bhpardo/ema_en · Datasets at Hugging Face

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European Medicines Agency
4.3 Contraindications
Common
avamys
M05BB03.
Ελλάδα Roche (Hellas) A. E.
3.
In reproductive toxicology studies in which animals were administered entecavir for up to 4 weeks, no evidence of impaired fertility was seen in male or female rats at high exposures.
Although specific interactions have not been studied, other protease inhibitors, such as saquinavir, and other CYP3A4 inhibitors, such as erythromycin, clarithromycin, itraconazole and grapefruit juice should be co-administered with caution as they would be expected to increase plasma concentrations of tadalafil (see section 4.4).
These symptoms can constitute an early
analyse leakage; see Important information about BEROMUN, below)
Less commonly patients have reported infections, strange taste, cataracts, bundle branch block, tooth disorder, skin problems, aching joints, arthritis, and thirst.
Renal impairment:
0.5 ml
INSTRUCTIONS ON USE
For a recovery 0.7 IU/ dl (average increase of factor IX), then:
Monitoring of cardiac and vital signs is recommended, along with appropriate symptomatic and supportive measures.
100 unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
- muscle stiffness (hypertonia), painful muscles (myalgia), muscular debility (myasthenia), back
Tel: + 420 222 001 111 gsk.czmail@gsk.com
Tardive Dyskinesia: in clinical trials of one year or less duration, there were uncommon reports of treatment emergent dyskinesia during treatment with aripiprazole.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
LIST OF EXCIPIENTS
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients
Insulin glulisine
10 mg
One vial of 5 ml contains 250 micrograms of palonosetron 50 micrograms/ ml (as hydrochloride)
Treatment of diabetes mellitus.
Following any confirmed or suspected overdose with aripiprazole, close medical supervision and monitoring should continue until the patient recovers.
Steady-state plasma concentrations are attained within 3 days after initiation of a once-daily dosing regimen.
Development of inhibitors is a known complication in the treatment of haemophilia A.
Slovenská republika GlaxoSmithKline Slovakia s. r. o.
8.
EXP:
NAME OF THE MEDICINAL PRODUCT
Blood uric acid levels were measured every month.
Half-life was also similar between adult and paediatric patients with CRF following both intravenous and subcutaneous administration.
4.4 Special warnings and precautions for use
You get a hypo if your blood sugar gets too low.
DK-2900 Hellerup Tlf: +45-35 25 35 50
Reproduction is authorised provided the source is acknowledged.
Paediatric patients
8
NAME OF THE MEDICINAL PRODUCT
The Committee recommended that Cancidas be given marketing authorisation.
15 January 2006
In infants and toddlers aged 6 to 23 months, the most frequent adverse events reported in excess of placebo were diarrhoea (3.7%), fever (2.3%) and insomnia (2.3%).
Ireland Biogen Idec (Ireland) Ltd. +353 (0)1 463 7799
15.
METHOD AND ROUTE(S) OF ADMINISTRATION
In paediatric patients the recommended target haemoglobin range is between 9.5 and 11 g/ dl (5.9 - 6.8 mmol/ l).
(7.8 - 10.7)
Common side effects are heartburn, indigestion, diarrhoea, stomach ache, nausea and flatulence.
Hb between 9.5 and 11 g/ dl (5.9 - 6.8 mmol/ l).
Subcutaneous tolerance studies indicate that Caelyx, as against standard doxorubicin hydrochloride, causes slighter local irritation or damage to the tissue after a possible extravasation.
Please discuss this with your doctor.
Due to its increased carbohydrate content darbepoetin alfa has a longer terminal half-life than r-HuEPO and consequently a greater
60 avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dl (7.5 mmol/ l) are observed are described below.
Myocardial Ischaemia The available data indicate that treatment with rosiglitazone may be associated with an increased risk of myocardial ischaemic events (see section 4.8).
If you are receiving this medicine by subcutaneous injection, your doctor may suggest that you learn how to give yourself the injections.
Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement (see sections 4.8 and 4.9).
If the patient is already receiving nonsteroidal anti-inflammatory drugs (NSAIDs) and/ or corticosteroids, these may be continued after starting leflunomide.
Its levels in the blood normally increase after the onset of darkness and peak in the middle of the night to promote sleep.
Arthralgia Myalgia Back pain General System disorders
EU/ 1/ 08/ 450/ 007
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
What is Avandia?
4.2 Posology and method of administration
STATEMENT OF ACTIVE SUBSTANCE(S)
What ABILIFY contains The active substance is aripiprazole.
Azomyr 0.5 mg/ ml oral solution desloratadine
4.
6.
Therefore this combination is not recommended (see section 4.4).
A short alpha-phase occurs immediately post-infusion, followed by a beta-phase with a half- life of 9 to 11 hours.
Calcium containing solutions should not be mixed with Bondronat concentrate for solution for infusion.
Tell your doctor if you are or think you may be pregnant or if you are breast-feeding.
A.
Such conditions should be corrected before the administration of Aprovel.
alli 60 mg hard capsules:
METHOD AND ROUTE(S) OF ADMINISTRATION
30 film-coated tablets 60 film-coated tablets 90 film-coated tablets Multipack containing 180 (2 packs of 90) film-coated tablets
Azomyr 2.5 mg orodispersible tablets desloratadine
Tell your doctor or pharmacist if you feel discomfort when using the spray.
Preliminary information suggests a relationship may exist between the presence of major deletion mutations in a patient's factor IX gene and an increased risk of inhibitor formation and of acute hypersensitivity reactions.
GlaxoSmithKline Biologicals s.a.
Common:
IMPORTANT INFORMATION ABOUT YOUR BYETTA PEN
Cartons of 56 x 1 film-coated tablet; 7 blister cards of 8 x 1 film-coated tablet each in PVC/ PVDC/ Aluminium perforated unit dose blisters.
15.
This regimen reduced the occurrence of new radiographic vertebral fractures by 62% (p=0.0001) over the three year duration of the study.
Children and adolescents:
Agitation, confusional state, depression, anxiety, thinking abnormal, insomnia
Treatment:
LIST OF EXCIPIENTS
75 14.
In a study in which leflunomide was given concomitantly with a triphasic oral contraceptive pill containing 30 µg ethinyloestradiol to healthy female volunteers, there was no reduction in contraceptive activity of the pill, and A771726 pharmacokinetics were within predicted ranges.
For preventing recurrence of manic episodes in patients who have been receiving aripiprazole, continue therapy at the same dose.
Disorders of the nerves and senses such as convulsions, tremor, dizziness, depression, drowsiness, numbness, muscle spasms, anxiety, changes in thinking or mood.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

