bhpardo/ema_en · Datasets at Hugging Face

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It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
49% (14.03, 69.49)
Combining ARICLAIM with a pelvic floor muscle training (PFMT) program may be more effective than either treatment alone.
Further information
A dose of 23 mg sodium is considered essentially ‘ sodium- free’.
Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician´s evaluation of the individual patient´s clinical course and condition is necessary.
If an elevated (or rising) serum potassium level is detected then consideration should be given to ceasing epoetin alfa administration until hyperkalaemia has been corrected.
Long-term carcinogenicity studies have not been carried out.
Packaging Tablet container Tablet container Tablet container
Alternatively, epoetin alfa can be administered at an initial dose of 450 IU/ kg subcutaneously once weekly.
Because the use of BeneFIX by continuous infusion has not been evaluated, BeneFIX should not be mixed with infusion solutions or be given in a drip.
Betaferon 250 microgram/ ml, Powder and solvent for solution for injection Interferon beta-1b
Nonacog alfa is a purified protein that has 415 amino acids in a single chain.
Gastrointestinal effects were observed in the dog at systemic exposure levels equivalent to or less than the clinical exposure at the recommended dose.
Skin and subcutaneous tissue disorders:
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Aripiprazole exhibited high binding affinity in vitro for dopamine D2 and D3, serotonin 5HT1a and 5HT2a receptors and moderate affinity for dopamine D4, serotonin 5HT2c and 5HT7, alpha-1 adrenergic and histamine H1 receptors.
METHOD AND ROUTE(S) OF ADMINISTRATION
9.
Vaccination with Ambirix should be postponed in patients with a severe sudden fever.
Your doctor will normally direct that Agenerase capsules should be taken with low doses of ritonavir to boost its efficacy.
4.
80 – 100 (pre - and pos toperative)
MARKETING AUTHORISATION HOLDER
Intracellular ara-GTP concentrations in leukaemic blasts were quantifiable for a prolonged period after nelarabine administration.
When duloxetine was administered at a dose of 60 mg twice daily with a single dose of desipramine, a CYP2D6 substrate, the AUC of desipramine increased 3-fold.
► If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands ► If you are drinking alcohol: watch for signs of a hypo and never drink alcohol on an empty stomach ► If you are exercising more than usual or if you want to change your usual diet ► If you are ill: carry on taking your insulin ► If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections.
Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Additional caution should be exercised with any co-medication which has an effect on the haematopoetic system.
The inter-subject variability was large, with a 7-fold difference in unbound AUC between patients.
Darbepoetin alfa stimulates erythropoiesis by the same mechanism as the endogenous hormone.
Eesti Roche Eesti OÜ Tel: + 372 - 6 177 380
Binocrit 8000 IU/ 0.8 ml solution for injection in a pre-filled syringe
Taking ABILIFY with food and drink ABILIFY can be taken regardless of meals.
For oral use.
Patients
Vascular disorders
Available data indicates that there may be an increased risk of spontaneous abortion.
Method of Administration:
Constipation
Do not freeze.
Population pharmacokinetic data (in the range of creatinine clearance tested of 30 - 156 ml/ min) demonstrate that Caelyx clearance is not influenced by renal function.
(34.8 - 48.1)
L01AB01.
BATCH NUMBER
HOW TO USE ARIXTRA
Marketing Authorisation Holder
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI:
Abseamed 8000 IU/ 0.8 ml injection
- increased risk of death when administered to target a haemoglobin of 12 g/ dl (7.5 mmol/ l) in
EXPIRY DATE
Nervous system disorders
INFORMATION IN BRAILLE
Grade All
Distribution:
This summary was last updated in 06-2008.
There is no information on the use of CELVAPAN below 18 years of age.
SmithKline Beecham plc 980 Great West Road Brentford, Middlesex TW8 9GS United Kingdom
Distribution The mean volume of distribution is approximately 63 l, indicating that tadalafil is distributed into tissues.
Like all medicines, Aldara cream can cause side effects, although not everybody gets them.
Adverse reactions were determined based on pooled data from seven randomised, double-blind, placebo-controlled studies of Aranesp with a total of 2112 patients (Aranesp 1200, placebo 912).
Content
There should be at least 14 days between stopping treatment with AZILECT and starting treatment with another monoamine oxidase inhibitor or with pethidine.
However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines.
DATE OF REVISION OF THE TEXT
Glycaemic control should be monitored closely.
Dialysis prescriptions may have to be adjusted periodically to maintain urea, creatinine and potassium in the desired range.
Not applicable.
Each film-coated tablet contains 300 mg of maraviroc.
Suspension for injection
Do not freeze.
Azomyr 0.5 mg/ ml oral solution desloratadine
6.3 Shelf life
Rare: post-operative infection
INSTRUCTIONS ON USE
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
To date, no adverse reactions reported in association with BeneFIX occurred with a frequency of ≥ 1/ 100 to < 1/ 10 (common).
It may harm them even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Clinical trials have shown a low but increased risk of guiding catheter thrombus in patients treated with fondaparinux for anticoagulation during PCI compared to control.
The dosage of Apidra should be individually adjusted.
United Kingdom GlaxoSmithKline UK Tel: + 44 (0)800 221441 customercontactuk@gsk. com
– The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
An increase in dose of a particular blood-thinning medicine (heparin) during haemodialysis is frequently required during the course of therapy with Binocrit.
79 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
EU/ 1/ 04/ 276/ 016
In order to ensure optimum response to epoetin alfa, adequate iron stores should be assured:
Your doctor will normally advise you to stop taking Aprovel as soon as you know you are pregnant.
The solution should be discarded if particulate matter is visible.
Tel: + 39 06 50 39 61
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Patients with Heparin Induced Thrombocytopenia Fondaparinux should be used with caution in patients with a history of HIT.
Common Uncommon
- possible new health risks in the countries to be visited,
Powder and solvent for
Manufacturer
Natural interferon beta and AVONEX (interferon beta-1a) are glycosylated and have a single N-linked complex carbohydrate moiety.
For a full list of excipients, see section 6.1.
Active liver disease was an exclusion criteria in all studies of Aranesp, therefore no data are available from patients with impaired liver function.
4 A probable case of toxic reaction to AMMONAPS (450 mg/ kg/ d) was reported in an 18-year old anorectic female patient who developed a metabolic encephalopathy associated with lactic acidosis, severe hypokalaemia, pancytopaenia, peripheral neuropathy, and pancreatitis.
STATEMENT OF ACTIVE SUBSTANCE(S)

