contents of container
Neutral glass ampoules or vials. Vials are
closed with a rubber stopper, sealed with an
aluminium collar and fitted with a plastic
flip-off top. Pack sizes: Boxes of 5 x 2.5 ml
ampoules, 5 x 5 ml ampoules and 2 x 25 ml
vials.
6.6 Special precautions for disposal and
other handling
None
7. MANUFACTURED IN INDIA BY:
TAJ PHARMACEUTICALS LTD.

Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai - 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-
800-222-825)
Monday through Saturday 9:00 a.m. to 7:00
p.m. EST
E-mail: tajgroup@tajpharma.com

Atricurium Besylate Injection USP Taj Pharma SMPC

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Atricurium Besylate Injection USP Taj Pharma SMPC

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Atracurium Besylate Inje ction US P 100 mg/10 ml / 50 mg/5 ml / 25 mg/2 .

ATRACURIUM BESYLATE 4.2 Posology and method of administration

Atracurium Besylate Injection USP recommended in neonates since there are

Pharma in ICU patients is independent of the Injection USP 100mg/10ml / 50mg/5ml /

abnormalities may increase or decrease the In common with other non-depolarising

- ketamine Treatment with anticholinesterases,

4.8 Undesirable effects Not Seizures

Management: It is essential to maintain a produces breakdown products which are

6.4 Special precautions for storage

7. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.

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