European Medicines Agency

4.3 Contraindications

Common

avamys

M05BB03.

Ελλάδα Roche (Hellas) A. E.

3.

In reproductive toxicology studies in which animals were administered entecavir for up to 4 weeks, no evidence of impaired fertility was seen in male or female rats at high exposures.

Although specific interactions have not been studied, other protease inhibitors, such as saquinavir, and other CYP3A4 inhibitors, such as erythromycin, clarithromycin, itraconazole and grapefruit juice should be co-administered with caution as they would be expected to increase plasma concentrations of tadalafil (see section 4.4).

These symptoms can constitute an early

analyse leakage; see Important information about BEROMUN, below)

Less commonly patients have reported infections, strange taste, cataracts, bundle branch block, tooth disorder, skin problems, aching joints, arthritis, and thirst.

Renal impairment:

0.5 ml

INSTRUCTIONS ON USE

For a recovery 0.7 IU/ dl (average increase of factor IX), then:

Monitoring of cardiac and vital signs is recommended, along with appropriate symptomatic and supportive measures.

100 unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.

- muscle stiffness (hypertonia), painful muscles (myalgia), muscular debility (myasthenia), back

Tel: + 420 222 001 111 gsk.czmail@gsk.com

Tardive Dyskinesia: in clinical trials of one year or less duration, there were uncommon reports of treatment emergent dyskinesia during treatment with aripiprazole.

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

LIST OF EXCIPIENTS

Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients

Insulin glulisine

10 mg

One vial of 5 ml contains 250 micrograms of palonosetron 50 micrograms/ ml (as hydrochloride)

Treatment of diabetes mellitus.

Following any confirmed or suspected overdose with aripiprazole, close medical supervision and monitoring should continue until the patient recovers.

Steady-state plasma concentrations are attained within 3 days after initiation of a once-daily dosing regimen.

Development of inhibitors is a known complication in the treatment of haemophilia A.

Slovenská republika GlaxoSmithKline Slovakia s. r. o.

8.

EXP:

NAME OF THE MEDICINAL PRODUCT

Blood uric acid levels were measured every month.

Half-life was also similar between adult and paediatric patients with CRF following both intravenous and subcutaneous administration.