It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

49% (14.03, 69.49)

Combining ARICLAIM with a pelvic floor muscle training (PFMT) program may be more effective than either treatment alone.

Further information

A dose of 23 mg sodium is considered essentially ‘ sodium- free’.

Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician´s evaluation of the individual patient´s clinical course and condition is necessary.

If an elevated (or rising) serum potassium level is detected then consideration should be given to ceasing epoetin alfa administration until hyperkalaemia has been corrected.

Long-term carcinogenicity studies have not been carried out.

Packaging Tablet container Tablet container Tablet container

Alternatively, epoetin alfa can be administered at an initial dose of 450 IU/ kg subcutaneously once weekly.

Because the use of BeneFIX by continuous infusion has not been evaluated, BeneFIX should not be mixed with infusion solutions or be given in a drip.

Betaferon 250 microgram/ ml, Powder and solvent for solution for injection Interferon beta-1b

Nonacog alfa is a purified protein that has 415 amino acids in a single chain.

Gastrointestinal effects were observed in the dog at systemic exposure levels equivalent to or less than the clinical exposure at the recommended dose.

Skin and subcutaneous tissue disorders:

7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.

Aripiprazole exhibited high binding affinity in vitro for dopamine D2 and D3, serotonin 5HT1a and 5HT2a receptors and moderate affinity for dopamine D4, serotonin 5HT2c and 5HT7, alpha-1 adrenergic and histamine H1 receptors.

METHOD AND ROUTE(S) OF ADMINISTRATION

9.

Vaccination with Ambirix should be postponed in patients with a severe sudden fever.

Your doctor will normally direct that Agenerase capsules should be taken with low doses of ritonavir to boost its efficacy.

4.

80 – 100 (pre - and pos toperative)

MARKETING AUTHORISATION HOLDER

Intracellular ara-GTP concentrations in leukaemic blasts were quantifiable for a prolonged period after nelarabine administration.

When duloxetine was administered at a dose of 60 mg twice daily with a single dose of desipramine, a CYP2D6 substrate, the AUC of desipramine increased 3-fold.

► If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands ► If you are drinking alcohol: watch for signs of a hypo and never drink alcohol on an empty stomach ► If you are exercising more than usual or if you want to change your usual diet ► If you are ill: carry on taking your insulin ► If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections.

Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).

Additional caution should be exercised with any co-medication which has an effect on the haematopoetic system.

The inter-subject variability was large, with a 7-fold difference in unbound AUC between patients.

Darbepoetin alfa stimulates erythropoiesis by the same mechanism as the endogenous hormone.

Eesti Roche Eesti OÜ Tel: + 372 - 6 177 380

Binocrit 8000 IU/ 0.8 ml solution for injection in a pre-filled syringe

Taking ABILIFY with food and drink ABILIFY can be taken regardless of meals.

For oral use.

Patients

Vascular disorders

Available data indicates that there may be an increased risk of spontaneous abortion.

Method of Administration:

Constipation

Do not freeze.

Population pharmacokinetic data (in the range of creatinine clearance tested of 30 - 156 ml/ min) demonstrate that Caelyx clearance is not influenced by renal function.

(34.8 - 48.1)

L01AB01.

BATCH NUMBER

HOW TO USE ARIXTRA

Marketing Authorisation Holder

Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI:

Abseamed 8000 IU/ 0.8 ml injection

- increased risk of death when administered to target a haemoglobin of 12 g/ dl (7.5 mmol/ l) in

EXPIRY DATE

Nervous system disorders

INFORMATION IN BRAILLE

Grade All

Distribution:

This summary was last updated in 06-2008.

There is no information on the use of CELVAPAN below 18 years of age.

SmithKline Beecham plc 980 Great West Road Brentford, Middlesex TW8 9GS United Kingdom

Distribution The mean volume of distribution is approximately 63 l, indicating that tadalafil is distributed into tissues.

Like all medicines, Aldara cream can cause side effects, although not everybody gets them.

Adverse reactions were determined based on pooled data from seven randomised, double-blind, placebo-controlled studies of Aranesp with a total of 2112 patients (Aranesp 1200, placebo 912).

Content

There should be at least 14 days between stopping treatment with AZILECT and starting treatment with another monoamine oxidase inhibitor or with pethidine.

However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines.

DATE OF REVISION OF THE TEXT

Glycaemic control should be monitored closely.

Dialysis prescriptions may have to be adjusted periodically to maintain urea, creatinine and potassium in the desired range.

Not applicable.

Each film-coated tablet contains 300 mg of maraviroc.

Suspension for injection

Do not freeze.

Azomyr 0.5 mg/ ml oral solution desloratadine

6.3 Shelf life

Rare: post-operative infection

INSTRUCTIONS ON USE

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

To date, no adverse reactions reported in association with BeneFIX occurred with a frequency of ≥ 1/ 100 to < 1/ 10 (common).

It may harm them even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Clinical trials have shown a low but increased risk of guiding catheter thrombus in patients treated with fondaparinux for anticoagulation during PCI compared to control.

The dosage of Apidra should be individually adjusted.

United Kingdom GlaxoSmithKline UK Tel: + 44 (0)800 221441 customercontactuk@gsk. com

– The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.

An increase in dose of a particular blood-thinning medicine (heparin) during haemodialysis is frequently required during the course of therapy with Binocrit.

79 PARTICULARS TO APPEAR ON THE OUTER PACKAGING

EU/ 1/ 04/ 276/ 016

In order to ensure optimum response to epoetin alfa, adequate iron stores should be assured:

Your doctor will normally advise you to stop taking Aprovel as soon as you know you are pregnant.

The solution should be discarded if particulate matter is visible.

Tel: + 39 06 50 39 61

CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

Patients with Heparin Induced Thrombocytopenia Fondaparinux should be used with caution in patients with a history of HIT.

Common Uncommon

- possible new health risks in the countries to be visited,

Powder and solvent for

Manufacturer

Natural interferon beta and AVONEX (interferon beta-1a) are glycosylated and have a single N-linked complex carbohydrate moiety.

For a full list of excipients, see section 6.1.

Active liver disease was an exclusion criteria in all studies of Aranesp, therefore no data are available from patients with impaired liver function.

4 A probable case of toxic reaction to AMMONAPS (450 mg/ kg/ d) was reported in an 18-year old anorectic female patient who developed a metabolic encephalopathy associated with lactic acidosis, severe hypokalaemia, pancytopaenia, peripheral neuropathy, and pancreatitis.

STATEMENT OF ACTIVE SUBSTANCE(S)