4.4 Special warnings and precautions for use

You get a hypo if your blood sugar gets too low.

DK-2900 Hellerup Tlf: +45-35 25 35 50

Reproduction is authorised provided the source is acknowledged.

Paediatric patients

8

NAME OF THE MEDICINAL PRODUCT

The Committee recommended that Cancidas be given marketing authorisation.

15 January 2006

In infants and toddlers aged 6 to 23 months, the most frequent adverse events reported in excess of placebo were diarrhoea (3.7%), fever (2.3%) and insomnia (2.3%).

Ireland Biogen Idec (Ireland) Ltd. +353 (0)1 463 7799

15.

METHOD AND ROUTE(S) OF ADMINISTRATION

In paediatric patients the recommended target haemoglobin range is between 9.5 and 11 g/ dl (5.9 - 6.8 mmol/ l).

(7.8 - 10.7)

Common side effects are heartburn, indigestion, diarrhoea, stomach ache, nausea and flatulence.

Hb between 9.5 and 11 g/ dl (5.9 - 6.8 mmol/ l).

Subcutaneous tolerance studies indicate that Caelyx, as against standard doxorubicin hydrochloride, causes slighter local irritation or damage to the tissue after a possible extravasation.

Please discuss this with your doctor.

Due to its increased carbohydrate content darbepoetin alfa has a longer terminal half-life than r-HuEPO and consequently a greater

60 avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dl (7.5 mmol/ l) are observed are described below.

Myocardial Ischaemia The available data indicate that treatment with rosiglitazone may be associated with an increased risk of myocardial ischaemic events (see section 4.8).

If you are receiving this medicine by subcutaneous injection, your doctor may suggest that you learn how to give yourself the injections.

Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement (see sections 4.8 and 4.9).

If the patient is already receiving nonsteroidal anti-inflammatory drugs (NSAIDs) and/ or corticosteroids, these may be continued after starting leflunomide.

Its levels in the blood normally increase after the onset of darkness and peak in the middle of the night to promote sleep.

Arthralgia Myalgia Back pain General System disorders

EU/ 1/ 08/ 450/ 007

DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION

What is Avandia?

4.2 Posology and method of administration

STATEMENT OF ACTIVE SUBSTANCE(S)

What ABILIFY contains The active substance is aripiprazole.

Azomyr 0.5 mg/ ml oral solution desloratadine

4.

6.

Therefore this combination is not recommended (see section 4.4).

A short alpha-phase occurs immediately post-infusion, followed by a beta-phase with a half- life of 9 to 11 hours.

Calcium containing solutions should not be mixed with Bondronat concentrate for solution for infusion.

Tell your doctor if you are or think you may be pregnant or if you are breast-feeding.

A.

Such conditions should be corrected before the administration of Aprovel.

alli 60 mg hard capsules:

METHOD AND ROUTE(S) OF ADMINISTRATION

30 film-coated tablets 60 film-coated tablets 90 film-coated tablets Multipack containing 180 (2 packs of 90) film-coated tablets

Azomyr 2.5 mg orodispersible tablets desloratadine

Tell your doctor or pharmacist if you feel discomfort when using the spray.

Preliminary information suggests a relationship may exist between the presence of major deletion mutations in a patient's factor IX gene and an increased risk of inhibitor formation and of acute hypersensitivity reactions.

GlaxoSmithKline Biologicals s.a.

Common:

IMPORTANT INFORMATION ABOUT YOUR BYETTA PEN

Cartons of 56 x 1 film-coated tablet; 7 blister cards of 8 x 1 film-coated tablet each in PVC/ PVDC/ Aluminium perforated unit dose blisters.

15.

This regimen reduced the occurrence of new radiographic vertebral fractures by 62% (p=0.0001) over the three year duration of the study.

Children and adolescents:

Agitation, confusional state, depression, anxiety, thinking abnormal, insomnia

Treatment:

LIST OF EXCIPIENTS

75 14.

In a study in which leflunomide was given concomitantly with a triphasic oral contraceptive pill containing 30 µg ethinyloestradiol to healthy female volunteers, there was no reduction in contraceptive activity of the pill, and A771726 pharmacokinetics were within predicted ranges.

For preventing recurrence of manic episodes in patients who have been receiving aripiprazole, continue therapy at the same dose.

Disorders of the nerves and senses such as convulsions, tremor, dizziness, depression, drowsiness, numbness, muscle spasms, anxiety, changes in thinking or mood.

CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT